As Brexit date approaches, the UK government has finalised draft amendments to key legislation which will ensure that the MHRA can take over the regulatory role previously exercised by the EMA.
Several key pieces of legislation have been amended to ensure the continued regulatory oversight of medicinal products and devices in the UK, with the changes laid before parliament on 24th July 2019.
These changes are required ahead of October’s planned Brexit date, in case the UK leaves the EU without a deal, as in this case there will be no implementation period for transitional arrangements:
- Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
- The Medical Devices (amendment) (EU exit) Regulations 2019
- The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019
The UK government press announcement emphasises that:
‘These Regulations make technical corrections to those instruments to ensure their proper functioning at exit day, but do not represent a change of any underlying policy.’
These pieces of legislation have been amended to ensure that the Medicine and Healthcare products Regulatory Agency (MHRA) can operate outside the EU regulatory network and take on responsibilities currently held by the European Medicines Agency (EMA). In particular, the MHRA will be the sole UK body regulating medicinal products and devices, conducting market surveillance and possessing relevant enforcement powers.
Parliament is expected to scrutinise and vote upon the amendments this autumn, in preparation for the Brexit date of 31st October 2019.
For further information, see MAP’s Brexit updates here.