4 October 2018 - Deborah Wilkes
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on how its legislation and regulatory processes would have to be modified if the UK does not secure a deal with the European Union after its departure from the European Union and there is no implementation period.
The MHRA said negotiating teams from the UK and the European Union had reached agreement on the terms of an implementation period after the UK exits the European Union on 29 March 2019. The implementation period is due to start on 30 March 2019 and last until 31 December 2020.
However, the regulatory agency added that talks were ongoing and a "responsible government should prepare for all potential outcomes, including the unlikely scenario in which no mutually satisfactory agreement can be reached".
"As part of this contingency planning it is necessary to make sure that the UK's regulatory processes for medicines, clinical trials and medical devices are legally coherent on exit day," added the MHRA.
MHRA's approach for no-deal scenario
The MHRA said the overall approach in the "unlikely event of a no-deal scenario" would be for the MHRA to be a "stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at the European Union level".
One of the key considerations, according to the MHRA, was to ensure there was "minimum disruption and burden on companies as the UK exits the European Union".
Ian Hudson, the MHRA's chief executive officer, urged "anyone that has an interest to share their comments".
Sheuli Porkess – deputy chief scientific officer at the Association of the British Pharmaceutical Industry (ABPI) – said it was "important that the UK puts plans in place for a no-deal Brexit".
"Pharmaceutical companies continue to plan for all possible outcomes from the negotiations and we will continue to work closely with the government on its plans," added Porkess. “But we have been very clear that the best way to protect patients and public health in the UK and in the European Union is to agree future cooperation between the MHRA and the European Medicines Agency (EMA) on the regulation of medicines."
The consultation – available online at https://www.gov.uk/government/consultations/mhra-consultation-on-eu-exit-no-deal-legislative-proposals – will close on 1 November 2018.
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