CANADA: DRUGS The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif. 95.232. 1. Member to Agreement notifying: Canada. If applicable, name of local government involved (Articles 3.2 and 7.2): 2. Agency responsible: Department of National Health and Welfare. 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 and number of pages of the notified document: Proposed Amendment to the Food and Drug Regulations (Schedule No. 774) (pages 2262-2265). 6. Description of content: This regulatory proposal amends the Food and Drug Regulations to ensure the following standards for all parenteral drugs: (1) except for those parenteral drugs which are inherently pyrogenic, all parenteral drugs must be free from pyrogens (fever-producing substances) including drugs where the individual dose recommended by the manufacturer is less than five millilitres; (2) that packaging components do not affect the purity or potency of the contents; (3) protection of the drug product from degradation sources such as gases, light and micro-organisms; (4) that containers, whether plastic or glass, permit the inspection of the contents either visually or by other means; (5) that there be a sufficient quantity of the drug in the container marketed to allow the withdrawal of the labelled amount. 7. Objective and rationale: Protection of human health. 8. Relevant documents: Canada Gazette, Part I, 8 July 1995. 9. Proposed date of adoption and entry into force: Not stated. 10. Final date for comments: 7 August 1995. (240)

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