Further news about the Falsified Medicines Directive

As part of the government's preparations to leave the EU, all eventualities are being considered, including leaving without an agreement. In a 'no-deal' scenario, we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK. In that case, it is unlikely that the Directive would come into effect in its current form.

Therefore, the legal obligation related to this would be removed for practices in the UK supply chain. Packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements.

Nevertheless, the government has been clear that it wants to retain a close working partnership with the EU to ensure patients have access to a safe medicine supply. This means that the MHRA regulations will need to be modified to achieve this.