The first DCP with RMS Bulgaria is now completed

The first DCP with RMS Bulgaria is now completed

The Bulgarian Drug Agency (BDA) announced that on May 10th, 2016 they completed the first decentralised procedure for authorising medicinal product where the reference member state (RMS) is Bulgaria. The procedure has been accepted by all six concerned member states. Gaining experience to act as RMS is an important step for the BDA. The lack […]

Type IA variations not required any more for administrative changes to EU QPPV and PSMF

Type IA variations not required any more for administrative changes to EU QPPV and PSMF

Based on the application of Article 57(2) of Regulation (EC) No 726/2004, as of 1 February 2016 the marketing authorisation holders of medicinal products for human use are no longer required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File […]

The next level upgrade of the Bulgarian reimbursement system

The next level upgrade of the Bulgarian reimbursement system

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 Health Insurance and in several regulations. Some of the main highlights are presented below. Introducing Health Technology Assessment (HTA). Prior to December 2015 […]

Mandatory use of electronic application forms

Mandatory use of electronic application forms

The Bulgarian Drug Agency (BDA) announced that starting from January 1st, 2016 the use of the EU Electronic Application Forms (eAF) for initial marketing authorisations, renewals and variations concerning medicinal products for human use is mandatory for national procedures, as well as mutual recognition and decentralised procedures. Along with the eAF the applicants have to […]

Regulating the OTC pricing?

Regulating the OTC pricing?

After the amendments made to the Bulgarian regulation on pricing and reimbursement in December 2014, it is now hard to say if the government is regulating or registering OTC prices in Bulgaria. According to the Bulgarian Law on Medicinal Products in Human Medicine (the Drug Law), the competent governmental body – the National Council on […]

The role of the local contact for pharmacovigilance issues

The role of the local contact for pharmacovigilance issues

Following the developments of the pharmacovigilance legislations at EU level Bulgaria imposed the requirement for the appointment by the marketing authorisation holders (MAHs) of a local contact person for pharmacovigilance issues (LPPV) for medicinal products for human use. The national legislation does not contain detailed requirements for the role and functions of the LPPV: they depend […]

Bulgaria: first steps to e-submissions

Bulgaria: first steps to e-submissions

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 will be operational and the next step will be joining the CESP. The project is currently under development and it is planned that […]

Romanian Drug Agency have now joined the CESP system for e-submissions

Romanian Drug Agency have now joined the CESP system for e-submissions

In June 2014 the Romanian National Agency for Medicines and Medical Devices (NAMMD) announced that in addition to the usual submission procedure – direct submission at the NAMMD headquarters, e-submission of documentation to the NAMMD may also be performed via the Common European Submission Platform (CESP) for electronic exchange of information between applicants and regulatory […]

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 […]