Plans to implement the European falsified medicines directive (FMD) are expected to continue, despite the UK’s recent decision to leave the European Union.
Dispensers, and practices with a wholesaler’s licence have been told to put anti-counterfeit technology in place by early 2019. And, from a letter to stakeholders, it is now clear that manufacturers and licence holders are not expected to pick up the bill for the new FMD dispensary and wholesaler equipment.
The Medicines and Healthcare products Regulatory Agency and the Department of Health have confirmed that they “are working to consider how best to transpose the delegated regulation and its flexibilities into UK law.”
The DDA, which has also been involved in the development of delegated FMD regulation, added: “It will largely be a condition of the UK trading with the EU in the future.”
Under the expected terms of the FMD, wholesalers and practices will each verify most prescription medicines: wholesalers at the point of receipt (and when returned) and dispensaries at the point of dispensing.
The delegated regulation, and the new medicine verification system it lays down, will come into force on 9 February 2019.
Further details on the published delegated regulation are available on the MHRA website and from the DDA. Safety features introduced by the FMD will consist of an anti-tampering device on the outer packaging and a unique identifier within a 2D barcode.
Manufacturers have warned that leaving the EU could result in slower access to new medicines. Mike Thompson, chief executive officer of the Association of the British Pharmaceutical Industry, said: “Applications for UK licence would come after the European licence due to the smaller patient population in the UK. EU exit risks the breakdown of international collaboration between scientists, doctors and industry which could slow down access to new drugs for patients in the UK… and a funding gap.”
Warwick Smith, director general of the British Generic Manufacturers Association and the British Biosimilars Association, said: “The single European marketing authorisation reduces cost and complexity for manufacturers, facilitating the production and regulation of high quality medicines and their availability to patients.”