The FAMHP again confirms and clarifies their interpretation of the rules set out in Annex 21 in the light of fiscal importation of medicines:
- “Fiscal importation” means the purchase/procurement ‘on paper’ of medicines that have not left the territory of the European Union (EU), from an entity based outside the EU.” The purchased medicines are then considered to be “fiscally imported” to market them in the EU.
- For the “import” of medicines, the FAMHP states, in accordance with Article 12bis, §1, paragraph 5 of the Law of 25 March 1964 on medicines for human use and Article 88 of Regulation 2019/6 on veterinary medicines, that importation is considered both a physical movement and the purchase of medicines, and that both activities require a Manufacturing Importation Authorisation (MIA) because the integrity of the distribution chain must be maintained.
- A Wholesale Distribution Authorisation (WDA) holder may purchase/procure medicines only from other EU-licensed wholesalers. “Procure” and “purchase”, in accordance with the Good Distribution Practice (GDP) guidelines, means obtaining, acquiring, procuring or buying medicinal products from manufacturers, importers or other wholesalers.
- A licensed wholesaler is not allowed to purchase medicines from a company, located outside the EU, i.e. a third country, whether or not the medicines in question have physically left EU territory. A licensed wholesaler may not purchase or acquire medicines manufactured and certified in the EU by the authorised person, which have not physically left the EU, from an entity, located outside the EU.
- As mentioned above, a licensed wholesaler wishing to carry out these activities must have a manufacturing authorisation, which includes the activity of importing.