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  

  • Application Forms and additional information on use: 

          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