Reflections from BADI’s 15th Anniversary The 15th anniversary of the Bulgarian Association for Drug Information (BADI) was more than a celebration of history. It was a forward-looking discussion about the future of regulatory affairs, the pharmaceutical industry and market access in Europe. Bringing together regulators, experts...
On July 5, 2024, significant amendments to Ordinance No. H-6 were promulgated, affecting the Bulgarian National Health Information System (NHIS). These changes aim to improve access to health information and enhance personal data security. What's changing? 1. Mobile Access through "eHealth" The major innovation is the ability to...
Regulatory Intelligence, as a systematic approach, includes the processes of regularly and proactively collecting regulatory information and analysing the latest updates that impact the operations of an organization. Regulatory Intelligence helps companies cope with the dynamics in regulations, accommodate changes, and ensure compliance. On February 23,...
In July 2019, the National Agency for Medicines and Medical Devices (NAMMD) was reorganised and changed its name to National Agency for Medicines and Medical Devices of Romania (NAMMDR). This change needs to be considered in relation to the communication with the Agency and, more...
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...
The Bulgarian Drug Law amendments were published on 12-Oct-2018 affecting the timelines which are legally set for the Bulgarian Drug Agency (BDA) to issue/refuse national manufacturing authorisations or wholesale distribution licenses. The previously provided 90 days are now reduced to 60 days. According to the...
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...
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....