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 […]

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 […]

10 Years Anniversary

10 Years Anniversary

This November 2017 PharmDedict are proud to celebrate 10 years of service. In this period, we have supported over 100 renowned international and domestic companies. Our clients’ profile throughout the years covers a wide range of products: innovative pharmaceuticals, orphan drugs, radiopharmaceuticals, biological products, generic medicinal products, cosmetic products, food supplements, nutraceuticals and foods for […]

PharmDedict on Pharma Boardroom

PharmDedict on Pharma Boardroom

Pharma Boardroom goes deep into key country markets, conducting hundreds of exclusive interviews with the movers and shakers of the industry in order to outline the pharmaceutical industry trends and to provide news and reports intended for senior professionals who want to understand local and global markets. Here is what PharmDedict shared with them.