The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Monday explained what pharmaceutical and medical device companies can expect during the period that the Brexit agreement is implemented.
During the implementation period, which will end in December 2020, pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, which will be recognized by the EU and vice versa, MHRA said.
But one of the setbacks is that for medicines, the UK will not have voting rights in EMA and EU committees during the implementation period, MHRA said.
“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),” the regulator added.
And UK-based companies will be able to apply for marketing authorisations via either the centralised or decentralised procedures.
For medical devices in the implementation period, the MHRA said that CE marking will continue to be used and recognized for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU.
"UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets,” MHRA said.
The EU Medical Devices Regulation will fully apply from May 2020, and MHRA noted that this takes place during the implementation period so the government “will fully implement the legislation.”
The new EU regulation on in vitro diagnostics (IVDs) “will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements.”
MHRA added: “We cannot pre-judge the outcome of negotiations which will inform what the future arrangements will be, however, the UK has been central to agreeing the new legislation and we are supportive of its aims to strengthen the regulatory system and increase the transparency of information about products on the EU market.”
As far as the new Clinical Trials Regulation (CTR), the MHRA says it is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the implementation period.
“If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty,” MHRA said.
In general, the MHRA also said that progress is being made to finalize the Withdrawal Agreement as a whole. “We will aim to agree this by October, alongside the framework for our future relationship with the EU.”
Falsified Medicines Directive
“UK will still be a Member State in February 2019 and will therefore implement the FMD Delegated Regulation in line with our existing obligations,” MHRA said. “When the UK exits the EU, the Withdrawal Act will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the FMD would continue to apply, unless specifically revoked.”
Technical information on what the implementation period means for the life science sector
What the implementation period means for the life science sector
Clinical Trials Regulation