* This post has been marked as outdated and is available in our archive.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* This post has been marked as outdated and is available in our archive.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* This post has been marked as outdated and is available in our archive.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* This post has been marked as outdated and is available in our archive.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* This post has been marked as outdated and is available in our archive.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...
This November 2017 PharmDedict are proud to celebrate 10 years of service. In this period, we have supported over 100 renowned international and domestic companies. Our clients’ profile throughout the years covers a wide range of products: innovative pharmaceuticals, orphan drugs, radiopharmaceuticals, biological products, generic...
* This post has been marked as outdated and is available in our archive. Following the recent changes to the Bulgarian pricing & reimbursement regulatory framework, a new procedure was introduced and put into practice: the medicinal products included in the Bulgarian Positive Drug List (PDL)...
* This post has been marked as outdated and is available in our archive. 2015 was the year marked by the Bulgarian government's upgrade of the pricing and reimbursement system by introducing changes in the Law on the Medicinal Products in Human Medicine, the Law on...
* This post has been marked as outdated and is available in our archive. After Romania joined the CESP system for e-submissions in June 2014, in September 2014 the Bulgarian Drug Agency announced that by September 2015 it is expected that the Agency’s platform for e-submissions...
In June 2014 the Notice to Applicants, volume 2B was updated with the publication of the new versions of application form for the submission of variations and application form for renewal of a marketing authorisation for drugs in human medicine. Update January 2016: Mandatory use of...