The UK Cabinet Office released a statement last Thursday 5th November 2020 that could provide some breathing space for the UK/EU pharmaceuticals sector during the Brexit transition, by indicating that a one year implementation period would apply to application of the protocol for certain matters.
For the pharmaceuticals sector, these include batch testing, importation and rules relating to falsified medicines (FMD).
The details of the exact scope of this relaxation are not clear from the statement and more guidance is to follow. This guidance will be important in establishing how compliance can be achieved from 1/1/21 given that importation, for example, has many regulatory aspects, some of which may continue to apply under the EU acquis from 1/1/21. The guidance could also shed light on what must change at the end of 2021 when the NIP is assumed to apply in full – subject to any further agreement.
The agreement of the Specialised Committee, set up under the NIP, clearly acknowledges difficulties in applying existing rules in Northern Ireland only once the Brexit implementation period comes to an end on 31/12/20, and how current systems and checks can be split apart, in practical terms, given well established regulatory infrastructure.