Swissmedic, the Swiss Agency for Therapeutic Products, published a revised Guidance document on the parallel import of human medicinal products under Article 14 paragraph 2 and 3 of the Therapeutic Products Act (TPA, SR 812.21), valid with effect from October 1, 2026. The update clarifies the "country of export", tightens primary and secondary packaging requirements, and aligns the "Other information" section of the Information for healthcare professionals and Patient information with the original medicinal product.
Swiss parallel importers holding an Article 14 para. 2 and 3 TPA authorisation, wholesale distributors placing parallel-imported medicines on the Swiss market, and community and hospital pharmacies dispensing them must align their authorisation dossiers and packaging with the revised guidance by October 1, 2026, or Swissmedic refuses or withdraws the parallel-import authorisation and rejects non-compliant packs at the authorisation stage. The revision removes a practice some importers relied on, in particular affixing translation labels to existing foreign primary packaging.
What changes in the revised guidance?
The revised Guidance document ZL106 restates four operational points that Swissmedic checks during parallel-import authorisation. "Country of export" is defined as the country that issued the national authorisation of the parallel-imported product and that applies equivalent medicinal product control; for authorisations granted under the EU Centralised Procedure (CP), it is the EU country from which the packs are procured, and "EU" may be used for multi-country CP packs. The primary packaging section stipulates that Swissmedic does not accept additional labels affixed to existing foreign primary packaging, for example to translate information into Swiss official languages, regardless of packaging type, material or the area covered. The secondary packaging section requires the excipient composition, storage instructions and handling information to match the foreign packaging, with relevant disclaimers placed on the secondary packaging. The "Other information" section of the Information for healthcare professionals and Patient information must be identical in all respects to that of the original medicinal product, with the exception of storage instructions, handling information and the statement of known deviations from the original.
The document also adds editorial corrections and further examples. The full revised guidance (ZL106, PDF) is the operative reference for every new and pending parallel-import application.
Who must align their parallel-import dossiers?
The guidance applies to authorisation holders under Article 14 para. 2 and 3 TPA, that is, Swiss parallel importers of human medicinal products who base their Swiss authorisation on a foreign authorisation from a country with equivalent medicinal product control. Wholesale distributors that place parallel-imported medicines on the Swiss market must ensure the packs they handle carry the compliant packaging, and community and hospital pharmacies dispensing these products should expect the updated information format in the materials they receive. The same dossier requirements apply whether the reference authorisation is an EU Centralised Procedure authorisation or a national authorisation of another recognised country.
What must change on the packaging and in the information?
The operational impact concentrates on three components of the parallel-imported pack and its documentation. Importers who used to add translation labels directly onto foreign primary packaging must stop that practice and source primary packaging that already carries the required Swiss-language information, or repackage. The secondary packaging and the medicinal product information must mirror the foreign pack's excipient, storage and handling statements, with the prescribed disclaimers added.
| Element | Requirement under the revised guidance |
|---|---|
| Country of export | The country that issued the national authorisation and applies equivalent medicinal product control; for EU CP authorisations, the EU country from which packs are procured, or "EU" for multi-country CP packs. |
| Primary packaging | No additional labels affixed to existing foreign primary packaging, irrespective of type, material or area covered. |
| Secondary packaging | Excipient composition, storage instructions and handling information as on the foreign packaging; relevant disclaimers on the secondary packaging. |
| "Other information" (HCP and patient information) | Identical in all respects to the original product, except storage instructions, handling information and the known-deviation statement; relevant disclaimers used. |
What happens if a pack does not comply?
Swissmedic checks packaging and medicinal product information at the authorisation stage. A parallel-import application whose primary packaging carries added labels, or whose secondary packaging or "Other information" section does not match the original, is rejected, and an existing authorisation can be withdrawn. Non-compliant packs are blocked before they reach the Swiss market. Continuous per-jurisdiction monitoring of Swissmedic guidance surfaces a revision like this immediately on publication, so importers can adapt dossiers before submission rather than after a refusal.
What to do next
- Review every pending and planned parallel-import dossier against the four points of the revised ZL106 guidance.
- Stop affixing translation labels to foreign primary packaging; source primary packaging with the Swiss-language information already in place, or repackage.
- Check that secondary packaging excipient, storage and handling statements match the foreign pack and that the required disclaimers are present.
- Reconcile the "Other information" section of the Information for healthcare professionals and Patient information with the original product.
- For EU CP-sourced products, document the country of export, or "EU" for multi-country packs, as defined in the revised guidance.
- Brief the regulatory affairs and packaging teams before the next submission to Swissmedic.
