Switzerland

Pharmacovigilance in Switzerland is regulated by the Swiss Agency for Therapeutic Products (Swissmedic) under the Therapeutic Products Ordinance (VAM). Marketing authorisation Holders (MAHs) must maintain an effective pharmacovigilance system, continuously evaluate the benefit–risk profile of their medicinal products, and designate a suitably qualified person responsible for pharmacovigilance. The official Swissmedic pharmacovigilance FAQ confirms that this person may be employed internally or contracted externally, provided the responsibilities are defined in writing, and does not necessarily have to reside in Switzerland. The person’s name and address must be supplied to Swissmedic upon request. According to Swissmedic’s official pharmacovigilance requirements, reportable serious suspected adverse reactions must generally be submitted within 15 days after awareness, while reportable non-serious reactions must be submitted within 60 days. For medicines containing a new active substance, the current PSUR/PBRER guideline generally requires annual twelve-month safety reports for the first four years following Swiss authorisation, unless Swissmedic specifies otherwise. The Swiss schedule should not automatically be inferred from the EU EURD list. Where the cited public sources do not expressly define pharmacovigilance system file, risk-management plan, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.