Regulatory information - Electronic application becomes mandatory

As of 1 July 2015 companies are obliged to use electronic application forms provided by the European Medicines Agency (EMA) for all centralised marketing authorisation applications for human and veterinary medicines.

Forms are available for initial marketing authorisations, variations and renewals and can be downloaded from the electronic Application Forms (eAF) website. The electronic application forms offer a more structured application process for users. Their use is expected to reduce the administrative burden for both the regulatory authorities and pharmaceutical companies.

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