Fiscal importation of medicinal products from third countries: clarification of the provisions
The provisions permitting wholesalers to import medicinal products from countries situated outside the European Economic Area are hereby clarified.
A marketing authorisation holder (Wholesaler's Distribution Authorisation or WDA) may not purchase medicinal products from a company situated outside the European Economic Area (EEA) that have been manufactured within the EEA and released by a batch releaser responsible person situated in the EEA; specifically, medicinal products that have not physically left the EEA or that have not undergone any manufacturing operation in the period between release of the batch by the responsible person of the batch releaser and their purchase from a company situated outside the European Economic Area.
A wholesaler may only acquire medicinal products from another authorised wholesaler situated within the European Union (EU). Furthermore, the Good Distribution Practice guidelines (GDP) also consider that purchase/invoicing constitutes an acquisition. The wholesaler may therefore not purchase medicinal products from a manufacturer or wholesaler outside the EU. If this is nevertheless the case, a manufacturing authorisation, namely an import licence, is required pursuant to Article 12bis of the Law on medicinal products of 25.03.1964.