UK Medicines and Medical Devices Bill begins passage through Parliament

20 February 2020

garnier.yasmine@blue-reg.com

  • The purpose of the Bill is to replace the EU Human Medicines Directive, which will expire in 2021 at the end of the transition period agreed between the UK and EU

 

  • The Bill will collate the existing regulatory powers for medicines, medical devices, and clinical trials exercised by the European Medicines Agency (EMA) and those which currently exist at national level via the Medicines and Healthcare products Regulatory Agency (MHRA) into a new regulatory framework for the UK

 

  • The Bill will delegate powers to the Secretary of State to allow updates to the regulations, currently conducted through the EU Human Medicines Directive, and provides additional tools (including a range of civil rather than criminal penalties) to prosecute breaches of the UK’s regulatory frameworks. This includes powers over important aspects of medical care such as who has the authority to prescribe medicines and implementation of rules around falsified medicines, as well as giving the Secretary of State

Further points to consider:

  • As the EU begins the implementation of the Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR), it should be noted that the Bill does not define a specific direction on whether the UK will align with these. However, it does provide the UK frameworks and UK powers that will be required to implement any resulting policy (if required).

 

  • The full text available here, and explanatory notes here.

garnier.yasmine@blue-reg.com

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