| |||||||||||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
 |
| ||||||||||||||||||||||||||||||||||||
 |
|||||||||||||||||||||||||||||||||||||
|
Vol. 137, No. 38 — September 20, 2003 Regulations Amending the Income Tax Regulations (Federal Crown Corporations)Statutory Authority Income Tax Act Sponsoring Department Department of Finance REGULATORY IMPACT Description Paragraph 149(1)(d) of the Income Tax Act (the Act) exempts federal Crown corporations from tax under Part I of the Act. Section 27 of the Act provides an exception to this exemption: a federal Crown corporation is taxable if it is prescribed by section 7100 of the Income Tax Regulations (the Regulations), or is controlled by any such corporation. Whether a corporation is a prescribed federal Crown corporation is also relevant for the purposes of the definition "private corporation" in subsection 89(1), the definition "long-term debt" in subsection 181(1), and subsection 124(3) of the Act. The amendments to Regulation 7100 effect five things. First, they clarify that the section applies for the purposes of the definition "private corporation", effective July 14, 1990. Second, they remove the reference to Canada Development Investment Corporation (CDIC) from the list of prescribed — and thus taxable — federal Crown corporations, effective from the date this corporation was mandated to wind up its operations (January 3, 1995). CDIC has not competed with private sector entities since that date. Consequential to the removal of CDIC from the list in section 7100, Canada Hibernia Holding Corporation (CHHC) and Theratronics International Limited (Theratronics) are added to the list, effective as of CDIC's removal. This is necessary to ensure that neither corporation, both of which compete with private sector companies and were wholly owned subsidiaries of CDIC, loses its tax status as a result of CDIC's change in status. However, Theratronics was privatized on May 20, 1998, and thus it will be removed from the list, effective May 21, 1998. Third, the amendments also remove the federal Crown corporation Farm Credit Canada (FCC) from the list of prescribed federal Crown corporations, applicable to taxation years that begin after December 10, 2001. FCC provides specialized financial services to farming operations, and is Canada's largest lender to primary producers and small- to medium-sized agribusinesses. This amendment will place FCC on the same footing for the purposes of federal taxes as Export Development Corporation and the Business Development Bank, both of which are federal Crown corporations that provide specialized financial services and are not prescribed under section 7100. Fourth, the final version of section 7100 effects the following miscellaneous program amendments: the removal of the references to "Teleglobe Canada" (since the federal government divested itself of that corporation on July 29, 1993), to "The St. Lawrence Seaway Authority" (reflecting its December 1, 1998 dissolution under section 96 of the Canada Marine Act, S.C. 1998, c. 10), and to "Petro Canada" (since that corporation is no longer a Crown corporation); and an update of the drafting style of the section. Fifth, a coordinating amendment provides for the possibility that the name of VIA Rail Canada Inc., which is currently listed as a prescribed federal Crown corporation, will be changed to "VIA Rail Canada" prior to the date on which the amendments are published in Part II of the Canada Gazette. Alternatives No alternatives were considered. Benefits and Costs As a result of being removed from the list of taxable Crown corporations, CDIC and FCC will be, as of January 3, 1995, and for taxation years that begin after December 10, 2001, respectively, exempt from federal income and capital taxes. However, the revenue impact will likely be minimal, since FCC in recent years has operated at a loss; as a result, it has paid no income taxes, only capital taxes. The exemption will, however, enable FCC to transfer these modest tax savings to its customers. Likewise, the revenue impact will be minimal with respect of CDIC, given that it has not generated taxable income since 1995, and since that time has only been liable to pay capital taxes. The other changes made as a result of these amendments serve only to bring the Act and Regulations in step with how they are presently administered, and have no impact on revenue. Consultation Two of the substantive measures — the addition of a reference to the definition "private corporation" in subsection 89(1) and the removal of FCC from the list in section 7100 — were publicly announced. Explanatory Notes released on May 30, 1991, announced that the reference to prescribed federal Crown corporations in the definition "private corporation" is a reference to the corporations listed in section 7100. The December 10, 2001 Budget announced the FCC change, and the amendment itself has been prepared in consultation with FCC. CDIC was consulted regarding its removal from the list, as well as with respect to the consequential amendments concerning CHHC and Theratronics. Compliance and Enforcement The Income Tax Act provides the necessary enforcement mechanisms for these regulations. The provisions allow the Minister of National Revenue to assess and reassess tax payable, and audit and seize relevant records and documents. Ryan Hall, Department of Finance, L'Esplanade Laurier Building, East Tower, 17th Floor, 140 O'Connor Street, Ottawa, Ontario K1A 0G5, (613) 996-5155. Notice is hereby given that the Governor in Council, pursuant to section 221 (see footnote a) of the Income Tax Act (see footnote b) , proposes to make the annexed Regulations Amending the Income Tax Regulations (Federal Crown Corporations). Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Ryan Hall, Tax Legislation Division, Department of Finance, L'Esplanade Laurier, 17th Floor, East Tower, 140 O'Connor Street, Ottawa, Canada, K1A 0G5. Ottawa, September 18, 2003
EILEEN BOYD
REGULATIONS AMENDING THE INCOME TAX REGULATIONS (FEDERAL CROWN CORPORATIONS) AMENDMENTS 1. (1) The portion of section 7100 of the Income Tax Regulations (see footnote 1) that is before the reference to "Canada Deposit Insurance Corporation" is replaced by the following: 7100. For the purposes of section 27, the definition "private corporation" in subsection 89(1) and subsection 124(3) of the Act, the following are prescribed federal crown corporations: (2) Section 7100 of the Regulations is amended by striking out the following:
(3) Section 7100 of the Regulations is amended by adding the following in alphabetical order:
(4) Section 7100 of the Regulations is amended by striking out the following:
(5) Section 7100 of the Regulations, as amended by subsections (1) to (4), is replaced by the following: 7100. For the purposes of subsections 27(2) and (3), the definition "private corporation" in subsection 89(1) and subsection 124(3) of the Act, the following are prescribed federal Crown corporations: (a) Canada Deposit Insurance Corporation; (b) Canada Hibernia Holding Corporation; (c) Canada Lands Company Limited; (d) Canada Mortgage and Housing Corporation; (e) Canada Post Corporation; (f) Canadian Broadcasting Corporation; (g) Cape Breton Development Corporation; (h) Freshwater Fish Marketing Corporation; (i) Royal Canadian Mint; and (j) VIA Rail Canada Inc. COORDINATING AMENDMENT 2. (1) Subsections (2) and (3) apply if Bill C-26, introduced in the 2nd session of the 37th Parliament and entitled the Transportation Amendment Act ("the Act"), receives royal assent and paragraph 81(b) of the Act comes into force on or before the day on which these Regulations are published in Part II of the Canada Gazette. (2) Paragraph 7100(j) of the Income Tax Regulations is replaced by the following: (j) VIA Rail Canada. (3) Subsection (2) comes into force or is deemed to have come into force on the day of the coming into force of paragraph 81(b) of the Act. APPLICATION 3. (1) The portion of section 7100 of the Regulations enacted by subsection 1(1) applies after July 13, 1990, except that for the period that begins on July 14, 1990 and ends on February 28, 1994, the portion of section 7100 of the French version of the Regulations before the reference to "Administration de la voie maritime du Saint-Laurent" is deemed to have read as follows: 7100. Les sociétés d'État, ou sociétés de la Couronne, prévues pour l'application de l'article 27, de la définition de " société privée " au paragraphe 89(1) et du paragraphe 124(3) de la Loi sont les suivantes : (2) Subsections 1(2) and (3) apply after January 2, 1995. (3) Subsection 1(4) applies after May 20, 1998. (4) Subsection 1(5) applies to taxation years that begin after December 10, 2001. [38-1-o] Regulations Amending the Fishery (General) RegulationsStatutory Authority Fisheries Act Sponsoring Department Department of Fisheries and Oceans REGULATORY IMPACT Description The Fishery (General) Regulations (FGR) are made under the authority of the Fisheries Act and include provisions of general application to all fisheries across Canada. In particular, the Regulations provide for the making of orders to vary close times, fishing quotas and the size and weight limits of fish that have been previously set out in other Fisheries Act regulations (e.g. the Maritime Provinces Fishery Regulations). These orders, called variation orders, allow for fishing restrictions to be adjusted quickly when necessary for the conservation of fish stocks. Variation orders, under the current FGR, may be made by different federal and provincial fisheries officials in a number of jurisdictions across Canada. For example, in Newfoundland, variation orders may be made by the Newfoundland Regional Director General of the Department of Fisheries and Oceans (DFO). In the Yukon Territory, under an agreement between DFO and the territorial government, the Director of the Fish and Wildlife Branch of the territorial Department of Renewable Resources may make variation orders for any species of fish other than salmon in non-tidal territorial waters. The current regulatory initiative proposes to amend the FGR as follows. (1) A provision will be added which will authorize the Director of the Fish and Wildlife Branch of the New Brunswick Department of Natural Resources and Energy (DNRE) to make variation orders for those species of fish listed in Appendix A of the Canada-New Brunswick Memorandum of Understanding on Recreational Fisheries (MOU). This MOU was signed on June 18, 2001, by the Minister of Fisheries and Oceans (representing Canada) and the Minister of Natural Resources and Energy (representing New Brunswick). The MOU reflects the cooperative approach that DFO and New Brunswick are undertaking to manage and administer the province's freshwater fisheries. It also formalizes and defines the extent of fisheries administration and management that the provincial government currently performs. The MOU also commits to making the necessary regulatory amendments to confer variation order power to the designated official of the New Brunswick Department of Natural Resources and Energy so that the province can "assume primary responsibility for the orderly management of recreational fisheries for those species listed in Appendix A." The fishing for those species (e.g. several species of trout, northern pike, white and yellow perch) is currently regulated under the Maritime Provinces Fishery Regulations (MPFR), which sets out quotas, size limits, close times and other fishing restrictions such as permitted gear. The proposed amendment to the FGR will state that where quotas, size limits and close times are set out in the MPFR for an area of New Brunswick, the provincial Fish and Wildlife Director may vary those restrictions for those listed species. This new provision will be virtually identical to similar provisions which have conferred variation order power to six other provinces or territories (Ontario, Quebec, Manitoba, Alberta, British Columbia and the Yukon Territory) that administer and manage provincial/ territorial recreational fisheries on behalf of the federal government. The New Brunswick fisheries agency has been involved, for a number of years, in the management and administration of certain elements of provincial recreational fisheries such as licence issuance, stock assessment programs for certain freshwater species, gathering statistics on recreational fisheries, assisting with enforcement programs and recommending regulatory change. This amendment will give the provincial government agency an additional authority to facilitate recreational fisheries management. (2) In a related amendment, an addition will be made to the existing provision that deals with the manner in which persons affected by variation orders are notified. A variety of methods for providing notice of variation orders are set out in the existing FGR, including print or electronic media announcements, radio broadcasts, postings in the affected areas, in-person notifications by fishery officers and publication of orders in respective annual provincial fishing summaries. The annual New Brunswick angling summary, Fish Angling Regulations and Licence Information, will be added as one of the authorized methods for providing notice of variation orders respecting that province's fisheries. (3) In addition to the above changes, an amendment to the FGR provision which currently confers variation order authority to the BC Ministry of Fisheries must be amended to reflect the reorganization of ministries in that province's government. The recently created BC Ministry of Water, Lands and Air Protection is now responsible for non-tidal fisheries management in that province. As a result, the provision in the FGR that identifies the title of the person empowered to vary fishing restrictions in non-tidal waters under the British Columbia Sport Fishing Regulations, 1996, must be changed. Currently, this provision refers to a Director in the former Ministry of Fisheries. In order to avoid the need for future amendments of this type, the proposed amendment will refer more generally to the Director responsible for fisheries management in the BC government ministry responsible for fisheries. (4) Finally, an amendment is being made in the FGR to correct a reference to the British Columbia Sport Fishing Regulations, 1996. A similar change will be made to the name of the Newfoundland Fishery Regulations, referred to in these regulations, to account for the recent name change of the province of Newfoundland to the province of Newfoundland and Labrador. Alternatives The only alternative open to consideration for the amendments detailed in items 1 and 2 above was the status quo. The status quo is not acceptable, as it would not fully implement the MOU between Canada and New Brunswick on recreational fisheries. In order for the New Brunswick fisheries agency to have the tools required to manage provincial recreational fisheries for Appendix A species, the FGR must be amended to give DNRE the authority to vary the quotas, size limits and close times set out in the Maritime Provinces Fisheries Regulations for those species. There are no alternatives to the administrative amendments outlined in items 3 and 4 above. Benefits and Costs The amendments described in items 1 and 2 will fulfill the federal government's MOU commitment to make the necessary regulatory change conferring variation order authority to the New Brunswick fisheries agency. The changes will further clarify the federal and provincial roles regarding the management of recreational fisheries for Appendix A species. The administrative and management authority for specific provincial recreational fisheries being given to New Brunswick is similar to that given to other provinces in the past. These amendments will not involve any costs to the fishing public, who should notice no real change in services related to recreational fishing. Costs to DFO and the New Brunswick fisheries agency will be minimal and limited to the cost of producing and publishing variation orders. Enforcement costs will not change as a result of this initiative, although some redistribution of enforcement effort may occur. There are no costs to government or to the public associated with the administrative amendments outlined in items 3 and 4. Consultation Recreational fishery stakeholders (e.g. the Nepisiquit Salmon Association, the New Brunswick Wildlife Federation, the New Brunswick Salmon Council, the Atlantic Salmon Federation, Bass Anglers), aboriginal representatives (e.g. St. Mary's First Nation, Eel Ground First Nation and Indian Island First Nation) and government agencies (DFO and DNRE) participated in the development of the Strategy for New Brunswick's Recreational Fisheries, prepared by the LGL Consulting Group in 1993. One of the cornerstones of the Recreational Fisheries strategy was the establishment of a Memorandum of Understanding between DFO and the Province of New Brunswick. Recreational fishing interests (e.g. the Miramichi Salmon Association, the New Brunswick Salmon Council, the Atlantic Salmon Federation, the New Brunswick Wildlife Federation, the New Brunswick Sport Fishery Advisory Board) and aboriginal representatives from First Nations with interests in watersheds adjacent to their lands reaffirmed their support for an MOU at a conference on Community Watershed Management in New Brunswick in 1996. In addition, in December 2000, a letter communicating the content of the Memorandum of Understanding on Recreational Fisheries and inviting comment was sent to the recreational fishing organizations above, among others. Recreational fishing representatives remain highly supportive of the initiative. The same letter inviting comment was also sent to aboriginal organizations such as the New Brunswick Aboriginal Peoples Council, the Atlantic Policy Congress of First Nation Chiefs, the Union of New Brunswick Indians and First Nations including Red Bank, Burnt Church, Big Cove and Eel River Bar. These organizations did not raise any specific concerns regarding the Memorandum of Understanding. Consultations and discussions on this amendment have been ongoing through the regular meetings of the Miramichi Watershed Management Committee, Restigouche River Watershed Management Council and the regular meetings of the Management Committee and sub-committees of the Canada-New Brunswick MOU on Recreationnal Fisheries. Compliance and Enforcement These amendments are administrative in nature and do not create additional regulations with which the public must comply. They merely shift the legal responsibility for issuing certain variation orders and notification of these orders from DFO to DNRE. DNRE will also take on the lead role for enforcement programs related to recreational fishing of Appendix A species. DFO will maintain its current conservation and enforcement responsibilities for all fishing activities. There are no new enforcement costs related to these amendments, although some redistribution of enforcement effort may occur. R. J. Allain, Director, Fisheries Management Branch, Gulf Region, 343 University Avenue, P.O. Box 5030, Moncton, New Brunswick E1C 9B6, (506) 851-7752 (Telephone), (506) 851-2504 (Facsimile), or Sharon Budd, Regulatory Analyst, Fisheries and Oceans Canada, 200 Kent Street, Ottawa, Ontario K1A 0E6, (613) 993-0982 (Telephone), (613) 990-2811 (Facsimile). Notice is hereby given that the Governor in Council, pursuant to section 43 (see footnote c) of the Fisheries Act, proposes to make the annexed Regulations Amending the Fishery (General) Regulations. Any interested person may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, the date of this notice and must be addressed to R.J. Allain, Director, Fisheries Management Branch, Gulf Region, 343 University Avenue, Box 5030, Moncton, New Brunswick E1C 9B6 Tel.: (506) 851-7752 FAX: (506) 851-2504. Ottawa, September 18, 2003
EILEEN BOYD
REGULATIONS AMENDING THE FISHERY (GENERAL) REGULATIONS AMENDMENTS 1. (1) Paragraph 3(4)(b) of the Fishery (General) Regulations (see footnote 2) is replaced by the following: (b) the British Columbia Sport Fishing Regulations, 1996; (2) Paragraph 3(4)(g) of the Regulations is replaced by the following: (g) the Newfoundland and Labrador Fishery Regulations; 2. (1) Subsection 6(3) of the Regulations is replaced by the following: (3) Where a close time, fishing quota or limit on the size or weight of fish is fixed in respect of an area of non-tidal waters for any species of fish other than salmon under the British Columbia Sport Fishing Regulations, 1996, the director responsible for fisheries management in the Ministry responsible for fisheries in the government of British Columbia may, by order, vary that close time, fishing quota or limit in respect of that area or any portion of that area. (2) Section 6 of the Regulations is amended by adding the following after subsection (4): (5) Where a close time, fishing quota or limit on the size or weight of fish is fixed in respect of an area of the province of New Brunswick under the Maritime Provinces Fishery Regulations, the director responsible for fisheries management in the Ministry responsible for fisheries in the government of New Brunswick may, by order, vary that close time, fishing quota or limit in respect of that area or any portion of that area for any species of fish listed in Appendix A of the Canada-New Brunswick Memorandum of Understanding on Recreational Fisheries, dated June 18, 2001, as amended from time to time. 3. (1) The portion of subsection 7(1) of the Regulations before paragraph (a) is replaced by the following: 7. (1) Subject to subsections (2) to (5), where a variation order is made under section 6, notice of the variation shall be given to the persons affected or likely to be affected by the variation by one or more of the following methods: (2) Section 7 of the Regulations is amended by adding the following after subsection (4): (5) Where a variation order is made under subsection 6(5), notice of the variation shall be given to the persons affected or likely to be affected by the variation (a) by one or more of the methods set out in subsection (1); or (b) by publishing the notice in Fish Angling Regulations and Licence Information, as published annually by the province of New Brunswick. 4. The Regulations are amended by replacing the word "Newfoundland" with the words "Newfoundland and Labrador" in paragraph 3(1)(b) and subsection 37(2). 5. The French version of the Regulations is amended by replacing the words "Terre-Neuve" with the words "Terre-Neuve-et-Labrador" in paragraph 39(1)(a). COMING INTO FORCE 6. These Regulations come into force on the day on which they are registered. [38-1-o] Regulations Amending the Narcotic Control Regulations and Other Related RegulationsStatutory Authority Controlled Drugs and Substances Act Sponsoring Department Department of Health REGULATORY IMPACT Description The purpose of this regulatory initiative is to amend provisions relating to the application and issuance of dealers' licences within the Narcotic Control Regulations (NCR) and Parts G (i.e. controlled drugs) and J (i.e. restricted drugs) of the Food and Drug Regulations (FDR). Under the present NCR and Parts G and J of the FDR, the Minister of Health may issue a dealer's licence to any person who, in the opinion of the Minister, is qualified to be a licensed dealer for narcotics, controlled drugs or restricted drugs. These provisions have not been amended since long before the Controlled Drugs and Substances Act (CDSA) came into force in 1997, which consolidated the earlier Narcotic Control Act and Parts III and IV of the Food and Drugs Act. Most of the information that a person must provide and the requirements that an applicant must meet are not stated in the current regulations. They appear, however, in an information package put together by the Office of Controlled Substances within the Drug Strategy and Controlled Substances Programme of Health Canada. This package is sent to persons wishing to apply for a licence to import, export, produce or distribute controlled drugs and substances in Canada. It includes, among other things, a circular letter addressing the requirements to be accepted as a Qualified Person in Charge (QPIC), and a Directive referring to the physical security requirements for controlled substances. The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) has recommended that the ministerial discretion provided by the term "in the opinion of the Minister" that appears in subsection 9(1) of the NCR be removed. The SJCSR is the Committee established to monitor the exercise of the power by regulation-making authorities on behalf of Parliament. To respond to the SJCSR's concerns, Health Canada is proposing to amend subsection 9(1) of the NCR, and comparable provisions in Parts G and J of the FDR to replace the discretionary power conferred to the Minister of Health with a more transparent and uniform licensing framework based on objective requirements. The NCR and Parts G and J of the FDR derive their legislative authority from the CDSA. The CDSA provides a legislative framework for the control of substances that can alter mental processes, and that may produce harm to the health of an individual and to society when diverted or misused. The NCR, and Parts G and J of the FDR govern the activities of importers, exporters, producers, distributors, pharmacists, practitioners and hospitals relating to narcotics (e.g. morphine), controlled drugs (e.g. amphetamines), and restricted drugs (e.g. LSD) respectively. Proposed Licensing Framework The licensing framework proposed within this regulatory amendment largely reflects the current administrative process for the issuance of licences under the NCR and Parts G and J of the FDR. It has been modelled on the more modern regulatory provisions respecting the issuance of a dealer's licence found within two other sets of regulations under the CDSA, the Benzodiazepines and Other Targeted Substances Regulations (Targeted Substances Regulations), and the Precursor Control Regulations (PCR). The proposed licencing framework is composed of the following components. Eligibility States the eligibility criteria to be a licensed dealer: the requirement for the licensed dealer to designate a Qualified Person In Charge (QPIC) of all controlled substance transactions; the possibility for the licensed dealer to designate an alternate QPIC (A/QPIC) who may perform the duties of the QPIC when that person is absent; and the qualifications of the QPIC and A/QPIC. Application for a Dealer's Licence Describes the information that must be submitted to apply for a dealer's licence. Among the new requirements proposed under the NCR and the FDR, a criminal record check in respect of "designated criminal offences" and "designated drug offences" defined in the proposed regulatory amendments would be required for the individual in charge of the premises, the QPIC and the A/QPIC prior to the issuance of a dealer's licence. This requirement is included in other regulations under the CDSA. The applicant would have the choice to either provide the criminal record check directly to Health Canada, or to have the individual to whom this requirement applies sign a consent form to have the criminal record check carried out for them by Health Canada through the RCMP. Issuance of a Dealer's Licence Presents the particulars of the content of the dealer's licence, which includes the activities permitted, the substances for which the activities are permitted, the security level required and the inventory limitation allowed at the premises. Grounds for Refusal Sets out the circumstances under which the Minister would refuse to issue, renew or amend a dealer's licence. Another new feature of the proposed licensing framework is that it explicitly states the measures that the Minister must take if she proposes to refuse to issue, amend or renew or proposes to revoke a dealer's licence. These include a requirement to set out the reasons for the refusal or revocation in writing, and to provide an opportunity for the applicant or the dealer's licence holder to be heard in respect of the refusal or revocation. Application for Renewal or Amendment Establishes the requirements that licensed dealers must meet for the renewal of their dealer's licence, which are similar to those encountered when submitting their original applications. It also describes the information that licensed dealers must submit to the Minister to have the content of their dealer's licence amended. Revocation or Suspension of a Dealer's Licence States the circumstances where the Minister would revoke or suspend a dealer's licence if, for example, false or misleading information was submitted regarding the licence application or the applicant no longer meets the eligibility requirements set out in the regulations. Duration of a Dealer's Licence Currently a dealer's licence for narcotics, controlled and restricted drugs expires on December 31 of each year, and has to be renewed annually. This proposed licensing framework would now provide flexibility with respect to the effective date and the expiry date of the dealer's licence. A licence will generally be valid for one year, although a maximum of three years is provided for. The length of validity may vary during the transition period in order to accommodate implementation of a staggered renewal schedule. Consequential Amendments In addition, a number of consequential amendments are required. Some changes are necessary to harmonize the terminology used in the NCR and Parts G and J of the FDR with that used in the CDSA, the Targeted Substances Regulations, and the PCR. Also, as a result of the proposed licensing framework, regulatory provisions within the NCR and Parts G and J of the FDR have been renumbered. Consequently, changes in numerical references within the Marihuana Medical Access Regulations (MMAR), and the Industrial Hemp Regulations (IHR), in which the renumbered provisions of the NCR are cross-referenced, are required. Alternatives The SJCSR has the authority to direct that amendments be made to regulations. Failure to comply with the Committee's recommendations can result in disallowance of the regulations in question. Leaving the regulations as they were written was therefore not an alternative. It was decided to model the amendments to the NCR and the FDR after similar provisions in the Targeted Substances Regulations and the PCR as: — the concerns of the SJCSR were addressed in these newer regulations; — many licensed dealers are already subject to, and familiar with, the licensing provisions of the Targeted Substances Regulations and the PCR; — these two sets of regulations are recent, having come into force in 2000 and 2002 respectively; — extensive consultations were conducted, and issues identified by stakeholders were addressed during the development of these regulations; and — they largely reflect current administrative processes for the issuance of licences respecting narcotics, controlled and restricted drugs. Benefits and Costs These amendments provide a more transparent licensing framework, which should be of benefit to licensed dealers and Health Canada in terms of clearer statements of rights and obligations. These changes, to a large extent, align the licensing processes set out in four sets of regulations under the CDSA that govern the activities of licensed dealers (i.e. the NCR, the FDR, the Targeted Substances Regulations, and the PCR), which will minimize confusion, increase efficiency, and facilitate compliance and enforcement for the parties involved. Because the proposed licensing framework largely reflects the current administrative processes in Health Canada, costs of implementation to both licensed dealers and Health Canada should be minimal. Licensed dealers may incur minimal costs to obtain the newly required criminal record check. This measure, which is a requirement under other regulations within the CDSA, will be beneficial to Canadians as it will minimize the risk of diversion of narcotics, controlled and restricted drugs to the illicit market, and therefore decrease public health risks and increase community security. The change in the licence renewal cycle will have a positive impact. Renewal applications will be processed more efficiently by Health Canada as they will be distributed over the course of a year, which should eliminate the end of calendar year backlog. To minimize impacts on licensed dealers, Health Canada will make every effort to ensure that the renewal cycles for the various dealer's licences will be synchronized with their business activities. In summary, there are minimal impacts associated with this initiative. Consultation These amendments are modelled after the provisions of the Targeted Substances Regulations and the PCR, which were the subject of extensive consultations. Prior to the promulgation of the Targeted Substances Regulations in September 2000, stakeholders were afforded three separate opportunities to comment. The first followed publication of the Notice of Intent in the Canada Gazette, Part I. The second followed the posting on the Internet of a policy proposal outlining the considered alternatives and the preferred options and direct distribution to over 200 stakeholders. The third comment period of 60 days followed the pre-publication of the proposed Regulations in the Canada Gazette, Part I. Prior to publication of the PCR in the Canada Gazette, Part I, extensive consultation with other government departments and industry took place during 2001 through various avenues. A Notice of Intent was published in the Canada Gazette, Part I, in March of 2001, followed by a discussion document. A consultation workshop was held that summer and was attended by various stakeholders from Canada, the United States and the European Union. Publication in the Canada Gazette, Part I, took place in April 2002 and resulted in 12 responses, which overall supported the regulatory framework. The PCR were promulgated in September 2002. In view of the foregoing, no objections to this amendment are anticipated. A 75-day comment period will follow publication in the Canada Gazette, Part I. Stakeholders, including the following, will be notified directly of pre-publication: the pharmaceutical industry, including licensed dealers, pharmaceutical associations, Deans of Pharmacy, Medicine, Dentistry and Veterinary Medicine, Provincial and Territorial Ministries of Health, Registrars of Pharmacy, Medicine, Dentistry and Veterinary Medicine. All comments received will be taken into consideration in the preparation of the final proposal. Compliance and Enforcement The proposed licensing framework does not alter existing compliance mechanisms under the provisions of the CDSA and its related regulations. The proposed licensing framework sets out licensing practices in clearer statements of rights and obligations for the licensed dealer, which will help to facilitate compliance and enforcement activities. Persons failing to comply with the proposed licensing framework could have their licence or permit revoked. A person conducting activities outside of those authorized by the proposed licensing framework could be subject to the punishments defined in the CDSA. Shereen Khan, Office of Controlled Substances, Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch, Address Locator 3503D, Macdonald Building, 3rd Floor, 123 Slater Street, Ottawa, Ontario K1A 1B9, (613) 941-6416 (Telephone), (613) 946-4224 (Facsimile), OCS_Policy_and_Regulatory_Affairs@hc-sc.gc.ca (Electronic mail). Notice is hereby given that the Governor in Council, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote d) , proposes to make the annexed Regulations Amending the Narcotic Control Regulations and Other Related Regulations. Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Shereen Khan, Office of Controlled Substances, Department of Health, Address Locator 3503D, Ottawa, Ontario K1A 1B9 (Fax: (613) 946-4224; e-mail: OCS_Policy_and_ Regulatory_Affairs@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, September 18, 2003
EILEEN BOYD
REGULATIONS AMENDING THE NARCOTIC CONTROL REGULATIONS AND OTHER RELATED REGULATIONS AMENDMENTS 1. (1) The definition "licence" in section 2 of the Narcotic Control Regulations (see footnote 3) is repealed. (2) The definition "licensed dealer" in section 2 of the Regulations is replaced by the following: "licensed dealer" means the holder of a licence issued under section 9.2; (distributeur autorisé) (3) Section 2 of the Regulations is amended by adding the following in alphabetical order: "competent authority" means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of narcotics into or from the country; (autorité compétente) "designated criminal offence" means (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code; (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code; (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code; (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d); (infraction désignée en matière criminelle) "international obligation" means an obligation in respect of a narcotic set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale) "qualified person in charge" means the individual with the qualifications specified in subsection 8.3(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable) "Security Directive" means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department, as amended from time to time; (Directive en matière de sécurité) 2. The heading before section 8 of the Regulations is replaced by the following: Dealers' Licences and Licensed Dealers 3. Subsection 8(1) of the Regulations is replaced by the following: 8. (1) Subject to these Regulations, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a narcotic. 4. Section 9 of the Regulations is replaced by the following: 8.2 To be eligible for a dealer's licence, a person must be (a) an individual who ordinarily resides in Canada; (b) a corporation that has its head office in Canada or operates a branch office in Canada; or (c) an individual who occupies a position that includes responsibility for narcotics on behalf of a department of the government of Canada or of a province, a police force, a hospital or a university in Canada. 8.3 (1) A licensed dealer (a) shall designate no more than one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to narcotics specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and (b) may designate an alternate qualified person in charge who must work at the premises specified in the licence and have authority to replace the qualified person in charge when that person is absent. (2) The qualified person in charge and, if applicable, the alternate qualified person in charge (a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties; (b) shall be a pharmacist or a practitioner registered with a licensing body of a province or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and (c) shall not have been convicted, as an adult, within the preceding 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii). 9. (1) To apply for a dealer's licence, a person shall submit an application to the Minister containing: (a) their name or, if the applicant is a corporation, their corporate name and any other name registered with a province, under which the applicant intends to carry out the activities specified in its dealer's licence or intends to identify itself; (b) the address, telephone number and, if applicable, the facsimile number and e-mail address for the premises to which the dealer's licence would apply and, if different, the mailing address for the premises; (c) the name, date of birth and gender of the individual in charge of the premises; (d) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises,
(ii) their academic qualifications, training and work experience relevant to their duties, (iii) their hours of work at the premises, (iv) their title at the premises, (v) the name and title of their immediate supervisor at the premises, and (vi) in the case of a pharmacist or a practitioner, the name of the province in which the person's current professional licence, certification or authorization was issued and the professional licence, certification or authorization number; (e) the name and gender of the individuals authorized to place an order for a narcotic on behalf of the applicant; (f) the activities referred to in section 8 for which the licence is sought that would be carried out at the premises to which the dealer's licence would apply; (g) in the case of a product or compound that contains a narcotic but is not a test kit and that would be made or assembled for or by the applicant,
(ii) the narcotic in each product or compound, (iii) the strength per unit of the narcotic in each product or compound, (iv) the quantity or package sizes of each product or compound, and (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and licence number of the other dealer; (h) if the licence is sought to produce a narcotic other than a product or compound that contains a narcotic,
(ii) the quantity that the applicant expects to produce under the dealer's licence and the period during which that quantity would be produced, and (iii) if the narcotic would be produced for another licensed dealer under a custom order, the name, address and dealer's licence number of the other dealer; (i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive; (j) a detailed description of the method that the applicant proposes to use for recording their narcotic transactions; and (k) for any activity referred to in section 8, other than the activities described in paragraphs (g) and (h), the name of the narcotic and the purpose for carrying out the activity. (2) An application for a dealer's licence must (a) be signed by the individual in charge of the premises to which the licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual has the authority to bind the applicant. (3) An application for a dealer's licence must be accompanied by (a) declarations signed by the individual in charge of the premises, the qualified person in charge and, if applicable, the alternate qualified person in charge, stating that they have not been convicted, as an adult, during the preceding 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); (b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the previous 10 years, of a designated drug offence or a designated criminal offence; (c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada; (d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience required under paragraph 8.3(2)(a); (e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner registered with a licensing body of a province, a copy of the person's degree required under paragraph 8.3(2)(b) and a copy of the course transcript for that degree; (f) if the applicant's name appears on the label of a product or compound that contains a narcotic, a copy of the inner label, as defined in section A.01.010 of the Food and Drug Regulations, for each product or compound to which the licence would apply; and (g) if the applicant is a corporation, a copy of
(ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer's licence or intends to identify itself. (4) The method proposed by the applicant under paragraph (1)(j) must (a) allow for the recording of narcotic transactions in accordance with section 15; and (b) permit the Minister to audit the activities of the licensed dealer with respect to narcotics. (5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing (a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years; (b) to provide all necessary information and to submit to any means of identification required to obtain the criminal record check; and (c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations. 9.1 The Minister may, on receiving an application made under these Regulations, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application. 9.2 Subject to section 9.4, the Minister shall, after examining the information and documents required under sections 9 and 9.1, issue a dealer's licence that contains: (a) the licence number; (b) the name of the licensee or, if the applicant is a corporation, its corporate name; (c) a list of the activities that are permitted; (d) the address of the premises at which the licensed dealer may carry on the permitted activities; (e) the name of the narcotic for which the activities are permitted; (f) the security level at the premises; (g) the effective date of the licence; (h) the expiry date of the licence, which may not be later than three years after its effective date; (i) any conditions to be met by the holder of the licence to
(ii) provide the security level referred to in paragraph (f), or (iii) reduce the potential security, public health or safety hazard, including the risk of the narcotic being diverted to an illicit market or use; (j) in the case of a producer of a narcotic, the quantity of the narcotic that may be produced under the licence and the period during which that quantity may be produced; and (k) in the case of the maker or assembler of a product or compound that contains a narcotic but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:
(ii) the brand name, if any, of each product or compound, (iii) the narcotic in each product or compound, (iv) the strength per unit of the narcotic in each product or compound, and (v) the quantity or package sizes of each product or compound. 9.3 A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only narcotics specified in their licence. 9.4 (1) The Minister shall refuse to issue, renew or amend a dealer's licence if: (a) the applicant is not eligible under section 8.2; (b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section 16; (c) false or misleading information or false or falsified documents were submitted in or with the application; (d) an activity for which the licence is requested would not be in compliance with an international obligation; (e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a narcotic to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation; (f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested; (g) the applicant is in contravention of or has contravened during the preceding 10 years,
(ii) a term or condition of another dealer's licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act; (h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a narcotic being diverted to an illicit market or use; (i) the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has been convicted, as an adult, within the preceding 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); (j) the proposed method referred to in paragraph 9(1)(j) is not capable of recording narcotic transactions as required under section 15 or of permitting the Minister to audit the applicant's activities with respect to narcotics in a timely manner; or (k) the additional information required under section 9.1 has not been provided or is insufficient to process the application. (2) The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant (a) does not have a history of non compliance with the Act or any regulation made or continued under it; and (b) has carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations. 9.5 (1) To apply to renew a dealer's licence, a licensed dealer shall submit to the Minister (a) the information referred to in paragraphs 9(1)(a) to (k); and (b) the following documents, namely,
(ii) if applicable and if not previously submitted in respect of the dealer's licence that is being renewed, the document referred to in paragraph 9(3)(e), and (iii) the original dealer's licence that is to be renewed. (2) An application for renewal must (a) be signed by the individual in charge of the premises to which the renewed dealer's licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual in charge has the authority to bind the applicant. (3) Subject to section 9.4, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section 9.1, issue a renewed dealer's licence that contains the information specified in paragraphs 9.2(a) to (k). 9.6 (1) To have its dealer's licence amended, a licensed dealer shall submit to the Minister (a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section 9 that are relevant to the proposed amendment; and (b) the original dealer's licence. (2) An application for amendment must (a) be signed by the individual in charge of the premises to which the amended dealer's licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual in charge has the authority to bind the applicant. (3) Subject to section 9.4, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer's licence in accordance with the application and may add any conditions to be met by the holder of the licence to (a) ensure that an international obligation is respected; (b) provide the security level referred to in paragraph 9.2(f) or the new level required as a result of the amendment being implemented; or (c) reduce the potential security, public health or safety hazard, including the risk of the narcotic being diverted to an illicit market or use. 9.7 (1) A licensed dealer shall (a) obtain the Minister's approval before making any of the following changes, namely,
(ii) the replacement or addition of
(B) the qualified person in charge and, if applicable, an alternate qualified person in charge at the premises to which the dealer's licence applies, and (C) an individual authorized to place an order for a narcotic on behalf of the licensed dealer; (b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in
(ii) the application to renew the dealer's licence under section 9.5, or (iii) the request for approval under paragraph (a); and (c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in
(ii) the application to renew the dealer's licence under section 9.5, or (iii) the request for approval under paragraph (a). (2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person: (a) in the case of the replacement of the individual in charge of the premises to which the dealer's licence applies,
(ii) the declarations specified in paragraph 9(3)(a) and, subject to subsection 9(5), the documents specified in paragraphs 9(3)(b) and (c); (b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer's licence applies,
(ii) the documents specified in paragraphs 9(3)(a), (d) and (e) and, subject to section 9(5), the documents specified in paragraphs 9(3)(b) and (c); and (c) in the case of the replacement or addition of an individual who is authorized to place an order for a narcotic on behalf of the licensed dealer, the individual's name and gender. 9.8 The Minister shall revoke a dealer's licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen. 9.9 (1) Subject to subsection (2), the Minister shall revoke a dealer's licence in accordance with section 9.92 if (a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application; (b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under these Regulations; (c) the licensed dealer is no longer eligible under section 8.2; or (d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises has been convicted, as an adult, within the preceding 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or (e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a narcotic to an illicit market or use. (2) The Minister is not required to revoke a dealer's licence under paragraph (1)(a) or (b) if the licensed dealer (a) has no history of non-compliance with the Act and the regulations made or continued under it; and (b) has carried out, or signed an undertaking to carry out, corrective measures to ensure compliance with the Act and these Regulations. 9.91 The Minister shall suspend a dealer's licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a narcotic from being diverted to an illicit market or use. 9.92 (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer's licence under these Regulations, the Minister shall (a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and (b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation. (2) The suspension of a dealer's licence under these Regulations takes effect as soon as the Minister notifies the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension. (3) A person who receives a notice of suspension referred to in subsection (2) may, within 10 days after receiving the notice, provide the Minister with reasons why the suspension of the licence is unfounded. 5. Section 11 of the Regulations is repealed. 6. Section 13 of the Regulations is replaced by the following: 13. The Minister shall revoke or suspend a permit issued under these Regulations if the Minister determines that the person to whom the permit was issued has failed to comply with any term or condition of the permit or any provision of these Regulations. 7. Subsection 14(1) of the Regulations is replaced by the following: 14. (1) A dealer's licence is valid until the earlier of (a) the expiry date set out in the licence; and (b) the revocation or suspension of the licence under section 9.8, 9.9 or 9.91. 8. Paragraphs 15(a) to (c) of the Regulations are replaced by the following: (a) the name and quantity of any narcotic received by the licensed dealer, the name and address of the person who sold or provided it and the date on which it was received; (b) the name, quantity and form of any narcotic sold or provided by the licensed dealer, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided; (c) the name and quantity of any narcotic used in the making or assembling of a product or compound containing that narcotic, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock; (c.1) the name and quantity of any narcotic produced and the date on which it was placed in stock; and 9. Section 16 of the Regulations is replaced by the following: 16. (1) The Minister may, in respect of a licensed dealer, require an inspection to be made, at any reasonable time, of (a) the premises used or intended to be used in producing, making, assembling or storing a narcotic; (b) the process and conditions of the producing, making, assembling or storing; and (c) the records relating to the producing, making, assembling or storing. (2) The Minister may, in respect of a licensed dealer, require a verification to be made, at any reasonable time, of the qualifications of its technical staff concerned with producing, making, assembling or storing a narcotic. 10. Paragraphs 19(b) and (c) of the Regulations are replaced by the following: (b) the premises in which a narcotic is produced, made, assembled or stored; and (c) the process and conditions of the producing, making, assembling or storing. 11. (1) Subsection 24(1) of the Regulations is replaced by the following: 24. (1) No licensed dealer shall sell or provide a narcotic to any person except in accordance with this section and sections 27 and 28. (2) The portion of subsection 24(2) of the Regulations before paragraph (a) is replaced by the following: (2) Subject to section 25, a licensed dealer may sell or provide any narcotic other than diacetylmorphine (heroin) or methadone to (3) The portion of subsection 24(3) of the Regulations before paragraph (a) is replaced by the following: (3) Subject to section 25, a licensed dealer may sell or provide methadone to (4) The portion of subsection 24(4) of the Regulations before paragraph (a) is replaced by the following: (4) Subject to section 25, a licensed dealer may sell or provide diacetylmorphine (heroin) to 12. (1) The portion of subsection 27(1) of the Regulations before paragraph (a) is replaced by the following: 27. (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of their dealer's licence, sell or provide a narcotic other than diacetylmorphine (heroin) or methadone to a person referred to in subsection 24(2), sell or provide methadone to a person referred to in subsection 24(3) and sell or provide diacetylmorphine (heroin) to a person referred to in subsection 24(4) if the licensed dealer has, on the premises specified in the licence, received (2) The portion of subsection 27(2) of the Regulations before paragraph (b) is replaced by the following: (2) A licensed dealer who has received an order referred to in paragraph (1)(a) may sell or provide a narcotic other than diacetylmorphine (heroin) or methadone to a person referred to in subsection 24(2), sell or provide methadone to a person referred to in subsection 24(3) and sell or provide diacetylmorphine (heroin) to a person referred to in subsection 24(4) if (a) the order is signed and dated
(ii) if the narcotic is to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order; and (3) Subsections 27(3) and (3.1) of the English version of the Regulations are replaced by the following: (3) A licensed dealer who has received an order referred to in paragraph (1)(b) or (c) may provide a narcotic to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order. (3.1) A licensed dealer who has received an order sent through a computer from a remote input device referred to in paragraph (1)(b) may provide methadone to a hospital employee or to a practitioner in a hospital if the order has been placed by a practitioner exempted under section 56 of the Act with respect to methadone. (4) Subsection 27(4) of the Regulations is replaced by the following: (4) A licensed dealer may sell or provide a narcotic pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements of subsections (6) and (7). (5) The portion of subsection 27(5) of the Regulations before paragraph (c) is replaced by the following: (5) A licensed dealer who has received a verbal order referred to in paragraph (1)(c), and has sold or provided a verbal prescription narcotic to a person referred to in paragraph 24(2)(b), (c) or (d), shall immediately record (a) the name of the person to whom the verbal prescription narcotic was sold or provided; (b) if the verbal prescription narcotic was provided to a hospital employee or a practitioner in a hospital, the name of the person who placed the order; and (6) The portion of subsection 27(9) of the Regulations before paragraph (a) is replaced by the following: (9) If a licensed dealer has not obtained a receipt from a pharmacist or practitioner under subsection (8) within the time prescribed by that subsection, the dealer shall not, until after obtaining the receipt, sell or provide a narcotic to the pharmacist or practitioner pursuant to any further 13. Section 28 of the Regulations is replaced by the following: 28. (1) No licensed dealer shall sell or provide a narcotic unless it is labelled in accordance with the Food and Drug Regulations. (2) No licensed dealer shall sell or provide a narcotic, other than a preparation described in section 36, unless the narcotic is securely packed in its immediate container and sealed in such a manner that the container cannot be opened without breaking the seal. 14. (1) Subsection 31(1) of the Regulations is replaced by the following: 31. (1) No pharmacist shall sell or provide narcotics except in accordance with subsections (2) and (3) and sections 34 to 36. (2) The portion of subsection 31(2) of the Regulations before paragraph (a) is replaced by the following: (2) A pharmacist may sell or provide a narcotic other than methadone to a person (3) The portion of subsection 31(3) of the Regulations before paragraph (a) is replaced by the following: (3) A pharmacist may sell or provide methadone to 15. Section 35 of the Regulations is replaced by the following: 35. (1) Subject to subsection (2), a pharmacist may provide a narcotic to an employee of a hospital or a practitioner in a hospital if the pharmacist receives a written order for the narcotic signed and dated by (a) the pharmacist in charge of the dispensary of the hospital; or (b) a practitioner who is authorized by the person in charge of the hospital to order the narcotic and who, in the case of methadone, is exempted under section 56 of the Act with respect to methadone. (2) Before providing a narcotic under subsection (1), the pharmacist receiving the order must know the signature on the order or verify it. 16. (1) The portion of subsection 36(1) of the Regulations before paragraph (a) is replaced by the following: 36. (1) Subject to subsection (2), a pharmacist may, without a prescription, sell or provide a preparation containing not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 mg or its equivalent of codeine phosphate per 30 mL in a liquid preparation if (2) Subsection 36(2) of the Regulations is replaced by the following: (2) No pharmacist shall sell or provide a preparation referred to in subsection (1) if the pharmacist has reasonable grounds to believe that the preparation is to be used for purposes other than recognized medical or dental purposes. 17. Paragraphs 38(d) and (e) of the Regulations are replaced by the following: (d) the name or initials of the pharmacist who sold or provided the narcotic; (e) the date on which the narcotic was sold or provided; and 18. Paragraph 39(f) of the Regulations is replaced by the following: (f) the date on which such oral prescription narcotic was sold or provided; and 19. Subsections 45(1) and (2) of the Regulations are replaced by the following: 45. (1) A pharmacist may, on receiving a written order for a narcotic signed and dated by (a) the licensed dealer who sold or provided the narcotic to the pharmacist, return that narcotic to that dealer; or (b) another pharmacist, sell or provide such quantity of the narcotic to that other pharmacist as is specified in the order as being required for emergency purposes. (2) A pharmacist shall, immediately after returning, selling or providing a narcotic under subsection (1) or after receiving a narcotic under paragraph (1)(b) or subsection 65(4), enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions. 20. (1) Subsection 53(1) of the Regulations is replaced by the following: 53. (1) No practitioner shall administer a narcotic to a person or animal, or prescribe, sell or provide a narcotic for a person or animal, except as authorized under this section or the Marihuana Medical Access Regulations. (2) The portion of subsection 53(2) of the Regulations before paragraph (a) is replaced by the following: (2) Subject to subsections (3) and (4), a practitioner may administer a narcotic to a person or animal, or prescribe, sell, or provide a narcotic for a person or animal, if (3) Subsections 53(3) and (4) of the Regulations are replaced by the following: (3) No practitioner shall administer methadone to a person or animal, or prescribe, sell or provide methadone for a person or animal, unless the practitioner is exempted under section 56 of the Act with respect to methadone. (4) A practitioner shall not administer diacetylmorphine (heroin) to an animal or to a person who is not an in-patient or out-patient of a hospital providing care or treatment to persons, and shall not prescribe, sell or provide diacetylmorphine (heroin) for an animal or such a person. 21. Subsection 54(1) of the Regulations is replaced by the following: 54. (1) A practitioner who sells or provides a narcotic to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the narcotic, keep a record showing the name and quantity of the narcotic sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided, if the quantity of the narcotic exceeds (a) three times the maximum daily dosage recommended by the producer, maker or assembler of the narcotic for that narcotic; or (b) three times the generally recognized maximum daily therapeutic dosage for the narcotic if the producer, maker or assembler has not recommended a maximum daily dosage. 22. Subparagraph 55(a)(i) of the Regulations is replaced by the following:
23. Section 56 of the Regulations is replaced by the following: 56. If a practitioner alleges or, in any prosecution for an offence under the Act or these Regulations, pleads that their possession of a narcotic was for use in their practice or that they administered it to a person or animal, or prescribed, sold, or provided it for a person or animal who or that was a patient under their professional treatment and that the narcotic was required for the condition for which the patient received treatment, the burden of proof in respect of the allegation or plea shall be on the practitioner. 24. Subparagraphs 63(a)(iii) and (iv) of the Regulations are replaced by the following:
(iv) the name and quantity of any product or compound that was made or assembled and that contains that narcotic and the date on which the product or compound was made or assembled, 25. (1) Subsections 65(1) to (5) of the Regulations are replaced by the following: 65. (1) No person in charge of a hospital shall permit a narcotic to be sold, provided or administered except in accordance with this section. (2) Subject to subsection (5), on receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic other than diacetylmorphine (heroin) to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or the person in charge of the animal. (3) Subject to subsections (5) and (5.1), the person in charge of a hospital may permit a narcotic to be provided, for emergency purposes, to a hospital employee or practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order. (4) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic other than diacetylmorphine (heroin) to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist. (5) No person in charge of a hospital shall permit methadone to be sold, provided or administered under subsection (2) or (3) unless the prescribing or ordering practitioner is exempted under section 56 of the Act with respect to methadone. (5.1) No person in charge of a hospital shall permit a narcotic to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the narcotic or has been verified. (2) Subsection 65(6) of the English version of the Regulations is replaced by the following: (6) A person in charge of a hospital may permit a narcotic to be provided to a person who is exempted under section 56 of the Act with respect to the narcotic and who is employed in a research laboratory in the hospital for the purpose of research. (3) Subsection 65(7) of the Regulations is replaced by the following: (7) The person in charge of a hospital providing care or treatment to persons may permit diacetylmorphine (heroin) to be sold, provided or administered to a person under treatment as an in-patient or out-patient of the hospital on receipt of a prescription or a written order signed and dated by a practitioner. 26. (1) The portion of subsection 68(3) of the Regulations before paragraph (a) is replaced by the following: (3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a narcotic in their possession, provide or deliver the narcotic to (2) Paragraph 68(4)(a) of the Regulations is replaced by the following: (a) for the purpose of its identification or analysis, provide or deliver the narcotic to a person exempted under section 56 of the Act with respect to the possession of that narcotic for that purpose; or (3) The portion of subsection 68(5) of the Regulations before paragraph (a) is replaced by the following: (5) An agent of a practitioner of medicine who has received a narcotic under subsection (3) shall immediately provide or deliver the narcotic (4) Paragraph 68(6)(a) of the Regulations is replaced by the following: (a) for the purpose of its identification or analysis, provide or deliver the narcotic to a person exempted under section 56 of the Act with respect to the possession of that narcotic for that purpose; or 27. The portion of section 69 of the Regulations before paragraph (a) is replaced by the following: 69. Every person who is exempted under section 56 of the Act with respect to the possession of a narcotic, other than a person to whom a narcotic has been administered, sold, provided, distributed or delivered by a practitioner of medicine exempted under section 56 of the Act from the application of any subsection of section 53 with respect to that narcotic, every practitioner of medicine who has received a narcotic under subsection 68(3) or (5) and every agent of a practitioner of medicine who has received a narcotic under subsection 68(3) shall CONSEQUENTIAL AMENDMENTS Industrial Hemp Regulations 28. The definition "competent laboratory" in section 1 of the Industrial Hemp Regulations (see footnote 4) is replaced by the following: "competent laboratory" means a laboratory that is owned or operated by a person who is a licensed dealer as defined in section 2 of the Narcotic Control Regulations, or a laboratory outside Canada that is recognized as a qualified laboratory, for the application of the United Nations' Single Convention on Narcotic Drugs, 1961, as amended from time to time, by the competent authorities of the country in which it is located. (laboratoire compétent) Marihuana Medical Access Regulations 29. The definition "medical practitioner" in subsection 1(1) of the Marihuana Medical Access Regulations (see footnote 5) is replaced by the following: "medical practitioner" means a person who is authorized under the laws of a province to practise medicine in that province and who is not named in a notice given under section 59 of the Narcotic Control Regulations. (médecin) COMING INTO FORCE 30. These Regulations come into force on the day on which they are registered. [38-1-o] Regulations Amending the Food and Drug RegulationsStatutory Authority Controlled Drugs and Substances Act Sponsoring Department Department of Health REGULATORY IMPACT For the Regulatory Impact Analysis Statement, see the Regulations Amending the Narcotic Control Regulations and other Related Regulations. Notice is hereby given that the Governor in Council, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote e) , proposes to make the annexed Regulations Amending the Food and Drug Regulations. Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Shereen Khan, Office of Controlled Substances, Department of Health, Address Locator 3503 D, Ottawa, Ontario K1A 1B9 (Fax: (613) 946-4224; e-mail: OCS_Policy_and_ Regulatory_Affairs@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, September 18, 2003
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS AMENDMENTS 1. (1) The definition "licence" in subsection G.01.001(1) of the Food and Drug Regulations (see footnote 6) is repealed. (2) The definition "licensed dealer" in subsection G.01.001(1) of the Regulations is replaced by the following: "licensed dealer" means the holder of a licence issued under section G.02.003.2; (distributeur autorisé) (3) Subsection G.01.001(1) of the Regulations is amended by adding the following in alphabetical order: "competent authority" means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of controlled drugs into or from the country; (autorité compétente) "international obligation" means an obligation in respect of a controlled drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale) "qualified person in charge" means the individual with the qualifications specified in subsection G.02.001.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable) (4) Subsection G.01.001(2) of the Regulations is amended by adding the following in alphabetical order: "designated criminal offence" means (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code; (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code; (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code; (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraphs (a) to (d). (infraction désignée en matière criminelle) "Security Directive" means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department, as amended from time to time. (Directive en matière de sécurité) 2. The portion of section G.01.003 of the French version of the Regulations before paragraph (a) is replaced by the following: G.01.003. L'article C.01.004 ne s'applique pas à une drogue contrôlée fournie par un pharmacien d'après une ordonnance, mais l'étiquette de l'emballage de la drogue contrôlée doit porter : 3. Section G.02.001 of the Regulations is replaced by the following: G.02.001. Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a controlled drug. G.02.001.1. To be eligible for a dealer's licence, a person must be (a) an individual who ordinarily resides in Canada; (b) a corporation that has its head office in Canada or operates a branch office in Canada; or (c) an individual who occupies a position that includes responsibility for controlled drugs on behalf of a department of the government of Canada or of a province, a police force, a hospital or a university in Canada. G.02.001.2. (1) A licensed dealer (a) shall designate no more than one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to controlled drugs specified in the licence and for ensuring on behalf of the licensed dealer that those activities comply with these Regulations; and (b) may designate an alternate qualified person in charge who must work at the premises specified the licence and have authority to replace the qualified person in charge when that person is absent. (2) The qualified person in charge and, if applicable, the alternate qualified person in charge (a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties; (b) shall be a pharmacist or a practitioner registered with a licensing body of a province or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and (c) shall not have been convicted, as an adult, within the preceding 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii). 4. Sections G.02.003 to G.02.007 of the Regulations are replaced by the following: G.02.003. (1) To apply for a dealer's licence, a person shall submit an application to the Minister containing: (a) their name or, if the applicant is a corporation, their corporate name and any other name registered with a province, under which the applicant intends to carry out the activities specified in its dealer's licence or intends to identify itself, (b) the address, telephone number and, if applicable, the facsimile number and e-mail address for the premises to which the dealer's licence would apply and, if different, the mailing address for the premises; (c) the name, date of birth and gender of the individual in charge of the premises; (d) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises,
(ii) their academic qualifications, training and work experience relevant to their duties, (iii) their hours of work at the premises, (iv) their title at the premises, (v) the name and title of their immediate supervisor at the premises, and (vi) in the case of a pharmacist or a practitioner, the name of the province in which the person's current professional licence, certification or authorization was issued and the professional licence, certification or authorization number; (e) the name and gender of the individuals authorized to place an order for a controlled drug on behalf of the applicant; (f) in the case of a product or compound that contains a controlled drug but is not a test kit and that would be made or assembled for or by the applicant, a list that sets out
(ii) the controlled drug in each product or compound, (iii) the strength per unit of the controlled drug in each product or compound, (iv) the quantity or package sizes of each product or compound, and (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and the dealer's licence number of the other dealer; (g) the activities referred to in section G.02.001 for which the licence is sought that would be carried out at the premises to which the dealer's licence would apply; (h) if the licence is sought to produce a controlled drug other than a product or compound that contains a controlled drug,
(ii) the quantity that the applicant expects to produce under the dealer's licence and the period during which that quantity would be produced, and (iii) if the controlled drug would be produced for another licensed dealer under a custom order, the name, address and dealer's licence number of the other dealer; (i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive, (j) a detailed description of the method that the applicant proposes to use for recording their controlled drug transactions; and (k) for any activity referred to in section G.02.001, other than the activities described in paragraphs (f) and (h), the controlled drug and the purpose for carrying out the activity. (2) An application for a dealer's licence must (a) be signed by the individual in charge of the premises to which the licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual has the authority to bind the applicant. (3) An application for a dealer's licence must be accompanied by (a) declarations signed by the individual in charge of the premises, the qualified person in charge and, if applicable, the alternate qualified person in charge, stating that they have not been convicted, as an adult, during the preceding 10 years of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); (b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years, of a designated drug offence or a designated criminal offence; (c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada; (d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience required under paragraph G.02.001.2(2)(a); (e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner registered with a licensing body of a province, a copy of the person's degree required under paragraph G.02.001.2(2)(b) and a copy of the course transcript for that degree; (f) if the applicant's name appears on the label of a product or compound that contains a controlled drug, a copy of the inner label, as defined in section A.01.010, for each product or compound to which the licence would apply; and (g) if the applicant is a corporation, a copy of
(ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer's licence or intends to identify itself. (4) The method proposed by the applicant under paragraph (1)(j) must (a) allow for the recording of controlled drug transactions in accordance with section G.02.014; and (b) permit the Minister to audit the activities of the licensed dealer with respect to controlled drugs. (5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing (a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years; (b) to provide all necessary information and to submit to any means of identification required to obtain the criminal record check; and (c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations. G.02.003.1. The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application. G.02.003.2. Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under sections G.02.003 and G.02.003.1, issue a dealer's licence that contains: (a) the licence number; (b) the name of the licensee or, if the applicant is a corporation, its corporate name; (c) a list of the activities that are permitted; (d) the address of the premises at which the licensed dealer may carry on the permitted activities; (e) the name of the controlled drug for which the activities are permitted; (f) the security level at the premises; (g) the effective date of the licence; (h) the expiry date of the licence, which may not be later than three years after its effective date; (i) any conditions to be met by the holder of the licence to
(ii) provide the security level referred to in paragraph (f), or (iii) reduce the potential security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use; (j) in the case of a producer of a controlled drug, the quantity of the controlled drug that may be produced under the licence and the period during which that quantity may be produced; and (k) in the case of the maker or assembler of a product or compound that contains a controlled drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:
(ii) the brand name, if any, of each product or compound, (iii) the controlled drug in each product or compound, (iv) the strength per unit of the controlled drug in each product or compound, and (v) the quantity or package sizes of each product or compound. G.02.003.3. (1) The Minister shall refuse to issue, renew or amend a dealer's licence if: (a) the applicant is not an eligible person under section G.02.001.1; (b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section G.02.015; (c) false or misleading information or false or falsified documents were submitted in or with the application; (d) an activity for which the licence is requested would not be in compliance with an international obligation; (e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation; (f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested; (g) the applicant is in contravention of or has contravened during the preceding 10 years
(ii) a term or condition of another dealer's licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act; (h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a controlled drug being diverted to an illicit market or use; (i) the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has been convicted, as an adult, within the previous 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); (j) the proposed method referred to in paragraph G.02.003(1)(j) is not capable of recording controlled drug transactions as required under section G.02.014 or permitting the Minister to audit the applicant's activities with respect to controlled drugs in a timely manner; or (k) the additional information required under section G.02.003.1 has not been provided or is insufficient to process the application. (2) The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant (a) does not have a history of non-compliance with the Act or any regulation made or continued under it; and (b) has carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations. G.02.003.4. (1) To apply to renew a dealer's licence, a licensed dealer shall submit to the Minister (a) the information referred to in paragraphs G.02.003(1)(a) to (k); and (b) the following documents, namely,
(ii) if applicable and if not previously submitted in respect of the dealer's licence that is being renewed, the document referred to in paragraph G.02.003(3)(e), and (iii) the original dealer's licence that is to be renewed. (2) An application for renewal must (a) be signed by the individual in charge of the premises to which the renewed dealer's licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual in charge has the authority to bind the applicant. (3) Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section G.02.003.1, issue a renewed dealer's licence that contains the information specified in paragraphs G.02.003.2(a) to (k). G.02.003.5. (1) To have its dealer's licence amended, a licensed dealer shall submit to the Minister (a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section G.02.003 that are relevant to the proposed amendment; and (b) the original dealer's licence. (2) An application for amendment must (a) be signed by the individual in charge of the premises to which the amended dealer's licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual in charge has the authority to bind the applicant. (3) Subject to section G.02.003.3, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer's licence in accordance with the application and may add any conditions to be met by the holder of the licence to (a) ensure that an international obligation is respected; (b) provide for the security level referred to in paragraph G.02.003.2(f) or the new level required as a result of the amendment being implemented; or (c) reduce the potential security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use. G.02.003.6. (1) A licensed dealer shall (a) obtain the Minister's approval before making any of the following changes, namely,
(ii) the replacement or addition of
(B) the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises to which the dealer's licence applies, and (C) an individual authorized to place an order for a controlled drug on behalf of the licensed dealer; (b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in
(ii) the application to renew the dealer's licence under section G.02.003.4, or (iii) the request for approval under paragraph (a); and (c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in
(ii) the application to renew the dealer's licence under section G.02.003.4, or (iii) the request for approval under paragraph (a). (2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person: (a) in the case of the replacement of the individual in charge of the premises to which the dealer's licence applies,
(ii) the declarations specified in paragraph G.02.003(3)(a) and, subject to subsection G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c); (b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer's licence applies,
(ii) the documents specified in paragraphs G.02.003(3)(a), (d) and (e) and, subject to section G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c); and (c) in the case of the replacement or addition of an individual who is authorized to place an order for a controlled drug on behalf of the licensed dealer, the individual's name and gender. G.02.003.7. The Minister shall revoke a dealer's licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen. G.02.003.8. (1) Subject to subsection (2), the Minister shall revoke a dealer's licence in accordance with section G.02.003.91 if: (a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application; (b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part; (c) the licensed dealer is no longer an eligible person under section G.02.001.1; (d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises, has been convicted, as an adult, within the preceding 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or (e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use. (2) The Minister is not required to revoke a dealer's licence under paragraph (1)(a) or (b) if the licensed dealer (a) has no history of non-compliance with the Act and the regulations made or continued under it; and (b) has carried out, or signed an undertaking to carry out, corrective measures to ensure compliance with the Act and these Regulations. G.02.003.9. The Minister shall suspend a dealer's licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a controlled drug from being diverted to an illicit market or use. G.02.003.91. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer's licence under this Part, the Minister shall (a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and (b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation. (2) The suspension of a dealer's licence under this Part takes effect as soon as the Minister notifies the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension. (3) A person who receives a notice of suspension referred to in subsection (2) may, within 10 days after receiving the notice, provide the Minister with reasons why the suspension of the licence is unfounded. G.02.004. A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the controlled drugs specified in their dealer's licence. 5. Sections G.02.011 and G.02.012 of the Regulations are replaced by the following: G.02.011. The Minister shall revoke or suspend a permit issued under this Part if the Minister determines that the person to whom the permit was issued has failed to comply with any term or condition of the permit or any provision of these Regulations. G.02.012. A dealer's licence is valid until the earlier of (a) the expiry date set out in the licence; and (b) the revocation or suspension of the licence under section G.02.003.7, G.02.003.8 or G.02.003.9. 6. Paragraphs G.02.014(1)(a) to (c) of the Regulations are replaced by the following: (a) the name and quantity of any controlled drug received by the licensed dealer, the name and address of the person who sold or provided it and the date it was received; (b) the name, quantity and form of any controlled drug sold or provided by the licensed dealer, the name and address of the person to whom it was sold or provided and the date it was sold or provided; (c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that narcotic, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock; (c.1) the name and quantity of any narcotic produced and the date on which it was placed in stock; and 7. Section G.02.015 of the Regulations is replaced by the following: G.02.015. (1) The Minister may, in respect of a licensed dealer, require an inspection to be made, at any reasonable time, of (a) the premises used or intended to be used in producing, making, assembling or storing a controlled drug; (b) the process and conditions of the producing, making, assembling or storing; and (c) the record of information referred to in section G.02.014. (2) The Minister may, in respect of a licensed dealer, require a verification to be made, at any reasonable time, of the qualifications of its technical staff concerned with producing, making, assembling or storing a controlled drug. 8. Paragraphs G.02.018(b) and (c) of the Regulations are replaced by the following: (b) the premises in which a controlled drug is produced, made, assembled or stored; and (c) the process and conditions of the producing, making, assembling or storing. 9. (1) The portion of section G.02.024 of the Regulations before paragraph (a) is replaced by the following: G.02.024. A licensed dealer shall not sell or provide a controlled drug to any person other than a (2) Paragraph G.02.024(e) of the Regulations is replaced by the following: (e) Regional Director of the Department; or 10. Paragraphs G.02.024.1(a) to (d) of the Regulations are replaced by the following: (a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2; (b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2; (c) sell or provide a controlled drug, other than a preparation, to a practitioner named in a notice given by the Minister under section G.04.004.2; or (d) sell or provide a preparation to a practitioner named in a notice given by the Minister under section G.04.004.2. 11. (1) The portion of subsection G.02.025(1) of the Regulations before paragraph (b) is replaced by the following: G.02.025. (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of their dealer's licence, sell or provide a controlled drug to a person referred to in section G.02.024 if (a) the drug is contained in a package that is authorized and described in the dealer's licence of the producer, maker or assembler of the drug; and (2) Subsections G.02.025(2) and (3) of the Regulations are replaced by the following: (2) A licensed dealer who has received an order referred to in subparagraph (1)(b)(i) and verified the signature on the order may sell or provide a controlled drug to a person referred to in section G.02.024, if the order is signed and dated by one of the following persons: (a) if the controlled drug is to be sold or provided to a person referred to in paragraph G.02.024(2)(a), (b), (c), (e) or (f), by that person; or (b) if the controlled drug is to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order. (3) A licensed dealer may sell or provide a controlled drug pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements of subsections (5) and (6). (3) Subsections G.02.025(3.1) and (3.2) of the English version of the Regulations are replaced by the following: (3.1) A licensed dealer who has received an order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii) may provide a controlled drug to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order. (3.2) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii) may provide a controlled drug listed in Part II or III of the schedule to this Part to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order. (4) Subsection G.02.025(4) of the Regulations before paragraph (c) is replaced by the following: (4) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii), and has provided a controlled drug listed in Part II or III of the schedule to this Part to a person referred to in paragraphs G.02.024(b) to (d), shall immediately record (a) the name of the person to whom the controlled drug was sold or provided; (b) if the drug was provided to a hospital employee or a practitioner in a hospital, the name of the pharmacist in charge of the dispensary of the hospital or the name of the practitioner authorized by the person in charge of the hospital to sign the order; and (5) The portion of subsection G.02.025(8) of the Regulations before paragraph (a) is replaced by the following: (8) If a licensed dealer has not received a receipt from a pharmacist or practitioner under subsection (7) within the time prescribed by that subsection, the dealer shall not, until after receiving the receipt, sell or provide a controlled drug to the pharmacist or practitioner pursuant to a further (6) Paragraphs G.02.025(8)(a) and (b) of the English version of the Regulations are replaced by the following: (a) order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii); or (b) verbal order referred to in subparagraph (1)(b)(iii). 12. (1) The portion of section G.02.026 of the Regulations before subparagraph (a)(i) is replaced by the following: G.02.026. A licensed dealer shall not sell or provide a controlled drug more than once in respect of one order unless (a) the order for the drug states that the quantity of the drug is to be sold or provided (2) Paragraph G.02.026(b) of the Regulations is replaced by the following: (b) at the time of receipt of the order the licensed dealer temporarily does not have in stock the quantity of the drug ordered, in which case the dealer may sell or provide against the order the quantity of the drug that the dealer has available and deliver the balance later in accordance with the order. 13. Subsection G.03.001(1) of the Regulations is replaced by the following: G.03.001. (1) A pharmacist, on receipt of a controlled drug from a licensed dealer, shall keep a record of the name and quantity of the controlled drug received by them, the name and address of the person who sold or provided it and the date it was received. 14. (1) The portion of section G.03.002 of the Regulations before paragraph (a) is replaced by the following: G.03.002. No pharmacist shall, except as otherwise provided in this Part, sell or provide a controlled drug to any person unless the pharmacist has first been provided with a prescription for it, and (2) Paragraphs G.03.002 (a) and (b) of the French version of the Regulations are replace by the following: a) si l'ordonnance est écrite, s'assurer qu'elle est signée et datée par le praticien dont elle émane et vérifier lui-même toute signature qu'il ne connaît pas; b) si l'ordonnance est verbale, prendre les précautions raisonnables pour s'assurer que la personne la prescrivant est bien un praticien. 15. Paragraphs G.03.002.1(a) to (d) of the Regulations are replaced by the following: (a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2; (b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2; (c) dispense, sell or provide a controlled drug, other than a preparation, to, or pursuant to a prescription or order given by, a practitioner named in a notice given by the Minister under section G.04.004.2; or (d) dispense, sell or provide a preparation to a practitioner or pursuant to a prescription or order given by a practitioner named in a notice given by the Minister under section G.04.004.2. 16. (1) The portion of section G.03.003 of the Regulations before paragraph (a) is replaced by the following: G.03.003. A pharmacist may sell or provide a controlled drug to a practitioner for use in their practice (2) Paragraph G.03.003(a) of the French version of the Regulations is replaced by the following: a) sur réception d'une commande écrite, signée et datée par le praticien, pourvu qu'il vérifie la signature du praticien si elle lui est inconnue; (3) Paragraph G.03.003(b) of the English version of the Regulations is replaced by the following: (b) upon a verbal order specifying the name and quantity of the drug if the pharmacist has taken reasonable precautions to satisfy themself that the person making the order is a practitioner. 17. Section G.03.004 of the Regulations is replaced by the following: G.03.004. A pharmacist shall, in respect of controlled drugs sold or provided to a practitioner under section G.03.003, keep in a special prescription file a record showing the date, the name and address of the practitioner, and the quantity and kind of controlled drug sold or provided. 18. Section G.03.005 of the English version of the Regulations is replaced by the following: G.03.005. A pharmacist may provide a controlled drug to a hospital employee or to a practitioner in a hospital on receipt of a written order signed and dated by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order, if the signature of that pharmacist or practitioner is known to the pharmacist or, if unknown, has been verified. 19. Paragraph G.03.007(e) of the Regulations is replaced by the following: (e) the date on which the controlled drug was sold or provided; and 20. Paragraph G.03.008(f) of the Regulations is replaced by the following: (f) the date on which the controlled drug was sold or provided; and 21. Paragraphs G.03.014(a) to (d) of the Regulations are replaced by the following: (a) the licensed dealer who sold or provided that drug to them, return that drug to that dealer; (b) another pharmacist, sell or provide any quantity of that drug to that other pharmacist that is specified in the order as being required for emergency purposes; (c) a Regional Director of the Department, sell or provide to or in accordance with the order of that Director any quantity of that drug, specified in the order, that is required by the Director in connection with their duties; and (d) a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to that controlled drug, sell or provide to that person any quantity of that drug that is specified in the order. 22. Section G.03.015 of the Regulations is replaced by the following: G.03.015. A pharmacist shall immediately after receiving, selling or providing a controlled drug under paragraph G.03.014(b) or (c) or subsection G.05.003(4) enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions. 23. The definition "administer" in subsection G.04.001(1) of the Regulations is replaced by the following: "administer" includes to prescribe, sell or provide; (administrer) 24. Subsection G.04.002(1) of the Regulations is replaced by the following: G.04.002. (1) A practitioner who sells or provides a controlled drug to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the drug, keep a record showing the name and quantity of the controlled drug sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided if the quantity of the controlled drug exceeds (a) three times the maximum daily dosage recommended by the producer, maker or assembler of the controlled drug; or (b) three times the generally recognized maximum daily therapeutic dosage for that controlled drug if the producer, maker or assembler has not recommended a maximum daily dosage. 25. Subparagraph G.04.002A(a)(i) of the Regulations is replaced by the following:
26. Section G.04.003 of the Regulations is replaced by the following: G.04.003. If a practitioner alleges or, in any prosecution for an offence under the Act, the Food and Drugs Act or this Part, pleads that their possession of a controlled drug was for use in their practice or that they administered it to a person or animal, or prescribed, sold, or provided it for a person or an animal who or that was a patient under their professional treatment and that the controlled drug was required for the condition for which the patient received treatment, the burden of proof in respect of the allegation or plea shall be on the practitioner. 27. Paragraph G.05.001(1)(c) of the Regulations is replaced by the following: (c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that controlled drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock; (c.1) the name and quantity of any controlled drug produced and the date on which it was placed in stock; 28. (1) Subsections G.05.003(1) to (4) of the Regulations are replaced by the following: G.05.003. (1) No person in charge of a hospital shall permit a controlled drug to be sold, provided or administered except in accordance with this section. (2) On receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a controlled drug to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or to the person in charge of the animal. (3) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be provided, for emergency purposes, to a hospital employee or a practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order. (4) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist. (2) Subsection G.05.003(5) of the English version of the Regulations is replaced by the following: (5) The person in charge of a hospital may permit a controlled drug to be provided to a person employed in a research laboratory in that hospital for the purpose of research. (3) Section G.05.003 of the Regulations is amended by adding the following after subsection (5): (6) No person in charge of a hospital shall permit a controlled drug to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the controlled drug or has been verified. 29. (1) The portion of subsection G.06.001(3) of the Regulations before paragraph (a) is replaced by the following: (3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a controlled drug in their possession, provide or deliver the drug to (2) The portion of subsection G.06.001(4) of the Regulations before paragraph (a) is replaced by the following: (4) If an agent of a practitioner of medicine receives a controlled drug under subsection (3), they shall immediately provide or deliver it (3) The portion of subsection G.06.001(5) of the Regulations before paragraph (a) is replaced by the following: (5) A practitioner of medicine who receives a controlled drug under subsection (3) or (4) shall immediately provide or deliver it 30. Subparagraph G.06.002.1(b)(i) of the Regulations is replaced by the following:
31. (1) The definition "licence" in section J.01.001 of the Regulations is repealed. (2) The definition "licensed dealer" in section J.01.001 of the Regulations is replaced by the following: "licensed dealer" means the holder of a licence issued under section J.01.007.2; (distributeur autorisé) (3) Section J.01.001 of the Regulations is amended by adding the following in alphabetical order: "competent authority" means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of restricted drugs into or from the country; (autorité compétente) "international obligation" means an obligation in respect of a restricted drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale) "qualified person in charge" means the individual with the qualifications specified in subsection J.01.003.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable) 32. Section J.01.003 of the Regulations is replaced by the following: J.01.003. Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a restricted drug. J.01.003.1. To be eligible to apply for a dealer's licence, a person must be (a) an individual who ordinarily resides in Canada; (b) a corporation that has its head office in Canada or operates a branch office in Canada; or (c) an individual who occupies a position that includes responsibility for restricted drugs on behalf of a department of the government of Canada or of a province, a police force, a hospital or a university in Canada. J.01.003.2. (1) A licensed dealer (a) shall designate no more than one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to restricted drugs specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and (b) may designate an alternate qualified person in charge who must work at the premises set out in the licence and have authority to replace the qualified person in charge when that person is absent. (2) The qualified person in charge and, if applicable, the alternate qualified person in charge (a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties; (b) shall be a pharmacist or a practitioner registered with a licensing body of a province or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and (c) shall not have been convicted, as an adult, within the previous 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii). 33. Sections J.01.007 and J.01.008 of the Regulations are replaced by the following: J.01.007. (1) To apply for a dealer's licence, a person shall submit an application to the Minister containing: (a) their name or, if the applicant is a corporation, their corporate name and any other name registered with a province, under which the applicant intends to carry out the activities specified in its dealer's licence or intends to identify itself, (b) the address, telephone number and, if applicable, the facsimile transmission number and e-mail address for the premises to which the dealer's licence would apply and, if different, the mailing address for the premises; (c) the name, date of birth and gender of the individual in charge of the premises; (d) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises,
(ii) their academic qualifications, training and work experience relevant to their duties, (iii) their hours of work, at the premises, (iv) their title at the premises, (v) the name and title of their immediate supervisor at the premises, and (vi) in the case of a pharmacist or a practitioner, the name of the province in which the person's current professional licence, certification or authorization was issued and the professional licence, certification or authorization number; (e) the name and gender of the individuals authorized to place an order for a restricted drug on behalf of the applicant; (f) the activities referred to in section J.01.003 for which the licence is sought that would be carried out at the premises to which the dealer's licence would apply; (g) in the case of a product or compound that contains a restricted drug but is not a test kit and that would be made or assembled for or by the applicant, a list that sets out
(ii) the restricted drug in each product or compound, (iii) the strength per unit of the restricted drug in each product or compound, (iv) the quantity or package sizes of each product or compound, and (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and the dealer's licence number of the other dealer; (h) if the licence is sought to produce a restricted drug other than a product or compound that contains a restricted drug
(ii) the quantity that the applicant expects to produce under the dealer's licence and the period during which that quantity would be produced, and (iii) if the restricted drug would be produced for another licensed dealer under a custom order, the name, address and licence number of the other dealer; (i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive; (j) a detailed description of the method that the applicant proposes to use for recording their restricted drug transactions; and (k) for any activity referred to in section J.01.003, other than the activities described in paragraphs (g) and (h), the restricted drug and the purpose for carrying out the activity. (2) An application for a dealer's licence must (a) be signed by the individual in charge of the premises to which the licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual in charge has the authority to bind the applicant. (3) An application for a dealer's licence must be accompanied by (a) declarations signed by the individual in charge of the premises, the qualified person in charge and, if applicable, the alternate qualified person in charge, stating that they have not been convicted, as an adult, during the previous 10 years of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); (b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years of a designated drug offence or a designated criminal offence; (c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada; (d) a statement, signed and dated by the individual in charge of the premises, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience required under paragraph J.01.003.2(2)(a); (e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner registered with a licensing body of a province, a copy of the person's degree required under paragraph J.01.003.2(2)(b) and a copy of the course transcript for that degree; (f) if the applicant's name appears on the label of a product or compound that contains a restricted drug, a copy of the inner label, as defined in section A.01.010, for each product or compound to which the licence would apply; and (g) if the applicant is a corporation, a copy of
(ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer's licence or intends to identify itself. (4) The method proposed by the applicant under paragraph (1)(j) must (a) allow for the recording of restricted drug transactions in accordance with section J.01.021; and (b) permit the Minister to audit the activities of the licensed dealer with respect to restricted drugs. (5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing (a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years; (b) to provide all information and to submit to any means of identification required to obtain criminal record check; and (c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations. J.01.007.1. The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application. J.01.007.2. Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under sections J.01.007 and J.01.007.1, issue a dealer's licence that contains: (a) the licence number; (b) the name of the licensee or, if the applicant is a corporation, its corporate name; (c) a list of the activities that are permitted; (d) the address of the premises at which the licensed dealer may carry on the permitted activities; (e) the name of the restricted drug for which the activities are permitted; (f) the security level at the premises; (g) the effective date of the licence; (h) the expiry date of the licence, which may not be later than three years after its effective date; (i) any conditions to be met by the holder of the licence to
(ii) provide the security level referred to in paragraph (f), or (iii) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use; (j) in the case of a producer of a restricted drug, the quantity of the restricted drug that may be produced under the licence and the period during which that quantity may be produced; and (k) in the case of the maker or assembler of a product or compound that contains a restricted drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:
(ii) the name, number or identifying mark, if any, of each product or compound, (iii) the restricted drug in each product or compound, (iv) the strength per unit of the restricted drug in each product or compound, and (v) the quantity or package sizes of each product or compound. J.01.007.3. (1) The Minister shall refuse to issue, renew or amend a dealer's licence if: (a) the applicant is not eligible under section J.01.003.1; (b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section J.01.025; (c) false or misleading information or false or falsified documents were submitted in or with the application; (d) an activity for which the licence is requested would not be in compliance with an international obligation; (e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation; (f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested; (g) the applicant is in contravention of or has contravened during the preceding 10 years
(ii) a term or condition of another dealer's licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act; (h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a restricted drug being diverted to an illicit market or use; (i) the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has been convicted, as an adult, within the previous 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); (j) the proposed method referred to in paragraph J.01.007(1)(j) is not capable of recording the applicant's restricted drug transactions as required under section J.01.023 or permitting the Minister to audit the applicant's activities with respect to restricted drugs in a timely manner; or (k) the additional information required under section J.01.007.1 has not been provided or is insufficient to process the application. (2) The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant (a) does not have a history of non-compliance with the Act or any regulation made or continued under it; and (b) has carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations. J.01.007.4. (1) To apply to renew a dealer's licence, a licensed dealer must submit to the Minister (a) the information required under paragraphs J.01.007(1)(a) to (k); and (b) the following documents, namely,
(ii) if applicable and if not previously submitted in respect of the dealer's licence that is being renewed, the document referred to in paragraph J.01.007(3)(e), and (iii) the original dealer's licence that is to be renewed. (2) An application for renewal must (a) be signed by the individual in charge of the premises to which the renewed dealer's licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual in charge has the authority to bind the applicant. (3) Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section J.01.007.1, issue a renewed dealer's licence that contains the information specified in paragraphs J.01.007.2(a) to (k). J.01.007.5. (1) To have its dealer's licence amended, a licensed dealer shall submit to the Minister (a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section J.01.007 that are relevant to the proposed amendment; and (b) the original dealer's licence. (2) An application for amendment must (a) be signed by the individual in charge of the premises to which the amended dealer's licence would apply; and (b) be accompanied by a statement signed by the individual in charge indicating that
(ii) the individual in charge has the authority to bind the applicant. (3) Subject to section J.01.007.3, the Minister shall, after examining the request for amendment and the supporting documentation, amend the dealer's licence in accordance with the request and may add any conditions to be met by the holder of the licence to (a) ensure that an international obligation is respected; (b) provide for the security level referred to in paragraph J.01.007.2(f) or the new level required as a result of the amendment being implemented; or (c) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use. J.01.007.6. (1) A licensed dealer shall (a) obtain the Minister's approval before making any of the following changes, namely,
(ii) the replacement or the addition of
(B) a qualified person in charge and, if applicable, an alternate qualified person in charge at the premises to which the dealer's licence applies, and (C) an individual authorized to place an order for a restricted drug on behalf of the licensed dealer; (b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in
(ii) the application to renew a dealer's licence under section J.01.007.4, or (iii) the request for approval under paragraph (a); and (c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in
(ii) the application to renew a dealer's licence under section J.01.007.4, or (iii) the request for approval under paragraph (a). (2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person: (a) in the case of the replacement of the individual in charge of the premises to which the dealer's licence applies,
(ii) the declarations specified in paragraph J.01.007(3)(a) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c); (b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer's licence applies,
(ii) the documents specified in paragraphs J.01.007(3)(a), (d) and (e) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c); and (c) in the case of the replacement or addition of an individual who is authorized to place an order for a restricted drug on behalf of the licensed dealer, the individual's name and gender. J.01.007.7. The Minister shall revoke a dealer's licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen. J.01.007.8. (1) Subject to subsection (2), the Minister shall revoke a dealer's licence in accordance with section J.01.007.91 if: (a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application; (b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part; (c) the licensed dealer is no longer an eligible person under section J.01.003.1; (d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises, has been convicted, as an adult, within the previous 10 years, of
(ii) a designated criminal offence, or (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or (e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use. (2) The Minister is not required to revoke a dealer's licence under paragraphs (1)(a) or (b) if the licensed dealer (a) has no history of non-compliance with the Act and the regulations made or continued under it; and (b) has carried out, or signed an undertaking to carry out, corrective measures to ensure compliance with the Act and these Regulations. J.01.007.9. The Minister shall suspend a dealer's licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a restricted drug from being diverted to an illicit market or use. J.01.007.91. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a licence under this Part, the Minister shall (a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and (b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation. (2) The suspension of a licence under this Part takes effect as soon as the Minister informs the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension. (3) A person who receives a notice of suspension referred to in subsection (2) may, in the 10 days following the receipt of the notice, provide the Minister with reasons why the suspension of the licence is unfounded. 34. Sections J.01.011 to J.01.013 of the Regulations are replaced by the following: J.01.011. A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the restricted drugs specified in their dealer's licence. J.01.012. The Minister shall revoke or suspend a permit issued under this Part if the Minister determines that the person to whom it was issued has failed to comply with any term or condition of the permit or any provision of this Part. J.01.013. A dealer's licence is valid until the earlier of (a) the expiry date set out in the licence; and (b) the revocation or suspension of the licence under section J.01.007.7, J.01.007.8 or J.01.007.9. 35. Paragraphs J.01.023(a) to (d) of the Regulations are replaced by the following: (a) the name, quantity and form of any restricted drug received by them, the name and address of the person who sold or provided it and the date it was received; (b) the name, quantity and form of any restricted drug sold or provided by them, the name and address of the person to whom it was sold or provided and the date it was sold or provided; (c) the name, quantity and form of any restricted drug they have used in making or assembling a product or compound containing that restricted drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock; (d) the name and quantity of any restricted drug produced and the date on which it was placed in stock; and 36. Section J.01.025 of the Regulations is replaced by the following: J.01.025. (1) The Minister may, in respect of a licensed dealer, require an inspection to be made, at any reasonable time, of (a) the premises used or intended to be used in producing, making, assembling or storing a restricted drug; (b) the process and conditions of the producing, making, assembling or storing; and (c) the records relating to the producing, making, assembling or storing. (2) The Minister may, in respect of a licensed dealer, require a verification to be made, at any reasonable time, of the qualifications of its technical staff concerned with producing, making, assembling or storing a restricted drug. 37. The portion of section J.01.026 of the Regulations before paragraph (a) is replaced by the following: J.01.026. Every person who sells or provides a restricted drug shall 38. Paragraphs J.01.027(b) and (c) of the Regulations are replaced by the following: (b) in the premises in which a restricted drug is produced, made, assembled or stored; and (c) in the process and conditions of producing, making, assembly or storage of a restricted drug. 39. Paragraph J.01.032(f) of the Regulations is replaced by the following: (f) the name and address of the producer, maker or assembler of the drug. 40. (1) The portion of subsection J.01.033(3) of the Regulations before paragraph (a) is replaced by the following: (3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a restricted drug, provide or deliver the restricted drug that they have in their possession to (2) The portion of subsection J.01.033(4) of the Regulations before paragraph (a) is replaced by the following: (4) if an agent of a practitioner has received a restricted drug under subsection (3), the agent shall immediately provide or deliver it (3) The portion of subsection J.01.033(5) of the Regulations before paragraph (a) is replaced by the following: (5) A practitioner who has received a restricted drug under subsection (3) or (4) shall immediately provide or deliver it 41. Subparagraph J.01.033.1(b)(i) of the Regulations is replaced by the following:
COMING INTO FORCE 42. These Regulations come into force on the day on which they are registered. [38-1-o] Regulations Amending the Collision RegulationsStatutory Authority Canada Shipping Act and Arctic Waters Pollution Prevention Act Sponsoring Department Department of Transport REGULATORY IMPACT Description The Collision Regulations promote uniform measures and ensure safe conduct of vessels by giving effect to the Convention on the International Regulations for Preventing Collisions at Sea, 1972 (COLREG Convention) and include Canadian modifications to those Regulations. The Collision Regulations describe the navigation conduct to be followed, steering and sailing rules, lights and shapes to be displayed, and the sound and light signals to be used by every vessel in Canadian waters and fishing zones and shipping safety zones and by every Canadian vessel in any waters in order to avoid a collision situation. These proposed Regulations amend the Collision Regulations for the following reasons: (a) To give effect to internationally agreed amendments to the COLREG Convention; (b) To give effect to an international requirement contained in Regulation V/10.7 of the International Convention for the Safety of Life at Sea, 1974 (Safety Convention) concerning mandatory ships' routing systems adopted by the International Maritime Organization (IMO); (c) To correct a previous amendment made to the Collision Regulations to maintain consistency with the language used in the COLREG Convention; and (d) To include requirements that specifically address the lighting of log tows. The International Maritime Organization adopted international amendments to the COLREG Convention in 2001 by Resolution A.910(22). These amendments come into force internationally on November 29, 2003. The amendments include, among other things: requirements to take into account Wing-in-Ground (WIG) craft for the first time, a clarification of Rule 8 concerning actions to avoid collisions, changes to no longer require the sounding of a bell on vessels of 12 metres or more in length but less than 20 metres, and modifications to some of the technical specifications contained in Annexes I and III. In Annex IV, references to two international publications have also been updated. On July 1, 2002, a revised Chapter V of the Safety Convention on Safety of Navigation came into force internationally. While other Canadian regulations are in the process of being amended to recognize the various new requirements of Chapter V, it is proposed in this amendment to locate new Regulation V/10.7 concerning the use of mandatory ship routing systems that have been adopted by the IMO in the Collision Regulations under Rule 10. A Canadian modification already exists in Rule 10 that addresses routing system requirements. In November 2002, amendments were made to the Collision Regulations to take into account concerns raised by the Standing Joint Committee for the Scrutiny of Regulations (SJC). The SJC expressed concerns over a number of apparent inconsistencies between the English and French text, primarily where the English text makes use of the words "practicable" and "possible" yet the French text only uses "possible". To try to address their concern, the amendment in November 2002 made several changes and replaced the English word "possible" with the word "practicable" throughout. On reflection, that amendment was in error since the Collision Regulations, other than the Canadian modifications, incorporate word for word the text of the COLREG Convention. This helps to ensure a consistent interpretation and understanding among mariners, which is essential for the Convention's global application. There is therefore no intention to change the terms of the COLREG Convention on its incorporation into the Collision Regulations. Also, under the COLREG Convention, the English and French texts are equally authentic. Lastly, it is proposed that the Collision Regulations be amended to specifically address the lighting of log tows. This is proposed as a result of a review that was initiated after the Council of Marine Carriers requested that current log tow lighting arrangements be recognized in the Collision Regulations. Current practice is to have a kerosene or oil lamp on each corner of the log tow. Such lights exhibit a white all-round light, with a visibility range of less than 2 miles. The Collision Regulations require inconspicuous, partly submerged towed objects or vessels that exceed 100 metres in length to exhibit a 3-mile all-round white light every 100 m along each side (Rule 24(g)). A typical log tow would therefore require 10 lights. However, the Collision Regulations also allow that where Rule 24(g) is impracticable, all possible measures must be taken to light the tow to indicate its presence (Rule 24(h)). To fit 10 lights to each log tow in compliance with Rule 24(g) is considered by towboat operators to be impracticable, costly and unnecessary from a safety perspective. The new Canadian modification, recognizing that full compliance with Rule 24(g) is impracticable for log tows, builds upon current practices and would require large log tows to carry two all-round white lights, one in the mid-point of each side of its length in addition to an all-round white light at each corner. Furthermore, it is proposed that lights used on log tows need not meet the vertical sector requirements of Annex I to Schedule I, as is currently the case for certain unmanned barges. This would allow log tows to make use of portable, battery powered lights instead of the kerosene lights. The advantage of this is that the portable lights will have a 3-mile range of visibility as required by the Collision Regulations, as opposed to the less than 2-mile range of the kerosene lights. This will help to address concerns raised by the Transportation Safety Board in recent years about the use of navigation lights in towing operations that may not have adequate visibility ranges to minimize risk of collision. Alternatives There are no alternatives to the proposed amendments that are the result of changes to the COLREG Convention and the Safety Convention. Canada is a Party to these conventions and has agreed to give effect to their requirements. With respect to the proposed amendments to correct changes that were made to address SJC concerns, the status quo would not be appropriate. Apart from the current text being inconsistent with the COLREG Convention, the differences between the international and Canadian text could cause confusion and differences in interpretation by mariners. The proposed amendment must therefore be made. For log tow lighting, consideration was given to among other things: the status quo, different spacing between the white all-round lights along the length of the tow, a single additional light in the middle, adding a light in mid-length along each side and use of a searchlight. It was also noted that the Collision Regulations allow alternative lighting for barges and in particular Rule 24(m), which requires an all-round white light located at the middle point for tows over 100 m. After reviewing the alternatives, the proposed amendment was determined to be the most suitable. Benefits and Costs There are no implementation costs associated with the international amendments and the correction that will revert to the international text other than the cost to the Government to process the amendment. As the international amendments were primarily intended to address safety concerns, the benefits will be improved safety at sea and protection of the marine environment. With respect to the log tow lighting requirements, large log tows will require two additional lights compared to current lighting practices, each light having a purchase cost of about $223. The lights will require a battery replacement, the cost of which is $3 after every seven days of use. However, the costs are substantially less than what the costs would be if the log tows were to comply with the international requirements for a partly submerged object being towed. The additional light requirements for log tows are considered to be an improvement over existing practices from a safety perspective with minimal additional costs. At the same time, the impracticality of full compliance with the international requirements for a partly submerged object being towed is recognized. Consultation The proposed amendments resulting from the amendments to the COLREG Convention and Chapter V of the Safety Convention have been communicated to the marine industry at national Canadian Marine Advisory Council (CMAC) meetings of the Standing Committee on Navigation and Operations. In the last two years, there have been numerous consultations with the marine industry and stakeholders concerning the log tow lighting proposed amendments. Consultations have taken place at both the Pacific Regional CMAC and the national CMAC. There have also been two Pacific regional working groups that have reviewed log tow lighting practices, accident information, alternatives and the present proposal. The proposed lighting arrangement has been communicated widely among the marine industry on the west coast. Most recently, at the March 2003 Pacific Regional CMAC and the May 2003 national CMAC meeting of the Standing Committee on Navigation and Operations, the marine industry was advised of the proposed lighting arrangement. To date there have been no negative comments on the proposed lighting requirements, but many comments from various sectors of the marine industry have expressed support for the proposal. Among those consulted were ship masters, recreational vessel associations, a port authority, towboat operators, the Canadian Coast Guard and the Transportation Safety Board. Compliance and Enforcement Compliance with the Collision Regulations is routinely carried out through statutory and periodic inspections by Marine Safety inspectors and by monitoring or responding to reports and complaints from other ships, government agencies, or the general public. Penalties for contravention of the Collision Regulations are contained in section 562.14 of the Canada Shipping Act. Robert Turner, AMSEC, Manager, Navigation Safety and Radiocommunications, Ships and Operations Standards, Department of Transport, Marine Safety, Place de Ville, Tower C, 330 Sparks Street, Ottawa, Ontario K1A 0N8, (613) 991-3134 (Telephone), (613) 993-8196 (Facsimile). Notice is hereby given, pursuant to subsection 562.12(1) (see footnote f) of the Canada Shipping Act, that the Governor in Council, pursuant to section 314 (see footnote g) and subsection 562.11(1) (see footnote h) of that Act and subparagraph 12(1)(a)(ii) of the Arctic Waters Pollution Prevention Act, proposes to make the annexed Regulations Amending the Collision Regulations. Ship owners, masters, seamen and other interested persons may make representations with respect to the proposed Regulations to the Minister of Transport within 60 days after the date of publication of this notice. All such representations must be in writing and cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to Robert Turner, Manager, Navigation Safety and Radiocommunications, Ships and Operations Standards, Marine Safety, Department of Transport, Place de Ville, Tower C, 330 Sparks Street, Ottawa, Ontario K1A 0N8. (Tel.: (613) 991-3134; fax: 613-993-8196; e-mail: turnerr@tc.gc.ca) Ottawa, September 18, 2003
EILEEN BOYD
REGULATIONS AMENDING THE COLLISION REGULATIONS AMENDMENTS 1. The definition "high-speed craft" in subsection 2(1) of the Collision Regulations (see footnote 7) is repealed. 2. (1) Paragraph (a) of Rule 3 of Schedule I to the Regulations is replaced by the following: (a) The word "vessel" includes every description of water craft, including non-displacement craft, WIG craft and seaplanes, used or capable of being used as a means of transportation on water. (2) Rule 3 of Schedule I to the Regulations is amended by adding the following after paragraph (l): (m) The term "Wing-in-Ground (WIG) craft" means a multimodal craft which, in its main operational mode, flies in close proximity to the surface by utilizing surface-effect action. 3. Paragraph (a) of Rule 8 of Schedule I to the Regulations is replaced by the following: (a) Any action to avoid collision shall be taken in accordance with the Rules of this Part and shall, if the circumstances of the case admit, be positive, made in ample time and with due regard to the observance of good seamanship. 4. Paragraph (a) of Rule 9 of Schedule I to the French version of the Regulations is replaced by the following: a) Les navires faisant route dans un chenal étroit ou une voie d'accès doivent, lorsque cela peut se faire sans danger, naviguer aussi près que possible de la limite extérieure droite du chenal ou de la voie d'accès. 5. (1) Rule 10 of Schedule I to the Regulations is amended by adding the following after paragraph (n): (n.1) A vessel shall use a mandatory ship routing system adopted by the International Maritime Organization as required for its category or the cargo carried and shall conform to the relevant provisions in force unless there are compelling reasons not to use a particular ship routing system. Any such reason shall be recorded in the vessel's log-book. (2) The portion of subparagraph (p)(iii) of Rule 10 of Schedule I to the English version of the Regulations before clause (A) is replaced by the following:
6. Rule 18 of Schedule I to the Regulations is amended by adding the following after paragraph (e): (f) (i) A WIG craft shall, when taking off, landing and in flight near the surface, keep well clear of all other vessels and avoid impeding their navigation.
7. Paragraphs (c) to (e) of Rule 23 of Schedule I to the Regulations are replaced by the following: (c) A WIG craft only when taking off, landing and in flight near the surface shall, in addition to the lights prescribed in paragraph (a) of this Rule, exhibit a high intensity all-round flashing red light. (d) (i) A power-driven vessel of less than 12 metres in length may in lieu of the lights prescribed in paragraph (a) of this Rule exhibit an all-round white light and sidelights.
Power-driven Vessels Underway—Canadian Modifications (e) Rule 23(d)(ii) does not apply to a Canadian power-driven vessel in any waters or to a non-Canadian power-driven vessel in the Canadian waters of a roadstead, harbour, river, lake or inland waterway. (f) In the waters of the Great Lakes Basin, a power-driven vessel when underway may, instead of the second masthead light and sternlight prescribed in paragraph (a), carry, in the position of the second masthead light, a single all-round white light or two such lights placed not over 800 millimetres apart horizontally, one on either side of the keel and so arranged that one or the other or both shall be visible from any angle of approach and for the same minimum range as the masthead lights. 8. Rule 24 of Schedule I to the Regulations is amended by adding the following after paragraph (p): (q) For the purpose of paragraph (h), within the Canadian waters of a roadstead, harbour, river, lake or inland waterway, where it is impracticable for a log tow to comply with paragraph (g), the log tow shall exhibit
(ii) if it is less than 25 metres in breadth and exceeds 100 metres in length, one additional all-round white light at or near the mid-point of one side of the length, (iii) if it is 25 metres or more in breadth, a total of four all-round white lights, one at or near each corner, and (iv) if it is 25 metres or more in breadth and exceeds 100 metres in length, an additional all-round white light at or near the mid-point of each side of the length. 9. Rule 31 of Schedule I to the Regulations is replaced by the following: RULE 31 Seaplanes Where it is impracticable for a seaplane or a WIG craft to exhibit lights and shapes of the characteristics or in the positions prescribed in the Rules of this Part she shall exhibit lights and shapes as closely similar in characteristics and position as is possible. 10. Paragraph (a) of Rule 33 of Schedule I to the Regulations is replaced by the following: (a) A vessel of 12 metres or more in length shall be provided with a whistle, a vessel of 20 metres or more in length shall be provided with a bell in addition to a whistle, and a vessel of 100 metres or more in length shall, in addition, be provided with a gong, the tone and sound of which cannot be confused with that of the bell. The whistle, bell and gong shall comply with the specification in Annex III to these Regulations. The bell or gong or both may be replaced by other equipment having the same respective sound characteristics, provided that manual sounding of the prescribed signals shall always be possible. 11. Paragraphs (i) to (k) of Rule 35 of Schedule I to the Regulations are replaced by the following: (i) A vessel of 12 metres or more but less than 20 metres in length shall not be obliged to give the bell signals prescribed in paragraphs (g) and (h) of this Rule. However, if she does not, she shall make some other efficient sound signal at intervals of not more than 2 minutes. (j) A vessel of less than 12 metres in length shall not be obliged to give the above-mentioned signals but, if she does not, shall make some other efficient sound signal at intervals of not more than 2 minutes. (k) A pilot vessel when engaged on pilotage duty may in addition to the signals prescribed in paragraphs (a), (b) or (g) of this Rule sound an identity signal consisting of four short blasts. Sound Signals in Restricted Visibility—Canadian Modification (l) Notwithstanding paragraph (j), in the Canadian waters of a roadstead, harbour, river, lake or inland waterway, a vessel that is
(ii) built or converted for the purpose of pushing or pulling any floating object, and (iii) not located within a recognized mooring, storage or booming area shall sound the signals prescribed for a vessel of 12 metres or more in length. 12. Paragraph 3(d) of Annex I to Schedule I to the French version of the Regulations is replaced by the following: d) Lorsqu'un seul feu de tête de mât est prescrit pour un navire à propulsion mécanique, ce feu doit se trouver en avant de la demi-longueur du navire; dans le cas d'un navire d'une longueur inférieure à 20 m, le feu n'a pas à être placé en avant de la demi-longueur du navire, mais il doit être placé aussi à l'avant qu'il est possible dans la pratique. 13. Subparagraph 9(b)(ii) of Annex I to Schedule I to the French version of the Regulations is replaced by the following: (ii) S'il est impossible dans la pratique de satisfaire au sous-alinéa (i) en plaçant un seul feu visible sur tout l'horizon, deux feux visibles sur tout l'horizon doivent être utilisés et convenablement placés ou masqués de manière à être perçus, dans la mesure du possible, comme un feu unique à une distance de un mille. 14. Paragraph 10(d) of Annex I to Schedule I to the Regulations is replaced by the following: (d) Where from any sufficient cause it is impracticable for an unmanned barge or log tow in Canadian waters of a roadstead, harbour, river, lake or inland waterway to exhibit lights that comply with the vertical sector requirements of paragraph (a), the lights on the unmanned barge or log tow need not comply with the vertical sector requirements but shall maintain the required minimum intensity on the horizontal. 15. Section 13 of Annex I to Schedule I to the Regulations is replaced by the following: 13. High-speed Craft* (a) The masthead light of high-speed craft may be placed at a height related to the breadth of the craft lower than that prescribed in subparagraph 2(a)(i) of this Annex, provided that the base angle of the isosceles triangles formed by the sidelights and masthead light, when seen in end elevation, is not less than 27°. (b) On high-speed craft of 50 metres or more in length, the vertical separation between foremast and mainmast light of 4.5 metres required by subparagraph 2(a)(ii) of this Annex may be modified provided that such distance shall not be less than the value determined by the following formula: 
where y is the height of the mainmast light above the foremast light in metres; a is the height of the foremast light above the water surface in service condition in metres; ψ is the trim in service condition in degrees; and C is the horizontal separation of masthead lights in metres. * Refer to the International Code of Safety for High-Speed Craft, 1994 and the International Code of Safety for High-Speed Craft, 2000. 16. (1) Paragraph 1(a) of Annex III to Schedule I to the Regulations is replaced by the following: (a) Frequencies and range of audibility
(2) Paragraph 1(c) of Annex III to Schedule I to the Regulations is replaced by the following: (c) Sound signal intensity and range of audibility
*1 When the measured frequencies lie within the range 180-450Hz *2 When the measured frequencies lie within the range 450-800Hz *3 When the measured frequencies lie within the range 800-2100Hz
17. Paragraph 2(b) of Annex III to Schedule I to the Regulations is replaced by the following: (b) Construction Bells and gongs shall be made of corrosion-resistant material and designed to give a clear tone. The diameter of the mouth of the bell shall be not less than 300 mm for vessels of 20 metres or more in length. Where practicable, a power-driven bell striker is recommended to ensure constant force but manual operation shall be possible. The mass of the striker shall be not less than 3% of the mass of the bell. 18. The portion of section 3 of Annex IV to Schedule I to the Regulations before paragraph (a) is replaced by the following: 3. Attention is drawn to the relevant sections of the International Code of Signals, the Merchant Ship Search and Rescue Manual and the following signals: 19. Annex IV to Schedule I to the Regulations is amended by adding the following after section 5: 6. For the purpose of section 3, attention is also drawn to the relevant sections of the International Aeronautical and Maritime Search and Rescue Manual (IAMSAR), Volume III, Mobile Facilities, published by the International Maritime Organization, as amended from time to time. 20. The English version of the Regulations is amended by replacing the word "practicable" with the word "possible" wherever it occurs in the following provisions: (a) subsection 3(5); (b) paragraphs (b) and (c) of Rule 1 of Schedule I; (c) paragraph (e) of Rule 1 of Schedule I; (d) subparagraph (b)(vi) of Rule 6 of Schedule I; (e) Rule 16 of Schedule I; (f) the portion of paragraph (c) of Rule 18 of Schedule I before subparagraph (i); (g) the portion of paragraph (d) of Rule 19 of Schedule I before subparagraph (i); (h) paragraphs (h) and (i) of Rule 24 of Schedule I; (i) paragraph (m) of Rule 24 of Schedule I; and (j) paragraph 10(c) of Annex I to Schedule I. COMING INTO FORCE 21. These Regulations come into force on the day on which they are registered. [38-1-o] S.C. 2000, c. 12, s. 142 (Sch. 2, par. 1(z.34)) R.S., c. 1 (5th Supp.) C.R.C., c. 945 S.C. 1991, c. 1, s. 12 SOR/93-53 S.C. 1996, c. 19 C.R.C., c. 1041 SOR/98-156 SOR/2001-227 S.C. 1996, c. 19 C.R.C., c. 870 R.S., c. 6 (3rd Supp.), s. 78 R.S., c. 6 (3rd Supp.), s. 35 R.S., c. 6 (3rd Supp.), s. 78 C.R.C., c. 1416 |
|||||||||||||||||||||||||||||||||||||||||
|
NOTICE:
|
||||||||||||||||||||||||||||||||||||||||||
