UK Pharmaceutical Law

This course explains the specifics of the revised UK legislation and guidance via a combination of live instructor-led virtual classrooms and self-paced learning online. Full details will be sent to you following registration.

On completion of this course, delegates will know and understand:

• The main changes to the UK legislation of medicines following the UK’s exit from the EU, including the consequence of the Northern Ireland Protocol
• The subsequent impact to:
  • UK marketing authorisations
  • UK manufacturing and wholesale sites
  • Product imported from the EU to the UK
  • Product exported from the UK to the EU

Introduction: Current UK legislation

• SI 2012 No. 1916 as amended including the exit legislation - SI 2020 No. 1488
• Medicines and Medical Devices Bill (which will hopefully be an Act of Parliament by the time of this course!)
• The Medicines for Human Use (Clinical Trials) Regulations 2004 as amended

Product authorisations to include:

• Part 5 of SI 2012 No. 1916 as amended, marketing authorisations
• Licensed products for Great Britain and Northern Ireland – including biosimilars, paediatrics, orphans and parallel importation
• Legal requirements for pharmacovigilance

Manufacturing and wholesale authorisations for Great Britain and Northern Ireland to include:

• Part 3 of SI 2012 No. 1916 as amended, manufacture and distribution of medicinal products and active substances
• Import / export including the Responsible Person for Import (RPi)

• Quality and regulatory personnel who already have a solid understanding of the European Medicines system as covered in our Pharmaceutical Law and Administration course
• Trainee QPs looking to have confidence prior to their UK viva

Rachel Carmichael - Rachel is a former UK MHRA GMP Inspector. She has extensive knowledge of pharmaceutical law and its practical implementation.

Helen Erwood - Helen has been working in pharmaceutical regulatory affairs and regulatory compliance for many years; she has wide experience in the regulation of medicines, medical devices and borderline/OTC/nanotechnology products.

Peter Gough - Peter has over 45 years’ experience in the pharmaceutical industry and specializes in EU and U.S. pharmaceutical law. He has had direct involvement in discussions with regulators on quality and GMP, having been the EU industry leader on the ICH Q9 working group.