Bulgaria Will be a reference Member State
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 2009. Following their assessment the applications under Art. 74 or 75 of LMPHM will be admitted.
