The European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency publish breaking Brexit information

(Information update: Brexit and medical devices)

Manufacturers of medical devices and medicines who are interested in finding out what the relationship between the European Union and the United Kingdom will be like after Brexit have at their disposal a publication produced by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) on 31 January.

On medical devices and Brexit, MHRA recalls that the UK will continue to follow EU rules for medical devices, including the Medical Devices Regulation that will enter into force on 26 May, during the transition period.

It also notes that an EU-based authorised representative will not be required for device manufacturers in the UK and that UK-based notified bodies “will continue to carry out third party conformity assessments in the UK and the results of these tests will continue to be used and recognised for both UK and EU markets”.

Reporting to MHRA for medical devices, including for serious adverse events, will remain unchanged during the transition period, and MHRA says the UK “will continue to report to systems to which [tiene] access”.

On the future after the transition period, the EU and the UK will begin negotiations on their future relationship in early March, with the aim of having an agreement in place before the end of the transition period. While both sides have emphasised the desire to reach an amicable agreement, some observers have expressed concern about whether they will be able to do so in just 10 months.

On medicines, EMA says that the legislation affecting EU pharmacists will continue to apply to the UK during the transition period (1 February to 31 December 2020), meaning that pharmaceutical companies can continue to operate until the end of the year.

During the transition period, marketing authorisation holders and applicants can remain in the UK, as can their qualified persons for pharmacovigilance (QPPVs), pharmacovigilance system master files (PSMFs) and quality control test sites.

Similarly, EMA comments that marketing authorisation holders have to ensure that their authorised medicines comply with EU legislation and to do so, they have until the end of the transition period to make changes. In this regard, updated Brexit-related guidance will be issued shortly.

Another point of note is that from 1 February 2020, “the UK will no longer be able to participate in EU institutions and decision-making”, and that no UK representatives will participate in EMA scientific meetings, working groups or the agency’s Management Board.


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