There is still a very strong possibility that there will be a “Hard Brexit”. The term “Hard Brexit” refers to the United Kingdom leaving the European Union without a deal.
The UK Government is now preparing legislation to allow the continued sale of and access to medicines manufactured in the remaining EU. This will be done through amendments to the existing UK Human Medicines Regulations 2012 (HMR 2012).
The changes that have been planned to the HMR 2012 consider that the UK will no longer be part of the harmonised EU pharmaceutical network after the date of exit in a no deal scenario. The current rules should be transferred to the 2019 Regulations, while taking into account EU requirements.
There will also be appropriate changes necessary for an independent regulatory authority outside the EU network. For example, the “UK” will be inserted before the term “Marketing Authorisation” in some parts. The UK government may also set out principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products.
If you would like to discuss your specific requirements relating to Brexit readiness and how MIAS Pharma can help you, get in touch with us today at +353 (1) 846 3605 or info@miaspharma.com. In the meantime, you can check out the services we offer here.
Source: https://www.gmp-compliance.org/gmp-news/hard-brexit-uk-amends-gmp-and-gdp-regulations
