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01 Dec

Posted at 17:11h in Pharmacovigilance

Following the developments of the pharmacovigilance legislations at EU level Bulgaria imposed the requirement for the appointment by the marketing authorisation holders (MAHs) of a local contact person for pharmacovigilance issues (LPPV) for medicinal products for human use. The national legislation does not contain detailed requirements...

11 Sep

Posted at 17:02h in Archived

* This post has been marked as outdated and is available in our archive. After Romania joined the CESP system for e-submissions in June 2014, in September 2014 the Bulgarian Drug Agency announced that by September 2015 it is expected that the Agency’s platform for e-submissions...

11 Jun

Posted at 11:57h in Archived

In June 2014 the Notice to Applicants, volume 2B was updated with the publication of the new versions of application form for the submission of variations and application form for renewal of a marketing authorisation for drugs in human medicine. Update January 2016: Mandatory use of...

24 Apr

Posted at 18:41h in Archived

* This post has been marked as outdated and is available in our archive. In January 2014 the Bulgarian Parliament passed amendments to the Medicinal Products in Human Medicine Act (the Drug Law) aiming restriction of the parallel trade with pharmaceutical products exported from Bulgaria. The...

11 Sep

Posted at 11:49h in Highlights, Pricing & Reimbursement

  The prices of RX medicinal products are regulated by the National Council on Pricing and Reimbursement in Bulgaria. Before placing any RX medicinal product (whether reimbursed or non-reimbursed) on the Bulgarian market the concerned marketing authorisation holders (MAH) have to initiate administrative procedure for price...

16 Apr

Posted at 14:26h in Archived

The new revised version 10.1 of the administrative information application form was published by the European Commission (Notice to applicants, medicinal products for human use, volume 2B, module 1.2). Marketing authorisation applicants shall use this form as from 3 June 2013, but may use it...