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


Modifications to guidance document Formal requirements

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


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


Benchmarking study 2022

International comparison of Swiss authorisation times


Changes to the guidance document on biosimilars

Update of section 5.10 on interchangeability


Medicinal products with a medical device component (combination products)

Implementation of the transitional provisions for medical devices


Delayed implementation time limits for replacement changes

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


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


Modification of the DMF form

Details of a contact for enquiries on the DMF form


Changes to the guidance document Product information for human medicinal products

The detailed Information for healthcare professionals and Patient information templates are being withdrawn


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


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


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

Application of Art. 13 TPA possible for temporary additional indications