Division 8

(a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;

(b) a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or

(c) a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.

C.08.001.1. For the purposes of this Division,

(a) a drug in respect of which a notice of compliance is issued pursuant to section C.08.004 and which is marketed in Canada by the innovator of the drug,

(b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued pursuant to section C.08.004 cannot be used for that purpose because it is no longer marketed in Canada, or

(c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); (produit de référence canadien)

“pharmaceutical equivalent” means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; (équivalent pharmaceutique)

“specifications” means a detailed description of a new drug and of its ingredients and includes

(a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients,

(b) a detailed description of the methods used for testing and examining the ingredients, and

C.08.002. (1) No person shall sell or advertise a new drug unless

(a) the manufacturer of the new drug has filed with the Minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the Minister;

(b) the Minister has issued, pursuant to section C.08.004, a notice of compliance to the manufacturer of the new drug in respect of the new drug submission or abbreviated new drug submission;

(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with that new drug, and a statement setting out the proposed date on which those labels will first be used.

(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

(a) a description of the new drug and a statement of its proper name or its common name if there is no proper name;

(b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug;

(c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;

(d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;

(e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug;

(f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug;

(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;

(h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;

(i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;

(k) a statement of all the representations to be made for the promotion of the new drug respecting

(l) a description of the dosage form in which it is proposed that the new drug be sold;

(m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and

(n) for a drug intended for administration to food-producing animals, the withdrawal period of the new drug.

(3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of a new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:

(a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;

(d) any additional information or material respecting the safety and effectiveness of the new drug.

C.08.002.1. (1) A manufacturer of a new drug may file an abbreviated new drug submission for the new drug where, in comparison with a Canadian reference product,

(a) the new drug is the pharmaceutical equivalent of the Canadian reference product;

(b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics;

(d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product.

(2) An abbreviated new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

(a) the information and material described in paragraphs C.08.002(2)(a) to (f) and (j) to (l);

(b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission;

(ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies;

(d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and

(e) for a drug intended for administration to food-producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.

(3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of an abbreviated new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:

(d) any additional information or material respecting the safety and effectiveness of the new drug.

C.08.003. (1) Notwithstanding section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended pursuant to section C.08.006, if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission or abbreviated new drug submission, unless

(b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement;

(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any label, including any package insert, product brochure and file card, intended for use in connection with the new drug, where a change with respect to any of the matters specified in subsection (2) is made that would require a change to the label.

(2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following:

(b) the brand name of the new drug or the identifying name or code proposed for the new drug;

(d) the plant and equipment used in manufacturing, preparation and packaging the new drug;

(e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;

(f) the tests applied to control the potency, purity, stability and safety of the new drug;

(3) A supplement to a new drug submission or to an abbreviated new drug submission, with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters.

C.08.003.1. The Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed.

C.08.004. (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,

(a) if that 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, issue a notice of compliance; or

(b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

(2) Where a new drug submission or abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material.

(3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,

(a) if that 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, issue a notice of compliance; or

(b) if that submission or supplement does not comply with the requirements of section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

(4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

SOR/84-267, ss. 1 to 3; SOR/85-143, s. 3; SOR/86-1009, s. 1; SOR/86-1101, s. 1; SOR/88-42, s. 1; SOR/88-257, s. 1; SOR/95-411, s. 6.

C.08.004.1. (1) Where a manufacturer files a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or a supplement to an abbreviated new drug submission for the purpose of establishing the safety and effectiveness of the new drug for which the submission or supplement is filed, and the Minister examines any information or material filed with the Minister, in a new drug submission, by the innovator of a drug that contains a chemical or biological substance not previously approved for sale in Canada as a drug, and the Minister, in support of the manufacturer’s submission or supplement, relies on data contained in the information or material filed by the innovator, the Minister shall not issue a notice of compliance in respect of that submission or supplement earlier than five years after the date of issuance to the innovator of the notice of compliance or approval to market that drug, as the case may be, issued on the basis of the information or material filed by the innovator for that drug.

(2) Subsection (1) does not apply where the manufacturer of a new drug for which a notice of compliance was issued pursuant to section C.08.004 gives written permission to another manufacturer to rely on the test or other data filed in respect of that new drug.

(3) Subsection (1) does not apply where the data relied upon by the Minister was contained in information or material filed by the innovator before January 1, 1994.

C.08.005. (1) Subject to subsection (1.1) and notwithstanding sections C.08.002 and C.08.003, a manufacturer of a new drug may sell it to a qualified investigator to be used solely for the purpose of clinical testing to obtain evidence with respect to the safety, dosage and effectiveness of that new drug, when the following conditions are met:

(a) before the sale, the manufacturer has filed with the Minister, in compliance with section C.08.005.1, a preclinical submission containing information and material respecting

(i) the brand name of the new drug or the identifying name or code proposed for the new drug,

(ii) the chemical structure or other specific identification of the composition of the new drug,

(v) the results of investigations made to support the clinical use of the new drug,

(vi) the contra-indications and precautions known in respect of the new drug and the suggested treatment of overdosage of the new drug,

(viii) the methods, equipment, plant and controls used in the manufacture, processing and packaging of the new drug,

(ix) the tests applied to control the potency, purity and safety of the new drug, and

(x) the names and qualifications of all investigators to whom the drug is to be sold and the names of all institutions in which the clinical testing is to be carried out;

(b) the Director has not, within 60 days after the date of receipt of the preclinical submission, sent by registered mail to the manufacturer a notice in respect of that new drug indicating that the preclinical submission is not satisfactory;

(c) all inner labels and outer labels used in conjunction with the sale of the new drug to qualified investigators carry the statements

(ii) “To Be Used By Qualified Investigators Only” or “Réservée uniquement à l’usage de chercheurs compétents”;

(d) before the sale, the manufacturer ascertains that every qualified investigator to whom the new drug is to be sold

(i) has the facilities for the clinical testing to be conducted by the investigator, and

(ii) has received the information and material referred to in subparagraphs (a)(i) to (vi); and

(e) every qualified investigator to whom the new drug is to be sold has agreed in writing with the manufacturer that the investigator will

(i) not use the new drug or permit it to be used other than for clinical testing,

(ii) not permit the new drug to be used by any person other than the investigator except under the investigator’s direction,

(iii) report immediately to that manufacturer and, if so required by the Director, report to the Director all serious adverse reactions encountered during the clinical testing, and

(iv) account to the manufacturer for all quantities of the new drug received, where so requested by the manufacturer.

(2) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator unless that manufacturer has, in respect of all previous sales of that new drug to any qualified investigator,

(a) kept accurate records of the distribution of that new drug and of the results of the clinical testing and has made those records available to the Director for inspection on the request of the Director; and

(b) immediately reported to the Director all information he has obtained with respect to serious adverse reactions.

(3) The Minister may notify the manufacturer of a new drug that sales of that new drug to qualified investigators are prohibited if, in the opinion of the Minister, it is in the interest of public health to do so.

(4) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator if the Minister has notified the manufacturer of that drug that such sales are prohibited.

(5) Paragraph (1)(c) does not apply to a radiopharmaceutical as defined in section C.03.201 or to a component or kit as defined in section C.03.205.

SOR/79-236, s. 5; SOR/85-143, s. 4; SOR/87-511, s. 1; SOR/93-202, s. 26; SOR/95-411, s. 7; SOR/2001-203, s. 6.

C.08.005.1. (1) Every manufacturer who files a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission, a supplement to an abbreviated new drug submission or a submission for the clinical testing of a new drug for veterinary use shall, in addition to any information and material that is required under section C.08.002, C.08.003 and C.08.005, include in the submission or supplement

(a) a copy of all clinical case reports respecting any subject of a study included in the submission or supplement if that subject has died, suffered a serious adverse reaction or an unexpected adverse reaction, or the study, insofar as it relates to this subject, has not been completed;

(b) a sectional report in respect of each human, animal and in vitro study included in the submission or supplement;

(c) a comprehensive summary of each human, animal and in vitro study referred to or included in the submission or supplement; and

(d) a submission certificate in respect of all information and material contained in the submission or supplement and any additional information or material filed to amend the submission or supplement.

(b) a summary of any additional information or material filed to amend the submission or supplement; and

(ii) a cross-referencing of the data to the relevant portions of the sectional report,

(iii) a description of the conditions under which the experiments from which the data were obtained were conducted,

(3) The comprehensive summary referred to in paragraph (1)(c) shall include a summary of the methods used, results obtained and conclusions arrived at in respect of all studies referred to or included in the submission or supplement and shall be cross-referenced to the relevant portions of the sectional reports.

(a) certify that all information and material included in the submission or supplement and any additional information or material filed to amend the submission or supplement are accurate and complete, and that the sectional reports and the comprehensive summary correctly represent the information and material referred to or included in the submission or supplement; and

(i) the senior executive officer in Canada of the manufacturer filing the submission or supplement, and

(5) No person shall sign a submission certificate if a sectional report, comprehensive summary or any information or material included in the submission or supplement, or any additional information and material filed to amend the submission or supplement,

(6) Every manufacturer who has filed a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission, a supplement to an abbreviated new drug submission or a submission for the clinical testing of a new drug for veterinary use, and has any relating clinical case reports or raw data that were not included therein, shall keep those reports or data and shall, within 30 days after receiving a written request from the Minister, submit them to the Minister.

SOR/85-143, s. 5; SOR/92-543, s. 1; SOR/94-689, s. 2(F); SOR/95-411, s. 8; SOR/2001-203, s. 7.

C.08.006. (1) For the purposes of this section, evidence or new information obtained by the Minister includes any information or material filed by any person pursuant to Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1.

(2) The Minister may, by notice to a manufacturer, suspend, for a definite or indefinite period, a notice of compliance issued to that manufacturer in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission, if the Minister considers

(a) that the drug is not safe for the use represented in the submission or supplement, as shown by evidence obtained from

(i) clinical or other experience not reported in the submission or supplement or not available to the Minister at the time the notice of compliance was issued, or

(ii) tests by new methods or tests by methods not reasonably applicable at the time the notice of compliance was issued;

(b) that, upon the basis of new information obtained after the issuance of the notice of compliance, there is lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended or proposed by the manufacturer;

(d) that the manufacturer has failed to establish a system for maintaining required records or has repeatedly or deliberately failed to maintain such records;

(e) that, on the basis of new information obtained after the issuance of the notice of compliance, the methods, equipment, plant and controls used in the manufacturing, processing and packaging of the drug are inadequate to assure and preserve the identity, strength, quality or purity of the new drug; or

(f) that, on the basis of new information obtained after the issuance of the notice of compliance, the labelling of the drug is false or misleading or incomplete in any particular and that this defect was not corrected by the manufacturer upon receipt of a written notice from the Director specifying the respect in which the labelling is false or misleading or incomplete.

C.08.007. Where a manufacturer has received a notice of compliance issued in respect of a new drug submission or abbreviated new drug submission or a supplement to either submission, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting

(a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug;

(b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug;

(c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug;

(d) any substitution of another substance for that new drug or any mixing of another substance with that new drug;

(e) any error in the labelling of that new drug or in the use of the labels designed for that new drug;

(f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug;

(g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and

C.08.008. No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister

(a) on request, reports of all records respecting the information described in paragraphs C.08.007(a) to (c);

(b) immediately on receipt by the manufacturer, reports of all records respecting the information described in paragraphs C.08.007(d) to (f); and

(c) within 15 days after the receipt by the manufacturer of information referred to in paragraphs C.08.007(g) and (h), a report on the information received.

C.08.009. (1) Where the Minister has decided

(a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or

(b) to suspend a notice of compliance issued in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,

the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision.

(2) Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons.

(3) Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman.

(4) Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee.

(4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

(5) The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman.

(6) The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations.

(7) The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister.

(7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

(8) Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate.

C.08.010. (1) The Director may issue a letter of authorization authorizing the sale of a quantity of a new drug for human or veterinary use to a practitioner named in the letter of authorization for use in the emergency treatment of a patient under the care of that practitioner, if

(ii) the data in the possession of the practitioner with respect to the use, safety and efficacy of that drug,

(i) report to the manufacturer of the new drug and to the Director on the results of the use of the drug in the medical emergency, including information respecting any adverse reactions encountered, and

(ii) account to the Director on request for all quantities of the drug received by him.

(2) The Director shall, in any letter of authorization issued pursuant to subsection (1), state

C.08.011. (1) Notwithstanding section C.08.002, a manufacturer may sell to a practitioner named in a letter of authorization issued pursuant to section C.08.010, a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.

(2) A sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations.

C.08.012. (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if

(a) as regards the drug or drugs used as the medicating ingredient of the medicated feed,

(i) the Director has assigned a drug identification number pursuant to section C.01.014.2, or

(b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription;

(i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed,

(ii) the species, production type and age or weight of the animals to be treated with the medicated feed,

(iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients,

(B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and

(2) For the purpose of this section, “medicated feed” has the same meaning as in the Feeds Regulations.

C.08.013. (1) Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Director for the purpose of conducting an experimental study in animals if

(a) the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and

“experimental studies certificate” means a certificate issued pursuant to subsection C.08.015(1); (certificat d’études expérimentales)

“experimental studies investigator” means a person named as the investigator in an experimental studies certificate; (expert en études expérimentales)

“experimental study” means a limited test of a new drug in animals carried out by an experimental studies investigator. (étude expérimentale)

C.08.014. (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Director, in writing, the following information and material:

(a) the brand name of the new drug or the identifying name or code proposed for the new drug;

(b) the objectives and an outline of the proposed experimental study of the new drug;

(e) the address of the premises in which the experimental study is to be conducted;

(f) a description of the facilities to be used to conduct the experimental study;

(g) the name, address and qualifications of the proposed experimental studies investigator;

(h) the chemical structure, if known, and the relevant compositional characteristics of the new drug;

(i) the proposed quantity of the new drug to be used for the experimental study;

(j) the results of any toxicological or pharmacological studies that may have been conducted with the new drug;

(2) Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator.

(3) The Director may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other information that the Director requests and where such samples or information are not submitted, the Director may refuse to issue an experimental studies certificate.

C.08.015. (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is satisfied that

(a) the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study,

(b) the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and

the Director shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator.

(2) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he shall refuse to issue an experimental studies certificate.

C.08.016. (1) The label of a new drug that is sold pursuant to section C.08.013 shall show

(a) the brand name of the new drug or the identifying name or code proposed for the new drug;

(b) a warning statement to the effect that the drug is for use only in an experimental study in animals;

(2) Sections C.01.004, C.01.005 and C.01.014 do not apply to a drug that is sold pursuant to section C.08.013 and labelled in accordance with subsection (1).

C.08.017. An experimental studies investigator shall

(a) use the new drug only in accordance with the outline of the experimental study;

(b) report immediately to the Director all serious adverse drug reactions associated with the use of the new drug;

(d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;

(e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Director;

(f) report promptly to the Director any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and

(g) account to the Director, on request, for all quantities of the new drug received by him.

C.08.018. (1) Where the Director is of the opinion that it is necessary in order to safeguard animal health or public health or to promote public safety, he may suspend for a definite or indefinite period or cancel an experimental studies certificate.

(2) Without limiting the generality of subsection (1), the Director may suspend or cancel an experimental studies certificate if

(a) the information and material submitted pursuant to section C.08.014 contains an untrue statement or contains any omission concerning the properties of the drug that were known or ought reasonably to have been known to the manufacturer or the experimental studies investigator;

(b) the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete;

(d) there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or

(e) an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002.

11. An application concerning the sale of a drug for human use for the purposes of a clinical trial that is received under Division 8 of the Food and Drug Regulations before September 1, 2001 is subject to those Regulations and any procedures established under those Regulations as they read at the time the application was received.]

C.09.001. This Division does not apply to

(a) a drug that is required by these Regulations or the Narcotic Control Regulations to be sold only on prescription; or

C.09.010. No manufacturer or importer shall, after June 30, 1986, sell a drug for analgesia that contains a combination of

(a) a salt or derivative of salicylic acid with another salt or derivative of salicylic acid or with salicylamide; or

(b) acetaminophen with a salt or derivative of salicylic acid or with salicylamide.

C.09.011. Each label of a drug that is intended for internal use and contains acetaminophen, salicylic acid or a salt or derivative thereof shall, after June 30, 1986, carry a caution

(a) to consult a physician if the underlying condition requires continued use for more than five days; and

(b) that it is hazardous to exceed the maximum recommended dose unless advised by a physician.

C.09.012. Each label of a drug that is intended for internal use and contains salicylic acid or a salt or derivative thereof shall after June 30, 1986, carry a warning statement to consult a physician before taking the drug during the last three months of pregnancy or when nursing.

C.09.020. (1) The adult standard dosage unit of acetaminophen shall be 325 mg.

(2) The children’s standard dosage units of acetaminophen shall be 80 mg or 160 mg.

C.09.021. (1) In this Division, “acetaminophen product” means a drug that contains

(2) No manufacturer or importer shall sell an acetaminophen product unless it meets the requirements of this Division.

C.09.022. (1) Subject to subsections (2) to (4), an acetaminophen product sold in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of acetaminophen per individual dosage form.

(2) An acetaminophen product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain 500 mg of acetaminophen per individual dosage form if it has a label that states that it is not a standard dosage unit product.

(3) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration may contain 325 mg of acetaminophen for immediate release and another 325 mg for subsequent release, if it has a label that states that it is not a standard dosage unit product.

(4) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per individual dosage form.

(5) An acetaminophen product in the form of a liquid that is intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per millilitre of the product.

(6) A package of an acetaminophen product described in subsection (5) shall be accompanied by a measuring device capable of accurately delivering 0.5 mL of the product.

(7) An acetaminophen product in the form of a liquid that is not intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit per teaspoon of the product.

(8) An acetaminophen product in the form of a liquid shall contain one adult standard dosage unit of acetaminophen per teaspoon of the product.

C.09.030. (1) The adult standard dosage unit of a salicylate shall be

(a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 325 mg; and

(a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 80 mg; and

C.09.031. (1) In this Division, “salicylate product” means a drug that contains

(d) a salt or derivative of salicylic acid in combination with caffeine and one or more buffering agents or antacids.

(2) No manufacturer or importer shall sell a salicylate product after June 30, 1986 unless it meets the requirements of this Division.

(3) No manufacturer or importer shall, until June 30, 1986, sell a salicylate product in a dosage unit other than one mentioned in this Division, unless the salicylate product was legally available for sale in Canada on February 1, 1984.

C.09.032. (1) Subject to subsections (2) and (3) and section C.09.035, a salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of a salicylate per individual dosage form.

(2) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

(a) 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate, or

per individual dosage form if it has a label that states that it is not a standard dosage unit product.

(3) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

(a) two adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains two adult standard dosage units; and

(b) three adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains three adult standard dosage units.

C.09.033. (1) Subject to subsection (2), a salicylate product in the form of a liquid shall contain one adult standard dosage unit of a salicylate per teaspoon.

(a) two adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains two adult standard dosage units; and

(b) three adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains three adult standard dosage units.

C.09.034. A salicylate product that is claimed to be buffered shall provide at least 1.9 milliequivalents of acid neutralizing capacity per adult standard dosage unit of a salicylate.

C.09.035. A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of a salicylate per individual dosage form.