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Information

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

01.06.2023

Delayed implementation time limits for replacement changes

Changes to the guidance documents Variations and Extensions HMP and Variations VMP

01.06.2023

Changes to guidance document Fast-track authorisation procedure and guidance document Temporary authorisation for human medicinal products

Exchange of documentation for the AAA now possible via the eGov portal

01.05.2023

Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers

Clarification of the requirements for the submission of audit reports

01.05.2023

Changes to the forms for new authorisations of and variations to human and veterinary medicinal products

Information on study design and data sources of RWE in application forms

01.05.2023

Modification of the DMF form

Details of a contact for enquiries on the DMF form

01.03.2023

Changes to the guidance document Product information for human medicinal products

The detailed Information for healthcare professionals and Patient information templates are being withdrawn

01.03.2023

New Mobile technologies guidance document for human and veterinary medicinal products

Regulations on the use of QR codes on packaging and in medicinal product information

15.02.2023

Modifications to guidance document "Formal requirements"

Clarification of documentation to be submitted for co-marketing medicinal products; conditions can be the subject of collective applications

15.01.2023

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

Application of Art. 13 TPA possible for temporary additional indications

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLSX, 267 kB, 01.11.2023)

Allocation of ATC code and IT groups KPA (XLSX, 255 kB, 01.09.2023)

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