PharmDedict together with the law firm Kinstellar contributed to the first edition of the Bulgarian country report of the Pharma Legal Handbook, which answers essential questions about the legal and regulatory environment for pharmaceuticals in Bulgaria. Our authors provide answers in the fields of manufacturing,...
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...
In May 2019 the Bulgarian Drug Agency (BDA) announced that after auditing the US FDA confirmed the BDA capacity and ability to perform GMP inspections equivalent to the US standards. On the basis of the sector agreement between the European Commission and the USA, there...
In the end of February 2019, the European Commission (EC) produced a letter concerning the withdrawal of the United Kingdom from the perspective of the EU rules for batch testing of medicinal products. The EC communication addressed the option that exemptions could be granted by...
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 Romanian Drug Agency (ANMDM) published on their website scientific decision No 4/24.10.2018 implementing the document of European Medicines Agency (EMA) on the defective product report (EMA/INS/GMP/35037/2017). Marketing authorisation holders (MAHs) have to report to ANMDM all the non-conformities related to the quality of medicinal...
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...
Starting in February 2018, the Bulgarian Drug Agency (BDA) applies additional requirements to the applicants when presenting proof of payment. These regard the fees paid for the administrative procedures managed by the BDA: marketing authorisations (MA) or registrations, variations, renewals of MA, transfer of MA,...
The Bulgarian Drug Agency (BDA) announced that they will initiate the procedure to become a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human...