In the context of the transparency policy conducted by the FAMHP, the FAMHP announced thematic audits starting from March 2022 at wholesalers in medicines for human use. These inspections will be unannounced.
The inspections will focus on the obligations of the wholesaler in terms of
– the FMD regulations and
– the storage of medicines, more specifically the management of stocks.
The legal basis of these obligations can be found in the Royal Decree of 14.12.2006 on medicines for human and veterinary use and the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features on the packaging of medicines.
Source: communication by FAMHP by email