PharmDedict
-1
archive,paged,author,author-admin,author-1,paged-6,author-paged-6,bridge-core-3.1.7,cookies-not-set,qode-page-transition-enabled,ajax_fade,page_not_loaded,,qode-title-hidden,qode_grid_1300,footer_responsive_adv,qode-child-theme-ver-1.0.0,qode-theme-ver-30.4.2,qode-theme-bridge,wpb-js-composer js-comp-ver-7.6,vc_responsive

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...

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....