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Archive

Please note that documents represented the latest scientific and technical findings and complied with the applicable legal requirements at the moment of their publication. After they have been published under “Latest news” and “Communications” on specific topics relating to complementary and herbal medicine, they will be moved to the Archive in due course so that they remain available as a compilation of information. Archived documents are not updated.

The current legislation and the latest scientific and technical findings are authoritative.

18.06.2025

Risk assessment relating to nitrosamines in active substances and/or finished medicinal products

Swissmedic establishes the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents

01.06.2025

Changes to the guidance document Time limits for authorisation applications

Time limits shortened for additional indications for Orbis type A and fast-track Orbis type B

01.04.2025

Expansion of the Swissmedic position paper on real world evidence

Swissmedic is expanding its position paper on real world evidence (RWE) with an overview of relevant international guidelines and publications

01.04.2025

Changes to the Guidance document Meetings for applicants for authorisation procedures

Optimisation of meetings for applicants for authorisation procedures

20.03.2025

Authorisations of complementary and herbal medicinal products in 2024

Orphan drug status for a herbal medicinal product

01.03.2025

Changes to the Guidance document Authorisation of herbal medicinal products

Content-related clarifications, additions and restructuring of the entire Guidance document

01.01.2025

Optimisation of labelling phase for human medicinal products

Swissmedic is optimising the labelling phase: text review letters should be avoided where possible and the Swissmedic time limits are being shortened

01.01.2025

Changes to the form Information for application Art. 13 TPA

The previous form Information for application Art. 13 TPA has been divided into two forms: one specifically for veterinary medicinal products and the other for human medicinal products

01.01.2025

Election of the members of the Swissmedic Medicines Expert Committees

Election and re-election of our external experts for the new period of office 2025–2028

01.01.2025

Amendment of the rules of the Swissmedic Medicines Expert Committees

Maximum number of ordinary VMEC members increased from seven to nine

Last modification 10.08.2022

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