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Swissmedic: Update of the TPLRO and TPLO annexes

1 July 2026

Swissmedic has updated and revised several of its published lists in the annexes to two ordinances, taking into account the current status of science and technology, the various reports received, and the applicable legal requirements. The lists concerned were Annexes 3a and 7a of the Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the Licensing Requirements for Therapeutic Products (TPLRO) and Annex 3 of the Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 on the Simplified Authorisation of Therapeutic Products and the Authorisation of Therapeutic Products by the Notification Procedure (TPLO).

At a meeting of Swissmedic's agency council on 17 April 2026, following the conclusion of the consultative process involving subject-matter experts and official bodies, it was decided that the annexes to the TPLRO and TPLO should be amended with effect from 1 July 2026. The affected annexes were Annex 3a TPLRO (pharmaceutical excipients of particular interest), Annex 7a TPLRO (list of variations to veterinary medicinal products under Articles 25a and 25b TPO), and Annex 3 TPLO (medicinal products and medicinal product groups with a manufacturing process subject to mandatory authorisation). Following the revision of Annex 7a TPLRO, the form variations TAM was adapted accordingly.

For more information, see here.

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