Information

20.01.2020

Notes on using Swissmedic templates for Information for healthcare professionals and Patient information

There are two versions of Swissmedic's templates for Information for healthcare professionals and Patient information for human medicinal products

15.01.2020

Updating of guidance document on authorisation of human medicinal products under Art. 13 TPA HMV4

Changed procedure for "Justified cases" pursuant to Art. 18 para. 2 TPO

19.12.2019

Adaptation of the strategic document SMEC Code

ZL003_00_001de_SD

01.12.2019

Modification of various documents relating to authorisation

ZL000_00_024e_WL / ZL101_00_007e_WL / ZL300_00_001e_WL

22.11.2019

Potential nitrosamine contamination: request to perform a risk evaluation

Marketing authorisation holders of human medicinal products asked to conduct their own evaluation of the potential risk of contamination with nitrosamines.

18.10.2019

Adaptation of the Forms Renewal of authorisation HMV4

ZL201_00_008e_FO / ZL201_00_010e_FO

30.09.2019

Fixed texts for medicinal products which are being reallocated from dispensing category C to B as of 2019

Adaptation of fixed texts for medicinal products that may continue to be dispensed by pharmacies without a medical prescription after expert advice.