MHRA Update

14 Mar 2019

All of the Statutory Instruments relating to the regulation of medicines, medical devices and clinical trials in the event of a No-Deal Brexit have now been passed.

Updates that could impact on Community Pharmacy include:

Falsified Medicines Directive:

The UK is proceeding with implementation of the EU requirements for new safety features to prevent the entry into the legal supply chain of falsified medicinal products in the UK. However, as stated in the MHRA’s consultation, in the event of no deal, it is expected UK stakeholders would no longer be able to comply with the requirement to verify and authenticate. Therefore, the legal obligations related to this would be removed for all actors in the UK supply chain.

Packs containing the Falsified Medicines Directive (FMD) safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements. In the interests of public safety, we will evaluate the options for a future UK falsified medicines regulatory framework, taking into account the investment already made by stakeholders.

Recognition of Prescriptions

The UK currently recognises prescriptions from all EU/EEA countries. Following EU Exit the UK will recognise prescriptions from an approved list of countries. The list on day 1 of exit will comprise all EEA/EU countries. Recognition of these prescriptions will be subject to the following:

  • As now, the ultimate decision to dispense remains with the dispenser.
  • For a prescription to be eligible, the prescriber must be of equivalent professional status to a profession that is eligible to prescribe in the UK.
  • As now, these prescriptions will be dispensed as private prescriptions at no cost to the NHS.

MHRA is regularly updating its guidance, click here to keep an eye on for further developments.