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 […]

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.  

EudraVigilance Go-Live: expecting 22 November 2017

EudraVigilance Go-Live: expecting 22 November 2017

The Announcement of the EMA Management Board earlier in May 2017 confirmed the full functionality of the EudraVigilance database. Hence, the transitional period in pharmacovigilance reporting in the EEA is about to expire. The simplified electronic reporting of suspected adverse reactions related to medicines by national competent authorities and marketing authorisation holders to EudraVigilance becomes […]

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 […]

Single central submission now mandatory for all periodic safety update reports.

Single central submission now mandatory for all periodic safety update reports.

Starting from 13 June 2016 onwards the transitional rules for submission of PSURs to the National Competent Authorities are no longer applicable. MAHs are now required to submit PSURs directly to the PSUR repository using the eSubmission Gateway. Except PSURs for products under Article 58 of Regulation (EC) No 726/2004, all other PSURs are affected […]

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 […]