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EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

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.

Introduction

  • Introduction (07/02/2011)
  • Commission Directive 2003/94/EC of 8 October 2003, repealed by Commission Directive 2017/1572/EU of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the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.
  • 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 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)

Part I - Basic Requirements for Medicinal Products

Part II - Basic Requirements for Active Substances used as Starting Materials

Part III - GMP related documents

Annexes

Annex 1

New - Manufacture of Sterile Medicinal Products - The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024

Manufacture of Sterile Medicinal Products  (previous version)

Annex 2

New - Manufacture of Biological active substances and Medicinal Products for Human Use (into operation since 26 June 2018)

Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.

Annex 3Manufacture of Radiopharmaceuticals
Annex 4Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 5Manufacture of Immunological Veterinary Medicinal Products
Annex 6Manufacture of Medicinal Gases
Annex 7Manufacture of Herbal Medicinal Products
Annex 8Sampling of Starting and Packaging Materials
Annex 9Manufacture of Liquids, Creams and Ointments
Annex 10Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
Annex 11Computerised Systems (revision January 2011)
Annex 12Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 13

Manufacture of Investigational Medicinal Products

Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014 (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

Annex 14Manufacture of Products derived from Human Blood or Human Plasma (May 2011)
Annex 15Qualification and validation (into operation since 1 October 2015)
Annex 16Certification by a Qualified Person and Batch Release (into operation since 15 April 2016)
Annex 17New - Parametric release (Deadline for coming into operation: 26 December 2018)
Further information on the consultation can be found here.
Annex 19Reference and Retention Samples
Annex 21Importation of medicinal products

Glossary

Part IV - GMP requirements for Advanced Therapy Medicinal Products

Other documents related to GMP and GDP