All statutory instruments in relation to the regulation of medicines, medical devices and clinical trials in case of a ‘no-deal’ Brexit have now been passed.
As per the Medicines and Healthcare products Regulatory Agency (MHRA) guidance, community pharmacies could see major changes regarding falsified medicines directive and recognition of prescriptions.
The legal commitment related to the verification and authentication of falsified medicinal products in the UK’s legal supply chain would be removed, as the UK stakeholders may no longer be able to comply with the requirements. The UK is now proceeding with the implementation of the EU requirements for new safety features.
“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,” the MHRA update read.
Following a ‘no deal’ Brexit, the UK will only recognise prescriptions from an approved list of countries, which will include all EEA and EU countries. These prescriptions will be dispensed as private prescriptions and ultimate decision to dispense will be with the dispenser. The prescriber’s professional status should be equivalent to an eligible prescriber in the UK.