Date: 20060607
Docket: T-1603-05
Citation: 2006 FC 708
Ottawa, Ontario, June 7th, 2006
PRESENT: The Honourable Mr. Justice Kelen
BETWEEN:
CANADIAN PHARMACEUTICAL TECHNOLOGIES INTERNATIONAL (C.P.T.) INC.
Applicant
and
ATTORNEY GENERAL OF CANADA
Respondent
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application for judicial review of a decision of Mr. Alain Bérubé, Operational Manager, Québec Operational Centre, Health Products and Food Branch Inspectorate, Health Canada dated September 16, 2005, which classified the applicant's generic drug vancomycin hydrochloride, marketed as "Vancopak", as a new drug in dosage form, and not an active pharmaceutical ingredient (API) for compounding. This case raises the issue of whether vancomycin hydrochloride, a drug in powder form for reconstitution with a liquid solvent, is a "drug in dosage form" under the Food and Drug Regulations, C.R.C., c. 870 (Regulations) which requires a Drug Identification Number (DIN) or is an API for compounding by a pharmacist so that it does not require a DIN.
Facts
[2] The applicant, CPTI, established eight years ago and based in the Province of Québec, refers to itself as a "consulting and distribution company". CPTI offered to supply vancomycin hydrochloride powder as an active pharmaceutical ingredient (API) to pharmacies and hospitals for compounding purposes. The parties agree that "compounding" is a term which describes the practice of a licensed pharmacist when combining an active pharmaceutical ingredient with non-medicinal ingredients to create a customized drug in dosage form to meet a specific patient need as evidenced by a prescription from a physician.
[3] Vancomycin hydrochloride, an antibiotic, is for the treatment of severe or life-threatening staphylococcal infections in patients who cannot receive or have failed to respond to penicillin or other medicaments or who have infections with staphylococci resistant to other antibiotics.
[4] CPTI offered to sell its vancomycin hydrochloride to a purchasing group for hospitals in the Province of Québec. A member of that purchasing group informed Health Canada that it had been contacted by CPTI to purchase this product without a Drug Identification Number.
[5] On January 17, 2005, CPTI in a letter to the purchasing group, stated that its vancomycin hydrochloride, which was then sold under the trade name Vancomysol, is presented in an amber bottle, in portions of 5 grams, to which a hospital pharmacist can add 100 ml of liquid to obtain a concentration of 50 mg/ml. The letter stated:
La préparation est stable pour 14 jours à une température variant entre 2 et 8. Cette quantité est, généralement, suffisante pour 7 jours selon le dosage habituellement recommandé pour adulte.
[6] On April 15, 2005, the Québec Operational Centre of the Health Products and Food Branch Inspectorate of Health Canada informed the applicant that Vancomysol is a drug which is subject to regulation under the Food and Drugs Act, R.S.C. 1985, c. F-27, as am. and Food and Drug Regulations, and that this product required a Drug Identification Number prior to sale. Vancomysol was recalled from the market because CPTI had not met the Food and Drugs Act regulatory requirements to sell the product.
[7] The applicant renamed the product "Vancopak" and changed its label from stating "for extemporaneous use" to "FOR Rx COMPOUNDING", which means that it is for compounding by a pharmacist in accordance with a prescription. These changes in the name and label did not affect the opinion of Health Canada, as seen from the Health Canada records between February 4, 2005 and the decision dated September 16, 2005.
Decision under review
[8] The Health Canada Québec Operational Manager for the Health Products and Food Branch Inspectorate in a letter to CPTI dated September 16, 2005, concluded that:
1. Vancopak is a drug for the purposes of the Food and Drugs Act and Regulations;
2. Vancopak, as a powder for solution, is a "well-recognized" pharmaceutical dosage form as defined in section C.01.005(3) of the Food and Drugs Regulations;
3. Vancopak, which is presented for use as a powder which only needs water to be added, is considered by Health Canada to be a drug in "dosage form"; and
4. Vancopak is not a product for "compounding" for the following reasons:
"• the product is not being prepared pursuant to a prescription within an established pharmacist-patient-prescriber relationship
• the product is being promoted and advertised
• there is a tradename associated to the product
• the product is being distributed by a third party (Valeo Pharma)
• the product is being provided in a final dosage form"
Relevant Legislation
[9] The legislation and administrative guidelines relevant to this application are:
1. Food and Drugs Act, R.S.C. 1985, c. F-27, as am.;
2. Food and Drug Regulations, C.R.C., c. 870, as am., Part C; and
3. Health Canada Policy, "Manufacturing and Compounding Drug Products in Canada"dated June 2000.
Issues
[10] The following two issues are raised on this application:
1. Did Health Canada breach its duty of fairness to the applicant by making the decision under review without providing the applicant with knowledge of the case it had to meet and an opportunity of responding?; and
2. Is the Health Canada decision classifying Vancopak as a "drug in dosage form", and not as an active pharmaceutical ingredient for compounding, based on erroneous findings of fact, mixed fact and law, or jurisdiction?
Standard of Review
[11] In determining the standard of review of Health Canada's decision, a pragmatic and functional analysis must be performed. As specified in the Supreme Court of Canada's decision in Dr. Q v. College of Physicians and Surgeons of British Columbia, [2003] 1 S.C.R. 226, four factors must be considered in this analysis:
1. the presence of a privative clause or statutory right of appeal;
2. the expertise of the tribunal relative to the reviewing court;
3. the purpose of the legislation; and
4. the nature of the question.
[12] For the first factor, there is no privative clause or statutory right of appeal in the legislation in respect of Health Canada's product classification decisions. Accordingly, this factor is neutral.
[13] For the second factor, Health Canada has a greater expertise relative to the Court in relation to classification, manufacture and safe sale of drugs. Determining whether a product should be classified and regulated as a "drug in dosage form" requires the exercise of judgment derived from special expertise in respect of basic and applied medical science. The line that divides drugs that are in "dosage form" from those that require further "manufacturing" is, in accordance with Parliament's intent, one that is best demarcated by regulators with expertise in drug regulation. As a result, deference is owed to the Health Canada's determination of factual questions.
[14] For questions of statutory interpretation or defining the scope of jurisdiction under the Act, the Court has greater expertise than Health Canada, and less deference is owed.
[15] The third factor is the purpose of the legislation; in this case, the applicable legislation is the Food and Drugs Act and Food and Drug Regulations. The purpose of the Act is, inter alia, to regulate the manufacture, distribution, use and sale of drugs to protect the health and safety of the Canadian public. The overriding purpose of "Part C DRUGS" of the Regulations is to ensure the safety and efficacy of drugs. Health Canada's product classification decisions are administrative and polycentric in nature, given that they protect the public's safety as gatekeeper to the pharmaceutical market. While classification decisions have some precedential value to Canada's pharmaceutical industry, in my view this factor is ancillary to the main purpose which is to protect the public interest. Accordingly, this factor favours great deference.
[16] The fourth factor is the nature of Health Canada's product classification decision at issue. In order to exempt itself from the labelling requirements of drugs under the Act and Regulations, a manufacturer or seller must establish that its product is not "a drug in dosage form" and is an API for compounding. Health Canada's classification decision, therefore, turns on these findings.
[17] The second issue, whether CPTI's Vancopak is a "drug in dosage form" which requires a Drug Identification Number on its label pursuant to section c.01.005(1) of Part C Drugs, Food and Drugs Regulations, or whether Vancopak is a drug to be compounded by a pharmacist pursuant to a prescription is a question of mixed law and fact, mostly fact. Accordingly, great deference is owed to Health Canada's determination of these factual questions. For this reason, the Court will review these questions on both a patently unreasonable and reasonableness standard of review. The Court is not satisfied that these questions of fact or mixed fact and law, go to the jurisdiction of Health Canada under the Act, and for this reason will not be reviewed on a standard of correctness.
[18] For questions of procedural fairness, it is established that the reviewing Judge does not need to engage in a standard of review inquiry. The Court determines the content of the duty of fairness as a question of law on the correctness standard. See Canadian Union of Public Employees (C.U.P.E.) v. Ontario (Minister of Labour), [2003] 1 S.C.R. 539 at paragraph 100 and Sketchley v. Canada(Attorney General)(2005), 344 N.R. 257 (F.C.A.) per Linden JA at paragraphs 52-55.
Analysis
Issue No. 1: Did Health Canadabreach its duty of fairness to the applicant by making the decision under review without providing the applicant with knowledge of the case it had to meet and an opportunity of responding?
[19] The Health Canada decision under review bans the applicant's Vancopak product. The common law duty of fairness owed by Health Canada to the applicant before making a decision which affects the right of the applicant to sell its pharmaceutical product is the requirement to provide the applicant with the case it has to meet (i.e. the reasons why Health Canada believes Vancopak requires a DIN), and a full opportunity to respond before making the decision. See [1979] 1 S.C.R. 311">Nicholson v. Haldimand-Norfolk Reg. Police Commrs., [1979] 1 S.C.R. 311 and Baker v. Canada(Minister of Citizenship and Immigration), [1999] S.C.R. 817">[1999] S.C.R. 817.
[20] In reviewing Health Canada's Record of Decision in this case and seeing the lack of pharmaceutical and other expert evidence which an applicant would normally have produced in response to the positions taken by Health Canada, I am satisfied that Health Canada has breached its duty of fairness in this case.
[21] The applicant would normally respond with expert evidence about whether Vancopak is in a form ready for use by the consumer without requiring any "further manufacturing", as per the definition of "a drug in dosage form" in subsection C.01.005(3) of the Regulations.
[22] The applicant would also presumably respond with expert evidence about whether Vancopak is a drug to be compounded by a pharmacist pursuant to a prescription, which under subsection C.05.005(2) means that no DIN is required for the drug. One question to be addressed is whether simply adding water to a powder would be considered "further manufacturing", or "transforming" the drug to another product.
[23] Also the applicant would normally respond with evidence about its letter to the Québec hospital purchasing group dated January 17, 2005, which said that the product presented in an amber bottle in a 5 gram portion, to which can be added 100 ml of liquid, is a seven day adult dosage of the drug.
[24] The applicant would also normally respond about whether Vancopak is an active pharmaceutical ingredient for compounding. This will presumably involve expert pharmaceutical and other evidence which the applicant would wish to present in relation to the Health Canada view expressed in the decision dated September 16, 2005, and not previously expressed to the applicant, that:
• the product is not being prepared pursuant to a prescription within an established pharmacist-patient-prescriber relationship
• the product is being promoted and advertised
• there is a tradename associated to the product
• the product is being distributed by a third party (Valeo Pharma)
• the product is being provided in a final dosage form
Issue No. 2: Is the Health Canadadecision classifying Vancopak as a "drug in dosage form", and not as an active pharmaceutical ingredient for compounding, based on erroneous findings of fact, mixed fact and law, or jurisdiction?
[25] Since the Court has found that Health Canada breached its duty of fairness, and not provided the applicant with a full opportunity of responding with evidence which would normally be expected of the applicant in response to the position taken by Health Canada, the Court cannot consider whether the Health Canada decision that Vancopak is a "drug in dosage form" under subsection C.01.005(3) of the Food and Drugs Regulations was based on erroneous findings. The evidentiary record is obviously incomplete.
Other matters
Agreement between the parties
[26] The parties at the hearing advised the Court that the issue of whether Vancopak was a "new drug" depends upon whether Vancopak is "a drug in dosage form". The parties also agreed that if Vancopak is not "a drug in dosage form", and is a drug compounded by a pharmacist pursuant to a prescription, it is not regulated under the Food and Drug Regulations, but under provincial legislation.
[27] Both parties agreed that Parliament has not yet legislated in respect of the oversight of active pharmaceutical ingredients for compounding. On December 7, 2002, Health Canada published a Notice of Intent to advise the public that it intended to develop a regulatory framework for APIs. Health Canada adopted a guidance document for the industry on October 3, 2002 entitled "Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients". However, this document has no legal effect until Parliament enacts regulations.
[28] This case highlights the urgent need for Canada to regulate with respect to APIs. The vancomycin hydrochloride sold by the applicant as Vancopak is imported in bulk from China in 5 kg factory sealed containers. In Canada it is repackaged in 5 g portions in bottles, and sold by the applicant under the trade name Vancopak. If the ultimate decision of Health Canada is that Vancopak is not subject to Regulation because it is an active pharmaceutical ingredient, and not "a drug in dosage form", then the purity and safety of this powerful antibiotic may not be subject to the regulatory oversight of most drugs in Canada. This could affect the health and safety of Canadians. Accordingly, both parties and the Court concurs, there is an urgent need for Parliament to regulate active pharmaceutical ingredients not being marketed as "drugs in dosage form". As both parties said, this is a "crack" in the drug regulations which needs to be "filled".
Alleged discrimination
[29] The applicant submits that Health Canada is discriminating against it because other companies in Canada are selling vancomycin hydrocholoride to pharmacists without requiring a DIN. The facts presented to the Court show that some vancomycin hydrocholoride powders are sold in Canada with DINs, and some are not. In this case there has been an inquiry or complaint against the applicant, and it is for this reason that Health Canada investigated the applicant, and made the decision under review. The respondent suggested that a similar decision may be made with respect to similar products at a future date. The fact that Health Canada has investigated the inquiry or complaint against the applicant does not mean that the applicant is being discriminated against. The Court agrees. Accordingly, the Court does not consider that Health Canada has discriminated against the applicant.
Costs
[30] The applicant is entitled to rely on the law in bringing its product to market. In this case, the applicant was not given a fair opportunity to know the case against it and to properly respond before the decision was made. For this reason, the applicant is entitled to its legal costs. Health Canada has acted in a reasonably expeditious fashion in dealing with this classification issue. The considerations
by Health Canada officials were important ones of public safety and show no evidence of bad faith or arbitrariness. Health Canada cannot be faulted in any way that would warrant legal costs, other than on a party-and-party basis on the ordinary scale.
JUDGMENT
THIS COURT ORDERS that:
1. This application for judicial review is allowed with costs; and
2. The Health Canada decision dated December 16, 2005 is set aside, and the matter is remitted to an appropriate senior Health Canada official in Ottawa on the following terms:
(i) the senior Health Canada official in Ottawa will not have been involved with the decision under review, but has expertise with respect to the compliance of health products under the Food and Drugs Act and Regulations;
(ii) the applicant is provided with an opportunity of providing the new decision-maker with evidence in response to the concerns raised by Health Canada in the letter dated September 16, 2005 and in the documents which constitute the record of decision, which were made known to the applicant as part of this Court process; and
(iii) the applicant will be provided with an opportunity to know any further concerns which Health Canada may have with respect to the additional evidence which may be submitted by the applicant, and provided with an opportunity to respond before the new Health Canada official makes a decision in this case.
"Michael A. Kelen"
Appendix "A"
RELEVANT LEGISLATION
1. Food and Drugs Act, R.S.C. 1985, c. F-27, as am.
| INTERPRETATION
Definitions
2. In this Act, [...]
"drug" includes any substance or mixture of substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
(b) restoring, correcting or modifying organic functions in human beings or animals, or
(c) disinfection in premises in which food is manufactured, prepared or kept; [...]
PART I
FOODS, DRUGS, COSMETICS AND DEVICES
Deception, etc., regarding drugs
9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. [...]
PART II
ADMINISTRATION AND ENFORCEMENT
Regulations
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
[...]
(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;
|
DÉFINITIONS
Définitions
2. Les définitions qui suivent s'appliquent à la présente loi. [...]
"drogue" Sont compris parmi les drogues les substances ou mélanges de substances fabriqués, vendus ou présentés comme pouvant servir:
a) au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal ou de leurs symptômes, chez l'être humain ou les animaux;
b) à la restauration, à la correction ou à la modification des fonctions organiques chez l'être humain ou les animaux;
c) à la désinfection des locaux où des aliments sont gardés. [...]
PARTIE I ALIMENTS, DROGUES, COSMÉTIQUES ET INSTRUMENTS
Fraude
9. (1) Il est interdit d'étiqueter, d'emballer, de traiter, de préparer ou de vendre une drogue - ou d'en faire la publicité - d'une manière fausse, trompeuse ou mensongère ou susceptible de créer une fausse impression quant à sa nature, sa valeur, sa quantité, sa composition, ses avantages ou sa sûreté. [...]
PARTIE II ADMINISTRATION ET CONTRÔLE
D'APPLICATION
Règlements
30. (1) Le gouverneur en conseil peut, par règlement, prendre les mesures nécessaires à l'application de la présente loi et, notamment:
[...]
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;
|
2. Food and Drug Regulations, C.R.C., c. 870, as am., Part C
| PART C DRUGS
DIVISION 1
General [...]
C.01.005. (1) The principal display panel of both the inner and outer label of a drug sold in dosage form shall show in a clear and legible manner the drug identification number assigned by the Director for that drug pursuant to subsection C.01.014.2(1), preceded by the words "Drug Identification Number" or "Drogue : identification numérique" or both, or the letters "DIN".
(2) Subsection (1) does not apply to a drug
(a) compounded by a pharmacist pursuant to a prescription or by a practitioner; or
(b) sold pursuant to a prescription, where the label of that drug indicates:
(i) the proper name, the common name or the brand name of the drug,
(ii) the potency of the drug, and
(iii) the name of the manufacturer of the drug.
(3) For the purposes of this section and section C.01.014, "a drug in dosage form" means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing.
[...]
Assignment and Cancellation of Drug Identification Numbers
C.01.014. (1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6. [...]
DIVISION 1A ESTABLISHMENT LICENCES
[...] Prohibition
C.01A.004. (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,
(a) fabricate, package/label, distribute as set out in section C.01A.003, import or wholesale a drug; or [...]
DIVISION 2 GOOD MANUFACTURING PRACTICES
[...]
C.02.002.1 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.
Sale
C.02.003. No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division. [...]
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. [...]
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;
(c) the notice of compliance in respect of the submission has not been suspended pursuant to section C.08.006; and
(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.
|
PARTIE C DROGUES
TITRE 1
Dispositions générales [...]
C.01.005. (1) L'espace principal des étiquettes intérieure et extérieure d'une drogue vendue sous forme posologique doit indiquer clairement et lisiblement l'identification numérique que lui a attribuée le Directeur conformément au paragraphe C.01.014.2(1), précédée de la mention "Drogue: identification numérique" ou de la mention "Drug Identification Number" ou des deux, ou de l'abréviation "DIN".
(2) Le paragraphe (1) ne s'applique pas à une drogue
a) préparée par un pharmacien, conformément à une ordonnance, ou par un praticien; ou
b) vendue conformément à une ordonnance, si l'étiquette de cette drogue indique:
(i) le nom propre, le nom usuel ou la marque nominative de la drogue,
(ii) l'activité de la drogue, et
(iii) le nom du fabricant de la drogue.
(3) Aux fins du présent article et de l'article C.01.014, une "drogue sous sa forme posologique" s'entend d'une drogue prête pour la consommation sans autre transformation.
[...]
Attribution et annulation de l'identification numérique des drogues
C.01.014. (1) Il est interdit à un fabricant de vendre, sous forme posologique, une drogue qui n'a pas fait l'objet d'une identification numérique, ou dont l'identification a été annulée selon l'article C.01.014.6. [...]
TITRE 1A LICENCE D'ÉTABLISSEMENT
[...] Interdiction
C.01A.004. (1) Sous réserve du paragraphe (2), il est interdit, sauf conformément à une licence d'établissement:
a) de manufacturer, d'emballer-étiqueter, de distribuer à titre de distributeur visé à l'article C.01A.003, d'importer et de vendre en gros une drogue; [...]
TITRE 2 BONNES PRATIQUES DE FABRICATION
[...]
C.02.002.1 Le présent titre ne s'applique pas aux activités visant à manufacturer, à emballer-étiqueter, à analyser, à entreposer ou à importer un agent antimicrobien.
Vente
C.02.003. Il est interdit au distributeur visé à l'alinéa C.01A.003b) et à l'importateur de vendre une drogue qui n'a pas été manufacturée, emballée-étiquetée, analysée ou entreposée conformément aux exigences du présent titre. [...]
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. [...]
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.
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3. Health Canada Policy, "Manufacturing and Compounding Drug Products in Canada" dated June 2000
| 1.0 Purpose
The purpose of this document is: [...]
2. To propose a policy framework to distinguish between compounding and manufacturing in Canada.
2.1 Proposed Guiding Principles
This framework is intended to meet the following guiding principles:
- The professional practice of compounding must not be used to bypass the drug review and approval system.
[...]
- Federal and provincial regulators must be capable of monitoring and enforcing compliance to regulation and standards related to compounding and manufacturing.
Drugs which are available in Canada must be safe, effective and of high quality. [...]
2.3.1 Manufacturing versus Compounding
Distinction between manufacturing and compounding is made as follows;
Manufacturing activities are subject to regulation under the Food and Drugs Act and Regulations, GMP guidelines and inspection by Health Canada, while compounding activities are conducted by a pharmacist or practitioner within the professional practice of pharmacy or medicine, regulated by provincial regulatory authorities in accordance with guidelines and standards that ensure the quality and safety of pharmaceuticals they compound. Compounded products are prepared for individual patients, within a specific population (refer to 4.0, definitions, established pharmacist-patient-prescriber relationship) pursuant to, or in anticipation of, a prescription within an established pharmacist-patient-prescriber relationship. [...]
[Footnotes omitted.]
2.3.4 Selling
[...] Although compensation may be paid to the provider for these services [compounding], any pharmacy that promotes or advertises that it compounds or repackages specific drugs or drug classes is subject to the Food and Drugs Act. As well, products intended for distribution outside the established pharmacist-patient-prescriber relationships of the compounding pharmacy and the hospitals in the agreement, are subject to full provisions of the Act. [...]
5.1.1 Commercially Available Products
Pharmacists may not compound products that are commercially available in a ready-to-use form, including products requiring reconstitution. [...]
5.2.2 Bulk Compounding
... [T]he full provisions of the Food and Drug Act will apply to any pharmacy that:
promotes or advertises that it compounds specific drugs or drug classes, and/or
compounds products intended for distribution or sale outside the established pharmacist-patient-prescriber relationship, and/or
compounds inordinate amounts of products in anticipation of receiving prescriptions.
|
1.0 Objet
L'objectif du présent document est: [...]
2. de proposer un cadre stratégique pour distinguer entre la préparation en pharmacie et la fabrication de drogues au Canada.
2.1 Principes directeurs proposés
Le présent document s'appuie sur les principes directeurs suivants :
- Il ne faut pas recourir à la pratique professionnelle de la préparation pour échapper au système d'examen et d'autorisation des médicaments.
[...]
- Les organismes fédéraux et provinciaux de réglementation doivent être en mesure de surveiller et d'assurer le respect de la réglementation et des normes liées à la préparation et à la fabrication.
- Les médicaments disponibles au Canada doivent être sûrs, efficaces et de qualité supérieure [...]
2.3.1 Fabrication ou préparation
La distinction entre fabrication et préparation s'établit comme suit :
Les activités de fabrication sont soumises à la Loi sur les aliments et drogues et à son Regulations d'application, aux lignes directrices sur les BPF et aux inspections de Santé Canada. Les activités de préparation sont effectuées par un pharmacien ou un praticien qui est un professionnel de la pharmacie ou de la médecine, sous la supervision des organismes provinciaux de réglementation, et conformément aux lignes directrices et aux normes garantissant l'innocuité et la qualité des produits pharmaceutiques que ces intervenants préparent. 10 Les produits préparés sont destinés à des patients individuels au sein d'une population donnée (voir la section 4, définitions, relation suivie entre pharmacien, patient et prescripteur), conformément à, ou en prévision de, la prescription établie dans le cadre d'une relation suivie entre le pharmacien, le patient et le prescripteur. [...]
2.3.4 Vente
[...] Même s'il arrive que le prestataire de ces services soit rémunéré, toute pharmacie qui annonce publiquement qu'elle prépare ou réemballe certaines drogues ou classes de drogues est soumise à la Loi sur les aliments et drogues. Par ailleurs, les produits destinés à une distribution hors du cadre de la relation pharmacien-patient-prescripteur entre la pharmacie qui a préparé ces produits et les hôpitaux parties à l'accord sont soumis à l'ensemble des dispositions de la Loi. [...]
5.1.1 Produits commercialisés
Les pharmaciens ne peuvent préparer des produits disponibles dans le commerce sous une forme prête à l'utilisation, y compris les produits qui requièrent une reconstitution. [...]
5.2.2 Préparation magistrale
... [L]a Loi sur les aliments et drogues s'appliquera à toutes pharmacies qui:
font la promotion ou la publicité qu'elles préparent certaines drogues ou classes de drogues;
préparent des produits à des fins de distribution ou de vente hors de la relation entre le pharmacien, le patient et le prescripteur;
préparent, en attendant de recevoir une prescription, des quantités excessives de médicaments.
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