New Swissmedic Technical Interpretation on Returns of Medicinal Products

Swissmedic has published a new Technical Interpretation (TI) entitled “Requirements for the return of medicinal products” (I-SMI.TI.28e, Version 1.0). The document has been valid since 30 June 2025 and is available for download on the Inspectorate website.

The responsibilities of the Qualified Person include, among other things, the decision regarding the final disposition of returned medicinal products and the approval of any re-entry into the saleable stock. In this context, the new document defines the minimum requirements for the handling of medicinal products returned by retailers (e.g. pharmacies) to wholesalers – in particular with regard to the time limits that must be observed between delivery and return of the products.

The key points can be summarized as follows:

• Returns from the wholesaler's customer within 10 days of delivery can be accepted through a routine procedure.
• Returns after 10 but within 30 days must be proven to be returns in the sense of legitimate returns and not a resale by the retailer to the wholesaler (e.g., due to stock clearance). Returns of sold goods for stock clearance reasons are not permitted.
• Returns after more than 30 days generally no longer meet GDP requirements and  must correctly be considered as a sale from the retailer to the wholesaler, which is generally not permitted. Re-entry into the saleable stock is only possible in exceptional cases and as part of deviation management.

It is explicitly emphasized that a procedure in which a wholesaler routinely accepts the return of medicinal products sold to retailers for resale after months or years violates the rules of Good Distribution Practice as well as the legal requirements of the Therapeutic Products Act (TPA) and the Medicinal Products Licensing Ordinance (MLPO).

In a general communication dated 1 July 2025, the following is also noted:: "In the past, Swissmedic addressed the handling of returns in connection with the authorisation requirement in Swissmedic Journal 05/2010. The content of this Swissmedic Journal publication (05/2010) is no longer valid, as it was rendered obsolete by the entry into force of the EU GDP guidelines (2013/C 343/01) and the comprehensive revision of the MPLO in 2019."