Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
Until 15/07/2026 the guidelines on Good Manufacturing Practice of Volume 4 apply to both human and veterinary medicinal products.
From 16/07/2026 onwards the Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council and Commission Implementing Regulation (EU) 2025/2154 of 17 October 2025 laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council apply for veterinary medicinal products.
Introduction
- Introduction (07/02/2011)
- Legal acts applicable to GMP manufacturing of medicinal products for human use:
- Commission Directive 2003/94/EC of 8 October 2003, repealed by Commission Directive 2017/1572/EU of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use.
- Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
- Commission Delegated Regulation (EU) 2017/1569 (for linguistic versions, click here) of 23 May 2017 supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
- Commission Directive (EU) 2017/1572 (for linguistic versions, click here) of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
- Legal acts appliable to GMP manufacturing of veterinary medicinal products:
- Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
- Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (applicable as of 16/07/2026)
- Commission Implementing Regulation (EU) 2025/2154 of 17 October 2025 laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (applicable as of 16/07/2026)
Despite having different legal bases, the GMP requirements for veterinary medicinal products and their active substances will remain aligned with those for medicinal products for human use and their active substances. The tables of correspondence below provide an overview of the relations between the two Commission Implementing Regulations and the GMP guidelines applicable to medicinal products for human and, until 15/07/2026, veterinary use:
- ToC for Commission Implementing Regulation (EU) 2025/2091 laying down good manufacturing practice for veterinary medicinal products
- ToC for Commission Implementing Regulation (EU) 2025/2154 laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products
Part I - Basic Requirements for Medicinal Products
- Chapter 1 - Pharmaceutical Quality System (into operation since 31 January 2013)
- Chapter 2 - Personnel (into operation since 16 February 2014)
- Chapter 3 - Premise and Equipment (into operation since 1 March 2015)
- Chapter 4 - Documentation (January 2011)
- Chapter 5 - Production (into operation since 1 March 2015)
- Chapter 6 - Quality Control (into operation since 1 October 2014)
- Chapter 7 - Outsourced activities (into operation since 31 January 2013)
- Chapter 8 - Complaints and Product Recall (into operation since 1 March 2015)
- Chapter 9 - Self Inspection
Part II - Basic Requirements for Active Substances used as Starting Materials
Part III - GMP related documents
- Site Master File
- Q9 Quality Risk Management
- Q10 Note for Guidance on Pharmaceutical Quality System
- MRA Batch Certificate
- Template for the "written confirmation" for active substances exported to the European Union for medicinal products for human use (Version 2, January 2013)
- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (all language versions are available here). A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use by 21 March 2016.
- Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
- Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice
- Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
Annexes
Glossary
Part IV - GMP requirements for Advanced Therapy Medicinal Products
Other documents related to GMP and GDP
- Compilation of Union Procedures on Inspections and Exchange of Information
- A revised version of the "Guidelines on Good Distribution Practice of Medicinal Products for Human Use" was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23.11.2013)
- Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (all language versions are available here). These guidelines will come into operation on 21 September 2015
- Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6
- Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6
- Guidance on good manufacturing practice and good distribution practice: Questions and answers
