Division 5: Drugs For Clinical Trials Involving Human Subjects

“adverse drug reaction” means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue)

“adverse event” means any adverse occurrence in the health of a clinical trial subject who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. (incident thérapeutique)

“clinical trial” means an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. (essai clinique)

“drug” means a drug for human use that is to be tested in a clinical trial. (drogue)

“good clinical practices” means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010. (bonnes pratiques cliniques)

“import” means to import a drug into Canada for the purpose of sale in a clinical trial. (importer)

“investigator’s brochure” means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005(e). (brochure du chercheur)

“protocol” means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. (protocole)

“qualified investigator” means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is

(a) in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and

(b) in any other case, a physician and a member in good standing of a professional medical association. (chercheur qualifié)

“research ethics board” means a body that is not affiliated with the sponsor, and

(a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and

(b) that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, that is composed of both men and women and that includes at least

(i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline,

(iii) one member knowledgeable in Canadian laws relevant to the biomedical research to be approved,

(iv) one member whose primary experience and expertise are in a non-scientific discipline, and

(v) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted. (comité d’éthique de la recherche)

“serious adverse drug reaction” means an adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave à une drogue)

“serious unexpected adverse drug reaction” means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out in the investigator’s brochure or on the label of the drug. (réaction indésirable grave et imprévue à une drogue)

“sponsor” means an individual, corporate body, institution or organization that conducts a clinical trial. (promoteur)

C.05.002. (1) Subject to subsection (2), this Division applies to the sale or importation of drugs to be used for the purposes of clinical trials involving human subjects.

(2) Except for paragraph C.05.003(a), subsections C.05.006(2) and (3), paragraphs C.05.010(a) to (i), section C.05.011, subsections C.05.012(1) and (2), paragraphs C.05.012(3)(a) to (d) and (f) to (h), subsection C.05.012(4) and sections C.05.013, C.05.016 and C.05.017, this Division does not apply to the sale or importation of a drug for the purposes of a clinical trial authorized under subsection C.05.006(2).

C.05.003. Despite sections C.01.014, C.08.002 and C.08.003, no person shall sell or import a drug for the purposes of a clinical trial unless

(b) the person complies with this Division and sections C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136, and C.01.435; and

(c) if the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug.

C.05.004. Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in a therapeutic benefit for a human being.

C.05.005. An application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial under this Division shall be submitted to the Minister, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer and shall contain the following information and documents:

(b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial;

(c) a clinical trial attestation, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, containing

(vii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor,

(viii) if the drug is to be imported, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor’s representative in Canada who is responsible for the sale of the drug,

(ix) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the qualified investigator, if known at the time of submitting the application,

(x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and

(A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and

(B) that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading;

(d) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application;

(e) an investigator’s brochure that contains the following information, namely,

(ii) the pharmacological aspects of the drug, including its metabolites in all animal species tested,

(iii) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested,

(iv) any toxicological effects in any animal species tested under a single dose study, a repeated dose study or a special study in respect of the drug,

(v) any results of carcinogenicity studies in any animal species tested in respect of the drug,

(vii) any information regarding drug safety, pharmacodynamics, efficacy and dose responses of the drug that were obtained from previous clinical trials in humans, and

(viii) if the drug is a radiopharmaceutical as defined in section C.03.201, information regarding directions for preparing the radiopharmaceutical, the radiation dosimetry in respect of the prepared radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;

(f) if the drug contains a human-sourced excipient, including any used in the placebo,

(i) information that indicates the human-sourced excipient has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, issued a notice of compliance under subsection C.08.004(1), as the case may be, or

(ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the human-sourced excipient;

(g) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, a notice of compliance has not been issued under subsection C.08.004(1), the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and

(h) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application.

C.05.006. (1) Subject to subsection (3), a sponsor may sell or import a drug, other than a drug described in subsection (2), for the purposes of a clinical trial if

(a) the sponsor has submitted to the Minister an application in accordance with section C.05.005;

(b) the Minister does not, within 30 days after the date of receipt of the application, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug for any of the following reasons:

(B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or

(ii) that based on an assessment of the application, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that

(A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person,

(B) the clinical trial is contrary to the best interests of a clinical trial subject, or

(c) for each clinical trial site, the sponsor has obtained the approval of the research ethics board in respect of the protocol referred to in paragraph C.05.005(a) and in respect of an informed consent form that contains the statement referred to in paragraph C.05.005(b); and

(d) before the sale or importation of the drug at a clinical trial site, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h), if it was not submitted in respect of that clinical trial site at the time of submitting the application.

(2) Subject to subsection (3), a sponsor may sell or import a drug for the purposes of a clinical trial in respect of

(a) a new drug that has been issued a notice of compliance under subsection C.08.004(1), if the clinical trial is in respect of a purpose or condition of use for which the notice of compliance was issued; or

(b) a drug, other than a new drug, that has been assigned a drug identification number under subsection C.01.014.2(1), if the clinical trial is in respect of a use or purpose for which the drug identification number was assigned.

(3) A sponsor may not sell or import a drug for the purposes of a clinical trial

(a) during the period of any suspension made under section C.05.016 or C.05.017; or

C.05.007. If the sale or importation of a drug is authorized under this Division, the sponsor may make one or more of the following changes if the sponsor notifies the Minister in writing within 15 days after the date of the change:

(a) a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and

(b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008.

C.05.008. (1) Subject to subsections (4) and (5), when the sale or importation of a drug is authorized under this Division and the sponsor proposes to make an amendment referred to in subsection (2), the sponsor may sell or import the drug for the purposes of the clinical trial in accordance with the amended authorization, if the following conditions are met:

(a) the sponsor has submitted to the Minister an application for amendment in accordance with subsection (3);

(b) the Minister does not, within 30 days after the date of receipt of the application for amendment, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug in accordance with the amendment for any of the following reasons, namely,

(i) that the information and documents in respect of the application for amendment

(B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or

(ii) that based on an assessment of the application for amendment, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that

(A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person,

(B) the clinical trial is contrary to the best interests of a clinical trial subject, or

(i) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved any amended protocol submitted under paragraph (3)(a) or approved any amended statement submitted under paragraph (3)(c), and

(ii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve any amendment to the protocol, its reasons for doing so and the date on which the refusal was given;

(d) before the sale or importation of the drug, the sponsor maintains records concerning

(ii) the information referred to in subparagraph C.05.005(c)(ix), if any of that information has changed since it was submitted;

(e) before the sale or importation of the drug in accordance with the amended authorization, the sponsor ceases to sell or import the drug in accordance with the existing authorization; and

(f) the sponsor conducts the clinical trial in accordance with the amended authorization.

(a) amendments to the protocol that affect the selection, monitoring or dismissal of a clinical trial subject;

(b) amendments to the protocol that affect the evaluation of the clinical efficacy of the drug;

(e) amendments to the protocol that extend the duration of the clinical trial; and

(f) amendments to the chemistry and manufacturing information that may affect the safety or quality of the drug.

(3) The application for amendment referred to in subsection (1) shall contain a reference to the application submitted under section C.05.005 and shall contain the following documents and information:

(a) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (e), a copy of the amended protocol that indicates the amendment, a copy of the protocol submitted under paragraph C.05.005(a), and the rationale for the amendment;

(b) if the application is in respect of an amendment referred to in paragraph (2)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data;

(c) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (f) and, as a result of that amendment, it is necessary to amend the statement referred to in paragraph C.05.005(b), a copy of the amended statement that indicates the new information; and

(d) if the application is in respect of an amendment referred to in paragraph (2)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment.

(4) If the sponsor is required to immediately make one or more of the amendments referred to in subsection (2) because the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor may immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the date of the amendment.

(5) A sponsor may not sell or import a drug for the purposes of a clinical trial

(a) during the period of any suspension made under section C.05.016 or C.05.017; or

C.05.009. If the information and documents submitted in respect of an application under section C.05.005 or an application for amendment under section C.05.008 are insufficient to enable the Minister to determine whether any of the reasons referred to in paragraph C.05.006(1)(b) or C.05.008(1)(b) exist, the Minister may require the sponsor to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination.

C.05.010. Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that

(a) the clinical trial is scientifically sound and clearly described in a protocol;

(b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division;

(d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site;

(e) at each clinical trial site, there is no more than one qualified investigator;

(f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator;

(g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks;

(h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of

(i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and

(ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial;

(i) the requirements respecting information and records set out in section C.05.012 are met; and

(j) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 to 4 except sections C.02.019, C.02.025 and C.02.026.

C.05.011. Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages:

(a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator;

(h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi).

C.05.012. (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.

(2) The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations.

(3) The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial, including

(b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change;

(c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the adverse event;

(d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons;

(e) records respecting the shipment, receipt, disposition, return and destruction of the drug;

(f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that

(i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and

(ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons;

(g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and

(h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.

(4) The sponsor shall maintain all records referred to in this Division for a period of 25 years.

C.05.013. (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that

(a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;

(b) the clinical trial is contrary to the best interests of a clinical trial subject;

(d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or

(e) information submitted in respect of the drug or the clinical trial is false or misleading.

(2) The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons.

C.05.014. (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows:

(a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and

(b) if it is fatal or life threatening, within seven days after becoming aware of the information.

(2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made.

(3) Sections C.01.016 and C.01.017 do not apply to drugs used for the purposes of a clinical trial.

C.05.015. (1) If a clinical trial is discontinued by the sponsor in its entirety or at a clinical trial site, the sponsor shall

(a) inform the Minister no later than 15 days after the date of the discontinuance;

(b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor;

(c) as soon as possible, inform all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and

(d) in respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold.

(2) If the sponsor has discontinued the clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the drug for the purposes of a clinical trial in its entirety or at a clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h).

C.05.016. (1) Subject to subsection (2), the Minister shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that

(a) the sponsor has contravened these Regulations or any provisions of the Act relating to the drug;

(b) any information submitted in respect of the drug or clinical trial is false or misleading;

(i) information or samples of the drug as required under section C.05.009 or C.05.013, or

(2) Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless

(a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension;

(b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that

(ii) the situation giving rise to the intended suspension has been corrected; and

(3) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

(a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension has been corrected; or

(b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).

C.05.017. (1) The Minister shall suspend an authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor an opportunity to be heard if the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a clinical trial subject or other person.

(2) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

(a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension did not exist or that it has been corrected; or

(b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).

C.06.001. In this Division,

(b) tests for identity, quantitative tests for arsenic, lead, copper, zinc, fluorine, and sulphur dioxide, and limit tests shall be made by the official methods; and

C.06.002. [S]. Conjugated estrogens shall be the drug conjugated estrogens described in The Pharmacopeia of the United States of America, XVIII (1970), except that

(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

C.06.003. [S]. Conjugated estrogens for injection shall be the drug conjugated estrogens for injection described in The Pharmacopeia of the United States of America, XVIII (1970), except that

(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

C.06.004. [S]. Conjugated estrogens tablets shall be the drug conjugated estrogens tablets described in The Pharmacopeia of the United States of America, XVIII (1970), except that

(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

C.06.100. and C.06.101. [Repealed, SOR/80-544, s. 12]

C.06.120. [S]. Digitoxin shall be the drug digitoxin described in the Pharmacopeia of the United States of America.

C.06.121. [S]. Digitoxin tablets shall be the drug digitoxin tablets described in the Pharmacopeia of the United States of America.

C.06.130. [S]. Digoxin shall be the drug digoxin described in the Pharmacopeia of the United States of America.

C.06.131. [S]. Digoxin Elixir shall be the drug digoxin elixir described in the Pharmacopeia of the United States of America.

C.06.132. [S]. Digoxin injection shall be the drug digoxin injection described in the Pharmacopeia of the United States of America.

C.06.133. [S]. Digoxin tablets shall be the drug digoxin tablets described in the Pharmacopeia of the United States of America.

C.06.140. to C.06.142. [Repealed, SOR/80-544, s. 12]

C.06.150. to C.06.153. [Repealed, SOR/80-544, s. 12]

C.06.154. to C.06.156. [Repealed, SOR/80-544, s. 12]

C.06.157. to C.06.160. [Repealed, SOR/80-544, s. 12]

C.06.161. [S]. Esterified estrogens shall be the drug esterified estrogens described in the Pharmacopeia of the United States of America.

C.06.162. [S]. Esterified estrogens tablets shall be the drug esterified estrogens tablets described in the Pharmacopeia of the United States of America.

C.06.170. Gelatin shall be the drug gelatin described in the Pharmacopeia of the United States or the British Pharmacopeia.

C.06.180. to C.06.183. [Repealed, SOR/80-544, s. 12]

C.06.230. to C.06.233. [Repealed, SOR/80-544, s. 12]

C.06.240. to C.06.242. [Repealed, SOR/80-544, s. 12]

C.06.250. Thyroid shall be the cleaned, dried, powdered thyroid glands of domestic animals used for food, and shall contain not less than 0.17 per cent, and not more than 0.23 per cent iodine and no added iodine in either inorganic or organic form, and

(i) General,—thyroid occurs as a cream-coloured, amorphous powder; the odour and taste are faint and meat-like, and

(ii) Microscopical,—when suitably mounted and examined under the microscope, thyroid shows the following: numerous smooth to striated hyaline fragments of colloids, of angular to irregular shape, that are colourless to pale yellow in water mounts, brown in Mallory’s stain and pink in solution of eosin, some of these fragments containing granules, minute vacuoles, crystalloidal bodies and cells; numerous irregular fragments of follicular epithelium staining brown with Mallory’s stain, the individual cells more or less polygonal to rounded-angular or irregularly cuboidal, often with prominent nuclei staining dark blue, their cytoplasm purplish with Delafield’s solution of haematoxylin; slender glistening segments of capillaries of closely undulate outline; numerous slender segments of neuraxons; numerous aggregates of particles of intercellular substance and slender, mostly straight connective tissue fibres staining blue to greenish blue with a mixture of Mallory’s stain and solution of phosphotungstic acid, the bundles of fibres often appearing reddish in Mallory’s stain; few glistening fragments of blood vessels with serrated or crenated ends as viewed in water mounts; and

(i) Inorganic iodine,—add to one gram of thyroid 10 millilitres of a saturated solution of zinc sulphate in water, shake, allow to stand five minutes, and filter through a fritted glass filter; add to five millilitres of the filtrate 0.5 millilitre of mucilage of starch and four drops each of a 10 per cent w/v solution of sodium nitrite in water and dilute sulphuric acid, shaking after each addition: no blue colour is produced, and

C.06.251. Thyroid shall be

C.06.252. [Repealed, SOR/80-544, s. 12]

C.06.260. to C.06.264. [Repealed, SOR/80-544, s. 12]

C.06.270. to C.06.280. [Repealed, SOR/80-544, s. 12]

C.07.001. The definitions in this section apply in this Division.

“Commissioner of Patents” means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets)

“General Council Decision” has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)

C.07.002. This Division applies to the sale of drugs for the purposes of implementing the General Council Decision.

C.07.003. An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents:

(a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act;

(b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug;

(i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or

(ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2;

(d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug;

(e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and

(f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c).

C.07.004. The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer's drug meets the requirements of the Act and these Regulations if

(a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

(b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1;

(c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and

(d) the Minister is satisfied that the manufacturer and the drug comply with the Act and these Regulations.

C.07.005. Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if

(a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the drug meets the requirements of the Act and these Regulations; and

(b) the manufacturer has received authorization under section 21.04 of the Patent Act.

C.07.006. Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division.

C.07.007. The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer's drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations.

C.07.008. No person shall sell a drug under this Division unless

(a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid;

(b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and

(c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”

C.07.009. The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004.

C.07.010. The manufacturer shall, with respect to a drug authorized to be sold under this Division,

(a) establish and maintain records, in a manner that enables an audit to be made, respecting the information described in section C.08.007; and

C.07.011. The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug.