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):
The applications should be applied from the date of entry into force of the Ordinace amending Ordinance No. 27/15.06.2007.
From 01.01.2010 the submission of the documentation in electronic format - eCTD or NeeS is obligatory.
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: