Legislation
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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...

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....