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Δευτέρα 9 Ιουλίου 2012

European Medicines Agency encourages companies to use electronic application tools


The European Medicines Agency reminds pharmaceutical companies that electronic application formsExternal link icon are available for use. Applicants can use the online forms for all applications for human and veterinary medicines in the centralised procedure. The electronic forms offer a convenient alternative to the paper versions and include the same content with structured data fields implementing controlled terminology lists and catalogues. 

The Agency is currently offering enhanced support for applicants using the electronic forms. This support is scheduled to continue until late July 2012. 

The Agency also encourages applicants to connect to the eSubmission GatewayExternal link icon, to allow for efficient and timely submission of their dossiers. Companies can use the eSubmission Gateway to send centralised procedure submissions to the Agency in electronic common technical document (eCTD) format instead of sending CDs or DVDs via courier mail. 

Use of this Gateway is particularly advisable over the next three months, when the Olympic and Paralympic Games will be taking place close to the Agency's offices in London.