Brexit update – 'Grandfathering' marketing authorisations

Last month Synapse reported the status of Brexit and an overview of the national no deal guidance applicable to the UK, Austria, France, Germany and the Netherlands, as well as EU Commission guidance.

This guidance remains applicable, but as a result of the EU Council meeting of 10 April, the leaving date of the UK from the EU has been delayed until 31 October 2019, unless there is prior approval of the draft Withdrawal Agreement by the UK Parliament or the UK refuses to participate in European elections in May.

If the Agreement is approved, the UK will leave on the terms of the Agreement at an earlier date. In the unlikely event that the UK refuses to participate in European elections, it will be required to leave without a deal on 1 June 2019.

Meanwhile more guidance has been issued on the 'grandfathering' of central authorised marketing authorisations (CAP MAs) in the event of a 'no deal'. In these circumstances, the MHRA has advised that existing CAP MAs will automatically be converted into UK MAs (converted EU MAs) and issued with a UK MA number on exit day, to ensure CAPs will continue to be authorised for use in the UK and allowing the continuation of medicines supply. The new guidance provides detail on the CAP grandfathering process and the actions that MA holders need to take.

In addition to the MHRA guidance, the Prescription Medicines Code of Practice Authority (PMCPA) issued a media release on 10 April 2019 to inform companies that the MHRA is allowing a period of 12 months after exit day to submit to the MHRA information on their CAPs and 33 months after exit day to implement changes to the MA numbers and MA holder's name and address in packs.

It is also advising that companies with CAP MAs should update this information in promotional materials as soon as possible after exit day and must do so when other changes are needed.

In addition, until the end of 2021 a complaint that the prescribing information for a previously centrally approved medicine does not have the new UK MA number or any new MA holder's name and address as required by Clause 4.2 (vii) ABPI Code will not be considered to be in breach of that clause, or of Clause 7.2, if the prescribing information includes the previous information and that any new MA holder can be contacted via the address given in the prescribing information.