Targeted stakeholder consultation on the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007

  • Targeted stakeholders
    All stakeholders involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products.  Comments from small and medium-sized enterprises (SMEs) are particularly welcome.
  • Period of consultation
    From 23 July 2015 to 12 November 2015
  • Objective of the consultation
    Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC requires the Commission to draw up guidelines on good manufacturing practice (“GMPs”) specific to advanced therapy medicinal products (“ATMPs”).
    With this public consultation, the Directorate General for Health and Food Safety intends to seek the view of stakeholders regarding the GMP requirements for ATMPs.
    The comments received will be taken into account by the European Commission when developing the Guidelines on good manufacturing practice specific to ATMPs.
  • How to submit your contribution
    Contributions should be sent before 12 November 2015 by e-mail exclusively to: SANTE-D5-ADVANCED-THERAPIES@ec.europa.eu
    When you submit your response, please explain if you are acting as a private individual or on behalf of a company, association or other legal entity.  Please state also your type of activity (e.g. R&D, manufacturing, marketing of ATMPs).
    If you represent a company, please state whether it falls within the EU definition of a small and medium-sized enterprise (i.e. less than €50million annual turnover and fewer than 250 employees).
    If your organisation is registered in the Transparency Register, please indicate your Register ID number at the beginning of your contribution.
  • Consultation document can be downloaded here
  • Contact details
    Unit D5 “Medicinal products – Authorisations, European Medicines Agency”
    SANTE-D5-ADVANCED-THERAPIES@ec.europa.eu
    European Commission
    DM24 02/133
    B-1049 Brussels (Belgium)

More information here