{"id":13192,"date":"2026-09-16T16:51:41","date_gmt":"2026-09-16T14:51:41","guid":{"rendered":"https:\/\/my-swiss-company.com\/?p=13192"},"modified":"2026-09-16T16:51:41","modified_gmt":"2026-09-16T14:51:41","slug":"start-pharmaceutical-company-switzerland","status":"publish","type":"post","link":"https:\/\/my-swiss-company.com\/en\/start-pharmaceutical-company-switzerland\/","title":{"rendered":"Starting a pharmaceutical company in Switzerland: three regimes, the Swissmedic establishment licence and the responsible person"},"content":{"rendered":"
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Starting a pharmaceutical company in Switzerland does not mean applying for a single “pharma licence”. Three regimes coexist. A medicinal product requires a Swissmedic establishment licence, granted after an inspection and tied to a named responsible person. A medical device requires no licence at all, but a Swiss authorised representative and a registration number. A food supplement is a foodstuff: no authorisation, only a notification of the activity to the cantonal authority.<\/p>\n

The regime you fall under determines your entry cost, your organisation and the first person you need to hire. This guide follows the order in which these questions actually arise, with the articles of the Therapeutic Products Act, its ordinances and the Swissmedic fees in force since 1 July 2026.<\/p>\n<\/div>\n

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Contents<\/h3>\n
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  1. Medicine, medical device, supplement: three regimes<\/a><\/li>\n
  2. The Swissmedic establishment licence<\/a><\/li>\n
  3. The responsible person: the heart of the file<\/a><\/li>\n
  4. What a pharmaceutical company costs in Switzerland<\/a><\/li>\n
  5. Trading, brokerage and foreign trade from Switzerland<\/a><\/li>\n
  6. Medical devices: Swiss representative and CHRN<\/a><\/li>\n
  7. Food supplements: a foodstuff, not a medicine<\/a><\/li>\n
  8. Legal form, premises and innovation taxation<\/a><\/li>\n
  9. The pitfalls of a pharmaceutical project<\/a><\/li>\n<\/ol>\n<\/div>\n

    Medicine, medical device, supplement: three regimes<\/h2>\n

    The first decision when you start a pharmaceutical company in Switzerland is to classify your product, because the Therapeutic Products Act (TPA) treats differently what acts through a medicinal mechanism and what does not. A medicinal product is defined as a product of chemical or biological origin intended to act medically on the human or animal organism, or presented as such. A medical device is a product for medical use “whose principal action is not obtained by a medicinal product”: instruments, apparatus, software, implants, in vitro diagnostics.<\/p>\n

    A food supplement falls outside the TPA. The Federal Food Safety and Veterinary Office defines it as a foodstuff that supplements a normal diet with vitamins, minerals or other substances having a nutritional or physiological effect. These three classifications determine the competent authority and the starting point of the project.<\/p>\n

    \n\n\n\n\n\n\n\n
    The three regimes for a health business in Switzerland<\/caption>\n
    Product<\/th>\nAuthority<\/th>\nCompany authorisation<\/th>\nStructural requirement<\/th>\n<\/tr>\n<\/thead>\n
    Medicinal product<\/td>\nSwissmedic<\/td>\nEstablishment licence, granted after inspection<\/td>\nResponsible person, quality assurance system<\/td>\n<\/tr>\n
    Medical device<\/td>\nSwissmedic<\/td>\nNo official authorisation<\/td>\nSwiss authorised representative if the manufacturer is abroad, CHRN registration<\/td>\n<\/tr>\n
    Food supplement<\/td>\nCantonal enforcement authority<\/td>\nNo authorisation, no product registration<\/td>\nNotification of the activity, responsible person, self-monitoring<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    The border is crossed faster than founders expect. A supplement advertised as treating a disease is no longer a foodstuff in the eyes of the law, and software that helps establish a diagnosis may qualify as a medical device. Settle this question before incorporating: the wrong regime means the wrong structure.<\/p>\n

    The Swissmedic establishment licence<\/h2>\n

    Any company that manufactures, imports, exports or wholesales medicinal products in Switzerland must hold an establishment licence issued by Swissmedic, the Swiss Agency for Therapeutic Products. Swissmedic states that the licence is granted “notamment sur la base d’une inspection”, and that, with few exceptions, it is issued for an unlimited duration.<\/p>\n

    Activities subject to a licence<\/h3>\n