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 been amended accordingly on this basis. While the form comes into force on 1 February 2026, it can be viewed now via the link below.
Up until 31 January 2026, variations and extensions for human medicinal products must be submitted using the existing form (valid until 31 January 2026) and, from 1 February, using the new form (valid from 1 February 2026).
Any questions regarding the new Variations and extensions HMP form can be submitted via this link General information.