In March 2018, the UK and European Union (EU) agreed the terms of an implementation period until the end of 2020. According to the Medicines Healthcare Products Regulatory Agency (MHRA), this transition stage is designed to give professionals time to plan for the UK’s withdrawal “with confidence”.
In guidance issued yesterday, the UK regulator explained that if the Withdrawal Agreement (WA) is agreed, and the implementation period approved, “no change to the legal framework” should be expected in the UK until the end of December 2020: “Our domestic implementation of EU law remains in place.”
When the transition period comes to an end, the MHRA will have worked closely with EU regulators “to facilitate a transfer to another leading authority, with minimal disruption to firms”, wrote the Agency.
The proposed implementation period begins March 29, 2019. At that time, undisrupted market access and ongoing data sharing will ensure that drug supply is maintained in both markets, stated the MHRA.
Specifically, the Agency said, “pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa.
“Marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP).”
Under the proposed WA, UK-based firms will be able to apply for marketing authorisations via centralised or decentralised procedures, the Agency added.
However, not all regulations will be maintained during the transition: “…for medicines the UK will not have voting rights in EMA [European Medicines Agency] and UK committees,” explained the MHRA.
And from 2021?
According to the MHRA, the WA would help offer clarity to UK and EU-based firms.
The Association of the British Pharmaceutical Industry similarly said moving towards a WA is positive news for the industry: “The EU Council’s agreement to progress to future partnership talks and their approval of a transition period is welcome news,” said CEO Mike Thompson in March this year.
Yesterday, the MHRA confirmed it aimed to finalise the WA by October, together with a framework detailing the future relationship between the UK and EU: “We are confident of a positive outcome from the negotiations with the EU and will continue to act in the best interests of patients, recognising that this will require continued close cooperation between the EU and UK.”
While the WA details remain unclear, the UK has voted to continue its involvement in the EMA’s regulatory network once it leaves the EU, as reported by the UK Parliament last month.
Unfortunately for the EMA, which is currently planning a relocation from London to Amsterdam as a result of the Brexit vote, not all employees will decide to move to the Netherlands. Approximately 30% of staff are expected to leave the EMA before the end of March 2019.
