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Information for citizens
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««« IMPORTANT! »»»
Important!

The Bulgarian Drug Agency informs the marketing authorization holders that in the cases of submission of group of variations to marketing authorization/s under the order of REGULATION (EC) No.1234/2008, the relevant taxes, specified in the Tariff of fees, collected under LMPHM, are paid for each single change in the group.

 
Important!

Dear colleagues,

In connection to the transition to åCTD format from 01.01.2010 we inform you that from the beginning of 2010 the documentation for renewal or variation to MA (marketing authorization) of medicinal products can be submitted in åCTD format or in the previous format (on paper or NeeS). When using eCTD it is preferable (if possible) to submit the whole file, in order to continue to maintain the electronic file during the whole life cycle of the medicinal product.

 
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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