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United Kingdom Regulatory Updates

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This is a compilation of the recent regulatory updates for the UK. Every week, we post an update of what's new, which you can view here.

2022

  • February 20: The government has yet to hold a public consultation on an anti-counterfeiting system for the UK. This was originally scheduled for January 2022.
  • January 2: The Medicines and Healthcare products Regulatory Agency (MHRA) stated that a future public consultation, with a date to be determined, will help inform the UK’s approach to a national system.

2021

  • August 8: There is disagreement between the EU and the UK on how to resolve medicines supply issues to Northern Ireland. The UK position is to remove medicines and negotiate the Northern Ireland Protocol, while the EU position is to leave the Northern Ireland Protocol intact and change EU and UK regulatory rules.
  • February 21: Public consultation is expected within the next 12 months on a UK Falsified Medicines System and the use of data within that system.
  • February 14: The Medicines and Medical Devices Bill is now law. The legislation, which confers upon the UK Government the legal authority to enact laws and regulations for identifying and verifying medicinal products, received Royal Assent on February 11, 2021. The UK Government plans on conducting a public consultation within the next 12 months on a UK Falsified Medicines System.
  • February 7: After extended debate, the United Kingdom’s Medicines and Medical Devices Bill, which confers upon the UK Government the legal authority to enact laws and regulations for identifying and verifying medicinal products, has now passed through Parliament and is awaiting Royal Assent, where it will become law.
  • February 7: The Department of Health and Social Care (DHSC) published a Policy Paper on falsified medicines that outlined the government’s intentions to create a falsified medicines system for the UK. The paper references the ability to learn from the UK’s previous participation in EU FMD and cites an opportunity to use the repository’s data beyond anti-counterfeiting. Public consultation on the system and data usage is planned within 12 months of the imminent Royal Assent on the Medicines and Medical Devices Bill.

 

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