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

The Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review at its April meeting.

PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system

The PRAC has advised that the combined use of medicines of different classes acting on the renin-angiotensin (RAS) system, a hormone system that controls blood pressure and the volume of fluids in the body, should not be recommended. The affected medicines (called RAS-acting agents) are used particularly in the treatment of hypertension (high blood pressure) and congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).

The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will adopt the Agency’s final opinion.

More information is provided in the following hyperlink:

Renin-angiotensin-system (RAS)-acting agents


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.