The obligation for local PhV contact person in Bulgaria

The obligation for local PhV contact person in Bulgaria

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) […]

Key amendments to the Bulgarian Drug Law

Key amendments to the Bulgarian Drug Law

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 […]

Welcome to our Blog

Welcome to our Blog

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 […]