Swissmedic - Swiss Agency for Therapeutic Products
Swissmedic - Swiss Agency for Therapeutic Products
10/01/2026 | Press release | Distributed by Public on 09/30/2026 23:50
Changes to the Guidance document “Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)”
Changes to the Guidance document "Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)"
Swissmedic has updated the Guidance document on parallel imports. In particular, the changes concern clarifications on country of export, additions to the requirements for packaging, storage instructions and information on handling in the medicinal product information for parallel imported medicinal products
01.10.2026
The term "country of export" is defined in more detail under "Definitions". In general, the country of export is the country in which the national authorisation of the parallel imported product was issued and which has equivalent medicinal product control. For authorisations according to the EU Centralised Procedure (CP), the country of export is the EU country from which the packs of the parallel imported medicinal product are procured. "EU" can be given as the country of export for multi-country packs of medicinal products authorised according to the EU CP.
The section on primary packaging requirements now stipulates that Swissmedic does not accept affixing of additional labels to existing foreign primary packaging, for example to provide translations of information into the official Swiss languages. This applies irrespective of the primary packaging type and material and of which areas of the primary packaging are to be covered by the affixed label.
The section on secondary packaging requirements has been amended to add that the statement on excipient composition, storage instructions and information on handling should be as stated on the foreign packaging. Relevant disclaimers should be placed on the secondary packaging.
In addition, the requirements for the "Other information" section in the Information for healthcare professionals and Patient information have been clarified. The text must be identical in all respects to that for the original medicinal product, with the exception of the storage instructions, information on handling and statement of known deviations from the original medicinal product. The relevant disclaimers must be used in the Information for healthcare professionals and Patient information.
The Guidance document also includes editorial corrections and additional examples.
The revised Guidance document on parallel imports is valid with effect from 1 October 2026.
Swissmedic - Swiss Agency for Therapeutic Products published this content on October 01, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on October 01, 2026 at 05:50 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]