Bulgaria: managing alerts during verification and decommissioning of medicines

Bulgaria: managing alerts during verification and decommissioning of medicines

After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed by Commission Delegated Regulation (EU) 2016/161) became applicable. The Bulgarian Drug Agency (BDA) and the Bulgarian Medicines Verification Organisation (BGMVO) published the first Guidelines for managing alerts during verification and decommissioning of medicines. The document […]

Bulgaria changes the structure of its ethics committees in clinical trials

Bulgaria changes the structure of its ethics committees in clinical trials

The Bulgarian Drug Law amendments published on 12-Oct-2018 introduced the biggest changes in the field of clinical trials in many years. Apart from synchronizing with Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, the national law amendments also completely restructure the national system of ethics committees. The ethics committees in […]

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 […]

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 […]

Before and After: The New Council on Pricing & Reimbursement in Bulgaria

Before and After: The New Council on Pricing & Reimbursement in Bulgaria

  A new Pricing & Reimbursement Regulation came into force in the beginning of May in Bulgaria. It continues the line of amendments in the national legal framework started at the end of 2012. The amendments came as a result of the heavy pressure to lower the prices of the medicinal products. Following the extreme […]

Key amendments to the Bulgarian Drug Law

Key amendments to the Bulgarian Drug Law

Although the main legislative act governing the pharma sector in Bulgaria (the Drug Law) is often subject to amendments, on 21-Dec-2012 some major changes were promulgated. The provisions of Directive 2010/84/EU and Directive 2011/62/EU were implemented, as well as some nationally specific changes were introduced. Here are some of the main highlights: –  Detailed provisions […]