All the regulations - in one place
Links below correspond to all active legislation that significantly impacts the QP. Both UK and EU law are included.
UK Primary Legislation
Human medicines (General)
Human Medicines Regulation 2012 - (Statutory instrument 2012:1916)
Medicines and Medical Devices Act 2021 - The MMD Act provides the Secretary of State for Health with a significant range of powers to amend the existing regulatory framework regarding human and veterinary medicines, and medical devices in the UK.
Human medicines (Amendments)
The Human Medicines (Amendment) Regulations 2013 - (SI 2013:1855) - This is the Falsified Medicines Directive incorporated into UK Law.
Human medicines (Brexit Amendments)
The Human Medicines (Amendment) Regulations 2019 - (SI 2019:62) - Safety features (Post Brexit)
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 - (SI 2019:775) - Brexit - Major amendments
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 - (SI 2019:1385) - Includes changes related to QPPV from Brexit
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 - (SI 2020:1488) - The Northern Ireland Protocol. Includes QP responsibilities for NI.
The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 - (SI 2021:1452) - to introduce a new route for supply of prescription only medicines from Great Britain (GB) into Northern Ireland (NI).
The Human Medicines (Amendment) Regulations 2023 - (SI 2023:437) - Windsor Framework - The “UK side” of Directive (EU) 2022/642 which introduced derogations to certain EU laws that apply to Northern Ireland under the Northern Ireland Protocol with the aim of ensuring continued supplies of medicines for human use to NI from GB.
Clinical Trials (General)
The Medicines for Human Use (Clinical Trials) Regulations 2004 - (SI 2004:1031)
Clinical Trials (Brexit Amendments)
The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 - SI 2019:744 - (SI 2019:744)
Veterinary Medicines
The Veterinary Medicines Regulations 2013 - (SI 2013:2033)
Veterinary Medicines (Amendments)
The Veterinary Medicines (Amendment) Regulations 2014 - (SI 2014:599)
Not massively relevant to the QP - this amends the Veterinary Medicines Regulations 2013 in Schedule 5 on medicated feedingstuffs and specified feed additives regarding an enforceable obligation. It also amends Schedule 7 on fees relating to marketing authorisations.
EU Legislation
The consolidated basis of EU legislation (and guidance) concerning Human and Veterinary Medicine is captures 10 Volumes of “The rules governing medicinal products in the European Union”
Volume 1 - Contains pharmaceutical legislation for medicinal products for human use
Volume 5 - Contains pharmaceutical legislation for medicinal products for veterinary use
Volume 1 and 5 also cover a lot that isn’t very QP relevant so I have cheated a little and only put the vital stuff below.
Human Medicines Legislation
Directive 2001/83/EC – Community Code Relating to Medicinal Products for Human Use. Establishes the legal framework for authorisation / manufacturing / distribution
(Repealed) Directive 2003/94/EC - Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use. This is only included here as it is still referenced in the QP Code of Practice.
Regulation (EC) No 726/2004 - Established the European Medicines Agency and outlined the central application procedure
Directive 2011/62/EC – Falsified Medicines Directive
Delegated Regulation EU No 161/2016 - Detailed rules for the safety features appearing on the packaging of medicinal products for human use.
Directive 2017/1572/EU - Principles and guidelines of good manufacturing practice for medicinal products for human use. Replaces 2003/94/EC
Regulation (EC) No 1394/2007 - ATMPS - Advanced therapy medicinal products
Clinical Trials Legislation
Directive 2001/20/EC – Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use - This is the “Clinical Trials Directive” it is out of date but is still referenced in UK law as it has been superseded post-Brexit.
Regulation EU No 536/2014 - The “Clinical Trials Regulation” which fully repealed the Clinical Trials Directive on 31 January 2023.
Regulation EU No 1569/2017 - specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections. This is viewed as supplementing Regulation (EU) No 536/2014.
Veterinary Medicines Legislation
Regulation (EU) No 2019/6 - The new veterinary regulation (NVR), legislates for the authorisation, use and monitoring of veterinary medicinal products in the European Union
Directive 91/412/EEC – Principles and Guidelines of Good Manufacturing Practice for Veterinary Medicinal Products
Repealed - Directive 2001/82/EC – Community Code Relating to Veterinary Medicinal Products. This is only included here as it is still referenced in the QP Code of Practice.
Directive 2004/28/EC - Community code relating to veterinary medicinal products
Regulation (EC) No 470/2009 - establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin
Active Substances Legislation
Delegated Regulation (EU) No 1252/2014 - Principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
If you think something is missing please contact me.
Disclaimer
This document is not a legal document not should it be interpreted in any fashion as a guide. This is a set of notes compiled as part of a personal CPD program. It is not complete or authoritative. I hope it gives you some value.
This is a personal effort and is not affiliated with my current role or employer.
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. If you use it to train someone else, fantastic, but give the QP Notebook a plug. Thanks