Over the past few months, the following lists published by Swissmedic:
- Annexes 3a and 7a of the Therapeutic Products Licensing Requirements Ordinance
(TPLRO[1]), and - Annexes 2 and 3 of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO[2])
have been updated and revised accordingly taking into account the current status of science and technology, on the basis of the various reports received and in keeping with the legal requirements and specifications,
At a meeting of Swissmedic’s Agency Council on 26 April 2024 following the conclusion of the consultative process involving subject-matter experts and official bodies, it was decided that the annexes to TPLRO and TPLO should be amended with effect from 1 July 2024.
The following annexes are affected:
- Annex 3a TPLRO Pharmaceutical excipients of particular interest,
- Annex 7a TPLRO List of variations to veterinary medicinal products according to Articles 25a and 25b TPO,
- Annex 2 TPLO Permitted active substances for the authorisation of veterinary medicinal products by the notification procedure, and
- Annex 3 TPLO Medicinal products and medicinal product groups with a manufacturing process subject to mandatory authorisation.