In the event that the United Kingdom (UK) leaves the European Union (EU) with no deal, contingency legislation has been published which outlines the regulation of medicines, medical devices and clinical trials. The legislation has been released to ensure that the Medicine and Healthcare Products Regulatory Agency (MHRA) can take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency (EMA) and other bodies.
The three separate legislation documents, which are subject to approval by Parliament, 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
The Regulations cover a detailed regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; labelling and advertising and pharmacovigilance.
The MHRA is the designated competent authority that administers and enforces laws on medical devices in the UK, therefore they have a range of investigatory and enforcement powers to ensure their safety and quality. The 2019 Regulations ensure that these required powers are provided for.
According to the Clinical Trial Regulations, all interventional clinical trials of medicines are to be authorised by the MHRA, and to be conducted according to Good Clinical Practice. The Regulation also outlines the requirements for the assessment and supply of investigational medicinal products and for safety reporting.