Federal Court Decisions

Decision Information

Reddy Cheminor Inc. v. Canada (Attorney General)

Court (s) Database	Federal Court Decisions
Date	2003-05-14
Neutral citation	2003 FCT 542
File numbers	T-2294-00
Notes	Digest

Decision Content

Date: 20030514

Docket: T-2294-00

Neutral citation: 2003 FCT 542

BETWEEN:

REDDY-CHEMINOR INC.,

Applicant,

- and -

THE ATTORNEY GENERAL OF CANADA and

THE MINISTER OF HEALTH,

Respondents.

REASONS FOR ORDER

LAYDEN-STEVENSON J.

[1] Reddy-Cheminor Inc. (Reddy) sought approval from the Minister of Health (the Minister) to market its version of the drug omeprazole pursuant to the Food and Drugs Act, R.S.C. 1985, c. F-27 (the FDA) and the Food and Drug Regulations, C.R.C., c. 870 (the Regulations). Reddy submitted an abbreviated new drug submission (ANDS) and referred to the Canadian reference product LOSEC. The officials acting for the Minister concluded that the medicinal ingredient in Reddy's drug is omeprazole while the medicinal ingredient in LOSEC is omeprazole magnesium. The Minister refused to process the submission and Reddy now seeks judicial review of the Minister's decision.

[2] Reddy requests an order directing the Therapeutic Products Directorate (the TPD) to review its ANDS in accordance with section C.08.002.1 of the Regulations, to place the ANDS in the review queue so that Reddy suffers no prejudice from the delay, and costs. At the hearing, it withdrew its request for a declaration that its product is pharmaceutically equivalent to corresponding strengths of the Canadian reference product, omeprazole magnesium tablets, for which a Notice of Compliance (NOC) was previously issued by the Minister.

FACTS

[3] On March 1, 1999, the applicant submitted its ANDS for omeprazole capsules to the TPD of Health Canada. Omeprazole is a drug that acts as a gastric proton-pump inhibitor and is used to treat ulcers. The ANDS referred to omeprazole magnesium tablets (LOSEC) marketed in Canada by AstraZeneca Canada Inc. (AstraZeneca) as the Canadian reference product. On July 2, 1999, the TPD issued a screening deficiency notice to Reddy asserting that the application could not proceed as an ANDS and that the applicant could obtain approval only by filing a new drug submission (NDS) pursuant to section C.08.002 of the Regulations.

[4] On August 16, 1999, Reddy responded to the screening deficiency notice explaining why the application should proceed as an ANDS. On September 13, 1999, the TPD issued a screening-based rejection letter on the same grounds as the initial screening deficiency notice. On December 6, 1999, Reddy submitted a Level I appeal in accordance with the TPD's published internal review process. On February 14, 2000, the Level I appeal was rejected. On March 10, 2000, Reddy requested a Level II appeal pursuant to the internal review policy. On June 23, 2000, the TPD Office of Science issued a report to the A/Director-General on the Level II appeal, recommending that the applicant's submission be reviewed as an ANDS. On July 18, 2000, the A/Director-General forwarded a memo to the Bureau of Pharmaceutical Assessment (the BPA) of the TPD wherein he concurred in the recommendation of the Office of Science. On the same date, he wrote to Reddy and advised that the Level II appeal had been resolved in its favour and that its submission would be returned to the BPA for review as an ANDS.

[5] On July 28, 2000, the Director of the BPA issued a memo to the A/Director-General in response to the latter's concurrence with the recommendation of the Office of Science and notification of such to Reddy. The BPA indicated an inability to follow the A/Director-General's directions on the basis that to do so would contravene the provisions of paragraph C.08.002.1(1)(a) of the Regulations. The BPA recommended that the A/Director-General rescind his position of July 18, 2000. The applicant's written argument references further discussions between Reddy and departmental officials, but there is no evidence in this regard. It is clear, however, that Reddy, on October 25 and November 8, 2000, wrote to the A/Director-General requesting a final decision regarding the Level II appeal of the screening-based rejection letter. By correspondence dated November 10, 2000, the A/Director-General notified Reddy that the Level II appeal was dismissed. The correspondence contains reasons that, briefly put, state that the Regulations require an ANDS drug to be the pharmaceutical equivalent of the Canadian reference product. Pharmaceutical equivalence requires that the drugs being compared contain identical amounts of identical medicinal ingredients in comparable dosage forms. Since omeprazole and omeprazole magnesium are different medicinal ingredients, the submission cannot be reviewed as an ANDS. It is with respect to this decision that Reddy seeks judicial review.

THE REGULATORY SCHEME FOR NEW DRUGS

[6] The relevant provisions of the Regulations are attached to these reasons as Schedule "A". Reference to specific provisions will be included herein as required for ease of reference and convenience. Subsection 30(1) of the FDA authorizes the Governor-in-Council to enact regulations with respect to, among other things: the sale of any drug; the method of manufacture, preparation and testing of any drug in the interest of or for the prevention of injury to the health of the purchaser or consumer; the method of manufacture, preparation, preservation, packing, storing and testing of any new drug; the sale or the conditions of sale of any new drug and defining, for purposes of the Act, the expression "new drug". The provisions regarding new drugs are contained in Division 8, Part C of the Regulations.

[7] It is common ground that drug manufacturers are prohibited from advertising or selling a new drug in Canada without obtaining a NOC. To seek a NOC, a manufacturer files a drug submission with the Minister (in practice, TPD Health Canada) pursuant to Division 8 , Part C of the Regulations. Specifically, subsection C.08.002(1) provides that no person shall sell a new drug unless the manufacturer has filed a NDS or an ANDS that is satisfactory to the Minister and has obtained a NOC.

[8] Subsection C.08.002(2) delineates the content requirements of a NDS. The NDS must include, among other things, detailed reports of the tests conducted to establish the safety of the new drug for the purpose and under the conditions recommended, as well as substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended. The evidence indicates that this information is typically voluminous, ranging from 100 to 300 volumes of data.

[9] A different form of drug submission is available to manufacturers who wish to copy a marketed drug without having to provide the voluminous detailed reports and substantial data demonstrating clinical safety and effectiveness. This form of submission is known as an ANDS. The ANDS requires the use of a Canadian reference product i.e., a drug for which safety and efficacy have already been demonstrated. The Canadian reference product is typically a brand-name drug and the proposed generic copy is required to be the pharmaceutical equivalent. The generic manufacturer uses the Canadian reference product to demonstrate bioequivalence rather than making a direct assessment of the clinical safety or efficacy of the generic drug on the basis of extensive clinical studies.

[10] Specifically, subsection C.08.002.1(1) provides that a manufacturer may file an ANDS for a new drug where, in comparison with a Canadian reference product, the new drug is the pharmaceutical equivalent of the Canadian reference product. In general, the two products must be bioequivalent, the route of administration must be the same, and the conditions of use of the new drug must fall within those approved for the Canadian reference product.

[11] Subsection C.08.002.1(2) outlines the submission content requirements for an ANDS. An ANDS must include sufficient material for the Minister to assess the safety and efficacy of the new drug. This includes, but is not limited to, material to establish that the new drug is the pharmaceutical equivalent of the Canadian reference product and , where the Minister considers it necessary, material to demonstrate that the drugs are bioequivalent, including the evidence from any studies conducted to demonstrate pharmaceutical equivalence and bioequivalence. The terms "Canadian reference product" and "pharmaceutical equivalent" are defined in section C.08.001.1, which reads as follows:

Canadian reference product" means

(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,

« _produit de référence canadien_ » Selon le cas :

a) une drogue pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 et qui est commercialisée au Canada par son innovateur;

(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

b) une drogue jugée acceptable par le ministre qui peut être utilisée pour la détermination de la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, lorsqu'une drogue pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 ne peut être utilisée à cette fin parce qu'elle n'est plus commercialisée au Canada;

(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);

c) une drogue jugée acceptable par le ministre qui peut être utilisée pour la détermination de la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, par comparaison à une drogue visée à l'alinéa a).

"pharmaceutical equivalent" means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in

« _équivalent pharmaceutique_ » S'entend d'une drogue nouvelle qui, par comparaison à une autre drogue, contient les mêmes quantités d'ingrédients médicinaux

comparable dosage forms. But that does not necessarily contain the same non-medicinal ingredients;

identiques, sous des formes posologiques comparables, mais pas nécessairement les mêmes ingrédients non médicinaux.

"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,

« _spécifications_ » S'entend de la description détaillée d'une drogue nouvelle et de ses ingrédients,notamment :

a) la liste des propriétés et des qualités des ingrédients qui ont trait à la fabrication et à l'emploi de la drogue nouvelle, y compris leur identité, leur activité et leur pureté;

[12] Where a submission satisfies the requirements under Part C, Division 8, a NOC is issued pursuant to section C.08.004. The issuance of a NOC for an ANDS serves not only the function of permitting the manufacturer to sell or advertise the new drug, but also constitutes a declaration that the new drug is equivalent to the Canadian reference product and thereby assists the provinces and other interested parties in identifying the acceptability of the new drug for use as a substitute for the Canadian reference product.

[13] The TPD has a published policy entitled "Management of Drug Submissions", the stated purpose of which is, to outline the manner in which the TPD will manage the information and material submitted by sponsors in accordance with the FDA and the Regulations. The policy applies to all submission types including, among others, a NDS, an ANDS and a SNDS (supplement to a new drug submission). It contains sections dealing with the filing of information and material, the screening of information and material, the evaluation of submissions, re-filed submissions, the appeal process and drug evaluation fees. Under the policy, the screening process is one whereby the information and material is screened for acceptability. If original information and material is found to be acceptable on screening, it is then accepted for review and considered to be a submission. If deficiencies are identified, a screening deficiency notice is issued identifying the deficiencies. A sponsor has 45 days within which to respond to a screening deficiency notice at which point (if the sponsor responds) a new screening period commences. The original information and material is considered a submission when all requested information is found to be acceptable. A sponsor may appeal a TPD decision to reject a submission at the screening level. There are two levels of appeal procedures. The first is to the Bureau Director responsible for the original decision. The second is to the Director-General of the Directorate and involves an independent review under the direction of the Director-General.

THE POSITIONS OF THE PARTIES

[14] Reddy takes the position that its ANDS should have been reviewed rather than rejected at the screening stage. A review, argues Reddy, affords the applicant a scientific assessment regarding the question of whether omeprazole and omeprazole magnesium are identical medicines and if so, pharmaceutically equivalent. No such scientific assessment was ever made by the TPD prior to refusing Reddy's submission. All correspondence, remarks and comments from the TPD flow from the initial, non-scientific decision.

[15] The foundation upon which Reddy's argument is built is the approach taken by the Minister regarding AstraZeneca's LOSEC. AstraZeneca and its predecessor companies have marketed omeprazole in Canada for many years. In approximately 1995, it submitted a SNDS to the TPD to change its product from omeprazole capsules to omeprazole magnesium tablets. Referring to section C.08.003, Reddy notes the conditions under which circumstances are considered to be sufficiently different to necessitate the filing of a SNDS. It contends that the section permits changes to marketed drugs but not the marketing of an entirely different drug. In short, Reddy submits that a SNDS cannot be used to approve a new drug. Since AstraZeneca's SNDS requested approval to change its product from omeprazole capsules to omeprazole magnesium tablets, the TPD must have considered the change, from omeprazole capsules to omeprazole magnesium tablets, not to have been a change in the drug itself. Thus, says Reddy, omeprazole and omeprazole magnesium must be the same medicine and therefore pharmaceutically equivalent.

[16] To bolster its position, Reddy refers to documents obtained under the Access to Information Act, R.S.C. 1985, c. A-1 relating to the AstraZeneca change and specifically relies on a handwritten minute from Dr. Klein (a reviewer of AstraZeneca's SNDS) to Dr. Lee that states:

Leo,

I want to discuss this with you on Tuesday. - Please see my notes on pages 18, 19, 21, 22, 23, 24; - As you can see I am in disagreement with you - I propose to do the following: - That you finalize the P.M. according to what we will discuss and based on my notes as above; - That I phone Astra and/or write them a note indicating that once we accepted the "bio" + pharmacodynamics for Losec tablets, the same condition will apply to any generic preparation. I will c.c. N. Pound for this info. AK.

[17] Reddy argues that this minute, and more particularly the phrase, ". . . the same condition will apply to any generic preparation", indicates that if an omeprazole to omeprazole magnesium comparison is valid for demonstrating safety and efficacy, then an omeprazole magnesium to omeprazole comparison must be equally valid. Therefore, according to Reddy, it follows that its product (omeprazole capsule) meets the test for submission of an ANDS in that it is the bioequivalent of the omeprazole magnesium tablet, the route of administration is the same as that of the AstraZeneca product, and its conditions of use fall within the conditions of use for AstraZeneca's omeprazole magnesium tablet.

[18] Relying on the Minister's position regarding the AstraZeneca product, Reddy submits that it satisfied the test and accordingly submitted its ANDS. The TPD's initial review did not involve a scientific review of the data and its decision was based solely on the difference in the names between the ingredients omeprazole and omeprazole magnesium. Reddy contends that the cross-examination of the A/Director-General confirms rejection at the screening stage.

[19] The applicant refers to the fact that "medicinal ingredient' is not defined in the FDA or in the Regulations. The affidavit of its expert, Dr. Thomas Foster, states that there exists no general basis upon which to determine the equivalence of the salt and base form of a drug. Dr. Foster's opinion is that omeprazole base and omeprazole salt differ not in their pharmaceutical natures but in non-therapeutic ways and therefore, whether salt or base, the substances are the same medicine. Thus, according to Dr. Foster, the medicinal ingredient in omeprazole magnesium is omeprazole, the same as in omeprazole simpliciter because only omeprazole is available at the site of absorption in the body.

[20] In relation to this issue, Reddy submits that the standard of review, for judicial review of an ANDS, is that of reasonableness. However, where the decision is made at the screening stage (a process not referred to in the Regulations), without the benefit of the review process (where the evidence regarding pharmaceutical equivalence is considered), the standard of review is correctness for it cannot be said that the Minister, at this stage, is assessing the safety and efficacy of the drug in question. Reddy refers to Novopharm Ltd. v. Minister of National Health and Welfare (1998), 78 C.P.R. (3d) 54 (F.C.T.D.) (Novopharm) wherein Hugessen J. determined that the Minister's functions under the Patented Medicines (Notice of Compliance) Regulations, SOR /93-133 are purely ministerial and that the standard of review is that of correctness.

[21] Lastly, Reddy takes issue with the A/Director-General's reversal of the Level II appeal and argues that it was denied natural justice. It submits that it was not informed of the request that the appeal be reopened and was not afforded the opportunity to make representations in this respect. Having made a decision with respect to the Level II appeal, the respondent could not then reopen the decision. Reddy should have been heard prior to the final decision being rendered.

[22] The respondent Minister submits that Parliament has entrusted the Minister and her officials with the authority to determine whether to permit a drug to be sold to the Canadian public. Reddy's application for judicial review, argues the respondent, constitutes a request that the court substitute its opinion for that of the Minister.

[23] The Minister, through the TPD, refused to process Reddy's submission for approval to market its version of the drug omeprazole because the Minister was not satisfied that the submission met the prerequisites established in Part C, Division 8 of the Regulations. The respondent argues that the interests affected by a decision to issue a NOC on the basis of an ANDS are much broader than those of the manufacturer alone. When a NOC is issued on the basis of an ANDS, it serves to indicate not only that the manufacturer is permitted to sell the drug and that the drug is considered safe and effective, but also to signal that the drug is equivalent to another. The definition of "pharmaceutical equivalent" in section C.08.001.1 of the Regulations states that it must contain identical amounts of the identical medicinal ingredients as the comparison drug.

[24] Regarding Reddy's reliance on the AstraZeneca approval, the respondent refers to the fact that the approval was in relation to a SNDS. The Regulations prescribe, in the case of an ANDS, that the drugs being compared contain "identical amounts of the identical medicinal ingredients". There exists no such requirement with respect to a SNDS. Thus, the respondent submits, the fact that the ingredients were not identical acted as a bar with respect to Reddy's ANDS. That was not the case with respect to AstraZeneca's SNDS. Moreover, says the respondent, the Minister is not bound by her previous decisions.

[25] Reddy's position, that once ingested and metabolized all forms of omeprazole are transformed into a sulfenamide metabolite (the substance having the therapeutic effect) and therefore the medicinal ingredients in both the omeprazole (base) and omeprazole magnesium (salt) are identical, is not satisfactory to the Minister. At best, this position suggests that the drugs are therapeutically equivalent. The respondent notes that Reddy does not dispute that the base and salt are different substances.

[26] Additionally, in relation to this argument, the respondent submits that before the Minister can be satisfied with an ANDS, the specifications of the drug's ingredients must be evaluated under paragraph C.08.002.1(2)(a) incorporating paragraph C.08.002(2)(c). These specifications are defined to include potency, purity, testing and examining methods and associated tolerances (C.08.001.1). The Minister cannot evaluate the specifications of a substance that is produced following in-vivo metabolism. The medicinal ingredient to be evaluated must actually be contained in the drug product. The respondent refers to Merck Frosst Canada & Co. v. Canada (Minister of Health) (2001), 185 F.T.R. 267, aff'd. (2001), 12 C.P.R. (4^th) 383 (F.C.A.). This authority, says the respondent, underscores the importance of maintaining a distinction between a drug and its metabolites.

[27] Insofar as the reversal of the Level II appeal is concerned, the respondent maintains that even if an opportunity for further submissions had been granted, it would not have made a difference because a full opportunity to make submissions had already been provided. Although the Minister has established an internal process for appeal, she owes no duty to drug manufacturers to follow any particular process. The respondent refers to Martineau v. Matsqui Institution Disciplinary Board, [1980] 1 S.C.R. 602 and says that the decision is not of a nature that entitles Reddy to the procedural protection it seeks.

[28] Lastly, the respondent submits that Reddy seeks an order in the nature of mandamus and that it has not satisfied the requirements to obtain such an order. Relying on Apotex Inc. v. Canada (A.G.), [1994] 1 F.C. 742 (C.A.), aff'd. [1994] 3 S.C.R. 1100 (Apotex 1), Reddy must establish, among other things, that a public duty to act is owed to it and that it has a clear right to performance of the duty.

ISSUES

[29] The primary issue is whether the court should intervene in the respondent's decision that Reddy's application for an ANDS approval would not be processed allegedly due to its failure to meet the requirements of section C.08.002.1 of the Regulations. The answer to that question entails an examination of the process and procedure followed by the respondent as well as a determination of the appropriate standard of review applicable to the decision.

[30] Although the respondent also raised the question of the applicant's failure, on this application, to meet the requisite criteria to obtain relief in the nature of mandamus and Reddy did not contest this submission, neither did the respondent develop the argument to any significant degree. I do not propose to deal further with this question since, in my view, the application can be determined on the basis of the arguments advanced in relation to the issues delineated above.

ANALYSIS

[31] Excluding the question of the A/Director-General's dismissal of Reddy's Level II appeal by correspondence dated November 10, 2000, after having advised that the appeal was resolved in its favour on July 28, 2000, all other issues identified by Reddy are inextricably connected to and based upon the Minister's approach to and approval of the Canadian reference product, AstraZeneca's LOSEC. I therefore prefer to address this matter at the outset since determination of this issue may well be relevant to Reddy's other concerns. The question, as framed by Reddy, is: "Was the applicant entitled to rely on the mode of approval of the Canadian reference product and the scientific conclusions to be drawn therefrom?" I referred briefly to the circumstances regarding this issue when summarizing the applicant's position earlier in these reasons.

[32] In approximately 1995, AstraZeneca's predecessor submitted a SNDS to change its product from omeprazole capsules to omeprazole magnesium tablets. Following the approval of the SNDS by the TPD, Astra withdrew the capsule product from the Canadian market and sold only tablets. In making the decision to proceed as an ANDS rather than a NDS, Reddy took into account the attitude of the TPD to omeprazole capsules and omeprazole magnesium tablets as manifested in the access to information results from the AstraZeneca SNDS submission regarding transition from capsules to magnesium tablets. The purpose of section C.08.003 (the SNDS provision) is to permit changes to marketed drugs, not to permit the marketing of a new drug. A new drug can be approved only for a NDS or an ANDS. Reddy concluded that if the safety and efficacy of omeprazole magnesium tablets can be demonstrated to the satisfaction of the TPD by comparison to omeprazole capsules, then it must also be so that the safety and efficacy of omeprazole capsules can be demonstrated by comparison to omeprazole magnesium tablets.

[33] While Reddy's position appears both logical and rational, I have concluded that the question (Was the applicant entitled to rely on the mode of approval of the Canadian reference product and the scientific conclusions to be drawn therefrom?) must be answered in the negative.

[34] I agree with the respondent that Reddy's position confuses the principles governing an ANDS with those governing a SNDS. The specified circumstances requiring the filing of a SNDS include matters such as the plant and equipment to be used in manufacturing, the manufacturing methods, the tests and controls to be applied and (of particular relevance here) the specifications of the ingredients of the drug. The manufacturer cannot market the drug unless the changes have been fully described in a supplement to the original NDS and the Minister is satisfied that the drug remains safe and effective and issues a NOC. This differs from an ANDS that may be submitted provided, among other things, that the drugs being compared contain "identical amounts of the identical medicinal ingredients". No similar provision is prescribed for a SNDS. Approval for an ANDS involves comparison to a Canadian reference product whereas approval for a SNDS involves satisfying the Minister of the safety and efficacy of the drug. There is no requirement that the medicinal ingredients be identical in relation to the latter.

[35] More importantly and while recognizing that consistency is an admirable objective, it cannot be paramount over a proper, objective consideration of individual submissions on a case-by-case basis. This is particularly so when regard is had to the potential seriousness, in the drug approval process, of the possibility of repeating mistakes. At the hearing, I questioned Reddy's counsel in this respect and specifically asked, what if the Minister was wrong when the NOC issued to AstraZeneca on the basis of its SNDS? Should Reddy nonetheless be entitled to rely on it? No satisfactory response was forthcoming.

[36] Finally, and while not directly applicable to these circumstances, there is authority to the effect that the existence of a conflict in administrative decisions (if indeed a conflict exists) does not constitute an independent basis for judicial review: Domtar Inc. v. Québec (Commission d'appel en matière de lésions professionelles), [1993] 2 S.C.R. 756. It is also noteworthy that had the Minister considered herself bound by the approval granted to the AstraZeneca SNDS, it could be said that she fettered her discretion relative to the Reddy ANDS. I conclude that the applicant was not entitled to rely on the mode of approval of the Canadian reference product.

[37] Reddy's next areas of concern are presented as questions that ask:

(a) Did the respondent fully address the scientific questions of the equivalency of the medicinal ingredient of the Canadian reference product and the applicant's product?, and

(b) Did the respondent form a proper scientific conclusion regarding the equivalency of the medicinal ingredients?

[38] The substance of the argument is that the Minister erred in rejecting Reddy's ANDS at the screening level and should have reviewed it. The TPD's objection to the ANDS resulted in the screening deficiency notice that stated an ANDS is not acceptable, ". . . since the medicinal ingredient in Omeprazole Delayed Release Capsules (omeprazole) is not pharmaceutically equivalent to that in the Canadian reference product (Losec Delayed Release Tablets; omeprazole magnesium)". Reddy argues that at this stage, no scientific assessment of whether omeprazole and omeprazole magnesium may be identical medicines, and therefore pharmaceutically equivalent, had been made. It alleges that the cross-examination of Dr. Peterson establishes that this initial decision was based solely on the differences in names between the ingredients omeprazole and omeprazole magnesium. I digress briefly from Reddy's submissions to observe that, while Dr. Peterson did acknowledge that no scientific assessment had been made at the screening stage, his responses to counsel's questions in relation to the word "name" included the qualification that "name" meant the chemical designation of a compound.

[39] At the end of the day, Reddy argues that the Minister refused to review its ANDS on the basis that its product is not pharmaceutically equivalent to the Canadian reference product and in so doing she erred because the Regulations require pharmaceutical equivalence to be established during the review. At the screening stage, the Minister does not refer to another manufacturer's submissions, but at the review stage, the Minister is specifically authorized to do so by virtue of the Regulations. Had Reddy's ANDS been reviewed, the Minister would have been able to access the AstraZeneca file. Whether the drugs are pharmaceutically equivalent goes to the merits of Reddy's submissions. Because of the evidence required to establish safety and because of the AstraZeneca SNDS file, Reddy's ANDS should not have been rejected at the screening stage without consideration on the merits.

[40] Reddy argues that because it meets all the tests set out in section C.08.002.1, the only outstanding issue is whether omeprazole magnesium and omeprazole are identical medicinal ingredients. If they are identical medicinal ingredients, then Reddy's product and the Canadian reference product are equivalent. Reddy notes that neither the FDA nor the Regulations define "medicinal ingredient". Relying on Dr. Foster's affidavit, Reddy submits that the medicinal ingredient in omeprazole magnesium is omeprazole, the same as in omeprazole simpliciter because only omeprazole is available at the site of absorption in the body.

[41] In a nutshell, Reddy's argument is that, in the present circumstances, its submission ought to have been reviewed because no scientific assessment was conducted at this level and the evidence (AstraZeneca's SNDS submission) by implication establishes that the drugs are pharmaceutically equivalent.

[42] I have difficulty with the alleged basis upon which Reddy insists that the Minister was obliged to conduct a review of its ANDS and I am not persuaded, in the absence of error by the Minister, that Reddy is entitled to a review of its ANDS. The content of the ANDS, in relation to the information or evidence to be provided by the manufacturer, is a matter within the discretion of the Minister and those acting on her behalf to determine.

[43] The Minister has developed a comprehensive policy for the management of drug submissions. Those that are rejected at the screening level (which provides for two levels of appeal) are not processed further, i.e., they are not evaluated, assessed or reviewed. Any number of deficiencies may be identified at the screening level. In Reddy's case various deficiencies were identified, but its failure to submit a product that contained identical amounts of the identical medicinal ingredients as the Canadian reference product was fatal to its submission and Reddy was invited to submit a NDS for its product. I note that the determination that omeprazole and omeprazole magnesium are different medicinal ingredients was consistent throughout, i.e. screening and both levels of appeal.

[44] Having determined that Reddy did not meet the requirement set out in paragraph C.08.002.1(1)(a), the Minister concluded that the submission was not acceptable. Reddy has not referred to any specific provision in the Regulations that requires the Minister to proceed with a review of a submission when a sponsor fails to meet the submission content requirements. The Minister, here, adhered to the policy whereby submissions found acceptable on screening will be reviewed. Since Reddy's submission was not found to be acceptable, it was not reviewed. Unless the policy contravenes or contradicts the provisions of the FDA or the Regulations, the court will not intervene. It seems to me that if Reddy is to succeed, it must establish reviewable error on the part of the ministerial delegate, the A/Director-General, with respect to his determination that Reddy did not meet the requirement set out in paragraph C.08.002.1(1)(a).

[45] The cornerstone authority regarding judicial review of administrative decisions, where a statute delegates power to an administrative decision-maker, is Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982 (Pushpanathan). Since the hearing of this application for judicial review, the Supreme Court has rendered additional decisions wherein it unequivocally reaffirms the primacy of the pragmatic and functional approach to determining the standard of judicial review of administrative decisions: Dr. Q v. College of Physicians and Surgeons of British Columbia, 2003 SCC 19 (Dr. Q); Law Society of New Brunswick v. Ryan, 2003 SCC 20 (Ryan). In every case, the court must begin by determining the standard of review on the Pushpanathan pragmatic and functional approach, which demands a nuanced analysis based on consideration of a number of factors: Dr. Q. The objective of the approach is articulated by McLachlin, C.J. at paragraph 22:

To determine standard of review on the pragmatic and functional approach, it is not enough for a reviewing court to interpret an isolated statutory provision relating to judicial review. Nor is it sufficient merely to identify a categorical or nominate error, such as bad faith, error on collateral or preliminary matters, ulterior or improper purpose, no evidence, or the consideration of an irrelevant factor. Rather, the pragmatic and functional approach calls upon the court to weigh a series of factors in an effort to discern whether a particular issue before the administrative body should receive exacting review by a court, undergo "significant searching or testing" (Southam, supra, at para. 57), or be left to the near exclusive determination of the decision-maker. These various postures of deference correspond, respectively, to the standards of correctness, reasonableness simpliciter, and patent unreasonableness.

[46] Determination of the standard of review requires consideration of four contextual factors - the presence or absence of a privative clause or statutory right of appeal; the expertise of the decision-maker relative to that of the reviewing court on the issue in question; the purposes of the legislation and the provision in particular; and, the nature of the question - law, fact, or mixed law and fact. The factors may overlap, but consideration of the four factors enables the court to address the core issues in determining the degree of deference: Dr. Q at para. 26.

[47] The first factor focuses generally on the statutory mechanism of review. While the presence of a "full" privative clause is compelling evidence that the court ought to show deference to the decision-maker, the absence of a privative clause does not imply a high standard of scrutiny, where other factors bespeak a low standard: Pushpanathan at para. 30.

[48] The second factor, relative expertise, recognizes that legislatures will sometimes remit an issue to a decision-making body that has particular topical expertise or is adept in the determination of particular issues. Where this is so, courts will seek to respect this legislative choice when conducting judicial review. Yet expertise is a relative concept, not an absolute one. Greater deference will be called for only where the decision-making body is, in some way, more expert than the courts and the question under consideration is one that falls within the scope of this greater expertise: Dr. Q at para. 28 citing Moreau-Bérubé v. New Brunswick (Judicial Council), [2002] 1 S.C.R. 249. The analysis under this heading has three dimensions: "the court must characterize the expertise of the tribunal in question; it must consider its own expertise relative to that of the tribunal; and it must identify the nature of the specific issue before the administrative decision-maker relative to this expertise": Pushpanathan at para. 33.

[49] The third factor is the purpose of the statute, i.e., the general purpose of the statutory scheme within which the administrative decision is taking place. If the question before the administrative body is one of law or engages a particular aspect of the legislation, the analysis under this factor must also consider the specific legislative purpose of the provision(s) implicated in the review. As a general principle, increased deference is called for where legislation is intended to resolve and balance competing policy objectives or the interests of various constituencies, characteristics described as "polycentric" in Pushpanathan: Dr. Q at para. 30. Provisions that confer a broad discretionary power upon a decision-maker will generally suggest policy-laden purposes and, consequently, a less searching standard of review. Reviewing courts should also consider the breadth, specialization, and technical or scientific nature of the issues that the legislation asks the administrative decision-maker to consider. Here, the principles animating the factors of relative expertise and legislative purpose tend to overlap. A legislative purpose that deviates substantially from the normal role of the courts suggests that the legislature intended to leave the issue to the discretion of the administrative decision-maker and, therefore, militates in favour of greater deference: Dr. Q at para. 31.

[50] The fourth factor is the nature of the problem. In the context of judicial review of administrative action, the nature of the question is just one of four factors to consider. When the finding being reviewed is one of pure fact, this factor will militate in favour of showing more deference towards the decision-maker's decision. An issue of pure law militates in favour of a more searching review. Regarding questions of mixed fact and law, this factor will call for more deference if the question is fact-intensive and less deference if it is law-intensive: Dr. Q at paras. 33 and 34.

[51] Where the balancing of the four noted factors suggests considerable deference, the patent unreasonableness standard will be appropriate. Where little or no deference is called for, a correctness standard will suffice. If the balancing of factors suggests a standard of deference somewhere in the middle, the reasonableness simpliciter standard will apply: Dr. Q at para. 35. There are only three standards of review and a reviewing court must not intervene unless it can explain how the administrative action is incorrect, unreasonable, or patently unreasonable, depending on the appropriate standard: Ryan at paras. 20, 26.

[52] With these guiding principles in mind, I turn to the matter at hand. For the reasons that follow, I conclude that the appropriate standard of review is that of patent unreasonableness.

[53] There is no privative clause here but neither is there a statutory right of appeal. Judicial review of the Minister's decision is available pursuant to section 18.1 of the Federal Court Act, R.S.C. 1985, c. F-7 provided that the grounds of review fall within subsection 18.1(4). This factor results in neither a high nor a low degree of deference.

[54] The criterion of expertise is next to be considered. The question is whether the decision-maker has greater expertise than the court with respect to the question under review. This expertise may be derived from specialized knowledge about a topic or from experience and skill in the determination of particular issues: Ryan at para. 30. The general rule, under the FDA and the Regulations, is that no new drug may be sold in Canada without the approval of the Minister and she must be satisfied of the safety and efficacy of the drug. Of necessity, determinations in this regard require, as stated by MacKay J. in Apotex Inc. v. Canada (Attorney General) (1993), 59 F.T.R. 85 (T.D.) (Apotex 2), ". . . judgment in light of special expertise . . . in related fields of applied and basic sciences". This, in my view, is not an area where it can be said that the court is as well-positioned as the statutory decision-maker in the area of expertise. Nor can it be said that the normal role of the court is to involve itself in the approval of drugs for sale to the Canadian public. The discrete and specific question, in issue here, involves determination of whether the applicant's ANDS is satisfactory to the Minister and more specifically, whether two drugs contain "identical medicinal ingredients". While such determinations may not require extensive scientific analysis, they do require scientific knowledge and judgment. The criterion of expertise militates in favour of deference.

[55] The third factor is the general purpose of the statutory scheme within which the administrative decision-making is taking place. Parliament has legislated that persons suffering from particular ailments and relying on particular products to alleviate those ailments must be assured that their reliance is not misplaced: Wrigley Canada v. Canada (1999), 164 F.T.R. 283 (T.D.), aff'd. (2000), 256 N.R. 387 (F.C.A.). The intent of the Regulations is to provide a process for approval of new drugs to be marketed in Canada that is ". . . in the interest of, or for the prevention of injury to the health of the purchaser or consumer": Apotex 2. Put another way, a drug manufacturer, under the scheme of the Regulations, must satisfy the Minister of the safety and effectiveness of a new drug before selling it in Canada: Merck & Co. v. Canada (Attorney General) (1999), 176 F.T.R. 21 (T.D.). The Regulations vest complete and exclusive discretion in the respondent Minister to determine the requirements of a new drug submission in terms of the information or evidence to be provided by the manufacturer. The discretion must be exercised on consideration of factors that are relevant to the purposes of the Act and regulations: Apotex 2. In my view, the purpose of the FDA and the Regulations passed pursuant thereto applies to all submissions for new drugs whether in the form of a NDS or an ANDS. Regarding the polycentric characteristics, Blanchard J., in Bristol-Myers Squibb Co. v. Canada (Attorney General) (2002), 22 C.P.R. (4^th) 345 (F.C.T.D.) stated:

The purpose of the notice of compliance provisions of the Food and Drug Regulations is to protect public health by assuring a certain level of safety and efficacy for drugs. As such, the decision that a new drug submission has satisfied the Food and Drug Regulations is a polycentric one, given that it involves the implementation of "social and economic policy in a broad sense". [Pfizer Canada Inc. v. Minister of National Health and Welfare et al., (1986) 12 C.P.R. (3d) 438 (F.C.A.)]

The third factor suggests a high degree of deference.

[56] The fourth factor is the nature of the problem. The contents of an ANDS must be satisfactory to the Minister. In comparison with a Canadian reference product, the drug manufacturer must establish the four conditions set out in subsection C.08.002.1(1) of the Regulations, the first of which is that the new drug is the pharmaceutical equivalent of the Canadian reference product. "Pharmaceutical equivalent", as defined by the Regulations, 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: Regulations, section C.08.001.1. Hence, the Minister will determine, as a fact, in my view, whether the drugs contain identical amounts of identical medicinal ingredients. If I am wrong and this determination is a question of mixed fact and law, I consider it to be one that is more fact-intensive than law-intensive. In either situation, the fourth factor calls for more deference.

[57] The balancing of these four factors suggests considerable deference and thus a standard of review of patent unreasonableness. I refer to the comments of MacKay J. in Apotex 2 at pp. 111-112:

In this case the discretion granted to the executive involves more than the determination of facts and the application of the law in determining the rights of a party that do not directly affect the welfare of others. More is here involved than is often the case where courts are called upon in an application for judicial review to review the process followed by an administrator or tribunal. Discretion here vested by the Act and regulations requires judgment in light of special expertise, in this case in related fields of applied and basic sciences, which judgment affects not merely the rights of an applicant party but is directed ultimately to the interests of, or prevention of injury to, the health of others, purchasers and consumers. In my view, discretion of this sort warrants judicial deference that recognizes the special expertise and responsibilities of the Minister and his advisers within HPH (Health Protection Branch] who must deal with numerous applications for approval of new drugs . . . it is now accepted that a court will intervene only where the decision maker has interpreted governing legislation in a manner that is so patently unreasonable that it demands intervention by the court . . .

[58] Regarding Reddy's reliance on Novopharm to support a standard of correctness, Novopharm involved the Patented Medicine (Notice of Compliance) Regulations, SOR/93-133 where there exists no independent decision-making power, no discretion and no policy-making role. The court specifically stated in that decision that the NOC Regulations have nothing to do with the subject of the protection of public health. That is not the situation that exists here. Further discussion of the distinctions between the NOC Regulations and the FDA Regulations may be found in Bristol-Myers, supra.

[59] A decision that is patently unreasonable is so flawed that no amount of curial deference can justify letting it stand: Ryan at para. 52. A court should not intervene unless the decision can be characterized as being "so gratuitous and oppressive that no reasonable person could think [it] justified": Mount Sinai Hospital Centre v. Quebec (Minister of Health and Social Services), [2001] 2 S.C.R. 281 at 317. Applying this reasoning to the circumstances here, it cannot be said that the Minister's decision is patently unreasonable. This conclusion, in my view, is self-evident. However, in relation to Reddy's submissions, I make the following observations.

[60] First, it is not suggested that the Minister failed to consider Reddy's ANDS, only that the Minister refused to proceed to a review of the ANDS. Having considered the applicant's submission, the Minister determined that it did not meet the requirements set out in paragraph C.08.002.1(1)(a). The submission contents, not having met the regulatory provisions, rendered it unacceptable for review. In short, in the exercise of the discretion afforded to the Minister by the Regulations, regard was had to the statutory provisions relative to an ANDS.

[61] Second, the general purpose of the Regulations is to ensure the safety and efficacy of drugs. Since the submission of an ANDS permits a generic to piggyback on an innovator's drug, specific submission contents for its ANDS, as compared to a Canadian reference product, are legislated to further the purpose of the Regulations. The submission must include, as a minimum, certain specified information as set out in subsection C.08.002.1(1). I agree with the respondent that satisfaction of the submission contents as set out in that subsection constitutes a condition precedent. Satisfaction of the condition precedent, in my view, is a mechanism chosen by the legislature to address the safety and efficacy of generic drugs.

[62] Third, Reddy does not suggest that the drugs in question contain identical medicinal ingredients but rather that the substances ultimately metabolize to become the same substance. It is that substance that has the therapeutic effect and on that basis, it argues that the two products contain the same medicinal ingredient. Reddy consistently refers to the "facts that exist here". I take that reference to mean its reliance on the Minister's approach regarding AstraZeneca's LOSEC. Reddy is not entitled to rely on the mode of approval of the Canadian reference product to remedy the deficiencies in its ANDS. Moreover, I agree with the respondent that the Minister cannot evaluate the specifications of a substance that may be produced following in vivo metabolism. The legislative requirement is to consider, as the medicinal ingredient, the ingredient contained in the drug.

[63] Finally, I add that, based on the definition of reasonableness simpliciter found in Ryan at paras. 55 and 56, the Minister's determination also meets the lower standard of reasonableness.

[64] Reddy's final question asks: "Was the respondent entitled to reverse [herself] after permitting the applicant's second level internal appeal, especially where [she] accepted submissions from an unknown party and did not give the applicant a chance to be heard in response?"

[65] As repeatedly stated earlier, the Regulations vest exclusive jurisdiction in the Minister to determine the requirements of an ANDS in relation to the information or evidence to be provided by the manufacturer. There is a policy in place that provides for two levels of appeal within the internal review process. Reddy's Level I appeal was rejected. At the Level II appeal, the Office of Science recommended that the appeal be allowed. Acting on that recommendation, the Minister, through the A/Director-General of the TPD, informed Reddy on July 18, 2000, that its ANDS would be returned to BPA for review. Subsequently, the BPA reported to the A/Director-General its conclusion that the Office of Science's recommendation was incorrect in view of its determination that omeprazole and omeprazole magnesium are different medicinal ingredients. It recommended that the A/Director-General rescind his letter of July 18, 2000 and issue a second letter outlining that an ANDS is not an acceptable regulatory option given the requirement for pharmaceutical equivalence. On November 10, 2000, the A/Director-General informed Reddy that its ANDS would not be processed.

[66] Reddy submits that the November 10^th correspondence refers to ". . . a request to reopen the appeal". Reddy was not informed of the source or of the grounds in support of that request. Upon reviewing Dr. Peterson's affidavit sworn April 25, 2001, Reddy learned that the request emanated from the BPA. Reddy emphasizes: that at the relevant time, it did not know who requested that this appeal be reopened; that the internal policy does not contemplate the reopening of decisions, and that it did not have an opportunity to review the "request to reopen the appeal" or to make representations regarding it. Reddy advances a single argument in this respect, that it ". . . experienced a failure of natural justice (audi alteram partem) in that the decision was reversed based on the input of a party of which [it] was not aware and on a point on which [it] was not heard". In short, without hearing Reddy, the respondent was not entitled to reverse the approval of the second level appeal. No authority is cited in support of this submission.

[67] I am not persuaded, on the basis of the evidence and argument before me, that Reddy was denied natural justice. The reason provided for dismissal of the second level appeal was that the drugs (Reddy's and the Canadian reference product) do not contain identical amounts of the identical medicinal ingredients. Reddy had the opportunity to make and did make submissions relative to that issue. The A/Director-General also rejected Reddy's position that inferences drawn from the approval of AstraZeneca's SNDS leads to the conclusion that the Minister accepted that the drugs are pharmaceutically equivalent. Again, Reddy had the opportunity to make and did make extensive submissions in relation to that issue. It was because of Reddy's submissions regarding the latter that the Office of Science recommended allowing the appeal. Although he initially concurred with that recommendation, the A/Director-General, after receipt of the BPA position (that the basis proposed by the Office of Science did not justify contravention of the Regulations), reconsidered his determination. The affidavit evidence, the cross-examination of Dr. Peterson and the decision of November 10, 2000, indicate that, in so doing, he considered Reddy's submissions. Moreover, Reddy forwarded written requests, on October 25, 2000, and again on November 8, 2000, to the A/Director-General asking for a final decision respecting the second level appeal. The response to those requests was provided in the November 10^th correspondence. Reddy does not suggest that it had further submissions to make. It alleges only that it was not afforded the opportunity.

[68] In the particular circumstances I have described, and in the absence of authority that states otherwise, a mere assertion alleging a denial of natural justice, without more, will not suffice. Whether different circumstances might yield a different result is best left for another day and I express no opinion in that regard.

CONCLUSION

[69] In the result, I conclude that Reddy is not entitled to rely on the Minister's mode of approval of the Canadian reference product to remedy the deficiencies in its ANDS. The standard of review applicable to the Minister's decision in the circumstances of this matter is that of patent unreasonableness. The Minister's decision to reject the applicant's ANDS at the screening level was made with regard to the provisions of the Regulations and was not patently unreasonable. Reddy was not denied natural justice. There is no basis upon which to grant the requested relief.

[70] For the reasons given, the application for judicial review is dismissed with costs to the respondent. An order will so provide.

___________________________________

Judge

Ottawa, Ontario

May 14, 2003.

FEDERAL COURT OF CANADA

Names of Counsel and Solicitors of Record

DOCKET: T-2294-00

STYLE OF CAUSE: Reddy Cheminor Inc. v. AGC et al

DATE OF HEARING: March 17, 2003

PLACE OF HEARING: Toronto, Ontario.

REASONS FOR ORDER BY: Layden-Stevenson J.

DATED: May 14, 2003

APPEARANCES BY: Douglas N. Deeth/Gordon S. Jepson

For the Applicant

Rick Woyiwada

For the Respondent

SOLICITORS OF RECORD: Douglas N. Deeth

Gordon S. Jepson

Toronto, Ontario

For the Applicant

F. Rick Woyiwada Department of Justice

Ottawa, Ontario

For the Respondent

SCHEDULE "A"

to the

Reasons for Order dated May 14, 2003

rendered by the Hon. Madam Justice Carolyn Layden-Stevenson

REDDY-CHEMINOR INC.

THE ATTORNEY GENERAL OF CANADA and

THE MINISTER OF HEALTH

T-2294-00

Food and Drugs Regulations, Règlement sur les aliments et drogues,

C.R.C., c. 870 C.R.C., ch. 870

DIVISION 8

New Drugs

C.08.001. For the purposes of the Act and this Division, "new drug" means(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. SOR/95-172, s. 2.

TITRE 8

Drogues nouvelles

C.08.001. Pour l'application de la Loi et du présent titre, « _drogue nouvelle_ » désigne :

a) une drogue qui est constituée d'une substance ou renferme une substance, sous forme d'ingrédient actif ou inerte, de véhicule, d'enrobage, d'excipient, de solvant ou de tout autre constituant, laquelle substance n'a pas été vendue comme drogue au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de ladite substance employée comme drogue;

b) une drogue qui entre dans une association de deux drogues ou plus, avec ou sans autre ingrédient, qui n'a pas été vendue dans cette association particulière, ou dans les proportions de ladite association pour ces drogues particulières, pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de cette association ou de ces proportions employées comme drogue; ou

c) une drogue pour laquelle le fabricant prescrit, recommande, propose ou déclare un usage comme drogue ou un mode d'emploi comme drogue, y compris la posologie, la voie d'administration et la durée d'action, et qui n'a pas été vendue pour cet usage ou selon ce mode d'emploi au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de cet usage ou de ce mode d'emploi pour ladite drogue. DORS/95-172, art. 2.

C.08.001.1. For the purposes of this Division,

"Canadian reference product" means

(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,

"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;

"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.08.001.1. Les définitions qui suivent s'appliquent au présent titre.

« _produit de référence canadien_ » Selon le cas :

a) une drogue pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 et qui est commercialisée au Canada par son innovateur;

« _équivalent pharmaceutique_ » S'entend d'une drogue nouvelle qui, par comparaison à une autre drogue, contient les mêmes quantités d'ingrédients médicinaux identiques, sous des formes posologiques comparables, mais pas nécessairement les mêmes ingrédients non médicinaux.

« _spécifications_ » S'entend de la description détaillée d'une drogue nouvelle et de ses ingrédients, notamment :

a) la liste des propriétés et des qualités des ingrédients qui ont trait à la fabrication et à l'emploi de la drogue nouvelle, y compris leur identité, leur activité et leur pureté;

b) la description détaillée des méthodes d'analyse et d'examen des ingrédients;

c) la liste des tolérances relatives aux propriétés et aux qualités des ingrédients.

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;

(j) a draft of every label to be used in conjunction with the new drug;

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

(i) the recommended route of administration of the new drug,

(ii) the proposed dosage of the new drug,

(iii) the claims to be made for the new drug, and

(iv) the contra-indications and side effects of the new drug;

(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;

(b) samples of the ingredients of the new drug;

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

C.08.002. (1) Il est interdit de vendre ou d'annoncer une drogue nouvelle, à moins que les conditions suivantes ne soient réunies :

a) le fabricant de la drogue nouvelle a, relativement à celle-ci, déposé auprès du ministre une présentation de drogue nouvelle ou une présentation abrégée de drogue nouvelle que celui-ci juge acceptable;

b) le ministre a, aux termes de l'article C.08.004, délivré au fabricant de la drogue nouvelle un avis de conformité relativement à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle;

c) l'avis de conformité relatif à la présentation n'a pas été suspendu aux termes de l'article C.08.006;

d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons des étiquettes-y compris toute notice jointe à l'emballage, tout dépliant et toute fiche sur le produit-destinées à être utilisées pour la drogue nouvelle, ainsi qu'une déclaration indiquant la date à laquelle il est prévu de commencer à utiliser ces étiquettes.

(2) La présentation de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle, notamment :

a) une description de la drogue nouvelle et une mention de son nom propre ou, à défaut, de son nom usuel;

b) une mention de la marque nominative de la drogue nouvelle ou du nom ou code d'identification projeté pour celle-ci;

c) la liste quantitative des ingrédients de la drogue nouvelle et les spécifications relatives à chaque ingrédient;

d) la description des installations et de l'équipement à utiliser pour la fabrication, la préparation et l'emballage de la drogue nouvelle;

e) des précisions sur la méthode de fabrication et les mécanismes de contrôle à appliquer pour la fabrication, la préparation et l'emballage de la drogue nouvelle;

f) le détail des épreuves qui doivent être effectuées pour contrôler l'activité, la pureté, la stabilité et l'innocuité de la drogue nouvelle;

g) les rapports détaillés des épreuves effectuées en vue d'établir l'innocuité de la drogue nouvelle, aux fins et selon le mode d'emploi recommandés;

h) des preuves substantielles de l'efficacité clinique de la drogue nouvelle aux fins et selon le mode d'emploi recommandés;

i) la déclaration des noms et titres professionnels de tous les chercheurs à qui la drogue nouvelle a été vendue;

j) une esquisse de chacune des étiquettes qui doivent être employées relativement à la drogue nouvelle;

k) la déclaration de toutes les recommandations qui doivent être faites dans la réclame pour la drogue nouvelle, au sujet

(i) de la voie d'administration recommandée pour la drogue nouvelle,

(ii) de la posologie proposée pour la drogue nouvelle,

(iii) des propriétés attribuées à la drogue nouvelle,

(iv) des contre-indications et les effets secondaires de la drogue nouvelle;

l) la description de la forme posologique proposée pour la vente de la drogue nouvelle;

m) les éléments de preuve établissant que les lots d'essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d'une manière représentative de la production destinée au commerce;

n) dans le cas d'une drogue nouvelle destinée à être administrée à des animaux producteurs de denrées alimentaires, le délai d'attente applicable.

(3) Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui fournir, selon ce que celui-ci estime nécessaire pour évaluer l'innocuité et l'efficacité de la drogue dans le cadre de la présentation de drogue nouvelle, les renseignements et le matériel suivants :

a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle et les nom et adresse des fabricants de la drogue nouvelle sous sa forme posologique proposée pour la vente;

b) des échantillons des ingrédients de la drogue nouvelle;

c) des échantillons de la drogue nouvelle sous sa forme posologique proposée pour la vente;

d) tout renseignement ou matériel supplémentaire se rapportant à l'innocuité et à l'efficacité de la drogue nouvelle.

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;

(i) the pharmaceutical equivalent of the Canadian reference product, and

(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:

(b) samples of the ingredients of the new drug;

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

C.08.002.1. (1) Le fabricant d'une drogue nouvelle peut déposer à l'égard de celle-ci une présentation abrégée de drogue nouvelle si, par comparaison à un produit de référence canadien :

a) la drogue nouvelle est un équivalent pharmaceutique du produit de référence canadien;

b) elle est bioéquivalente au produit de référence canadien d'après les caractéristiques pharmaceutiques et, si le ministre l'estime nécessaire, d'après les caractéristiques en matière de biodisponibilité;

c) la voie d'administration de la drogue nouvelle est identique à celle du produit de référence canadien;

d) les conditions thérapeutiques relatives à la drogue nouvelle figurent parmi celles qui s'appliquent au produit de référence canadien.

(2) La présentation abrégée de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle, notamment :

a) les renseignements et le matériel visés aux alinéas C.08.002(2)a) à f) et j) à l);

b) les renseignements permettant d'identifier le produit de référence canadien utilisé pour les études comparatives menées dans le cadre de la présentation;

c) les éléments de preuve, provenant des études comparatives menées dans le cadre de la présentation, établissant que la drogue nouvelle :

(i) d'une part, est un équivalent pharmaceutique du produit de référence canadien,

(ii) d'autre part, si le ministre l'estime nécessaire d'après les caractéristiques pharmaceutiques et, le cas échéant, d'après les caractéristiques en matière de biodisponibilité de celle-ci, est bioéquivalente au produit de référence canadien selon les résultats des études en matière de biodisponibilité, des études pharmacodynamiques ou des études cliniques;

d) les éléments de preuve établissant que les lots d'essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d'une manière représentative de la production destinée au commerce;

e) dans le cas d'une drogue destinée à être administrée à des animaux producteurs de denrées alimentaires, les renseignements permettant de confirmer que le délai d'attente est identique à celui du produit de référence canadien.

(3) Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui fournir, selon ce que celui-ci estime nécessaire pour évaluer l'innocuité et l'efficacité de la drogue dans le cadre de la présentation abrégée de drogue nouvelle, les renseignements et le matériel suivants :

a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle et les nom et adresse des fabricants de la drogue nouvelle sous sa forme posologique proposée pour la vente;

b) des échantillons des ingrédients de la drogue nouvelle;

c) des échantillons de la drogue nouvelle sous sa forme posologique proposée pour la vente;

d) tout renseignement ou matériel supplémentaire se rapportant à l'innocuité et à l'efficacité de la drogue nouvelle.

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

(a) the manufacturer of the new drug has filed with the Minister

(i) a supplement to that new drug submission, or

(ii) a supplement to that abbreviated new drug submission;

(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:

(a) the description of the new drug;

(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;

(g) the labels used in connection with the new drug;

(h) the representations made with regard to the new drug respecting

(i) the recommended route of administration of the new drug,

(ii) the dosage of the new drug,

(iii) the claims made for the new drug,

(iv) the contra-indications and side effects of the new drug, and

(v) the withdrawal period of the new drug; and

(i) the dosage form in which it is proposed that the new drug be sold.

(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) Malgré l'article C.08.002, il est interdit de vendre une drogue nouvelle à l'égard de laquelle un avis de conformité a été délivré à son fabricant et n'a pas été suspendu aux termes de l'article C.08.006, lorsqu'un des éléments visés au paragraphe (2) diffère sensiblement des renseignements ou du matériel contenus dans la présentation de drogue nouvelle ou la présentation abrégée de drogue nouvelle, à moins que les conditions suivantes ne soient réunies :

a) le fabricant de la drogue nouvelle a déposé auprès du ministre :

(i) soit un supplément à la présentation de drogue nouvelle,

(ii) soit un supplément à la présentation abrégée de drogue nouvelle;

b) le ministre a délivré au fabricant un avis de conformité relativement au supplément;

c) l'avis de conformité relatif au supplément n'a pas été suspendu aux termes de l'article C.08.006;

d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons de toute étiquette-y compris une notice jointe à l'emballage, un dépliant et une fiche sur le produit-destinée à être utilisée pour la drogue nouvelle, dans le cas où la modification d'un des éléments visés au paragraphe (2) nécessite un changement dans l'étiquette.

(2) Pour l'application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants :

a) sa description;

b) sa marque nominative ou le nom ou code sous lequel il est proposé de l'identifier;

c) les spécifications de ses ingrédients;

d) les installations et l'équipement à utiliser pour sa fabrication, sa préparation et son emballage;

e) la méthode de fabrication et les mécanismes de contrôle à appliquer pour sa fabrication, sa préparation et son emballage;

f) les analyses effectuées pour contrôler son activité, sa pureté, sa stabilité et son innocuité;

g) les étiquettes à utiliser pour la drogue nouvelle;

h) les observations faites relativement :

(i) à la voie d'administration recommandée pour la drogue nouvelle,

(ii) à sa posologie,

(iii) aux propriétés qui lui sont attribuées,

(iv) à ses contre-indications et à ses effets secondaires,

(v) au délai d'attente applicable à celle-ci;

i) sa forme posologique proposée pour la vente.

(3) Le supplément à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle doit contenir, à l'égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, les renseignements et le matériel nécessaires pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle relativement à ces éléments.

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.08.003.1. Le ministre peut examiner les renseignements ou le matériel que lui présente toute personne, conformément au titre 5 ou aux articles C.08.002, C.08.002.1, C.08.003, C.08.005 ou C.08.005.1, pour déterminer l'innocuité et l'efficacité de la drogue nouvelle visée par la présentation ou le supplément.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.

C.08.004. (1) Sous réserve de l'article C.08.004.1, après avoir terminé l'examen d'une présentation de drogue nouvelle, d'une présentation abrégée de drogue nouvelle ou d'un supplément à l'une de ces présentations, le ministre :

a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l'article C.08.005.1, délivre un avis de conformité;

b) si la présentation ou le supplément n'est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, en informe le fabricant.

(2) Lorsqu'une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l'une de ces présentations n'est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, le fabricant qui l'a déposé peut le modifier en déposant des renseignements ou du matériel supplémentaires.

(3) Sous réserve de l'article C.08.004.1, après avoir terminé l'examen des renseignements et du matériel supplémentaires déposés relativement à une présentation de drogue nouvelle, à une présentation abrégée de drogue nouvelle ou à un supplément à l'une de ces présentations, le ministre :

a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l'article C.08.005.1, délivre un avis de conformité;

b) si la présentation ou le supplément n'est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, en informe le fabricant.

(4) L'avis de conformité délivré à l'égard d'une drogue nouvelle d'après les renseignements et le matériel contenus dans la présentation déposée conformément à l'article C.08.002.1 indique le nom du produit de référence canadien mentionné dans la présentation et constitue la déclaration d'équivalence de cette drogue.

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.08.004.1. (1) Lorsque le fabricant dépose une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l'une de ces présentations en vue de faire déterminer l'innocuité et l'efficacité de la drogue nouvelle qui en est l'objet, et que le ministre examine les renseignements et le matériel présentés, dans une présentation de drogue nouvelle, par l'innovateur d'une drogue contenant une substance chimique ou biologique dont la vente comme drogue n'a pas été préalablement approuvée au Canada et s'appuie sur les données y figurant pour étayer la présentation ou le supplément du fabricant, il ne peut délivrer un avis de conformité à l'égard de cette présentation ou de ce supplément avant l'expiration du délai de cinq ans suivant la date à laquelle est délivré à l'innovateur l'avis de conformité ou l'approbation de commercialiser cette drogue, selon le cas, d'après les renseignements ou le matériel présentés par lui pour cette drogue.

(2) Le paragraphe (1) ne s'applique pas lorsque le fabricant d'une drogue nouvelle pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 autorise par écrit un autre fabricant à se fonder sur les résultats d'essais ou d'autres données présentés au sujet de la drogue nouvelle.

(3) Le paragraphe (1) ne s'applique pas lorsque les données sur lesquelles le ministre s'appuie étaient contenues dans les renseignements et le matériel présentés par l'innovateur avant le 1er janvier 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,

(iii) the source of the new drug,

(iv) a detailed protocol of the clinical testing,

(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,

(vii) all ingredients of the new drug, stated quantitatively,

(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

(i) "Investigational Drug" or "Drogue de recherche", and

(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.

(1.1) This section applies only in respect of a new drug for veterinary use.

(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.

C.08.005. (1) Sous réserve du paragraphe (1.1) et par dérogation aux articles C.08.002 et C.08.003, le fabricant d'une drogue nouvelle peut vendre celle-ci à un chercheur qualifié à la seule fin d'effectuer un essai clinique pour obtenir des preuves sur l'innocuité, la posologie et l'efficacité de la drogue nouvelle, si les conditions suivantes sont réunies :

a) le fabricant a, avant la vente, déposé auprès du ministre, conformément à l'article C.08.005.1, une présentation préclinique contenant des renseignements et du matériel se rapportant à ce qui suit :

(i) la marque nominative de la drogue nouvelle ou le nom ou code d'identification projeté pour celle-ci,

(ii) la structure chimique ou tout autre détail spécifique qui permet de déterminer la composition de la drogue nouvelle,

(iii) la provenance de la drogue nouvelle,

(iv) un protocole détaillé de l'essai clinique,

(v) les résultats des recherches effectuées pour motiver l'usage clinique de la drogue nouvelle,

(vi) les contre-indications et les précautions connues relativement à la drogue nouvelle, ainsi que le traitement recommandé en cas d'absorption de dose excessive,

(vii) tous les ingrédients de la drogue nouvelle, déclarés sous forme quantitative,

(viii) l'usine, les méthodes, l'outillage et les contrôles utilisés pour la fabrication, le conditionnement et l'empaquetage de la drogue nouvelle,

(ix) les essais effectués en vue de contrôler l'activité, la pureté et l'innocuité de la drogue nouvelle,

(x) les noms et les titres et compétences de tous les chercheurs auxquels la drogue doit être vendue, ainsi que les noms de tous les établissements où l'essai clinique doit avoir lieu;

b) dans les 60 jours suivant la date de réception de la présentation préclinique, le Directeur n'a pas fait parvenir au fabricant, par courrier recommandé, un avis indiquant que la présentation de drogue nouvelle n'est pas satisfaisante;

c) toutes les étiquettes intérieures et extérieures utilisées relativement à la vente de la drogue nouvelle portent les mentions suivantes :

(i) « Drogue de recherche » ou « Investigational Drug » ,

(ii) « Réservé uniquement à l'usage de chercheurs compétents » ou « To Be Used By Qualified Investigators Only » ;

d) le fabricant, avant la vente, vérifie que tout chercheur compétent à qui il est censé vendre la drogue nouvelle :

(i) dispose des installations voulues pour l'essai clinique qu'il doit effectuer,

(ii) a reçu les renseignements et la documentation visés aux sous-alinéas a)(i) à (vi);

e) tout chercheur compétent à qui la drogue nouvelle doit être vendue a convenu par écrit avec le fabricant qu'il :

(i) n'utilisera pas la drogue nouvelle ou ne permettra pas son utilisation à d'autres fins que l'essai clinique,

(ii) ne permettra pas l'usage de la drogue nouvelle par une personne autre que lui-même, sauf sous sa direction,

(iii) signalera immédiatement au fabricant, ainsi qu'au Directeur si celui-ci le lui demande, tout ce qui touche les réactions indésirables importantes qui auront été observées pendant l'essai clinique,

(iv) rendra compte au fabricant, sur demande de celui-ci, de toutes les quantités de drogue nouvelle qu'il aura reçues.

(1.1) Le présent article ne s'applique qu'aux drogues nouvelles pour usage vétérinaire.

(2) Nonobstant le paragraphe (1) ci-dessus, il est interdit à tout fabricant de vendre une drogue nouvelle à un chercheur compétent, à moins que, au sujet de toutes les ventes préalables de cette drogue nouvelle à n'importe quel chercheur compétent, le fabricant n'ait

a) tenu des registres exacts de la distribution de cette drogue nouvelle et des résultats des épreuves cliniques, et présenté lesdits registres à l'inspection, à la demande du Directeur; et

b) rapporté immédiatement au Directeur tous les renseignements obtenus par lui-même au sujet de réactions fâcheuses importantes.

(3) Le ministre peut aviser le fabricant d'une drogue nouvelle que la vente de cette drogue nouvelle aux chercheurs compétents est interdite si, de l'avis du ministre, cette mesure est dans l'intérêt de la santé publique.

(4) Nonobstant le paragraphe (1) ci-dessus, il est interdit à un fabricant de vendre une drogue nouvelle à un chercheur compétent si le ministre a avisé ce fabricant que la vente de ladite drogue est interdite.

(5) L'alinéa (1)c) ne s'applique pas aux produits pharmaceutiques radioactifs définis à l'article C.03.201, ni aux constituants ni aux trousses définis à l'article C.03.205.

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. (2) A sectional report referred to in paragraph (1)(b) shall include (a) a summary of each study included in the submission or supplement; (b) a summary of any additional information or material filed to amend the submission or supplement; and (c) where raw data is available to the manufacturer in respect of a study, (i) a summary of the data, (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, (iv) the details of the data treatment process, and (v) the results and conclusions of the study. (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. (4) The submission certificate referred to in paragraph (1)(d) shall (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 (b) be signed and dated by (i) the senior executive officer in Canada of the manufacturer filing the submission or supplement, and (ii) the senior medical or scientific officer of the manufacturer. (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, (a) is false or misleading; or (b) contains omissions that may affect its accuracy and completeness. (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.		C.08.005.1. (1) Le fabricant qui dépose une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle, un supplément à l'une de ces présentations ou une présentation pour l'essai clinique d'une drogue nouvelle pour usage vétérinaire doit, en plus des renseignements et du matériel exigés aux articles C.08.002, C.08.003 et C.08.005, y inclure : a) une copie des rapports d'observations cliniques relatifs à chaque sujet ayant participé à une étude comprise dans la présentation ou le supplément si celui-ci soit est mort, soit a subi une réaction indésirable grave ou une réaction indésirable imprévue, ou si l'étude, dans la mesure où elle a trait au sujet, n'a pas été complétée; b) un résumé de section pour chaque étude sur l'homme, sur l'animal et in vitro comprise dans la présentation ou le supplément; c) une synthèse globale de chaque étude sur l'homme, sur l'animal et in vitro qui est comprise dans la présentation ou le supplément ou à laquelle il est fait renvoi; d) une attestation concernant les renseignements et le matériel que contient la présentation ou le supplément, ainsi que les renseignements ou le matériel supplémentaires déposés, le cas échéant, aux fins de la modification de la présentation ou du supplément. (2) Le résumé de section visé à l'alinéa (1)b) doit comprendre : a) un résumé de chaque étude comprise dans la présentation ou le supplément; b) un sommaire des renseignements ou du matériel supplémentaires déposés, le cas échéant, aux fins de la modification de la présentation ou du supplément; c) lorsque le fabricant dispose des données brutes d'une étude : (i) un sommaire de ces données, (ii) les renvois aux parties pertinentes du résumé de section, (iii) la description des conditions dans lesquelles se sont déroulées les expériences desquelles les données ont été obtenues, (iv) les détails du mode de traitement des données, (v) les résultats et les conclusions de l'étude. (3) La synthèse globale visée à l'alinéa (1)c) doit comprendre un sommaire des méthodes utilisées, des résultats obtenus et des conclusions émises pour les études qui sont comprises dans la présentation ou le supplément ou auxquelles il est fait renvoi, et doit indiquer les renvois aux parties pertinentes des résumés de sections. (4) L'attestation visée à l'alinéa (1)d) doit : a) attester que les renseignements et le matériel compris dans la présentation ou le supplément et tout renseignement ou matériel supplémentaire déposé aux fins de la modification de la présentation ou du supplément sont exacts et complets, et que les résumés de sections et la synthèse globale représentent fidèlement les renseignements et le matériel qui sont compris dans la présentation ou le supplément ou auxquels il est fait renvoi; b) être datée et signée à la fois par : (i) le premier dirigeant au Canada du fabricant qui dépose la présentation ou le supplément, (ii) le directeur médical ou scientifique du fabricant. (5) Il est interdit de signer une attestation si un résumé de section, la synthèse globale ou tout renseignement ou matériel compris dans la présentation ou le supplément, ou tout renseignement ou matériel supplémentaire déposé aux fins de la modification de cette présentation ou de ce supplément : a) soit est faux ou trompeur; b) soit comporte des omissions qui peuvent avoir une incidence sur son exactitude et son intégralité. (6) Le fabricant qui a déposé une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle, un supplément à l'une de ces présentations ou une présentation pour l'essai clinique d'une drogue nouvelle pour usage vétérinaire sans y inclure les fiches d'observations cliniques ou les données brutes y ayant trait doit conserver ces fiches ou ces données et les soumettre au ministre, s'il en fait la demande par écrit, dans les trente jours suivant la réception de celle-ci.

. . .		. . .

Food and Drugs Act, c. F-27

30. (1) The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations

(a) declaring that any food or drug or class of food or drugs is adulterated if any prescribed substance or class of substances is present therein or has been added thereto or extracted or omitted therefrom;

(b) respecting

(i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,

(ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,

(iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and

(iv) the use of any substance as an ingredient in any food, drug, cosmetic or device,

to prevent the purchaser or consumer thereof from being deceived or misled in respect of the design, construction, performance, intended use, quantity, character, value, composition, merit or safety thereof, or to prevent injury to the health of the purchaser or consumer;

(c) prescribing standards of composition, strength, potency, purity, quality or other property of any article of food, drug, cosmetic or device;

(d) respecting the importation of foods, drugs, cosmetics and devices in order to ensure compliance with this Act and the regulations;

(e) respecting the method of manufacture, preparation, preserving, packing, storing and testing of any food, drug, cosmetic or device in the interest of, or for the prevention of injury to, the health of the purchaser or consumer;

(f) requiring persons who sell food, drugs, cosmetics or devices to maintain such books and records as the Governor in Council considers necessary for the proper enforcement and administration of this Act and the regulations;

(g) respecting the form and manner of the Minister's indication under section 12, including the fees payable therefor, and prescribing what premises or what processes or conditions of manufacture, including qualifications of technical staff, shall or shall not be deemed to be suitable for the purposes of that section;

(h) requiring manufacturers of any drugs described in Schedule E to submit test portions of any batch of those drugs and respecting the form and manner of the Minister's indication under section 13, including the fees payable therefor;

(i) respecting the powers and duties of inspectors and analysts and the taking of samples and the seizure, detention, forfeiture and disposition of articles;

(j) exempting any food, drug, cosmetic or device from all or any of the provisions of this Act and prescribing the conditions of the exemption;

(k) prescribing forms for the purposes of this Act and the regulations;

(l) providing for the analysis of food, drugs or cosmetics other than for the purposes of this Act and prescribing a tariff of fees to be paid for that analysis;

(l.1) respecting the assessment of the effect on the environment or on human life and health of the release into the environment of any food, drug, cosmetic or device, and the measures to take before importing or selling any such food, drug, cosmetic or device;

(m) adding anything to any of the schedules, in the interest of, or for the prevention of injury to, the health of the purchaser or consumer, or deleting anything therefrom;

(n) respecting the distribution or the conditions of distribution of samples of any drug;

(o) respecting

(i) the method of manufacture, preparation, preserving, packing, labelling, storing and testing of any new drug, and

(ii) the sale or the conditions of sale of any new drug,

and defining for the purposes of this Act the expression "new drug"; and

(p) authorizing the advertising to the general public of contraceptive devices and drugs manufactured, sold or represented for use in the prevention of conception and prescribing the circumstances and conditions under which, and the persons by whom, those devices and drugs may be so advertised.

Loi sur les aliments et drogues, ch. F-27

30. (1) Le gouverneur en conseil peut, par règlement, prendre les mesures nécessaires à l'application de la présente loi et, notamment_:

a) déclarer qu'un aliment ou une drogue, ou une catégorie d'aliments ou de drogues, est falsifié si une substance ou catégorie de substances prévue par règlement s'y trouve, y a été ajoutée ou en a été extraite, ou en est absente;

b) régir, afin d'empêcher que l'acheteur ou le consommateur d'un article ne soit trompé sur sa conception, sa fabrication, son efficacité, l'usage auquel il est destiné, son nombre, sa nature, sa valeur, sa composition, ses avantages ou sa sûreté ou de prévenir des risques pour la santé de ces personnes, les questions suivantes_:

(i) l'étiquetage et l'emballage ainsi que l'offre, la mise à l'étalage et la publicité, pour la vente, d'aliments, de drogues, de cosmétiques et d'instruments,

(ii) le volume, les dimensions, le remplissage et d'autres spécifications pour l'emballage des aliments, drogues, cosmétiques et instruments,

(iii) la vente ou les conditions de vente, de tout aliment, drogue, cosmétique ou instrument,

(iv) l'emploi de toute substance comme ingrédient entrant dans la fabrication d'un aliment, d'une drogue, d'un cosmétique ou d'un instrument;

c) établir des normes de composition, de force, d'activité, de pureté, de qualité ou d'autres propriétés d'un aliment, d'une drogue, d'un cosmétique ou d'un instrument;

d) régir l'importation d'aliments, de drogues, de cosmétiques et d'instruments, afin d'assurer le respect de la présente loi et de ses règlements;

e) prévoir le mode de fabrication, de préparation, de conservation, d'emballage, d'emmagasinage et d'examen de tout aliment, drogue, cosmétique ou instrument, dans l'intérêt de la santé de l'acheteur ou du consommateur de l'article ou afin de prévenir tout risque pour la santé de ces personnes;

f) enjoindre aux personnes qui vendent des aliments, des drogues, des cosmétiques ou des instruments de tenir les livres et registres qu'il juge nécessaires pour l'application et l'administration judicieuses de la présente loi et de ses règlements;

g) prévoir les modalités selon lesquelles sera donnée l'attestation du ministre dans le cadre de l'article 12, notamment les droits à payer, ainsi que les locaux ou procédés ou conditions de fabrication, notamment la compétence du personnel technique, qui doivent ou ne doivent pas être considérés comme appropriés à l'application de cet article;

h) exiger des fabricants de toute drogue mentionnée à l'annexe E qu'ils donnent, pour examen, un échantillon de chaque lot de la drogue et fixer les modalités selon lesquelles sera donnée l'attestation du ministre dans le cadre de l'article 13, notamment les droits à payer;

i) prévoir les pouvoirs et fonctions des inspecteurs et des analystes, ainsi que le prélèvement d'échantillons et la saisie, la rétention, la confiscation et l'aliénation d'articles;

j) exempter un aliment, une drogue, un cosmétique ou un instrument de l'application, en tout ou en partie, de la présente loi et fixer les conditions de l'exemption;

k) établir des formules pour l'application de la présente loi et de ses règlements;

l) prévoir l'analyse d'aliments, de drogues ou de cosmétiques autrement que pour l'application de la présente loi ainsi que le tarif des droits à payer pour ces analyses;

l.1) régir l'évaluation de l'effet sur l'environnement ou sur la vie et la santé humaines des rejets dans l'environnement de tout aliment, drogue, cosmétique ou instrument et les mesures à prendre préalablement à leur importation ou à leur vente;

m) modifier les annexes, dans l'intérêt de la santé de l'acheteur ou du consommateur d'un article ou afin de prévenir tout risque pour la santé de ces personnes;

n) régir la distribution ou les conditions de distribution des échantillons de toute drogue;

o) prévoir, pour l'application de la présente loi, une définition de « drogue nouvelle » ainsi que_:

(i) les méthodes de fabrication, de préparation, de conservation, d'emballage, d'étiquetage, d'emmagasinage et d'examen de toute drogue nouvelle,

(ii) la vente ou les conditions de vente de toute drogue nouvelle;

p) autoriser que soit faite auprès du grand public de la publicité relative à des moyens anticonceptionnels et des drogues fabriquées ou vendues pour servir à prévenir la conception, ou présentées comme telles, et déterminer les circonstances et les conditions dans lesquelles ces moyens et ces drogues peuvent faire l'objet d'une telle publicité, ainsi que les personnes qui peuvent en être chargées.

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