BDA: further measures related to COVID-19

BDA: further measures related to COVID-19

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 is to encourage remote submissions and to reduce the number of visits to the administrative department and the reception desk. CESP was already […]

Bulgaria: State of Emergency

Bulgaria: State of Emergency

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 be done remotely and the access of visitors to BDA will be limited. Further […]

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

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

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 document related trips and visits, all submissions shall be made via mail service or […]

The Pharma Legal Handbook: Bulgaria

The Pharma Legal Handbook: Bulgaria

PharmDedict together with the law firm Kinstellar contributed to the first edition of the Bulgarian country report of the Pharma Legal Handbook, which answers essential questions about the legal and regulatory environment for pharmaceuticals in Bulgaria. Our authors provide answers in the fields of manufacturing, marketing authorisation, pricing and reimbursement, clinical and preclinical trials, marketing, […]

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. […]