Common use of Regulatory Framework Clause in Contracts

Regulatory Framework. 13. The accession of Bulgaria to the European Union in 2007 and its participation in the nCADREAC Agreement has facilitated the establishment of EU standards of drug regulation. The implementation of the Medicinal Products in Human Medicine Act (MPHMA) 10 has been instrumental in this. The law was drafted in 2007 to align the Bulgarian regulatory framework with European standards, but has since undergone 20 amendments. The scope of the MPHMA is broad, covering the role and responsibilities of the Bulgarian Drug Agency (BDA) as regulatory body dealing with medicinal products marketing authorizations, distribution, import, advertising etc., as well as provisions relating to the pricing of prescription and over-the-counter (OTC) medicines11 and the establishment and maintenance of the Positive Drug List (PDL). For product registration it provides for centralized, decentralized and national procedures. 14. In addition to the MPHMA and the various amendments to it, the sector is also subject to a significant number or other laws and ordinances. Of particular relevance are:  Health Law (1 January 2005);  Health Facilities Law (5 July 1999);  Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products (30 April 2013);  Ordinance № 4 on the terms and conditions for prescribing and dispensing of medicines (4 March 2009);  Ordinance No 10 on the terms and conditions for payment of medicinal products, dietary foods under Art. 262, para 6, part 1 of the MPHMA as well as medicinal products for health-related activities under Art. 82, para 2, part 3 of the Health Act (24 March 2009);  Ordinance № 28 on the structure, terms and conditions of work of the pharmacies and nomenclature of medicinal products (9 December 2008);  Ordinance № 34 on the terms and conditions for payment from the state budget for the treatment of diseases outside the scope of mandatory health insurance (25 November 2005);  Ordinance № 38 defining the list of diseases for which medicines, medical devices and dietary foods for outpatient treatment fully or partially paid for by the NHIF (16 November 2004);  Ordinance № 39 on the principles and requirements of Good Distribution Practice (13 September 2007); and  Ordinance № 40 for determining the basic package of health services guaranteed by the NHIF budget (24 November 2004), 9 ▇▇▇▇▇ ▇ et al. Pharmaceutical Health Information System (PHIS) Pharma Profile, Bulgaria 2010. 10 Medicinal Products in Human Medicine Act 2007. At ▇▇▇▇://▇▇.▇▇▇.▇▇/images/stories/documents/legal_acts/ZLPHM_en.pdf 11 In conjunction with the Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products, effective 30 April 2013 15. The Bulgarian Drug Agency (BDA) reports to the Ministry of Health and is responsible for assessing and ensuring the quality, effectiveness and safety of medicinal products. Its role includes:  Marketing authorization for medicines;  Authorization and oversight of manufacturing, import, wholesaling and retailing of medicines;  Authorization and oversight of clinical trials;  Advertising;  Pharmacovigilance and drug information;  Classification (scheduling) of medicines. 16. The BDA is funded in part from the budget of the Ministry of Health as well as from revenues generated by its activities, which include fees for laboratory analyses, application and evaluation fees, annual registration charges, and GMP inspections. Fees and charges are set by the Council of Ministers.

Regulatory Framework. 13. The accession of Bulgaria to the European Union in 2007 and its participation in the nCADREAC Agreement has facilitated the establishment of EU standards of drug regulation. The implementation of the Medicinal Products in Human Medicine Act (MPHMA) 10 has been instrumental in this. The law was drafted in 2007 to align the Bulgarian regulatory framework with European standards, but has since undergone 20 amendments. The scope of the MPHMA is broad, covering the role and responsibilities of the Bulgarian Drug Agency (BDA) as regulatory body dealing with medicinal products marketing authorizations, distribution, import, advertising etc., as well as provisions relating to the pricing of prescription and over-the-counter (OTC) medicines11 and the establishment and maintenance of the Positive Drug List (PDL). For product registration it provides for centralized, decentralized and national procedures. 14. In addition to the MPHMA and the various amendments to it, the sector is also subject to a significant number or other laws and ordinances. Of particular relevance are:  • Health Law (1 January 2005);  • Health Facilities Law (5 July 1999);  • Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products (30 April 2013);  • Ordinance № 4 on the terms and conditions for prescribing and dispensing of medicines (4 March 2009);  • Ordinance No 10 on the terms and conditions for payment of medicinal products, dietary foods under Art. 262, para 6, part 1 of the MPHMA as well as medicinal products for health-related activities under Art. 82, para 2, part 3 of the Health Act (24 March 2009);  • Ordinance № 28 on the structure, terms and conditions of work of the pharmacies and nomenclature of medicinal products (9 December 2008);  • Ordinance № 34 on the terms and conditions for payment from the state budget for the treatment of diseases outside the scope of mandatory health insurance (25 November 2005);  • Ordinance № 38 defining the list of diseases for which medicines, medical devices and dietary foods for outpatient treatment fully or partially paid for by the NHIF (16 November 2004);  • Ordinance № 39 on the principles and requirements of Good Distribution Practice (13 September 2007); and  • Ordinance № 40 for determining the basic package of health services guaranteed by the NHIF budget (24 November 2004), 9 ▇▇▇▇▇ ▇ et al. Pharmaceutical Health Information System (PHIS) Pharma Profile, Bulgaria 2010. 10 Medicinal Products in Human Medicine Act 2007. At ▇▇▇▇://▇▇.▇▇▇.▇▇/images/stories/documents/legal_acts/ZLPHM_en.pdf 11 In conjunction with the Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products, effective 30 April 2013 15. The Bulgarian Drug Agency (BDA) reports to the Ministry of Health and is responsible for assessing and ensuring the quality, effectiveness and safety of medicinal products. Its role includes:  • Marketing authorization for medicines;  • Authorization and oversight of manufacturing, import, wholesaling and retailing of medicines;  • Authorization and oversight of clinical trials;  • Advertising;  • Pharmacovigilance and drug information;  • Classification (scheduling) of medicines. 16. The BDA is funded in part from the budget of the Ministry of Health as well as from revenues generated by its activities, which include fees for laboratory analyses, application and evaluation fees, annual registration charges, and GMP inspections. Fees and charges are set by the Council of Ministers.

Regulatory Framework. 13. The accession of Bulgaria to the European Union in 2007 and its participation in the nCADREAC Agreement has facilitated the establishment of EU standards of drug regulation. The implementation of the Medicinal Products in Human Medicine Act (MPHMA) 10 has been instrumental in this. The law was drafted in 2007 to align the Bulgarian regulatory framework with European standards, but has since undergone 20 amendments. The scope of the MPHMA is broad, covering the role and responsibilities of the Bulgarian Drug Agency (BDA) as regulatory body dealing with medicinal products marketing authorizations, distribution, import, advertising etc., as well as provisions relating to the pricing of prescription and over-the-counter (OTC) medicines11 and the establishment and maintenance of the Positive Drug List (PDL). For product registration it provides for centralized, decentralized and national procedures. 14. In addition to the MPHMA and the various amendments to it, the sector is also subject to a significant number or other laws and ordinances. Of particular relevance are:  Health Law (1 January 2005);  Health Facilities Law (5 July 1999);  Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products (30 April 2013);  Ordinance № 4 on the terms and conditions for prescribing and dispensing of medicines (4 March 2009);  Ordinance No 10 on the terms and conditions for payment of medicinal products, dietary foods under Art. 262, para 6, part 1 of the MPHMA as well as medicinal products for health-related activities under Art. 82, para 2, part 3 of the Health Act (24 March 2009);  Ordinance № 28 on the structure, terms and conditions of work of the pharmacies and nomenclature of medicinal products (9 December 2008);  Ordinance № 34 on the terms and conditions for payment from the state budget for the treatment of diseases outside the scope of mandatory health insurance (25 November 2005);  Ordinance № 38 defining the list of diseases for which medicines, medical devices and dietary foods for outpatient treatment fully or partially paid for by the NHIF (16 November 2004);  Ordinance № 39 on the principles and requirements of Good Distribution Practice (13 September 2007); and  Ordinance № 40 for determining the basic package of health services guaranteed by the NHIF budget (24 November 2004), 15. The Bulgarian Drug Agency (BDA) reports to the Ministry of Health and is responsible for assessing and ensuring the quality, effectiveness and safety of medicinal products. Its role includes: 9 ▇▇▇▇▇ ▇ et al. Pharmaceutical Health Information System (PHIS) Pharma Profile, Bulgaria 2010. 10 Medicinal Products in Human Medicine Act 2007. At ▇▇▇▇://▇▇.▇▇▇.▇▇/images/stories/documents/legal_acts/ZLPHM_en.pdf 11 In conjunction with the Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products, effective 30 April 2013 15. The Bulgarian Drug Agency (BDA) reports to the Ministry of Health and is responsible for assessing and ensuring the quality, effectiveness and safety of medicinal products. Its role includes: 2013  Marketing authorization for medicines;  Authorization and oversight of manufacturing, import, wholesaling and retailing of medicines;  Authorization and oversight of clinical trials;  Advertising;  Pharmacovigilance and drug information;  Classification (scheduling) of medicines. 16. The BDA is funded in part from the budget of the Ministry of Health as well as from revenues generated by its activities, which include fees for laboratory analyses, application and evaluation fees, annual registration charges, and GMP inspections. Fees and charges are set by the Council of Ministers.