Commercialisation Binding Text and Guidance

Market access for ATMPs  

BINDING EU TEXTS 

  • 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, as amended. 
  • Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (Text with EEA relevance), OJ L 168, 30.6.2009, p. 33–34, CELEX number: 32009L0053 
    • Proposal (Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products {SEC (2008) 273} {SEC (2008) 274}, COM/2008/0123 final - COD 2008/0045, CELEX number: 52008PC0123) 
    • Original text 
  • Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance), OJ L 334, 12.12.2008, p. 7–24, CELEX number: 32008R1234 

Action Plan on ATMPs

Marketing authorization pathway    

Standard approval process: centralized procedure  

GUIDELINES 

Marketing Authorisation Application file  

GUIDELINES 

For GTMP

For Cell Therapy and Tissue Engineered Products 

Expediting access pathways   

Conditional MA    

BINDING EU TEXT 

  • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance), OJ L 136, 30.4.2004, p. 1–33, CELEX number: 32004R0726 
  • Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance), OJ L 92, 30.3.2006, p. 6–9, CELEX number: 32006R0507 

GUIDELINES 

MA under exceptional circumstances  

BINDING EU TEXTS 

  • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance), OJ L 136, 30.4.2004, p. 1–33, CELEX number: 32004R0726 
  • 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, as amended. 

GUIDELINES 

Accelerated Assessment  

BINDING EU TEXTS

  • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance), OJ L 136, 30.4.2004, p. 1–33, CELEX number: 32004R0726 

GUIDELINES AND OTHER EMA GUIDANCE DOCUMENTS 

Biosimilars 

BINDING EU TEXTS

  • 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, as amended. 
  • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance), OJ L 136, 30.4.2004, p. 1–33, CELEX number: 32004R0726 

GUIDELINES AND OTHER EMA GUIDANCE DOCUMENTS 

EMA regulatory support schemes   

PRIME   

GUIDELINES 

Adaptive pathways   

GUIDELINES AND OTHER GUIDANCE DOCUMENTS 

 

Distribution 

Good Distribution Practices   

BINDING EU TEXTS 

  • 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, as amended. 

GUIDELINES and Other Guidance documents 

 

Advertising 

This section is in development.

 

    Pharmacovigilance (medicines/ATMP)   

    BINDING EU TEXTS 

    • 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 (Text with EEA relevance), OJ L 65, 8.3.2013, p. 17–18, CELEX number: 32013R0198 
    • Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (Text with EEA relevance), OJ L 299, 27.10.2012, p. 1–4, CELEX number: 32012L0026 
    • 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 (Text with EEA relevance), OJ L 316, 14.11.2012, p. 38–40, CELEX number: 32012R1027 
    • Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), OJ L 159, 20.6.2012, p. 5–25, CELEX number: 32012R0520 
    • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance), OJ L 348, 31.12.2010, p. 74–99, CELEX number: 32010L0084 
    • Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (Text with EEA relevance), OJ L 348, 31.12.2010, p. 1–16, CELEX number: 32010R1235 
    • 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 

    Good Pharmacovigilance Practices 

    GUIDELINES 

     

    Pricing & reimbursement   

    BINDING EU TEXTS 

    • Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU, OJ L 458, 22 December 2021, p. 1–32, CELEX number: 32021R2282 
    • Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (Text with relevance for the EEA and for Switzerland), OJ L 166, 30.4.2004, p. 1–123, CELEX number: 32004R0883 
    • Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems, OJ L 40, 11.2.1989, p. 8–11, CELEX number: 31989L0105 

     

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