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« Back to: Global GMPs

Background: GMPs for the EU

  • 1989, 1st Addition of EU Guide to GMPs [EudraLex (Rules Governing Medicinal Products in EU)] published
    -Sterile Medicinal Products Annex

  • 1991, Commission Directives: Dir 91/356/EEC and 91/412/EEC
    -Created GMPs for Human Medicinal Products and Veterinary MP's

  • 1992, 2nd Addition of EU Guide to GMPs with 12 more annexes

  • 1995, EMEA Created

  • 2000, ICH Published Q7A
    - Annex 18 implemented as EU API GMPs
    - Used on a Voluntary Basis
    - First Guidance Specific for APIs

  • Community Code Directive, 2001/83/EC
    - Combined in one act nearly all aspects of the EU Law on Medicinal Products

  • 2003, Directive 2003/94/EC (medicinal products) and 91/412/ECC published (veterinary products) amended Dir 91/56/ECC

  • 2004, More Annexes added to GMPs

  • 2005, GMP Guide Restructured (Part I - Medicinal Products and Part II - Active Substances), implemented Directives 2004/27/EC and 2004/28/EC, Total Annexes now 17, Annex 18 replaced with "Part II".  (Implementation of their own GMP rather than reference ICH Q7 and API GMPs now law)

  • 2008, ICH Q9 Implemented as Annex 20