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Switzerland

Federal Law of December 15, 2000 on Medicinal Products and Medical Devices (status as of January 20, 2004)

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Switzerland

Year of current version:2004
Date of last amendment:June 20, 2003
Date of entry into force of original text:January 1, 2002
Date of Text (Enacted):December 15, 2000
Type of Text:IP-related Laws: enacted by the Legislature
Subject Matter:Enforcement of IP and Related Laws, Patents (Inventions), Undisclosed Information (Trade Secrets)
Notes:
The notification by Switzerland to the WTO under Article 63.2 of TRIPS states:
Article 12 grants the protection to the first applicant seeking marketing authorization for medicinal products. Pursuant to Art. 39.3 of the TRIPS Agreement, Article 12. 2 ensures a ten year data exclusivity period for medical products to the first applicant (the holder of the original market approval).

Article 14.3 provides an exclusion from the simplified market authorization procedure for as long as the original preparation is protected by patent.

Articles 61 to 64 concern the undisclosed information including trade secrets and test data related to medicines.'
Available Texts: 
French

Loi fédérale du 15 décembre 2000 sur les médicaments et les dispositifs médicaux (état le 20 janvier 2004) Loi fédérale du 15 décembre 2000 sur les médicaments et les dispositifs médicaux (état le 20 janvier 2004), Complete document (pdf) [208 KB]

Related Legislation:
WIPO Lex No.:CH119

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