SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
• The documentation must include all necessary information for Switzerland, particularly medicinal product information and labeling texts (Article 16 paragraph 1 lit c of the OMP). • The documentation must be provided in an official Swiss language or in English. If a translation is sub- mitted, the applicant must confirm that it is correct (Article 16 paragraph 1 lit d of the OMP). Articles 16–20 of the OMP provide detailed provisions on the application of Article 13 of the TPA and Swiss- medic has issued a respective guidance document on the procedure (“Authorisation Human Medicial Prod- uct 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 regulatory authorities (see Swiss- medic guidance “Authorisation in Accordance with Art. 14 paragraph 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 Agree- ment (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, including 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 respec- tive products to be placed on the Swiss market and within the territory of the contracting party with as few obstacles as possible. For medicinal products, Swit- zerland has signed MRAs under which each contract- ing 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 manufacturing authori- sations 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 currently allows only a limited regulatory reliance. Following the expi- ration of the MRA between Switzerland and the EU, Switzerland unilaterally recognises conformity certifi- cates (CE markings) issued by recognised bodies in EU/European Economic Area (EEA) countries (Article 25 paragraph 4 of the MedDO and Article 21 para- graph 4 of the IvDO), provided additional requirements are met. These additional requirements include the appointment of an authorised representative in Swit- zerland, who is responsible for ensuring compliance with both formal and safety-related requirements and who must be registered with Swissmedic (Articles 51 and 55 of the MedDO and Articles 44 and 48 of the IvDO). In terms of recent developments, in 2022, the two Swiss parliamentary chambers adopted a motion mandating the Swiss Federal Council to amend the current legislation so that medical devices conform- ing to non-European regulatory systems (including FDA-approved devices) can be placed on the market in Switzerland by way of unilateral recognition. The FOPH is currently examining how this motion can be implemented.
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