The State Agency Of Medicines Regulation

Original Language Title: Zāļu valsts aģentūras nolikums

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Cabinet of Ministers Regulations No. 1006 Riga 2004 December 7 (pr. No. 70 11) the State Agency of medicines of the Regulations Issued under the public law agency 8. the third paragraph of article i. General questions 1. Medicine Government Agency (hereinafter the Agency) is the Minister of health in the national monitoring authority.
2. the Agency aims to provide pharmaceutical market research and effective, safe, and high quality access to medicines to residents of Latvia.
II. Agency functions, tasks and rights 3. the Agency shall have the following functions: 3.1 to evaluate and register drugs, to determine the status of the medicinal product (prescription or non-prescription medication), create and update a register of medicinal products of Latvia;
3.2. control the quality of the medicinal product;
3.3. to issue the drug import, export, transit and distribution permissions;
3.4. to collect information on the consumption of medicinal products;
3.5. to collect information about the observed side effects caused by the use of the medicinal product, as well as clinical trials of medicinal products and pharmacovigilance observation;
2.2. authorisation of medicinal products for clinical trials and monitoring its performance.
3.7. to assess the advertiser's advertising materials submitted for compliance with regulatory requirements;
3.8. to assess drug clinical trial compliance with good clinical practice requirements;
3.9. to assess the compliance of the company's pharmaceutical operations and issue a special permit (license) the pharmaceutical activities;
3.10. According to competence to cooperate with other competent national and international bodies.
4. the Agency shall have the following tasks: 4.1. assess and make a decision on registration, renewal, suspension, cancellation of the registration and approval of changes to the registration documentation, assign registration numbers and codes for medicinal products;
4.2. perform the testing of medicinal products and expertise in determining their conformity with the requirements of technical regulations;
4.3. to organize the collection of information on new developments in the quality control of medicinal products;
4.4. check data and documents submitted by the medicine import, export, transit and distribution authorisation and to take appropriate decisions;
4.5. to organize the collection of information relating to drug safety issues and to assess them on the basis of the latest scientific knowledge;
4.6. create and maintain a database on drug consumption statistics, medicine, clinical trials, drug induced reactions and observations and the use of other database according to the Agency's mission;
4.7. perform inspection of documents submitted to the Agency in accordance with the scope of the Agency;
4.8. to check the hospital's compliance with good clinical practice requirements and issue the relevant confirmation, as well as to monitor the progress of a clinical trial and drug use in the observation process compliance with legislative requirements;
4.9. According to competence, cooperating with the doctor and the pharmacist professional bodies and industry non-governmental organizations;
4.10. in accordance with the competency to participate in international events, to collaborate with other professionals in the industry, professional associations and associations of foreign countries and international institutions, as well as to ensure the exchange of information within the scope of the Agency;
4.11. the issue of a pharmaceutical company in compliance with good manufacturing practice certificates.
5. the Agency shall have the following rights: 5.1. 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. publish informative material and give the media information on the competence of the Agency questions;
5.3. the charge for public services provided by the Agency;
5.4. invite experts, as well as to create the Council and the Commission of experts of Agency functions;
5.5. According to area of activity to organise conferences, seminars, courses, training and other educational and information activities.
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. The Director recruiting and dismissal of the Health Minister. The Director of the Agency can be alternates.
7. the Agency shall be entitled to form a unit. Its departments operate in accordance with the rules approved by the Agency's Director.
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 referred to agency transactions in accordance with the relevant conditions of the Ministry of health.
V. Agency Advisory Council 10. To promote implementation of the national policy and cross-sectoral cooperation, as well as to develop proposals with pharmaceutical industry related issues, the Minister of health shall establish the Agency's Advisory Board (hereinafter 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 tasks: to promote the development of the Agency 12.1. strategies for effective implementation;
12.2. to encourage and support national and local government bodies, non-governmental organizations, natural and legal persons, as well as the cooperation of foreign authorities to question the competence 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.