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/eaf/index.html 

Reporting of adverse effects

  • Form for reporting of adverse effects

Marketed Medicinal Products

Certificates of quality of medicinal products entering the international market