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Pokyny EMA, EC, CMD and HMA

Rules Governing Medicinal Products in the European Union

  • Volume 2    Notice to Applicants
    • 2A Procedures for Marketing Authorisation
      • Kapitola 1:  Marketing Authorisation
      • Kapitola 2:  Mutual Recognition
      • Kapitola 3:  Community Referral
      • Kapitola 4:  Centralised Procedure
      • Kapitola 5:  Variations
      • Kapitola 6:  Decision Making Procedure for the Adoption of Commission Decisions
      • Kapitola 7:  General Information
    • 2B Presentation and Content of the Dossier
    • 2C Regulatory Guidelines
  • Volume 4    Good Manufacturing Practice
  • Volume 9    Pharmacovigilance
  • Volume 10  Clinical Trials

Guidelines on Good Distribution Practice of Medicinal Products for Human Use  (94/C 63/03)

Scientific Guidelines

  • Quality Guidelines (Chemical and Herbal)
  • Biologicals Guidelines
  • Non-Clinical Guidelines
  • Clinical Efficacy and Safety Guidelines
  • Multidisciplinary Guidelines

Plasma Master File (PMF)

Vaccine Antigen Master File

Herbal Medicinal Products

Orphan medicinal products



Working Group - Heads of Medicines Agencies - HMA

WG - homeopathics

WG on PSUR synchronisation