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.

01.12.2023

Transitionally approved Chinese medicinal products without indication

The lists of medicinal products concerned have been updated. The lists and related information can be found on the website under Asian medicinal products.

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

06.09.2023

Implementation of the full declaration for homeopathic and anthroposophic medicinal products without indication

The requirements for the declaration of active substances and pharmaceutical excipients of human medicinal products (full declaration) also apply to homeopathic and anthroposophic medicinal products without indication.

06.09.2023

Complementary and herbal medicines containing ethanol in paediatric populations

The benefits of the use of the medicinal product containing ethanol must outweigh the potential risks.

17.08.2023

Benchmarking study 2022

International comparison of Swiss authorisation times

01.07.2023

Revision 1.7.2023 – Updating of KPTPO annexes

KPTPO: Updating of Annexes 6, 9 and 10

Last modification 10.08.2022

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