SWITZERLAND: FEDERAL MEDICINES ACT The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.129. 1. Member to Agreement notifying: SWITZERLAND. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Federal Office of Public Health. 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): Medicinal products, blood and blood products, transplants, medical devices and in vitro diagnostic devices. 5. Title, number of pages and language(s) of the notified document: Federal Medicines Act. 6. Description of content: The law regulates: The control of the quality, safety and efficacy of medicines by means of analytical, conformity and registration procedures, the control of manufacturing practices (GMP), and post-marketing surveillance; the control of the import and export of medicines; the official monitoring of the clinical trials (GCP); establishment of a system of control of medicines in Switzerland and the establishment of a Swiss Institute for Medicines. 7. Objective and rationale: In order to protect the health of humans and animals, the law ensures that marketed medicines are of a high quality, safety and efficacy and will be used correctly. This act provides a uniform regulation of the medicines in Switzerland. 8. Relevant documents: Regulations governing the implementation of the Act, if not yet in force, will be issued at a later date in the form of decrees. 9. Proposed date of adoption: 1 July 2000; Proposed date of entry into force: 1 July 2000. 10. Final date for comments: 9 June 1997. 11. Text available from: National enquiry point. (0112)

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