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 […]

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 […]

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from 13 June 2016 onwards the transitional rules for submission of PSURs to the National Competent Authorities are no longer applicable.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 […]

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 […]

Following the developments of the pharmacovigilance legislations at EU level Bulgaria imposed the requirement for the appointment by the marketing authorisation holders (MAHs) of a local contact person for pharmacovigilance issues (LPPV) for medicinal products for human use. The national legislation does not contain detailed requirements for the role and functions of the LPPV: they depend […]

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 […]