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* This post has been marked as outdated and is available in our archive.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* This post has been marked as outdated and is available in our archive.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* This post has been marked as outdated and is available in our archive.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 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...

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...

The new revised version 10.1 of the administrative information application form was published by the European Commission (Notice to applicants, medicinal products for human use, volume 2B, module 1.2). Marketing authorisation applicants shall use this form as from 3 June 2013, but may use it...