eSubmission

The European standards for the application form and application dossier (EU eCTD) have been approved and issued (published) in July 2004.

eCTD (Electronic Common Technical Document)

A European standard for basic information (Module 1) was issued in July 2004. A standard for Modules 2-5 (eCTD) has been in force for two years and is identical for the European Economic Area (EEA), the United States, Canada and Japan. Individual EEA states can optionally request the application dossier to be submitted in paper form also. IMCA requests applicants to submit Module 1 in paper format for centrally authorised medicinal products and medicinal products marketed under the Mutual Recognition Procedure, whereas all Modules are requested in paper format in the case of pure national authorisations, along with the electronic format.

Concurrent to the implementation of the eCTD application form, a composite European Review System (ERS) is being developed, which can be utilised by experts of the Member States to review data accompanying the applications. The system undergoes client tests at most of the medicinal products agencies and several pharmaceutical manufacturing companies have shown interest in using the same system as the agencies.

The long-time strategy of the Agency to have a paperless work environment and electronic archiving will be formalised in coming months in cooperation with the European Medicines Agency (EMEA), other agencies in the European Economic Area and the Icelandic Government.

Electronic Application Form

A European standard for electronic application forms was issued in July 2004.

Nevertheless applicants must still submit a Cover Letter signed by the applicant’s representative.