BDA triggers a timetable definition in order to prepare slots for assessment of the MAA in MRP and DCP procedures
BDA triggers a timetable definition in order to prepare slots for assessment of the marketing authorization applications in MRP and DCP procedures for which Bulgaria is to be a reference Member State under Art. 76 (1) and (3) of LMPHM.

Prior to submission of the application forms under Art. 74 or 75 of LMPHM, a certain preliminary information should be provided, aiming an initial evaluation of the applicants. Template for the data necessary is available in the section "Marketing Authorization of Medicinal Products/Announcement".

Documents specified are to be applied by the end of February 2008. Following their assessment the applications under Art. 74 or 75 of LMPHM will be admitted.

Public consultation on the revision of Annex I to Directive 2001/83/EC
For your information, a public consultation has been launched today on the revision of Annex I to Directive 2001/83/EC in order to adapt it to the specificities of advanced therapy medicinal products. The public consultation paper is available at:

http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/index.htm

Contributions to this public consultation should be sent by e-mail to nicolas.rossignol@ec.europa.eu , before 10 June 2008.

Dr. Emil Hristov in front of The Informa Healthcare Journals Archives
The Bulgarian Drug Agency: a youngester with a bit of a bite
Accession countries to the European Union are faced with numerous challenges and this is particularly amplified in the healthcare sector, where regulatory mistakes have a direct impact of human life. Against this backdrop, the Bulgarian Drug Agency has made an impressive effort to keep pace with its older EU counterparts. The agency's Executive Director, Emil Hristov, the driving force behind its progress, talks to EURALex about the tribulations, the successes and what lies ahead.