Update of TPLRO and TPLO Annexes

5. Juli 2024 – Swissmedic has updated and revised the annexes of the Therapeutic Products Licensing Requirements Ordinance (TPLRO) and the Ordinance on the Simplified Licensing of Therapeutic Products (TPLO) to reflect current scientific and technological standards. Changes were made to:

  • Annex 3a TPLRO: Pharmaceutical excipients of particular interest.
  • Annex 7a TPLRO: List of variations to veterinary medicinal products.
  • Annex 2 TPLO: Permitted active substances for veterinary medicinal products.
  • Annex 3 TPLO: Medicinal products with a manufacturing process subject to mandatory authorization.

These updates are effective from 1 July 2024.

For more information, see here.