Manufacturing Binding Text and Guidance

Binding EU Text: 

  • Commission Directive (EU) 2017/1572 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 (Text with EEA relevance), C/2017/6127, OJ L 238, 16.9.2017, p. 44–50, CELEX number: 32017L1572 
  • Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance), C/2017/3368, OJ L 238, 16.9.2017, p. 12–21, CELEX number: 32017R1569 
  • Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use Text with EEA relevance, OJ L 337, 25.11.2014, p. 1–7 
  • Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance), OJ L 91, 9.4.2005, p. 13–19, CELEX number: 32005L0028 
  • Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Text with EEA relevance), OJ L 262, 14.10.2003, p. 22–26, CELEX number: 32003L0094 

Guidelines Specific to ATMPs: 

For GTMP:

For Cell Therapy and Tissue Engineered Products:

Guidelines on Medicinal Products Potentially Applicable to ATMPs:

Manufacturing Authorisation

This section is in development.

Good Manufacturing Practice

Selection of GMP cell line 

 

Process Validation 

Generation of Master and Working Cell Banks 

 

Development of Standard Operating Procedures (SOPs) 

 

GMP Training – Validation and Execution 

 

CMC (Chemistry, Manufacturing, and Controls) 

 

Release Testing 

 

European Pharmacopeia

This section is in development.

Investigational Medicinal Products Dossier

This section is in development.

Capability

This section is in development.

Scalability

This section is in development.

Packaging and Labeling

Binding EU Text

  • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67–128, CELEX number: 32001L0083. See Title V, Articles 54 to 69 on packaging and labelling. 
  • Directive 2001/83/EC has been amended regarding packaging and labelling by the following legal texts: 
  • Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance), OJ L 136, 30.4.2004, p. 34–57, CELEX number: 32004L0027 
  • Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance), OJ L 174, 1.7.2011, p. 74-87, CELEX number: 32011L0062 
  • Commission delegated regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, OJ L 32, 9.2.2016, pp. 1–27. 
  • Regulation (EU) no 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance, OJ L 316, 14.11.2012, pp. 38–40. 
  • Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring, OJ L 65, 8.3.2013, p. 17–18. 
  • Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance), OJ L 324, 10.12.2007, p. 121–137. 
  • Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, OJ L 378, 27.12.2006, pp. 1–19. 

EMA Guidelines

Relevant European Medicines Agency guidance 

Relevant European Medicines Agency’s guidelines on checking process 

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