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

Posted at 18:34h in Regulatory Affairs

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,...

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29 Jan The Bulgarian Drug Agency initiates PIC/S membership procedure

Posted at 12:07h in GMP/GDP, Regulatory Affairs

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...

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29 Dec BDA: Guidance on the implementation of safety features in Bulgaria

Posted at 19:00h in Regulatory Affairs

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...

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24 Oct PharmDedict on Pharma Boardroom

Posted at 15:32h in Company News, Highlights

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...

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18 Oct EudraVigilance Go-Live: expecting 22 November 2017

Posted at 14:49h in Pharmacovigilance

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...

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11 Aug The first MRP with RMS Bulgaria is now on track

Posted at 14:23h in Regulatory Affairs

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...

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

Posted at 20:33h in Pharmacovigilance

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...

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14 May The first DCP with RMS Bulgaria is now completed

Posted at 16:34h in Regulatory Affairs

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...

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29 Feb Type IA variations not required any more for administrative changes to EU QPPV and PSMF

Posted at 18:27h in Pharmacovigilance, Regulatory Affairs

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...

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25 Jan The next level upgrade of the Bulgarian reimbursement system

Posted at 15:45h in Legislation, Pricing & Reimbursement

2015 was the year marked by the Bulgarian government's upgrade of the pricing and reimbursement system by introducing changes in the Law on the Medicinal Products in Human Medicine, the Law on Health Insurance and in several regulations. Some of the main highlights are presented...

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