SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
foreign submission are permissible if they are justified (Article 16 paragraph 2 of the OMP). Such differences may, in particular, concern a different name for the medicinal product, a different pack size, or a different secondary packaging. • The full and final assessment reports from the foreign regulatory agency must be available (Article 16 lit b of the OMP). • The documentation must include all neces- sary information for Switzerland, particularly medicinal product information and labeling texts (Article 16 lit c of the OMP). • The documentation must be provided in an official Swiss language or in English. If a translation is submitted, the applicant must confirm that it is correct (Article 16 lit d of the OMP). Articles 16–20 of the OMP provide detailed pro- visions on the application of Article 13 of the TPA and Swissmedic has issued a respective guidance document on the procedure ( “Authori- sation Human Medicial Product Under Art. 13 TPA” ). The current list of countries recognised by Swissmedic as having comparable regulatory oversight for human medicinal products (Article 16 paragraph 4 of the OMP) is available on the Swissmedic website. In practice, the Article 13 TPA procedure can significantly reduce approval timelines – saving several months compared to the standard process. In addition, Article 14 of the TPA provides for certain simplified authorisation procedures, which may apply when a medicinal product has already been approved by international regu- latory authorities (see Swissmedic guidance “Authorisation in Accordance with Art. 14 para- graph 1 abis-quarter TPA” ), as follows.
• A medicinal product may qualify for simplified authorisation if its active substances have been used in an approved medicinal product for at least ten years in an EU or European Free Trade Agreement (EFTA) country and if it is comparable to a foreign-authorised product in terms of indication, dosage (strength and recommendation), and route of administration (Article 14 paragraph 1 lit abis and Article 14a paragraph 1 lit a in conjunction with Article 17a and 17b of the OSMA). • Furthermore, a non-prescription medicinal product with a stated indication may qualify for simplified authorisation if it has been medically used for at least 30 years, includ- ing at least 15 years in EU or EFTA countries (Article 14 paragraph 1 lit ater of the TPA and Article 14a paragraph 1 lit b of the TPA, in conjunction with Article 17c of the OSMA). Finally, Switzerland has entered into multiple mutual recognition agreements (MRAs) that allow for respective products to be placed on the Swiss market and within the territory of the contracting party with as few obstacles as pos- sible. For medicinal products, Switzerland has signed MRAs under which each contracting party recognises the results of GMP inspections conducted by the competent inspectorates of the other party. Additionally, these agreements provide for the mutual acceptance of manufac- turing authorisations issued by the respective regulatory authorities, thereby reducing the need for duplicate inspections and authorisations. A comprehensive list of all MRAs is available on the Swissmedic website. Medical Devices Regarding medical devices, Swiss law cur- rently allows only a limited regulatory reliance. Following the expiration of the MRA between Switzerland and the EU, Switzerland unilaterally
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