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Information for citizens
Information for medical specialists
Information for companies
««« IMPORTANT! »»»

From 01.01.2010 for all types of procedures for marketing authorization - national, by mutual recognition, decentralized - it is obligatory the applicants to submit the documentation in electronic format - eCTD or NeeS.

Additional information for the requirements to the electronic documentation can be found in Guidance for electronic submission of documents eCTD and NEES ver. 04, 31.03.2009 on the web site of BDA.

The documentation is submitted on electronic storage devices (CD or DVD), with the exception of the following documents with original signature, which are submitted on paper and are considered as a part of the eCTD documentation:

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