{"id":236234,"date":"2026-09-16T16:54:10","date_gmt":"2026-09-16T14:54:10","guid":{"rendered":"https:\/\/www.rister.ch\/?p=236234"},"modified":"2026-09-16T16:54:10","modified_gmt":"2026-09-16T14:54:10","slug":"pharmaceutical-company-geneva","status":"publish","type":"post","link":"https:\/\/www.rister.ch\/en\/post\/pharmaceutical-company-geneva\/","title":{"rendered":"Setting up a pharmaceutical, medtech or food supplement company in Geneva: the Swissmedic licence, the site and the Swiss representative"},"content":{"rendered":"
\n

Setting up a pharmaceutical company in Geneva turns on three questions that incorporation alone does not answer: which product, which activity, which site. A medicinal product requires a Swissmedic establishment licence, attached to a responsible person and to an inspected establishment. A medical device requires no licence, but an authorised representative established in Switzerland. A food supplement is sold without authorisation, once the activity has been notified to the cantonal authority.<\/p>\n

In Geneva, such a project is as likely to take the form of a trading company, a distribution subsidiary or a representative office as of a production site. For those first three, misunderstandings are expensive. RISTER\u00ae sets out what a Geneva office does and does not allow.<\/p>\n<\/div>\n

\n

Contents<\/h3>\n
    \n
  1. Classify the product before incorporating<\/a><\/li>\n
  2. Is a Geneva office enough? The licence follows a site<\/a><\/li>\n
  3. Trading, importing, brokering: what Swissmedic licenses<\/a><\/li>\n
  4. The responsible person and their independence<\/a><\/li>\n
  5. The cost of a Swissmedic licence<\/a><\/li>\n
  6. Medtech: the Geneva company as representative or importer<\/a><\/li>\n
  7. Food supplements: notification and self-monitoring<\/a><\/li>\n
  8. Premises, plans and Geneva taxation<\/a><\/li>\n
  9. Mistakes seen on these files<\/a><\/li>\n<\/ol>\n<\/div>\n

    Classify the product before incorporating<\/h2>\n

    For a pharmaceutical company in Geneva as anywhere in Switzerland, the classification of the product determines the authority, the authorisations and the key person of the project. The Therapeutic Products Act distinguishes the medicinal product, intended to act medically on the organism or presented as such, from the medical device, “whose principal action is not obtained by a medicinal product”. The food supplement falls under food law.<\/p>\n

    \n\n\n\n\n\n\n\n
    What each classification requires of the company<\/caption>\n
    Classification<\/th>\nCompany authorisation<\/th>\nKey person or formality<\/th>\n<\/tr>\n<\/thead>\n
    Medicinal product<\/td>\nSwissmedic establishment licence, after inspection<\/td>\nResponsible person<\/td>\n<\/tr>\n
    Medical device<\/td>\nNo official authorisation<\/td>\nSwiss authorised representative, CHRN registration<\/td>\n<\/tr>\n
    Food supplement<\/td>\nNo authorisation<\/td>\nCantonal notification, responsible person<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    Classification does not depend on the product alone, but also on how it is presented. A vitamin capsule sold with a promise to prevent disease is no longer a foodstuff; software supporting diagnosis may fall within medical devices. The corporate purpose is drafted once that question is settled, not before.<\/p>\n

    Is a Geneva office enough? The licence follows a site<\/h2>\n

    A Geneva address alone is not enough: a Swissmedic establishment licence is granted for an establishment, a site and a person. The Ordinance on Establishment Licences is explicit: the licence names in particular the responsible person, the authorised activities and the site of the establishment, and it is non-transferable to other persons or to other sites (Art. 40 OEL).<\/p>\n

    The establishment covers all buildings, installations and means involved in manufacturing, testing, importing, exporting, wholesaling, foreign trading or brokering medicinal products, whether on one site or several (Art. 2(k) OEL). The licence is granted only where the file is complete and the applicant meets all the required conditions “on each site of the establishment” (Art. 39 OEL), which the authority verifies by inspection.<\/p>\n

    In practice, a company domiciled with a third party, with nobody on site and no documentation system, does not meet those requirements. A trading or brokerage office, by contrast, can constitute the establishment, provided the activity is genuinely organised there: responsible person, written procedures, records, checks on counterparties. It is a question of substance, not of address.<\/p>\n

    Trading, importing, brokering: what Swissmedic licenses<\/h2>\n

    The Act makes a Swissmedic licence mandatory for anyone who, on a professional basis, manufactures medicinal products (Art. 5 TPA), imports or exports them for distribution or dispensing, trades them abroad from Switzerland without their entering the country, acts as a broker or agent from Switzerland (Art. 18 TPA), or wholesales them (Art. 28 TPA).<\/p>\n

    International trading from Geneva<\/h3>\n

    Take a Geneva company that buys medicines in India and resells them in Africa without the goods transiting through Switzerland: it carries on the “foreign trade” of Art. 18(1)(c) TPA, and needs a licence even though no carton enters the country. Where goods are held under customs control, the Act is equally clear: storage in a customs warehouse or a bonded warehouse counts as an import (Art. 18(4) TPA).<\/p>\n

    The broker and the agent<\/h3>\n

    A broker or agent connecting suppliers and buyers must demonstrate a quality assurance system, a responsible person and a documentation system (Art. 24 OEL). The duties of care are precise: ensure that the supplier and the recipient are authorised for the operations they carry out and be able to evidence it, verify that the medicines do not come from illegal trade, and pass on quality and safety information, in particular on recalls (Art. 25 OEL). Agents must also keep copies of the documents relating to the conclusion of transactions.<\/p>\n

    \n

    Important<\/h4>\n

    Dispensing medicines to the public is a cantonal matter, not a Swissmedic one: anyone who dispenses medicinal products must hold a cantonal authorisation (Art. 30 TPA). None of the activities described here may begin before the licence is granted, and no processing time is published. If the classification of your activity is arguable, consult Swissmedic or a specialised lawyer before signing with a supplier.<\/p>\n<\/div>\n

    The responsible person and their independence<\/h2>\n

    The responsible person exercises direct technical supervision of the establishment and ensures that medicinal products are handled properly. Their profile determines the licence, and their position in the company’s governance is regulated.<\/p>\n