CANADA: PROPOSED AMENDMENT TO THE FOOD AND DRUG REGULATIONS -- SCHEDULE NO. 979 The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.245. 1. Member to Agreement notifying: CANADA. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: HEALTH CANADA. Agency or authority designated to handle comments regarding the notification can be indicated if different from above. 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Drugs. 5. Title, number of pages and language(s) of the notified document: Proposed Amendment to the Food and Drug Regulations -- Schedule No. 979. 6. Description of content: This Amendment revokes Division 10 of the Food and Drug Regulations, thereby eliminating the assignment of a numbered certificate of registration (GP number) for proprietary medicines. Division 10 of the Regulations was introduced in the mid-1970s in order to regulate the sale of proprietary medicines. These medications are intended for self-medication to relieve the symptoms of minor self-limiting ailments. At that time, it was determined that special attention be given to the safety of the ingredients at the dosages and under the conditions of use recommended. Under the current legislation, an application for a GP number must be accompanied by additional information which may include: Details of the plan and equipment used in manufacturing -- reports of investigations conducted to determine the toxicity of the drug and substantial evidence of the effectiveness of the drug under the conditions of use recommended by the manufacturer. Based on the established low risk associated with GP products, the need for manufacturers to submit additional information has diminished and Division 10 of the Regulations is considered unnecessarily restrictive. Furthermore, the current legislation requires the issuance of a separate GP number for products differing from each other only in flavour, fragranceor colour. The Health Protection proposes to regulate all drug products by requiring the manufacturers to apply for a DIN. The Regulations prohibit a manufacturer from selling a drug product unless a valid DIN has been assigned and not cancelled. Consumer drug products currently possessing valid GP numbers will be assigned DINs administratively upon review of an application cross-referenced to their existing file. The Therapeutic Products Programme is exploring mechanisms to facilitate the registration of former GP products as DIN registered drugs without presenting a financial hardship to existing manufacturers. 7. Objective and rationale: Remove an unnecessary burden on manufacturers and streamline the drug review process. 8. Relevant documents: Canada Gazette, Part I. 9. Proposed date of adoption: Not state; Proposed date of entry into force: Not stated. 10. Final date for comments: 31 August 1997. 11. Text available from: National enquiry point. (0170)

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