Swissmedic 更新人用药品平行进口指南，明确出口国定义与包装要求，2026年10月1日生效
Changes to the Guidance document “Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)”
Swissmedic 更新了人用药品平行进口指南，修订涉及出口国定义、包装要求以及贮存和处理信息，修订版自2026年10月1日起生效。指南明确出口国一般为签发该平行进口产品国家上市许可且药品监管等效的国家，依据欧盟集中审评程序批准的药品，其出口国为采购该产品的欧盟国家。初级包装方面，Swissmedic 不接受在原有境外初级包装上粘贴附加标签，无论包装类型、材质及拟覆盖区域为何。
该修订细化了出口国定义并新增包装与说明书要求，可供从事平行进口的相关方核对受影响条款。
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.
来源：Swissmedic 药品质量与 GMP 更新 · swissmedic.ch