Cabinet of Ministers Regulations No. 1007 Riga 2004 December 7 (pr. 70. § 12) pharmaceutical price regulations Issued by the national agency, in accordance with the law of public agencies 8. the third paragraph of article i. General questions 1. Drug prices, a Government Agency (hereinafter the Agency) is the Minister of health in the national monitoring authority.
2. the Agency's goal is for State or municipal budget funds the purchase of medicinal products, medical devices and therapeutic efficiency of goods and economic evaluation of costs, as well as outpatient treatment for the eligible list of medicines, to ensure that medicines, medical equipment and the purchase of goods for compensation (compensation).
II. Agency functions, tasks and rights 3. the Agency shall have the following functions: to provide for the country's 3.1 or municipal budget funds the purchase of medicinal products, medical devices and the cost of the economic evaluation of the goods;
3.2. ensuring rational pharmacotherapy of medicinal product recommendations;
3.3. take medicine farmakoekonomisk evaluation;
3.4. to cooperate with foreign and international institutions, as well as to ensure the exchange of information on matters relating to the scope of the Agency;
3.5. to participate in the compensation systems development project;
3.6. analyze information on the State of the countervailable medicine, medical equipment and consumer goods and to prepare proposals for health care resources effectively;
3.7 prepare advice on the State of the countervailable medicine, medical equipment and rational use of the goods.
4. the Agency shall have the following tasks: 4.1 examine the registration certificate holder (owner) or his authorized representative, wholesaler of medicinal products (other than the manufacturer of the medicinal product or the holder of the registration certificate) (parallel importing) or his authorized representative or the State Agency of medicines authorisation for the import of medicines not registered owner or his authorized representative, an application for medicine or medical product into the eligible list of medicines;
4.2. to take a decision on the eligible list to be included in the medicinal drugs, medical equipment and goods compensation base price;
4.3. create a list of the medicinal products eligible;
4.4 based on farmakoekonomisk assessment of the medicinal product, the fixing of prices for products which are purchased for State or municipal budget;
4.5. developing a medicine farmakoekonomisk the calculation methodology;
4.6. elaborate and issue recommendations to the medical people, to promote the drugs, medical devices and goods efficiently and rational use;
4.7. to develop compensation systems development projects;
4.8. collect and analyze public institutions, professional associations, medical institutions, pharmaceutical lieltirgotav, pharmaceutical companies and pharmacies to provide recommendations and proposals to the Ministry of Health concerning the amendments to the list of products eligible;
4.9. to collect and analyze information about medicines, medical equipment and the purchase of goods, the actual compensation to patients;
4.10. in accordance with the Agency's competency and concluded international treaties to represent Latvia abroad and cooperate with international organizations in the economic evaluation of medicines.
5. the Agency shall have the following rights: 5.1 according to the competence to request and receive, free of charge from the State and municipal institutions, as well as from natural and legal persons in the Agency's functions and tasks, the necessary information;
5.2. the charge for public services provided by the Agency;
5.3. invite experts and enter into agreements with natural and legal persons;
5.4. prepare and submit proposals to the Ministry of health in the development of legislation relating to economic evaluation of medicines and compensation.
III. Agency governance 6. The work of the agency headed by the Director of the Agency. The Agency's Director of law by public agency and the equipment of the public administration Act direct authorities managerial functions.
7. The Director recruiting and dismissal of the Health Minister. The Director of the Agency can be alternates.
IV. the Agency's financial resources and assets 8. the Agency's financial resources shall consist of: 8.1. State budget grant from the general revenue;
8.2. own revenue, including revenue on public services provided by the Agency;
8.3. foreign financial assistance;
8.4. donations and gifts.
9. The law on the Agency's budget and financial management in the order with the permission of the Minister of Finance has the right to take loans and commitments. Prior authorization of the Minister of finance, the Agency said business conditions into line with the Health Ministry.
V. Agency Advisory Council 10. To promote implementation of the national policy and cross-sectoral cooperation, as well as develop proposals for compensation systems development and economic evaluation of medicines, Health Minister creates Advisory Council of the Agency (hereinafter referred to as the Board). The Advisory Forum is an advisory agency of the law.
11. the Advisory Council shall operate in accordance with the regulations approved by the Minister of health.
12. the Advisory Board has the following main tasks: 12.1. the activities of the Agency to analyze the results and give the Health Minister's opinions and proposals on the Agency's medium-term actions and development strategy (the strategy) implementation and development of the activities of the Agency;
12.2. to promote effective implementation of the strategy;
12.3. to promote cooperation with the Agency in the implementation of the participating institutions;
12.4. to collect and provide to the Agency Director proposals for the functions and duties of the Agency.
13. the work of the Council to ensure the Agency's facilities.
Vi. Activities of the Agency in ensuring the rule of law and reporting 14. Agency staff decisions and actual action may be challenged, submitting the application the Agency Director.
15. The Director of the Agency to succeed administrative provisions and actual action may be challenged in the Ministry of health. The Ministry of health decision may appeal to the Court.
16. the Agency shall prepare and provide to the current Ministry of health, and an annual report on its activities and the use of financial resources.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: the entry into force of the provisions to 10 December 2004.