Challenges to orphan drugs access in Eastern Europe: The case of Bulgaria

Author:

Iskrov Georgi,Miteva-Katrandzhieva Tsonka,Stefanov Rumen

Publisher

Elsevier BV

Subject

Health Policy

Reference31 articles.

1. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official journal of the European Union (2004/L 136/1). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:EN:PDF.

2. Medicinal Products in Human Medicine Act. State gazette (13.04.2007/31). http://www.mh.government.bg/Articles.aspx?lang=bg-BG&pageid=380&categoryid=2996.

3. Council of Ministers. Ordinance on the conditions, rules and procedures for regulating and registering the prices of medicines. State gazette (11.12.2007/104). http://www.lex.bg/bg/laws/ldoc/2135573293.

4. Council of Ministers. Ordinance on the conditions, rules and criteria for inclusion, amendments and/or exclusion of drugs from PDL and the terms and conditions of work of the Commission on PDL. State gazette (21.12.2007/110). http://www.lex.bg/bg/laws/ldoc/2135574508.

5. Ministry of Health. Positive drug list of Bulgaria. http://www.mh.government.bg/Articles.aspx?lang=bg-BG&pageid=384&categoryid=1355.

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