The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit. Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week.
On 8 October the UK Government issued its “No Deal Readiness Report”. Whilst it is not yet known whether the UK will leave with or without a Withdrawal Agreement at the end of October, the report sets out guidance for industry across a range of sectors – including providers of medicines and medical devices. Guidance can be found via the link here. Please see page 78 and further for the guidance on the various legislation per industry sector. In summary, if there is no deal: The UK would manage its own set of regulations on manufactured goods separate from the EU if we leave without a deal, and UK businesses exporting to the EU would need to meet EU rules. Many manufactured goods sectors, such as chemicals, aerospace goods, human and veterinary medicines, medical devices and automotive vehicles, are subject to common rules across the EU. These rules establish common requirements for manufacturing, testing and marketing products from these sectors. Currently, it is a legal requirement to follow these rules before selling regulated products in the EU. Having separate regulatory regimes for manufactured goods will mean that: The UK will be able to set its own regulations that the businesses in the EU and other countries will have to follow before selling products on the UK market. This means that the UK could set regulations for imports into the UK rather than having to follow EU regulations. UK businesses exporting to the EU will need to make sure they meet EU rules. This includes, where relevant, having goods approved by EU-based bodies or having legal representatives in the EU. Approvals and authorisations on goods issued by UK bodies will not be accepted in the EU, even where these meet EU regulations or were issued by a UK body while the … Read More