The European Medicines Agency is recommending that marketing-authorisation applicants and holders use electronic application formsExternal link icon, following the successful completion of the pilot phase. The electronic application forms allow pharmaceutical companies to apply for initial marketing authorisations, variations or renewals for human and veterinary medicines using interactive PDF forms. Their benefits include:
- improvements to data quality and consistency during data entry;
- access to the underlying data entered in an XML format;
- integration with dynamic lists of controlled terms.
The European Commission, the European Medicines Agency and regulatory authorities in Member States worked together to produce the forms.
Applicants should download the latest version of the electronic forms from the European Medicine Agency's eSubmission websiteExternal link icon or via the European Commission's Eudralex website. Registration is no longer necessary before using the electronic application forms.
To keep informed about new releases of the electronic application forms, the European Medicines Agency recommends subscribing to the RSS news feed. For more information, see the eSubmission website, http://esubmission.ema.europa.eu/eaf/index.html