To the attention of all Marketing Authorisation Holders
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.
The applications should be applied from the date of entry into force of the Ordinace amending Ordinance No. 27/15.06.2007.