Cabinet of Ministers Regulation No. 309
Riga on 9 July 2019 (Prot. 32 § 25)
Regulations of the Health Inspectorate
Issued in accordance with State Administration facilities
section 16, Paragraph one of the Law
I. General questions
1. The Health Inspectorate (hereinafter - Inspectorate) is a direct administration institution under the authority of the Minister for Health.
2. The purpose of the activity of the Inspectorate is to implement the functions of the State administration in the supervision and control of the health sector in order to ensure compliance with and fulfilment of the requirements of the regulatory enactments regulating the abovementioned field for quality and qualified health care, as well as safe and healthy living environment.
II. Functions, tasks and Rights of the Inspectorate
3. The inspection shall have the following functions:
3.1. to supervise the implementation of the regulatory enactments binding medical treatment institutions in the field of health care and expert-examination of working capacity, as well as the quality of expert-examination of professional and working capacity of health care;
3.2. to supervise the implementation of the regulatory enactments regulating the field of pharmacy in relation to circulation and advertising of medicinal products and active substances intended for human use, circulation of narcotic and psychotropic substances and medicinal products, circulation of alcohol, as well as circulation of precursors;
3.3. to supervise the conformity of sensitive subjects, environmental factors affecting the health of the population, chemical substances available on the market, chemical mixtures (including biocidal products and detergents), cosmetic products, tobacco products (including newly introduced tobacco products), herbal smoking products, electronic cigarettes and refill containers with the requirements specified in regulatory enactments;
3.4. to supervise compliance with the requirements specified for medical devices and in vitro diagnostic medical devices, including those medical devices equipped with an artificial intelligence system;
3.5. to maintain a register of medical treatment institutions, medical practitioners and medical treatment support persons;
3.6. to take a decision regarding payment of the remuneration or refusal to disburse the remuneration from the medical risk Fund;
3.7. to perform the tasks intended for the competent authority in accordance with the requirements determined by:
3.7.1. Articles 4, 7, 9, 11 and 14 of 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 legislation;
3.7.2. The first paragraph of Article 9 of Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 on the avoidance of diversion of trade in certain essential medicinal products to the European Union;
3.7.3. Article 14, first paragraph, of Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the compulsory licensing of patents for the manufacture of pharmaceutical products for export to countries with public health problems;
3.7.4. The second paragraph of Article 10 of Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors;
3.7.5. The first, second and third paragraphs of Article 26 of Regulation (EC) No 111/2005 of the European Parliament and of the Council of 22 December 2004 laying down rules for the monitoring of trade in drug precursors between the Community and third countries;
3.7.6. Article 34(1) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products;
3.7.7. Articles 93, 94, 95 and the first and second paragraphs of Article 97 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directives 2001/83/EC, (EC) No 178/2002 and (EC) No 1223/2009 and repealing Council Directives 90/385/EC and 93/42/EEC;
3.7.8. Articles 88, 89 and 90 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision;
3.7.9. Articles 19 and 26 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance with regard to the marketing of products and repealing Regulation (EEC) No 339/93;
3.7.10. Regulation No 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules in the field of artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828.
(As Grozits by Cabinet Regulation No 466 of 22.07.2025)
4. In order to perform the specified functions, the inspection shall have the following tasks:
4.1. to perform examinations, expert-examinations and to provide opinions regarding the quality of health care and health-performance expert-examination;
4.2. to control the conformity of the activities of medical treatment institutions with the regulatory enactments regulating the field of health care and whether medical practitioners have certificates of a medical practitioner issued by a certification institution. To check whether medical treatment institutions comply with the mandatory requirements specified for medical treatment institutions and their units (including in relation to observance of the procedures for the circulation of medicinal products and provision of quality and qualified health care services), as well as to suspend unauthorised medical treatment;
4.3. to control the conformity of pharmaceutical activity undertakings with the regulatory enactments regulating the field of pharmacy;
4.4. to control the circulation of narcotic and psychotropic substances and medicinal products, as well as precursors;
4.5. to control the compliance with the procedures for reimbursement of expenditures for the purchase of medicinal products and medical devices intended for outpatient medical treatment in pharmaceutical activities in undertakings;
4.6. to control compliance with the requirements for distribution and advertising of medicinal products;
4.7. to control the implementation of measures for the prevention and anti-epidemic of infectious diseases specified in regulatory enactments, as well as compliance with hygiene requirements in high risk subjects;
4.8. in the cases specified in regulatory enactments or upon request of a natural or legal person to issue the conditions for compliance with hygiene requirements and to assess the conformity of the building design and the installation with hygiene requirements;
4.9. to evaluate the environmental health risk factors and the impact thereof on human health and quality of life (including the risks of chemical substances to human health);
4.10. to control the fulfilment of the requirements for the harmlessness and quality assurance of drinking water in public drinking water supply facilities from the place of water abstraction to the consumer, as well as to control the fulfilment of the requirements for the protection of drinking water abstraction sites, to organise and perform monitoring of the quality of drinking water and bathing water;
4.11. to control the conformity of chemical substances, chemical mixtures (including biocidal products and detergents) and cosmetic products in trade (placed on the market and distributed) with the requirements specified in regulatory enactments;
4.12. to control the conformity of the provided information and tobacco products, herbal smoking products, electronic cigarettes, refill containers and newly introduced tobacco products placed on the market with the requirements specified in regulatory enactments;
4.13. to participate in the rapid notification system regarding the safety of non-food products and services between the European Commission and Member States (RAPEX) in order to provide information regarding dangerous goods discovered on the Latvian market and to verify the information received regarding dangerous goods;
4.14. to control the operation of medical devices and in vitro diagnostic medical devices, including such medical devices which are equipped with an artificial intelligence system, in medical treatment institutions and the conformity of medical devices placed on the market, including such medical devices which are equipped with an artificial intelligence system with regulatory enactments;
4.15. to carry out registration of medical treatment institutions, medical practitioners and medical treatment support persons, to supplement and maintain the data of the relevant registers, to ensure public accessibility thereof, as well as to perform analysis of the data of registers;
4.16. to issue documents for recognition of professional qualifications in foreign States and Latvia and to perform the tasks provided for the competent authority in the Internal market information system in relation to medical practitioners in the regulated profession in the field of health care in accordance with the laws and regulations regarding regulated professions and recognition of professional qualifications;
4.17. to perform expert-examinations, to provide opinions within the scope of the medical risk Fund regarding the existence of harm caused to the health and life of a person, the amount of harm and compensation, as well as to evaluate the relation of medical treatment expenses with the reduction or elimination of the consequences of harm caused to a patient;
4.18. to participate in the implementation of international health protection regulations in the field of implementation of health protection;
4.19. in conformity with the competence to provide support to the national Health Service for ensuring the operation of the cross-border health care contact point;
4.20. to include medical treatment institutions in the list of providers of health tourism services;
4.21. to perform other tasks specified in regulatory enactments.
(As Grozits by Cabinet Regulation No 466 of 22.07.2025)
5. In order to perform the tasks specified, the inspection shall have the following rights:
5.1. to request and receive free of charge from State and local government institutions, medical treatment institutions, as well as from natural persons and legal persons governed by private law the information and documents necessary for the performance of tasks (including medical documents);
5.2. to remove documents (including medical documents) or receive certified copies thereof;
5.3. to request and receive explanations from such persons who are responsible for compliance with the requirements of regulatory enactments;
5.4. in the cases provided for in regulatory enactments to order natural or legal persons to suspend acts or omissions harmful to the interests, health and life of the public and the individual and to eliminate the detected non-conformities. Control the performance of the tasks assigned to those persons;
5.5. to provide the competent authorities with proposals regarding the necessity to suspend or revoke special permits (licences) and professional activity certificates, if violations have been detected in the fields of activity within the competence of the inspection;
5.6. to issue administrative acts or administrative decisions in the cases specified in external regulatory enactments, as well as to perform administrative violation proceedings;
5.7. to order to take specific measures for the elimination of non-conformity of goods and to control the performance of the given tasks, to prohibit or suspend distribution in the cases provided for in regulatory enactments, to remove, recall chemical substances and mixtures placed on the market or distributed (including biocidal products and detergents), cosmetic products, tobacco products, herbal smoking products, electronic cigarettes, refill containers thereof, medicinal products and narcotic and psychotropic medicinal products, medical devices, to suspend water supply;
5.8. in the cases provided for in regulatory enactments without prior warning, special permit, fees and other restrictions, to visit and control without hindrance any facility throughout the territory of the Republic of Latvia regardless of the subordination and attendance regime thereof, except places of imprisonment and other restricted access institutions and territories specified in regulatory enactments, the attendance of which shall be co-ordinated with the management of the relevant institution or the administration of the territory;
5.9. to request that the natural and legal persons to be controlled ensure the presence of the manager of the object to be inspected, the responsible official or another representative during the control;
5.10. to take samples of the environment and goods at the objects to be inspected in accordance with the procedures laid down in laws and regulations, organise a laboratory examination thereof or other type of expert-examination in accordance with the annual monitoring and control plan (programme) or in cases if there are justified suspicions regarding the non-conformity of the activities of the relevant object with the requirements laid down in laws and regulations;
5.11. to perform measurements and control purchases;
5.12. to charge for the services provided in accordance with the price list of inspection fee services;
5.13. to invite specialists of professional organisations when performing an expert-examination, if necessary;
5.14. to verify whether medical treatment institutions, medical practitioners and medical treatment support persons have made registration in the relevant registers;
5.15. in conformity with the competence to develop informative materials in order to inform or warn the public;
5.16. to perform other activities specified in regulatory enactments.
III. Organisation of inspection activities
6. The inspection shall be conducted by the head of the inspection. The manager shall be a public civil servant.
7. The Head of the Inspectorate shall be appointed and dismissed by the Minister for Health.
8. The head of the inspection shall determine the organisational structure of the inspection.
9. The following inspection officials shall have control and supervision powers: the Head of the Inspectorate, Deputy Head of the Inspectorate, Head of departments and Deputy Head, Head and Deputy Head of Control and monitoring units, Senior Inspectors, Inspectors, Senior medical experts, medical experts, Assistant medical experts, Senior hygiene doctors, hygiene doctors and Assistant hygiene Physicians, Senior Technical monitoring Inspectors, Technical monitoring Inspectors, public Health Analysts, environmental Health Analysts. Officials of the Inspectorate shall hold service certificates in the performance of their duties.
IV. Ensuring the legality of inspection activities and reporting
10. The lawfulness of the activities of the inspection shall be ensured by the head of the inspection. The head of the Inspectorate shall be responsible for the establishment and operation of the inspection system for the decisions of the Office.
11. Decisions and actual actions of officials of the Inspectorate may be contested by submitting a relevant submission to the head of the Inspectorate. The decision of the head of the inspection may be appealed to the court.
12. Decisions of the head of the inspection (except the decision referred to in Paragraph 11 of these Regulations) and actual action may be contested in the Ministry of Health. The decision of the Ministry of Health may be appealed in court.
13. The Inspectorate shall, not less than once a year, provide the Minister for Health with a report on the fulfilment of the functions of the Office and the utilisation of the State budget resources allocated to the Inspectorate.
V. Final question
14. Declare Cabinet Regulation No. 76 of 5 February 2008, by Cabinet of Ministers Inspectorate, repealed (Latvijas Vestnesis, 2008, No. 22; 2009, No. 147; 2010, No. 204; 2012, No. 66; 2013, No. 208).
Instead of the Prime Minister -
Member of the Prime Minister,
Justice Minister J. Bordans
Minister for Health I. Viņķele