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Dear Marketing Authorisation Holders,

In accordance with the entry into force of the new European legislation regarding pharmacovigilance of medicinal products for human use, the Bulgarian Drug Agency (BDA) notifies Marketing Authorisation Holders (MAHs) for all medicinal products authorised/registered in Bulgaria, on the following temporary reporting requirements of the information on adverse drug reaction (ADR) in E2B format during the transitional period (until 6 months after the technical functionality of the database of the European Medicines Agency (EMA) - EudraVigilance has been declared):

  • For all serious ADR from the territory of Bulgaria in 15 days simultaneously to the BDA (ID-BDA) and to the EudraVigilance, Postauthorisation module (ID-EVHUMAN).
  • For all serious ADR outside the territory of the European Economical Area (EEA) in 15 days only to the EudraVigilance, Postauthorisation module (ID-EVHUMAN).
  • For all non serious ADR from the territory of Bulgaria, other EEA or non EEA countries – there is no need to report information neither to BDA, nor to the EudraVigilance.

We inform you that in connection with the forthcoming promulgation of the Ordinance amending Ordinance No. 27/15.06.2007, on the web site of BDA are published the approved forms of applications for marketing authorization of medicinal product, renewal of marketing authorization, marketing authorization/registration of homeopathic medicinal product, variation to marketing authorization/registry certificate of medicinal product, transfer of the rights over marketing authorization of medicinal product and modification of the product information (the text and/or the package layout and/or leaflet, which is not connected with change of the short product characteristics) (There is no concomitant variation procedure).

The applications should be applied from the date of entry into force of the Ordinace amending Ordinance No. 27/15.06.2007.

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.

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:

Dear colleagues,

In connection to the transition to eCTD 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.