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««« IMPORTANT! »»»

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.

 

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INTEGRATED MANAGEMENT SYSTEM

INTEGRATED MANAGEMENT SYSTEM :: MOODY INTERNATIONAL CERTIFICATION EN ISO 9001:2008 INTEGRATED MANAGEMENT SYSTEM :: MOODY INTERNATIONAL CERTIFICATION BS ISO/IEC 27001:2005

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Quality and Information Security Policy

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