Issuing, Variations and Renewal of Marketing Authorisations

  • Guidelines for Applicants (see: "Electronic Application Form"): 

          http://ec.europa.eu/health/documents/eudralex/vol-6/index_en.htm  

          http://esubmission.ema.europa.eu/eaf/index.html 

  • Applicants are requested to follow the instructions regarding formats and other information on submissions for veterinary products and also take notice at new developments that occur in this website: 

         http://esubmission.ema.europa.eu/tiges/vetesub.htm 

Reporting of adverse effects

  • Form for reporting of adverse effects

Marketed Medicinal Products

  • Form for submission of data on launch, disruption of medicinal products
  • Notice: instead of the code please enter MA number.

Certificates of quality of medicinal products entering the international market