We are glad to announce that PharmDedict is now part of the family of the Digital Health and Innovations Cluster Bulgaria. The DHI Cluster is a non-profit organization that supports companies and organizations in the field of digital solutions and innovations in healthcare to build...
If you explore our website, you may notice some changes. This is because we refreshed the design and made a few enhancements. We hope you like it. ...
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...
* This post has been marked as outdated and is available in our archive. 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...
* This post has been marked as outdated and is available in our archive. 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...
* This post has been marked as outdated and is available in our archive. 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...
* This post has been marked as outdated and is available in our archive. 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...
* This post has been marked as outdated and is available in our archive. 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...
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...