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 is included in the GMP Mutual Recognition Agreement between EU and USA

Bulgaria is included in the GMP Mutual Recognition Agreement between EU and USA

In May 2019 the Bulgarian Drug Agency (BDA) announced that after auditing the US FDA confirmed the BDA capacity and ability to perform GMP inspections equivalent to the US standards. On the basis of the sector agreement between the European Commission and the USA, there will be mutual recognition of GMP inspections of drug manufacturing […]

Brexit: the exemption for quality control testing

Brexit: the exemption for quality control testing

In the end of February 2019, the European Commission (EC) produced a letter concerning the withdrawal of the United Kingdom from the perspective of the EU rules for batch testing of medicinal products. The EC communication addressed the option that exemptions could be granted by the competent authorities on case by case basis, allowing marketing […]

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. […]

Bulgaria changes the structure of its ethics committees in clinical trials

Bulgaria changes the structure of its ethics committees in clinical trials

The Bulgarian Drug Law amendments published on 12-Oct-2018 introduced the biggest changes in the field of clinical trials in many years. Apart from synchronizing with Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, the national law amendments also completely restructure the national system of ethics committees. The ethics committees in […]

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 […]