Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 18 January (HL4659), whether, after exit from the EU, the licensing regime for medical isotopes will be the responsibility of the Medicines and Healthcare Products Regulatory Agency (MHRA) even where those isotopes are manufactured outside the UK; and if so, how the MHRA will ensure the safety of manufacture outside the Euratom framework.

Medical isotopes may be either medicinal products or medical devices regulated according to the appropriate legislation. The system of regulation after exiting the European Union depends on agreements reached as part of current negotiations, however, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to be responsible for the regulation of such products placed on the market in the United Kingdom.

Medical isotopes or radiopharmaceuticals that are medicinal products are regulated in accordance with the laws applicable to all medicines. Currently there are products regulated nationally by national competent authorities (such as MHRA) or centrally by the European Medicines Agency (EMA). National competent authorities have a shared role in the licencing of centrally authorised products.

If required as a result of the terms of the EU exit, the MHRA will regulate products licenced nationally and those that would have been authorised via the centralised route including verification of compliance with good manufacturing practice.

Currently medical isotopes that are medical devices are regulated in accordance with the laws applicable to medical devices implementing directives 93/42/EEC, 98/79/EC and 90/385/EEC.

The three directives do refer to EURATOM requirements but these aspects are covered in the UK by other organisations such as the Department of Health and Social Care, the Department for Business, Energy and Industrial Strategy, the Health and Safety Executive and the Environment Agency under the relevant UK legislation.

The new European medical device regulations (2017/745 and 2017/746) are in force and are due to apply from May 2020 for medical devices and May 2022 for In Vitro Diagnostic medical devices. Again, these refer to EURATOM requirements but these aspects are similarly covered in the UK by other organisations.

The situation after exiting the EU depends on any agreements reached but is likely that the other Government agencies mentioned above will continue to be responsible for those aspects currently covered by the EURATOM legislation.