Falsified Medicines Directive – Changes to existing Wholesale Dealer’s Licences

The Falsified Medicines Directive (2011/62/EU) – (FMD) was transposed into UK law as The Human Medicines (Amendment) Regulations 2013 (SI 2013/1855) which came into force on 20 August 2013. Subsequent to transposition of the legislation MHRA is revising the format of Wholesale Dealer’s licences (WL) and Wholesale Dealer’s (General Sales List) licences (WDL) for human medicines (not for veterinary medicines). The revisions will align MHRA issued licences with the standardised document being brought into use across the EU. Furthermore, the revision will dispense with the separate WL and WDL documents which will be replaced by a single Wholesale Distribution Authorisation for Human use, abbreviated as WDA (H).