The Health Inspection Rules

Original Language Title: Veselības inspekcijas nolikums

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Cabinet of Ministers Regulations No. 76 in Riga in 2008 February 5 (pr. Nr. 7) 35 § health inspection regulations Issued pursuant to the public administration Act, article 16 of the equipment the first part i. General questions health inspection 1 (hereinafter referred to as the Inspectorate) is the Minister of Health's direct regulatory authority.
2. inspection activities to implement the public health functions of Government under the supervision and control of the sector, to ensure that the scope of regulatory compliance laws and enforcement.
II. Inspection functions, tasks and rights 3. inspection shall have the following functions: 3.1 to monitor and control treatment institutions binding enforcement of the laws on health care and the availability of expertise, as well as a health care professional and working quality of medical expertise;
3.2. in accordance with the competency to provide medicine, veterinary medicine, detergents and cosmetics market surveillance;
3.3. in accordance with the competence to monitor and control the natural and legal persons who carry out activities in a controlled narcotic substances, psychotropic substances and precursors in the lists of substances and medicinal products;
3.4. According to the competence to monitor and control the observance of the laws and the epidemiological safety and environmental health, drinking water safety, chemicals and chemical products (including detergent and biocides) trade and professional use (dez infection, pest control and pest extermination);
3.5. in accordance with the competence to monitor and control pharmaceutical and veterinary pharmaceutical regulatory laws specific requirements to take the medicine and veterinary medicine distribution and promotion;
3.6. control regulations on pricing principles prescribed medicines, including outpatient treatment for the eligible drug pricing principles;
3.7. According to competence to control the circulation of alcohol policy;
2.4. appropriate competence control of pharmacovigilance, next to the phenomenon of the reporting and monitoring procedures;
3.9. the appropriate competence to control of prescriptions and prescription form of order;
3.10. monitor and control the movement of the confiscated and removed from the storage and liquidation of the medicinal product;
3.11. in accordance with the competence to monitor the statutory hygiene requirements;
3.12. the control over the statutory communicable disease prevention and epidemic measures;
3.13. to monitor drinking water safety requirements for public drinking water supply facilities of the water intake to the consumer, as well as control the sampling sites for drinking water protection requirements;
3.14. control operating equipment and vehicles acoustic noise levels the noise limit values regulations and compliance, as well as the permissible size of the observed vibrations residential and public buildings in the premises;
3.15. the competent authority of the proposed tasks under requirements established: 3.15.1. The European Parliament and of the Council of 27 October 2004 of Regulation (EC) No 2006/2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws;
3.15.2. Council of 26 May 2003 of Regulation (EC) no 953/2003 to avoid some of the most important pharmaceutical trade diversion into the European Union;
3.15.3. Of the European Parliament and of the Council of 17 May 2006 Regulation (EC) no 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, article 14;
3.15.4. European Parliament and Council of 11 February 2004, Regulation (EC) No 273/2004 on drug precursors;
3.15.5. Council of 22 December 2004 Regulation (EC) No 111/2005 laying down rules for the supervision of trade in drug precursors between the community and third countries;
3.15.6. Commission on July 27, 2005 Regulation (EC) No 1277/2005 on the implementation of the provisions of European Parliament and Council Regulation (EC) No 273/2004 on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the trade in drug precursors between the community and third countries supervision;
3.16. the control of medicinal products, including the illicit manufacture of narcotic drugs and psychotropic drug use in treatment of reasonableness;
3.17. the control of the medical authority is the appropriate conformity assessment bodies issued a declaration of conformity and certification of persons or treatment is provided to the institution of the medical certificate, and whether they are registered in the register of persons for treatment.
4. in order to carry out certain functions, the Inspectorate has the following tasks: 4.1 make expertise and provide advice on health care and the quality of expertise working medical institution, irrespective of its form of ownership or the benchers, the quality of treatment if the person took the medication of treatment outside the hospital, and to assess whether the treatment is not allowed by a person without medical training, caused a person to health;
4.2. to inform the medical authorities, conformity assessment bodies on possible non-compliance with treatment services regulations concerning minimum requirements for the medical authorities, where there is a reasonable suspicion about the hospital's significant non-compliance with those requirements;
4.3. According to competence to examine natural and legal persons complaints, applications and proposals;
4.4. If the Court or the criminal proceedings to deliver opinions at the request of the health and integrity of the expertise in quality control;
4.5. in accordance with the competence to issue administrative acts;
4.6. to ensure access to information on the supervision of the enterprises and institutions;
4.7. create and maintain cosmetic ingredients and ingredients of tobacco products database;
4.8. gather tests for information on legislation, as well as to submit proposals in the Ministry of health on the development of legislation within the competence of the inspection areas;
4.9. the administrative offences code, to examine the cases provided for in the administrative offences and impose administrative penalties;
4.10. to inform the public about the activities of the inspection;
4.11. in accordance with the competency to ask to fix the discrepancy established and control tasks;
4.12. to carry out other legal tasks.
5. inspections shall have the following rights: 5.1. to request and receive, free of charge from State and local government institutions, medical institutions, as well as the laws and regulations in the order of natural persons and private law legal persons the tasks required for the implementation of the information and documents (including medical records);
5.2. According to competence to request and receive their personal oral and written explanations, which are responsible for compliance with the laws or have provided the service;
5.3. in the cases provided for by law without prior warning, special permissions, fees and other restrictions to attend unharmed and to control any object in the entire territory of the Republic of Latvia, regardless of subordination and attendance mode, except in the prisons and other legislation in certain limited access and areas where attendance matched with relevant authorities or administration of the territory management;
5.4. in accordance with the competency to provide competent no information on the proposals on the need to stop or cancel special permissions (licenses) and professional certificates, if irregularities are observed in the competence of the inspection activities;
5.5. in the cases provided for in the law to prohibit or suspend product, medicine and veterinary medicine, as well as to take such decisions: 5.5.1. for the merchant or any merchant-owned company's suspension, which works on the basis of the special permission (license), and dealing with drug production, standardization, quality control, or distribution;
5.5.2. the space, buildings, parts of buildings, utilities, as well as you desire or suspension system, which are subject to epidemiological safety regulatory laws;
5.5.3. for medical authorities or the suspension;
5.6. the laws and regulations in order to take the product and environmental samples and organize their laboratory or other types of expertise, if found any discrepancies or has a reasonable suspicion about the object in question, the goods or services do not conform to the laws and requirements or inspection is necessary to establish a hygienic situation and pretepidēmij measures taken;
5.7. during controls smoothly take medicines, veterinary medicines and other products, goods, products, property, vehicles, premises, facilities, equipment and other objects look;
5.8. the request to manageable physical and legal persons ensure the object, the object's officers or other representative present during controls;

5.9. take control without the presence of a representative of the object, if the controlled person fails to comply with this provision the requirements referred to in point 5.8;
5.10. in the cases provided for by law to ask for legal and physical persons to stop the population and consumer interests, health and life harmful acts or omissions;
5.11. If necessary, make the expertise of professional associations to call on specialists;
5.12. to cooperate with the national regulatory authorities, private individuals, as well as with foreign public authorities, international and non-governmental organizations, their representatives and experts;
5.13. legislation in the cases other than documents or certified copies thereof to receive it;
5.14. in accordance with the competence to organise seminars, conferences and congresses;
5.15. in the cases provided for in the Act fully or partially publish the newspaper "Gazette" and inspections in the internet homepage of the inspection, subject to the legislative or regulatory requirements (with the publication of the expenses borne by the administrative act unfavourable to recipient);
5.16. in the cases provided for in the law require that natural and legal persons of the specified period end the breaches committed, demonstrating the commitment in writing, and to put the evidence of persons inspecting homepage on the internet;
5.17. the monitoring of the take measurements with the instrumental method;
5.18. to carry out mystery shopping;
5.19. to carry out other specific legislation.
III. activities of the inspection organisation inspecting work 6 conducts the inspection. Inspection Manager performs the installation of Public Administration Act direct authorities managerial functions.
7. the head of the inspection shall be appointed and relieved of the post of Health Minister. The head of the Inspectorate's Deputy.
8. inspection leader determines the organisational structure of the Inspectorate.
9. Control and monitoring powers are the following: inspection of inspection officers, Deputy Chief, Department of control and surveillance of executives and managers, Senior Deputy Inspectors, surveyors, inspectors, experts, experts, parents and later experts.
IV. Inspection activity ensuring the rule of law and reporting Inspection activities 10. the rule of law provide the head of the inspection. Inspection Manager is responsible for management decisions to the establishment and operation of the system.
11. inspection officer decisions and actual action may be challenged, by submitting the application, the head of the inspection. The head of the Inspectorate's decision can be appealed in court.
12. the decision of the head of the inspection (except this rule the decision referred to in paragraph 11) and actual action may be challenged in the Ministry of health. The Ministry of health decision may appeal to the Court.
13. inspection at least once a year, give the Health Minister's overview of the regulatory and inspection function for the State budget funds.
V. closing question 14. Be declared unenforceable: 14.1. Cabinet of Ministers of 29 April 2003 rules No. 227 "state sanitary inspection rules" (Latvian journal, 2003, 66 no);
14.2. The Cabinet of Ministers of 29 March 2005, Regulation No 218 "medical care and integrity inspection quality control inspection rules" (Latvian journal, 2005, nr. 53);
14.3. The Cabinet of Ministers of 28 March 2006, Regulation No 232 "national pharmaceutical inspection rules" (Latvian journal, 2006, 52 no).
Prime Minister i. Godmanis Health Minister i. Morris Editorial Note: rules shall enter into force on 9 February 2008.