The next level upgrade of the Bulgarian reimbursement system

The next level upgrade of the Bulgarian reimbursement system

2015 was the year marked by the Bulgarian government’s upgrade of the pricing and reimbursement system by introducing changes in the Law on the Medicinal Products in Human Medicine, the Law on Health Insurance and in several regulations. Some of the main highlights are presented below. Introducing Health Technology Assessment (HTA). Prior to December 2015 […]

Mandatory use of electronic application forms

Mandatory use of electronic application forms

The Bulgarian Drug Agency (BDA) announced that starting from January 1st, 2016 the use of the EU Electronic Application Forms (eAF) for initial marketing authorisations, renewals and variations concerning medicinal products for human use is mandatory for national procedures, as well as mutual recognition and decentralised procedures. Along with the eAF the applicants have to […]