Legislation has been published which, in the event of the UK
leaving the EU with no agreement, will cover the regulation of
medicines, medical devices and clinical trials.
Leaving the EU with a deal remains the Government’s top priority.
This has not changed. However a responsible government must plan
for every eventuality, including a no-deal scenario.
Contingency legislation is needed in order for the Medicines and
Healthcare products Regulatory Agency (MHRA) to be able to take
on regulatory processes for human medicines and devices that are
currently undertaken by the European Medicines Agency and other
bodies.
The three separate pieces of legislation will allow for the
continued sale of, and access to, medicines, medical devices and
clinical trials:
-
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
These Regulations have been approved by Parliament and were made
in April 2019.
The Human Medicines and
Medical Devices (Amendment etc.) (EU exit) Regulations
2019 have been laid in parliament today (24 July 2019).
This instrument makes a number of changes to the Human Medicines
(Amendment etc.) (EU Exit) Regulations 2019 and the Medical
Devices (Amendment etc.) (EU Exit) Regulations 2019 to ensure
that the UK legislation accurately reflects technical updates at
EU level since April 2019 and also corrects drafting errors and
omissions to reflect published policy in the event of a no deal
Brexit.
Full details of the changes are set out in the explanatory
memorandum.
The legislation will be subject to parliamentary scrutiny and
approval which we anticipate in the autumn.
Background
These Regulations set out a comprehensive regime for the
authorisation of medicinal products for human use; for the
manufacture, import, distribution, sale and supply of those
products; for their labelling and advertising; and for
pharmacovigilance.
They also provide for enforcement powers for the authorisation
and supervision of medicinal products for human use.
The 2012 Regulations (as amended by the 2019 Regulations) make
reference to various pieces of EU
guidance, as that stood immediately before exit day (29 March
2019).
The Agency is the designated competent authority that administers
and enforces the law on medical devices in the UK. It has a range
of investigatory and enforcement powers to ensure their safety
and quality. These regulations ensure that the required powers
are provided for.
The Clinical Trial Regulations require all interventional
clinical trials of medicines to be authorised by the MHRA, as the
national competent authority in the UK; to have a favourable
ethics opinion; and to be conducted according to Good Clinical
Practice. They also include requirements for the assessment and
supply of investigational medicinal products and for safety
reporting.
