Changes at the Romanian Drug Agency

Changes at the Romanian Drug Agency

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 importantly, this change will lead to changes of the bank […]

Bulgaria have joined the CESP system

Bulgaria have joined the CESP system

Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. However, during the pilot phase CESP submissions will be limited. It will be applicable only to the new marketing authorisation applications via DCP/MRP. Purely national MA procedures and variations are excluded from CESP […]

Bulgaria: managing alerts during verification and decommissioning of medicines

Bulgaria: managing alerts during verification and decommissioning of medicines

After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed by Commission Delegated Regulation (EU) 2016/161) became applicable. The Bulgarian Drug Agency (BDA) and the Bulgarian Medicines Verification Organisation (BGMVO) published the first Guidelines for managing alerts during verification and decommissioning of medicines. The document […]

How to use the defective product report to notify a quality defect to the Romanian Drug Agency

How to use the defective product report to notify a quality defect to the Romanian Drug Agency

The Romanian Drug Agency (ANMDM) published on their website scientific decision No 4/24.10.2018 implementing the document of European Medicines Agency (EMA) on the defective product report (EMA/INS/GMP/35037/2017). Marketing authorisation holders (MAHs) have to report to ANMDM all the non-conformities related to the quality of medicinal products authorised in Romania under MRP/DCP or purely national procedure. […]

BDA: new requirements for the “proof of payment” document

BDA: new requirements for the “proof of payment” document

Starting in February 2018, the Bulgarian Drug Agency (BDA) applies additional requirements to the applicants when presenting proof of payment. These regard the fees paid for the administrative procedures managed by the BDA: marketing authorisations (MA) or registrations, variations, renewals of MA, transfer of MA, line-extensions, notification for changes in product information, parallel import, annual […]

The Bulgarian Drug Agency initiates PIC/S membership procedure

The Bulgarian Drug Agency initiates PIC/S membership procedure

The Bulgarian Drug Agency (BDA) announced that they will initiate the procedure to become a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. PIC/S aims at harmonising inspection procedures […]

BDA: Guidance on the implementation of safety features in Bulgaria

BDA: Guidance on the implementation of safety features in Bulgaria

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplemented Directive 2001/83/EC regarding the safety features appearing on the packaging of medicinal products for human use. In line with that, it is required that manufacturers place safety features consisting of a unique identifier (2D data matrix with a unique serial number) and an anti-tampering device […]

The first MRP with RMS Bulgaria is now on track

The first MRP with RMS Bulgaria is now on track

In May 2016 the Bulgarian Drug Agency (BDA) completed the first DCP with RMS Bulgaria. They now announced that in August 2016 the first mutual recognition procedure (MRP) will start with reference member state (RMS) Bulgaria and the concerned member state is Romania. Both procedures where the BDA acts for the RMS concern Bulgarian based […]

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 […]