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Published on 12 March 2012

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EMA launches e-application form pilot

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The European Medicines Agency has launched a pilot of electronic application forms for submission of centralised marketing authorisation applications.

The pilot, which runs for four months until mid-July 2012, allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.

The pilot is a key step forward in the Agency’s drive towards the use of electronic applications as standard, using the Electronic Common Technical Document (eCTD) format.

This is expected to simplify and speed up the application process by:

  • improving data quality and consistency;
  • providing access to data in Extensible Markup Language
  • (XML) format;
  • integrating application data with controlled vocabulary lists
    .

The forms were developed by the European Medicines Agency, working together with the European Commission services and medicines regulatory authorities in European Union Member States.

Full details on how to register are available in the electronic application forms guidance.

EMA

 



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