Information

12.02.2024

Authorisations of human medicinal products with a new active substance and additional indications 2023

41 human medicinal products with new active substances authorised

01.02.2024

Voluntary prior notification of new applications with new active substance for human medicinal products

Prior notification of a new application with a new active substance enables Swissmedic to plan resources early on and supports efficient processing of applications

15.01.2024

Changes to guidance document Authorisation of human medicinal product with known active pharmaceutical ingredient

Medicinal products whose known chemical active pharmaceutical ingredient has a complex, heterogeneous structure may be deemed to be medicinal products with a known active pharmaceutical ingredient (known API, with or without innovation)

15.01.2024

Changes to the guidance document Temporary authorisation of human medicinal products

Clarification of the term "equivalent medicinal product" and timing of criteria assessment for temporary authorisation

15.01.2024

Changes to the Guidance document Fast-track authorisation procedure

Optimisation of the application procedure for the implementation of a fast-track authorisation procedure (FTP)

15.01.2024

Changes to the guidance document Authorisation of human medicinal products under Art. 13 TPA

The guidance document Authorisation of human medicinal products TPA and the form Information for application Art. 13 TPA have been revised

15.01.2024

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA updated

Explanations regarding dispensing category classification and clarification of the requirements for the application documentation for authorisations according to Art. 14 para. 1 letter abis-quater TPA

01.01.2024

New guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)

Simplification of parallel imports of human medicinal products already authorised in Switzerland

01.10.2023

Changes to the guidance document Mobile technologies and the related form

Training documents according to the most recently approved RMP are considered to be information required by therapeutic products legislation

01.10.2023

Modifications to guidance document Formal requirements

Clarification on submission via eDOK and eCTD for co-marketing medicinal products

15.09.2023

Changes to the guidance document Temporary authorisation of human medicinal products

Clarification regarding authorised medicinal products, harmonised deadlines for applications before expiry of temporary authorisation and changes to terminology

17.08.2023

Benchmarking study 2022

International comparison of Swiss authorisation times

22.06.2023

Changes to the guidance document on biosimilars

Update of section 5.10 on interchangeability

21.06.2023

Medicinal products with a medical device component (combination products)

Implementation of the transitional provisions for medical devices