Bulgaria: State of Emergency*

Bulgaria: State of Emergency*

* This post has been marked as outdated and is available in our archive.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 epidemiological situation in the state. Audiences and consultations will […]

Romania: the drug agency announced restrictions related to COVID-19*

Romania: the drug agency announced restrictions related to COVID-19*

* This post has been marked as outdated and is available in our archive.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 in order to avoid as much as possible any […]

Updated versions of variations and renewal application forms*

Updated versions of variations and renewal application forms*

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 electronic application forms * This post has been marked […]

Updated Application Form*

Updated Application Form*

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 even before. The electronic version is also available from May […]