Swissmedic - Swiss Agency for Therapeutic Products

02/01/2026 | Press release | Distributed by Public on 02/01/2026 02:57

Updating of Annex 7 TPLRO – Revised list of variations

Updating of Annex 7 TPLRO - Revised list of variations

A revised list of variations according to Articles 21-24 TPO comes into force on 1 February 2026

01.02.2026

The lists published by Swissmedic, incl. Annex 7 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO; SR 812.212.22) have been revised and amended. A need for revision, particularly of Annex 7 TPLRO, was identified on the basis of the collected reports and in keeping with the requirements and specifications of EU legislation. This annex has been harmonised as far as possible with the EU list of variations. The form Variations and extensions HMP has also been amended accordingly on this basis.

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