Information

01.10.2024

The “Public Summary SwissPAR” is now called the “Summary report on authorisation”

Swissmedic is changing the name of the “Public Summary SwissPAR” to the “Summary report on authorisation”

20.09.2024

Unvollständige Angaben auf perforierten Blistern

Überprüfung der Druckvorlagen von perforierten Blistern

01.09.2024

New form No marketing / interruption of distribution for veterinary medicinal products

A new separate form has been created for notification of no marketing and interruption of distribution for veterinary medicinal products.

01.09.2024

Electronic data sets from pivotal bioequivalence studies

From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation

01.09.2024

Mobile technologies – Submission of films as additional information regarding the safety, efficacy and quality of medicinal products

From 1 September 2024, Swissmedic will be accepting the submission of films as part of the authorisation of QR codes

01.09.2024

SEND data sets for new authorisation applications for human medicinal products with new active substances

From 1 September 2024, Swissmedic is accepting SEND data sets for applications for new authorisation for human medicinal products with new active substances

01.09.2024

Changes to the guidance document Time limits for authorisation applications

To standardise practice, written notification regarding the “Doc. OK” milestone will in future no longer be sent following a formal objection

24.07.2024

Benchmarking study 2023

International comparison of Swiss authorisation times

02.07.2024

Update to the forms New authorisation of human medicinal products and Variations and authorisation extensions HAM

Swissmedic clarifies in the authorisation forms how to describe the indication of the medicinal product and simplifies the standardised consents for sharing information with partner authorities

01.07.2024

TPLRO, TPLO: Update of annexes

Update of the TPLRO and TPLO annexes

01.07.2024

Ordinance 3 on Measures to Combat the Coronavirus (COVID-19) ceases to apply as of 30 June 2024

As there will no longer be any legal basis for doing so, Swissmedic will cease granting exceptions with regard to the authorisation and importing of medicinal products for the treatment or prevention of COVID-19

01.07.2024

Standardisation of practice on publication of indications in Swiss Public Assessment Report

The new practice and the revised Guidance document SwissPAR come into effect on 1 July 2024

15.06.2024

Simplification of requirements for renewed authorisation of medicinal products

Swissmedic has simplified the requirements for renewed authorisation of medicinal products

01.06.2024

Changes to the Guidance document Variations and extensions HAM

Simplification of rules on issuing new packaging codes and elimination of subsumption of fees for multiple applications

01.06.2024

Changes to the Guidance document Meetings for applicants for authorisation procedures

Preliminary Decision Clarification Meeting introduced as a pilot