The Bulgarian Drug Agency (BDA) announced on March 10, 2021, further measures related to the risk of COVID-19. For the duration of the extraordinary epidemic situation declared by the state, the BDA will accept the documentation required for clinical trial applications and applications for substantial...
Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. During the pilot phase CESP submissions were limited. From 1 July 2020 BDA resumes accepting all types of applications and documents via CESP, except...
The Bulgarian Drug Agency (BDA) announced today (March 24, 2020) further measures related to the risk of COVID-19. The measures mainly concern the flow of communication with the agency. The primary aim is to encourage remote submissions and to reduce the number of visits to...
Following the announcement late at night on March 12 that Bulgaria is about to declare national State of Emergency, the Bulgarian Drug Agency (BDA) also took measures in view of the current epidemiological situation in the state. Audiences and consultations will be done remotely and...
The Romanian ANMDMR (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale din Romania) announced on 12.03.2020 restrictions of the activity of their Registration Department. In view of the current epidemiological context and in order to avoid as much as possible any document related trips and...
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...