As part of the update of the Guidance document “Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)” of 1 October 2026, it was explicitly clarified in the requirements for primary packaging in section 5.5.1 that affixing of additional labels to existing foreign primary packaging is not accepted. This applies in particular to labels providing translations of information into the official Swiss languages, irrespective of the format and material of the primary packaging or the position of the area to be covered by the affixed label.
The following transitional rule applies to parallel imported medicinal products that have already been authorised and for which additional labels on the primary packaging were approved:
- An application for variation to remove the additional labels must be submitted within a year of publication of this communication.
- Batches that have already been released are not affected by this rule and can continue to be placed on the market and sold.
- New batches can continue to be released according to the currently approved design of the primary packaging until the variation procedure is completed.
Swissmedic recommends that affected marketing authorisation holders plan the necessary changes and submission of the relevant variations in good time.