Over the past few months, the following lists published by Swissmedic:
- Annexes 3a and 7 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO; SR 812.212.22), 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; SR 812.212.23)
have been reviewed taking into account the current status of science and technology. On the basis of the collected reports and in keeping with the requirements and specifications of EU legislation, a need for revision was only found in Annex 7 TPLRO.
At a meeting of Swissmedic’s Agency Council on 22 April 2022 following the conclusion of the consultative process involving subject-matter experts and official bodies, it was decided that Annex 7 TPLRO should be amended with effect from 1 July 2022.
In addition to clarifications of conditions and documentation requirements, the current revision of Annex 7 TPLRO also includes a new quality change for Type II. This concerns B.I.a.5 b): Changes associated with changes to the active substance of a human SARS-CoV-2 vaccine, including the replacement or addition of a serotype, strain, antigen or coding sequence or a combination of serotypes, strains, antigens or coding sequences. The EMA has incorporated a similar amendment in its catalogue of variations.
The form Variations and extensions HMP HMV4 has been amended accordingly on this basis.