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WORLD TRADE G/TBT/N/CAN/160/Rev.1 12 April 2011 ORGANIZATION (11-1828) Original: English/ French Committee on Technical Barriers to Trade NOTIFICATION Revision The following notification is being circulated in accordance with Article 10.6. 1. Member to Agreement notifying: CANADA If applicable, name of local government involved (Article 3.2 and 7.2): 2. Agency responsible: Department of Health Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above: Canadian Enquiry Point 200-270 Albert Street Ottawa, Ontario Canada, K1P 6N7 Tel.: + 1 613 238 3222 Fax: + 1 613 569 7808 E-mail: [email protected] 3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Prescription status of medicinal ingredients for human use (ICS: 11.120) 5. Title, number of pages and language(s) of the notified document: Proposed Amendment to the Food and Drug Regulations (Notice of Intent – Project No. 1431 — Schedule F) (4 pages, available in English and French). 6. Description of content: The purpose of this Notice of Intent (NOI) is to provide an opportunity to comment on the revised proposal to amend Part I of Schedule F to the Food and Drug Regulations to add quinine, its salts and derivatives except in oral dosage form that provides 50 mg or less of quinine base per dosage unit or per daily dose. This would result in affected products being regulated as prescription drug products under the Food and Drug Regulations. Since quinine meets the definition of a natural health product, products sold that contain an oral dosage form of 50 mg or less per unit dose or per daily dose would continue to be regulated under the Natural Health Products Regulations, and would not require a prescription. Sections C.01.041 to C.01.049 of the Food and Drug Regulations control the sale of medicinal ingredients that are listed in Schedule F. Part I of Schedule F lists medicinal ingredients that require a prescription for human use and for veterinary use. Part II of . /. G/TBT/N/CAN/160/Rev.1 Page 2 Schedule F lists medicinal ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. Description of the medicinal ingredient: Quinine is a medicinal ingredient that was originally made from the bark of several species of the cinchona tree and was used for centuries as the primary treatment for malaria. The use of quinine as a malaria treatment declined over the years as new synthetic derivatives of the drug such as chloroquine and mefloquine were developed and used. However, with increasingly drug-resistant strains of malaria appearing, there has been renewed interest in the use of quinine to treat malaria. Quinine is now being used in combination with other drugs such as antibiotics to treat non-severe malaria infections caused by specific organisms that are resistant to other anti-malarial drugs. A review of the available scientific literature on quinine indicates that the use of quinine to treat malaria requires individualized instructions and/or direct practitioner supervision. There is a narrow margin of safety between the therapeutic and toxic doses of quinine, especially in populations such as seniors, children, pregnant women or nursing mothers. There are potential or known undesirable or severe side effects at normal therapeutic dosage levels that would need to be managed by a practitioner. 7. Objective and rationale, including the nature of urgent problems where applicable: Protection of human health 8. Relevant documents: Canada Gazette, Part I, 26 March 2011, Pages 1083-1086 (available in English and French) 9. Proposed date of adoption: Normally within 6 to 8 months of publication in the Canada Gazette, Part I. Proposed date of entry into force: On the date the measure is adopted. 10. Final date for comments: 9 June 2011 11. Text available from: National enquiry point [X], or address, telephone and fax numbers, e-mail and web-site addresses, if available of the other body: The electronic version of the regulatory text can be downloaded at: http://canadagazette.gc.ca/rp-pr/p1/2011/2011-03-26/pdf/g1-14513.pdf (Canada Gazette) or http://canadagazette.gc.ca/rp-pr/p1/2011/2011-03-26/html/notice-avis-eng.html#d110 (English) http://canadagazette.gc.ca/rp-pr/p1/2011/2011-03-26/html/notice-avis-fra.html#d110 (French)