SWEDEN: DRAFT REGULATION AMENDING THE MEDICAL PRODUCT AGENCY'S REGULATIONS (LVFS 1995:9) CONCERNING APPLICATION OF THE MEDICAL PRODUCTS ACT (1992:859) TO CERTAIN PRODUCTS The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.410. 1. Member to Agreement notifying: SWEDEN. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Medical Products Agency. 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): Food supplements. 5. Title, number of pages and language(s) of the notified document: Draft Regulation Amending the Medical Product Agency's Regulations (LVFS 1995:9) Concerning Application to the Medical Products Act (1992:859) to Certain Products (1 page, in Swedish). 6. Description of content: The proposal defines the borderline between food supplements and proprietary medicinal products. 7. Objective and rationale: Protection of public health. 8. Relevant documents: Draft Regulation. 9. Proposed date of adoption: As soon as possible; Proposed date of entry into force: As soon as possible. 10. Final date for comments: 7 November 1997. 11. Text available from: National enquiry point. (0252)

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