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Information

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

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

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The detailed Information for healthcare professionals and Patient information templates are being withdrawn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

15.01.2023

Changes to the Guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

Extension of the time limit for finalising the decision minutes. Exchange of documentation for the AAA now possible via the eGov portal.

01.01.2023

Changes to SwissPAR HMV4 guidance document

Section 5, Clinical Assessment, of the Public Assessment Report is not part of the SwissPAR

15.12.2022

Clarification of terminology for combination products (medicinal products with a medical device component)

Current status and revision of specification documents

01.12.2022

Expansion of scope of temporary authorisations

Temporary additional indications will also be possible from 1 January 2023

01.09.2022

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

Clarification of safety-relevant updates to medicinal product information for authorisations according to Art. 14 para. 1 let. abis TPA

16.08.2022

Benchmarking study 2021

International comparison of Swiss approval times

01.08.2022

Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

Filing of Submission Plans to evaluate the efficacy of existing COVID-19 medicinal products against new SARS-Cov-2 variants

01.07.2022

Revision of the Therapeutic Products Licensing Requirements Ordinance

Update to Annex 7 TPLRO

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLSX, 266 kB, 23.05.2023)

Allocation of ATC code and IT groups KPA (XLS, 2 MB, 01.03.2022)

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