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 […]

Regulating the OTC pricing?

Regulating the OTC pricing?

After the amendments made to the Bulgarian regulation on pricing and reimbursement in December 2014, it is now hard to say if the government is regulating or registering OTC prices in Bulgaria. According to the Bulgarian Law on Medicinal Products in Human Medicine (the Drug Law), the competent governmental body – the National Council on […]

The role of the local contact for pharmacovigilance issues

The role of the local contact for pharmacovigilance issues

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 for the role and functions of the LPPV: they depend […]

Bulgaria: first steps to e-submissions

Bulgaria: first steps to e-submissions

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 will be operational and the next step will be joining the CESP. The project is currently under development and it is planned that […]

Romanian Drug Agency have now joined the CESP system for e-submissions

Romanian Drug Agency have now joined the CESP system for e-submissions

In June 2014 the Romanian National Agency for Medicines and Medical Devices (NAMMD) announced that in addition to the usual submission procedure – direct submission at the NAMMD headquarters, e-submission of documentation to the NAMMD may also be performed via the Common European Submission Platform (CESP) for electronic exchange of information between applicants and regulatory […]

Updated versions of variations and renewal application forms*

Updated versions of variations and renewal application forms*

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 electronic application forms * This post has been marked […]

Bulgaria: restrictions on the export of medicinal products

Bulgaria: restrictions on the export of medicinal products

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 justification given for this action was to avoid shortages of medicinal products on Bulgarian market. Considering the lack of clear criteria regulating the […]

Bulgaria: Medicinal Products Pricing Calculator

Bulgaria: Medicinal Products Pricing Calculator

  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 approval and publishing in the public registers. The procedure […]