Pharma and medical device regulation—United Kingdom—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Pharma and medical device regulation—United Kingdom—Q&A guide
  • 1. Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.
  • 2. Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?
  • 3. Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.
  • 4. What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?
  • 5. What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?
  • 6. Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?
  • 7. How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?
  • 8. What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?
  • 9. To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?
  • More...

Pharma and medical device regulation—United Kingdom—Q&A guide

This Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device regulation in United Kingdom published as part of the Lexology Getting the Deal Through series by Law Business Research (published: September 2020).

Authors: Arnold & Porter Kaye Scholer LLP—Adela Williams; Jackie Mulryne ; Lincoln Tsang; Ewan Townsend

1. Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.

Medicinal products and medical devices

The UK healthcare system comprises both public and private services. Since 1999, the UK provision of healthcare has been devolved to the administrations of each of the United Kingdom’s four constituent countries. Public healthcare is provided through the National Health Service (NHS) in England and by equivalent bodies in Northern Ireland, Scotland and Wales. The Secretary of State for Health and Social Care is ultimately responsible for the provision of medical services, but discharges this role through the hospitals, clinics and related institutions contracted by NHS Trusts and Health Authorities and statutory bodies called clinical commissioning groups (CCGs) created under the Health and Social Care Act 2012.

The Health and Social Care Act 2012 made fundamental changes to the core structure of the NHS so that, since 1 April 2013, CCGs within NHS England and local area teams share the responsibilities of commissioning healthcare services for

Popular documents