CANADA: DRUGS The following notification has been received in GATT Document TBT/Notification 95.5 dated 12 January 1995. 1. Party to agreement notifying: Canada. 2. Agency responsible: Department of National Health and Welfare. 3.Notified under Article 2.5.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): drugs. 5. Title and number of pages of the notified document: Proposed Amendment to the Food and Drug Regulations, Pages 4787-4799. 6. Description of content: this initiative establishes a regulatory framework for abbreviated new drug submissions. The amendment provides a definition for a Canadian reference product thereby providing manufacturers and consumers with a clearly defined standard. This regulatory initiative also defines specific requirements for an abbreviated new drug submission. 7. Objective and rationale: protection of human safety. 8. Relevant documents: Canada Gazette, Part I, 24 December 1994. 9. Proposed date of adoption and entry into force: not stated. 10. Final date for comments: 22 February 1995. (031)

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