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Health Products and Food Branch Inspectorate Graham Spry Building, 3Rd Floor 250 Lanark Avenue Address Locator # 2003A Ottawa, Ontario K1A 0K9

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Health Products and Food Branch Inspectorate Graham Spry Building, 3Rd Floor 250 Lanark Avenue Address Locator # 2003A Ottawa, Ontario K1A 0K9 Health Products and Food Branch Inspectorate Graham Spry Building, 3rd Floor 250 Lanark Avenue Address Locator # 2003A Ottawa, Ontario K1A 0K9 October 6, 2006 06-122768-420 To: Provincial Pharmacy Associations, Pharmacy Regulatory Authorities, National Association of Pharmacy Regulatory Authorities, Canadian Pharmacists Association, and Provincial/Territorial Ministries of Health RE: Reminder of obligations with respect to the advertising and sale of drugs In order to promote the continued regulatory compliance of pharmacies within your jurisdiction, this letter is to clarify the obligations of pharmacies, including Canadian Internet pharmacies, under the Food and Drugs Act and Food and Drug Regulations in regard to the advertising and sale of drugs which have not been approved for use in Canada. It is a violation of the Food and Drugs Act and Food and Drug Regulations to advertise or sell, at retail or via the Internet, drugs that are not approved for sale in Canada. This applies to all Canadian pharmacies selling over the Internet, even in cases where the unapproved drugs do not enter Canada but are dispensed by foreign pharmacies and delivered to patients outside of Canada. Pharmacies licensed in Canada that engage in such activity are considered to be advertising and selling unapproved drugs in Canada. As you are aware, the advertising and sale of an unapproved drug in Canada is a violation of the Food and Drugs Act and the Food and Drug Regulations. In particular, as the products at issue will typically be “new drugs” for the purposes of the Food and Drug Regulations, the advertising and sale of “foreign versions of Canadian approved drugs” is a violation of section C.08.002 of the Food and Drug Regulations. When Health Canada becomes aware that a product or activity is potentially not meeting the applicable regulatory requirements, the information is verified. If necessary, Health Canada works with the responsible party to bring the product or activity into compliance with the regulations. .../2 - 2 - A number of measures are available to Health Canada to address non-compliance with the requirements of the Regulations (e.g., search and seizure, seizure and detention, injunction, prosecution, public advisory or public warning, customs activities, letters to trade and regulated parties, stop-sale, etc.). These measures are further described in Policy-0001 which is available on Health Canada's website at: http://hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/pol/pol_1_tc-tm_e.html For your information, Appendix I to this letter provides additional references to the regulatory requirements under the Food and Drugs Act and Food and Drug Regulations regarding this matter. In addition to the aforementioned violations of the Food and Drugs Act and Food and Drug Regulations regarding the sale and advertisement of “foreign versions of Canadian approved drugs” in Canada, Health Canada is concerned about the broader implications of such activities. Offering products for sale that have not been approved for use in Canada opens the door for the entry into the Canadian market of products of substandard quality and, possibly, of counterfeit origin. Patients ordering pharmaceutical products from Canadian Internet pharmacies expect to receive products of the same quality as those ordinarily made available to Canadian citizens. The introduction of products that have not been approved for use in Canada undermines the federal regulatory framework which seeks to ensure that all drug products sold in Canada meet strict standards with respect to their quality and efficacy. It also tarnishes the image of not only the Canadian Internet pharmacy industry, but Canadian pharmacies in general. You are encouraged to review these requirements and to remind those pharmacies within your jurisdiction that are engaged in the sale of drugs including Canadian Internet pharmacies of the restrictions in the Food and Drugs Act and Food and Drug Regulations on the advertisement and sale of “foreign versions of Canadian approved drugs” from within Canada. Should you have any question about the obligations of pharmacies with respect to the advertising and sale of drugs, please contact the Health Products and Food Branch Inspectorate Operational Centre nearest you (see list in Appendix II). Yours truly, Original signed by Diana Dowthwaite Director General Attachments: Appendix 1: Food and Drug Act Definition of Sell Appendix 2: HPFBI - Operational Centres Appendix I – Food and Drug Act Definition of Sell Section 2 of the Food and Drugs Act defines “sell” and “advertisement” as follows; “Sell” includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration; “Advertisement”includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device; Section 9 of the Food and Drugs Act : 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. (2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). Referenced Food and Drug Regulations 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. Appendix II – Health Products and Food Branch Inspectorate – Operational Centres ATLANTIC OPERATIONAL CENTRE 16th floor, suite 1625 1505 Barrington Street Halifax, Nova Scotia B3J 3Y6 Tel: (902) 426-2160 Fax: (902) 426-6676 E-mail: [email protected] QUEBEC OPERATIONAL CENTRE 1001 St-Laurent Street West Longueuil, Québec J4K 1C7 Tel: (450) 646-1353 Fax: (450) 928-4455 E-mail: [email protected] ONTARIO OPERATIONAL CENTRE 2301 Midland Avenue Scarborough, Ontario M1P 4R7 Tel: (416) 973-1600 Fax: (416) 973-1954 E-mail: [email protected] MANITOBA AND SASKATCHEWAN OPERATIONAL CENTRE 510 Lagimodière Blvd Winnipeg, Manitoba R2J 3Y1 Tel: (204) 984-1341 Fax: (204) 984-2155 E-mail: [email protected] WESTERN OPERATIONAL CENTRE 4th Floor 4595 Canada Way Burnaby, British-Colombia V5G 1J9 Tel: (604) 666-3350 Fax: (604) 666-3149 E-mail: [email protected] .
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