Aid for Ukraine: export of medicinal products to the conflict area – update

Medical care in Ukraine is at risk. Under the current therapeutic products legislation, legal entities and natural persons need the appropriate licences in order to collect and export medicinal products. The quickest way to deliver medicinal products is through companies and organisations that already have the necessary licences. Private individuals should not collect any medicinal products themselves, but should support the Ukrainian people by donating to aid organisations.

Since medical care in Ukraine has been put at risk by the Russian war of aggression, Swissmedic has received regular questions on how medicinal products can be exported to the conflict area. It is understandable that people wish to send medicinal products to areas where they are urgently needed for humanitarian reasons and in solidarity.

Medicinal products also need to be safe, effective and of impeccable quality in crisis situations. It is therefore vital that they come from controlled sources and are correctly stored and transported (cold chain, sterility, etc.), and that the recipient is able to handle them properly. The collection and exportation of medicinal products therefore requires the appropriate licences to ensure the safety of these products. This applies to both human and veterinary medicinal products.

Recommendation for private initiatives, organisations or companies without an export licence

Under the Medicinal Products Licensing Ordinance (MPLO) a licence is required to export medicinal products in order to safeguard the health of patients, as improperly handled medicinal products could pose a health risk. Applicants must prove that their infrastructure, healthcare professionals and quality assurance system meet the international requirements of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

The time taken by Swissmedic to issue establishment licences primarily depends on the documentation provided by the applicant. Those wishing to deliver medicinal products to Ukraine or its neighbouring countries are advised to contact companies that already have the appropriate licences. Holders of an export licence have the necessary experience, and are able to check, store, transport and deliver medicinal products in accordance with the regulations.

[ This update replaces Swissmedic’s communication of 17 March 2022 ]