Regulations of the Health Inspectorate

 

Valid since 09.02.2008
Published: newspaper “Latvijas Vēstnesis” on 08.02.2008
                       
Cabinet Regulation No 76
Riga, 5 February 2008 (Minutes No 7, #35)
Issued pursuant to Paragraph 1 of Section 16 of the State Administration Structure Law
 
Regulations of the Health Inspectorate
 
I General provisions
1. The Health Inspectorate (hereinafter referred to as the Inspectorate) is a state administrative institution directly supervised by the Ministry of Health.
2. The goal of the Inspectorate is to perform state administration functions in the field of supervision and control of the health sector, in order to fulfil and implement requirements set by the laws and regulations valid in the said sphere.
 
II Functions, tasks and rights of the Inspectorate
3. Functions of the Inspectorate are as follows:
3.1. supervise and control implementation of the laws and regulations binding to health care institutions in the field of health care and capacity checks, as well as the quality of professional health care services and capacity checks at health care institutions;
3.2. basing on the competence supervise the market of medication, veterinary narcotic and psychotropic drugs, detergents and cosmetics;
3.3. basing on the competence supervise and control natural and legal persons handling narcotic substances, psychotropic substances and substances and drugs listed by precursors, which are controlled in Latvia;
3.4. basing on the competence supervise and control compliance with the laws and regulations in the field of epidemiological safety and environmental health, safe drinking water and trade and professional use (disinfection, disinsection and rat extermination) of chemical substances and products (including detergents and biocides);
3.5. basing on the competence supervise and control implementation of the requirements set by the laws and regulations in the field of pharmacy and veterinary pharmacy as regards distribution and promotion of medication and veterinary narcotic and psychotropic drugs;
3.6. control compliance with the principles on setting the price of medication, including medication reimbursement for out‑patient medical treatment, set by the laws and regulations;
3.7. basing on the competence control compliance with the procedure set for circulation of ethanol;
3.8. basing on the competence control compliance with the procedure for reporting and controlling side‑effects resultant from the use of medication;
3.9. basing on the competition control compliance with the procedure for prescription and circulation of prescription forms;
3.10. supervise and control storage and liquidation of confiscated medication and medication withdrawn from circulation;
3.11. basing on the competence control compliance with the standards of hygiene set by the laws and regulations;
3.12. control implementation of preventive measures regarding infectious diseases and anti‑epidemic measures set by the laws and regulations;
3.13. control compliance with the requirements on provision of safe drinking water in public drinking water supply units from the location of extraction of water to consumer and control compliance with the requirements on the safety of locations for extraction of water;
3.14. control compliance with the normative for acoustic noise caused by running equipment and vehicle and compliance with the set noise limits, as well as compliance with the restrictions regarding vibration in living accommodations and public premises;
3.15. carry out tasks set for the competent authority under the following regulations:
3.15.1. Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws;
3.15.2. Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines;
3.15.3. Article 14 of Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems;
3.15.4. Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors;
3.15.5. Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors;
3.15.6. Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors;
3.15.7. (deleted under Cabinet Regulation No 284 of 24.04.2012)
3.16. control justification of the use of medication, including narcotic and psychotropic drugs in the course of treatment;

3.17. control wheather a health care institution comply with the requirements set out regulations and wheater medical practitioners have a medical certificates issued by certification authorities;

3.18. (deleted under Cabinet Regulation No 284 of 24.04.2012)
3.19. (deleted under Cabinet Regulation No 284 of 24.04.2012)
3.20. register health care institutions in the Register of Medical Institutions, medical practitioners and persons providing medical assistance – in the Register of Medical Practitioners and Medical Support Staff;
3.21. basing on the competence control implementation of the laws and regulations in the field of health care, operation of medical devices and technical supervision, as well as supervise the health care and pharmacy market.
(Amended by the Cabinet Regulation No 1038 of 08.09.2009.; Cabinet Regulation No 1150 of 21.12.2010.; amendment of 3.15.7. deletion shall enter into force on 12.10.2012., see Cabinet Regulation No 284 of 24.04.2012.)
4. In order to fulfil its functions the Inspectorate has been set the following tasks:
4.1. carry out examinations and provide opinions on the quality of health care and capacity examination at health care institutions, irrespective of the type of holding or subordination; on the quality of medical assistance, if a medical practitioner has provided medical assistance outside the premises of a health care institution; and appraise whether unauthorised medical assistance provided by an unqualified practitioner has harmed the health of a patient;
4.2. (deleted under Cabinet Regulation No 1038 of 08.09.2009);
4.3. basing on the competence consider complaints, applications and suggestions of natural persons and legal persons;
4.4. upon request from the court or an initiator of a criminal procedure provide opinion on control of the quality of health care and the capacity examination;
4.5. basing on the competence issue administrative provisions;
4.6. provide access to information on the supervised enterprises and authorities;
4.7. create and maintain a data base of components of cosmetics;

(Amending Cabinet Regulation No 284 of 24.04.2012)
4.8. summarise the information on compliance with the laws and regulations acquired during inspections and submit to the Ministry of Health proposals for improvement of laws and regulations in the fields covered by the competence of the Inspectorate;
4.9. consider the cases of administrative violations and impose penalty in the cases set by the Latvian Administrative Violations Code;
4.10. inform the public on the work carried out by the Inspectorate;
4.11. basing on the competence instruct to eliminate established discrepancies and control implementation of the tasks;
4.12. carry out tasks set by other laws and regulations;
4.13. organise and carry out monitoring of the quality of drinking water and bathing water;
4.14. in the cases set by the laws and regulations or upon request from a natural or legal person assess compliance of a construction plan and construction object with the hygiene requirements and appraise the risks to human health imposed by chemical substances;
4.15. (deleted under Cabinet Regulation No 284 of 24.04.2012);
4.16. basing on the competence assist in implementation of the International Health Regulations;
4.17. assist in management of emergency situations related to the threat to public health;
4.18. carry out tasks set by other laws and regulations.
(Amending Cabinet Regulation No 1038 of 08.09.2009)
5. Rights of the Inspectorate are as follows:
5.1. request and obtain from state and municipal institutions, health care institutions and under the procedure set by the laws and regulations – from natural persons or legal persons regulated by private rights free information and documents required for implementation of the tasks (including medical records);
5.2. basing on the competence request and obtain oral and written explanations from persons responsible for compliance with the requirements set by the laws and regulations or persons, which have provided the particular services;
5.3. in the cases set by the law without prior notice, special authorisation, charge and other restrictions and without hindrance visit and control any object in the territory of the Republic of Latvia, irrespective of the subordination and visiting hours, except prisons and other establishments and territories, which under the laws and regulations have been set as of limited access and which can be visited under prior authorisation granted by management of the establishment or administration of the relevant territory;
5.4. basing on the competence submit to the competent authorities proposals on the necessity to suspend or annul special licences and certificates on professional activity in case of violations established in a field of competence of the Inspectorate;
5.5. in the cases set by the law prohibit or suspend distribution of products, medication and veterinary narcotic and psychotropic drugs and decide upon the following:
5.5.1. suspension of activity of a merchant or an enterprise owned by the merchant, which operates on the grounds of special licence and is involved in production, standardisation, quality control or distribution of medication;
5.5.2. suspension of activity of premises, buildings, utilities, as well as equipment or installations subject to the requirements set by the laws and regulations regulating the epidemiological safety;
5.5.3. suspension of activity of a health care institution or its structural unit;
5.6. in line with the procedure set by the laws and regulations take product and environment samples and organise laboratorial or other type of examination in case of established discrepancies or in case of reasonable suspicion of the object, goods or service non‑compliance with the requirements set by the laws and regulations or if such examination is required for the purposes of setting the level of sanitary and taken anti‑epidemic measures;
5.7. during the control procedure inspect medication, veterinary narcotic and psychotropic drugs and other products, produce, goods, vehicles, premises, equipment, devices and other objects without hindrance;
5.8. require to the controlled natural and legal persons to ensure the presence of a manager of the object, a responsible person or other authorised person during the inspection;
5.9. exercise control when an authorised person for the object is not present, provided that the examined person does not comply with the condition set by Paragraph 5.8 of the Regulations;
5.10. in the cases set by the law request natural and legal persons to cease activity or inactivity harming the interests, health and life of citizens and consumers;
5.11. involve experts of professional bodies in the examination process, if necessary;
5.12. collaborate with state administration bodies, private individuals and foreign public administration bodies, international and non‑governmental organisations, their representatives and experts;
5.13. in the cases set by the laws and regulations receive documents or attested copies of such documents;
5.14. basing on the competence organise seminars, conferences and congresses;
5.15. in the cases set by the law fully or partially publish resolutions of the Inspectorate in the newspaper “Latvijas Vēstnesis” and the Inspectorate’s website in accordance with the requirements set by the laws and regulations (publication costs shall be covered by the addressee of the unfavourable administrative act);
5.16. in the cases set by the law request to natural and legal persons to cease the violations, submit a written determination and post determinations of such persons in the Inspectorate’s website;
5.17. for the purposes of supervision carry out measurements using the instrumental method;
5.18. make test purchases;
5.18.1. collect charges for the provided public services;
5.19. undertake other activities set by the laws and regulations.
(Amending Cabinet Regulation No 1038 of 08.09.2009)
 
III Organisation of the work of the Inspectorate
6. Work of the Inspectorate is managed by the Head of the Inspectorate. Head of the Inspectorate performs functions of a manager of an institution of direct administration set by the State Administration Structure Law.
7. Head of the Inspectorate is appointed and dismissed by the Minister of Health. Head of the Inspectorate shall have deputies.
8. Head of the Inspectorate lays down the organisational structure of the Inspectorate.
9. The authority of control and supervision shall be granted to the following officials of the Inspectorate: head of the Inspectorate, deputy head, heads and deputy heads of structural units dealing with control and supervision matters, senior inspectors, inspectors, junior inspectors, senior experts, experts and junior experts.
10. Head of the Inspectorate shall provide compliance of the activities of the Inspectorate with the rule of law. Head of the Inspectorate shall be responsible for development and operation of administrative decision examination system.
11. Decisions and actions of officials of the Inspectorate can be contested submitting an appropriate application to the Head of the Inspectorate. Decision of the Head of the Inspectorate may be appealed to the court.
12. Decisions passed by the Head of the Inspectorate (with the exception of the decision set by Paragraph 11 of the Regulations) and actions of the Head of the Inspectorate can be contested at the Ministry of Health. Decision of the Ministry of Health may be appealed to the court.
13. The Inspectorate shall report to the Minister of Health at least once a year on fulfilment of administrative functions and application of the public funding allocated to the Inspectorate.
 
V Final provisions
(Title under Cabinet Regulation No 1038 of 08.09.2009)
14. Declare the following regulations void:
14.1. Cabinet Regulation No 227 of 29 April 2003 “Regulations of the State Sanitary Inspectorate” (“Latvijas Vēstnesis”, 2003, #66);
14.2. Cabinet Regulation No 218 of 29 March 2005 “Regulations of the Quality Control Inspection for Expert-Examination in Medical Care and Ability to Work” (“Latvijas Vēstnesis”, 2005, #53);
14.3. Cabinet Regulation No 232 of 28 March 2006 Ministers “Regulations of the State Pharmacy Inspectorate” (“Latvijas Vēstnesis”, 2006, #52);
15. Paragraph 3.20 and 3.21 of the Regulations shall come into effect as of 1 October 2009.
 
(Cabinet Regulation No 1038 of 08.09.2009)
Prime Minister                                                       I.Godmanis
Ministry of Health                                                  I.Eglītis