Dialogue and Interaction with the Executive and Legislative Authorities
By its expert participation in the discussions on Human Medicines and Pharmacies Act amendment in 2002, the Association of Bulgarian Pharmaceutical Manufacturers supported the work of parliamentary majority and thus contributed to the harmonization of Bulgarian legislation with the European directives on production and use of pharmaceutical products in the EU and progressively introduced Bolar provision in the Bulgarian regulatory practice.
The Bulgarian Generic Pharmaceutical Association /since 2008/ aims to participate actively in the process of working out of a National Drug Policy, in cooperation with institutions as the Ministry of Health, National Health Insurance Fund, Bulgarian Drug Agency and Parliamentary Health Commission, as well as on current amendments of regulations, concerning the control of registration regimes for pharmaceutical products on the free and subsidized market in the country.
The Association’s main task is the constructive cooperation on building and maintenance of economic regulatory mechanisms in support of competitiveness of the Bulgarian pharmaceutical industry as a part of the national and global market of generic pharmaceutical products, aiming at wider use and distribution of affordable drugs for the needs of the healthcare of more consumers and patients.
Contacts and Cooperation with International Organizations
The Association of Bulgarian Pharmaceutical
Manufacturers was officially announced as a full member of the European Generic medicines Association by its Director General Mr Greg Perry at the General Meeting held in October 2002 in Sofia. EGA represents more than 500 European pharmaceutical companies, manufacturers of generic products and active ingredients, which are independent members or represented by their national associations. As an official representative organization of the European generic industry, EGA participates actively in the process of pharmaceutical legislation improvement in Europe and maintains constant dialogue with the European Union institutions as well as other international, European and national organizations.
The Association of Bulgarian Pharmaceutical Manufacturers considers as very important its participation in international conferences, like the organized by PERF / Pan-European Regulatory Forum/ and EMA /European Medicines Agency/, IGPA /International Generic Producers Association/, DIA /Drugs Information Agency/ etc., where regular discussions on the regulatory and marketing problems, jointly with representatives of the different European Commission Directorates, occupied directly in the drafting of new and amendment of current regulations, directives and resolution of the European Parliament.
