News
Swissmedic: Amendment of the guidance document on parallel import

1 January 2025

Swissmedic: Amendment of the guidance document on parallel import

Swissmedic announced that the revised guidance document on the import of a human medicinal product according to art. 14 para. 2 and 3 of the Therapeutic Products Act (TPA) (parallel import) came into force on 1 January 2025. The new clarifications and explanations emphasize that the importer of a parallel-imported medicinal product must meet the same safety and quality requirements for the entire duration of authorization as the marketing authorization holder of the original medicinal product. This includes the implementation of market surveillance measures that may be ordered for the original medicinal product due to safety signals or quality defects, which must also be applied to the parallel-imported medicinal product.

Additionally, it is clarified that the transfer of marketing authorization for a parallel-imported medicinal product is governed by the guidance document on the transfer of marketing authorization.

For more information, see here.

More News

Subscribe to newsletter