+359 2862 9127
In June 2014 the Notice to Applicants, volume 2B was updated with the publication of the new versions of application form for the submission of variations and application form for renewal of a marketing authorisation for drugs in human medicine. Update January 2016: Mandatory use of electronic application forms * This post has been marked […]
In January 2014 the Bulgarian Parliament passed amendments to the Medicinal Products in Human Medicine Act (the Drug Law) aiming restriction of the parallel trade with pharmaceutical products exported from Bulgaria. The justification given for this action was to avoid shortages of medicinal products on Bulgarian market. Considering the lack of clear criteria regulating the […]
A draft document containing the expected new fees concerning the pharmaceutical industry was published on the website of the Bulgarian Ministry of Health. The marketing authorisation holders (MAHs) are now expected to have the opportunity to pay reduced fees for grouped variations which is currently not possible. Some other fees are reduced as well, […]
The prices of RX medicinal products are regulated by the National Council on Pricing and Reimbursement in Bulgaria. Before placing any RX medicinal product (whether reimbursed or non-reimbursed) on the Bulgarian market the concerned marketing authorisation holders (MAH) have to initiate administrative procedure for price approval and publishing in the public registers. The procedure […]
A new Pricing & Reimbursement Regulation came into force in the beginning of May in Bulgaria. It continues the line of amendments in the national legal framework started at the end of 2012. The amendments came as a result of the heavy pressure to lower the prices of the medicinal products. Following the extreme […]
The new revised version 10.1 of the administrative information application form was published by the European Commission (Notice to applicants, medicinal products for human use, volume 2B, module 1.2). Marketing authorisation applicants shall use this form as from 3 June 2013, but may use it even before. The electronic version is also available from May […]
With the amendments in the EU pharmacovigilance framework the Member States have the option to request the nomination of a contact person for pharmacovigilance issues at national level reporting to the EU QPPV, European qualified person responsible for pharmacovigilance activities (article 104, paragraph 4 of Directive 2001/83/EC as amended by Directive 2010/84/EU). Some Member States […]
With the Bulgarian Drug Law amendments published on 21-Dec-2012 a new obligation was imposed concerning all marketing authorisation holders (MAHs) in Bulgaria. Based on article 104, paragraph 4 of Directive 2001/83/EC as amended by Directive 2010/84/EU, Bulgaria has opted to implement obligation for the MAHs to appoint a local contact person for pharmacovigilance issues (LPPV) […]
Although the main legislative act governing the pharma sector in Bulgaria (the Drug Law) is often subject to amendments, on 21-Dec-2012 some major changes were promulgated. The provisions of Directive 2010/84/EU and Directive 2011/62/EU were implemented, as well as some nationally specific changes were introduced. Here are some of the main highlights: – Detailed provisions […]
In November 2012 we celebrated PharmDedict’s 5th anniversary and we would like to thank all our partners and clients who trusted the services of PharmDedict. We found this to be a good occasion to present our website in a new design and to start this Blog. We hope this could be a simple source of […]