Blog
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In order to achieve the most effective resolution of all regulatory matters, we have chosen to conduct business in a network of selected nationally based companies in almost all of the member states of the European Union plus Norway, Switzerland and Lichtenstein. We are proud to...

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...

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...