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Information

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

01.07.2022

Changes to the Guidance document Product information for human medicinal products HMV4

Clarifications on boxed warnings and other topics

01.07.2022

Swissmedic position paper on the use of real-world evidence

Swissmedic considers real world data (RWD) as all data other than those collected through a clinical trial conducted as per ICH GCP

01.06.2022

Changes to guidance document Authorisation of human medicinal product with known active substance HMV4

ZL101_00_007e_WL

01.05.2022

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

Clarifications on the prioritisation and fast-tracking of pandemic medicinal products and on the patient information requirements

23.03.2022

Changes to the guidance document Formal requirements HMV4 and the form Import of a medicinal product according to Art. 14 (2) TPA (parallel import) HMV4

ZL_00_020e_WL / ZL106_00_002e_FO

25.02.2022

Authorisations of human medicinal products with a new active substance and additional indications 2021

Overview of new authorisations 2021

01.02.2022

Use of titanium dioxide in medicinal products

The pharmaceutical excipient titanium dioxide remains permissible in Switzerland until further notice

01.01.2022

Changes to the guidance document Project Orbis HMV4

Change in procedure for Project Orbis: Swissmedic information requests now to be sent exclusively to the applicant in Switzerland

01.01.2022

Changes to the guidance document Temporary authorisation of human medicinal products HMV4

Simplification of the procedure for “ex officio" temporary authorisation

01.11.2021

New guidance document: Involvement of patient organisation in assessment of patient information HMV4

The new guidance document is valid with effect from 1 November 2021.

17.09.2021

Changes to guidance document Authorisation of human medicinal product with new active substance HMV4

ZL101_00_005e_WL

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLSX, 265 kB, 29.09.2022)

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

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