By-laws of the Health Inspectorate

Issued pursuant to
Section 16, Paragraph one of the State Administration Structure Law

I. General Provisions

1. The Health Inspectorate (hereinafter - the Inspectorate) is an institution of direct administration under the subordination of the Minister for Health.

2. The purpose of the activity of the Inspectorate is to implement the functions of State administration in supervision and control of the health sector in order to ensure conformity with and fulfilment of the requirements of the laws and regulations governing the abovementioned field.

II. Functions, Tasks, and Rights of the Inspectorate

3. The Inspectorate has the following functions:

3.1. to supervise and control the fulfilment of the laws and regulations binding on medical treatment institutions in the field of health care and expert-examination of the capacity for work, as well as the professional quality of health care and expert-examination of the capacity for work in medical treatment institutions;

3.2. according to its competence to ensure the supervision of the market for medicinal products, veterinary narcotic and psychotropic medicinal products, detergents, and cosmetic products;

3.3. according to its competence to supervise and control natural persons and legal persons who perform activities with substances and medicinal products included in the lists of narcotic substances, psychotropic substances, and precursors to be controlled in Latvia;

3.4. according to its competence to supervise and control conformity with the laws and regulations in the field of epidemiological safety and environmental health, in the field of drinking water safety, trade in chemical substances and chemical products (including detergents and biocidal products) and professional use (disinfection, disinsectisation, and deratisation);

3.5. according to its competence to supervise and control the fulfilment of the requirements laid down in the laws and regulations governing the field of pharmacy and veterinary medicine in respect of the distribution and advertising of medicinal products and veterinary narcotic and psychotropic medicinal products;

3.6. to control conformity with the principles for the price formation of medicinal products specified in laws and regulations, including the principles for the price formation of reimbursable medicinal products intended for outpatient medical treatment;

3.7. according to its competence to control conformity with the procedures for the circulation of ethanol;

3.8. according to its competence to control conformity with the procedures for the reporting and monitoring of adverse reactions caused by the use of medicinal products;

3.9. according to its competence to control conformity with the procedures for the prescribing of prescriptions and the circulation of prescription forms;

3.10. to supervise and control the storage and disposal of confiscated and withdrawn medicinal products;

3.11. according to its competence to control the fulfilment of the hygiene requirements laid down in laws and regulations;

3.12. to control the fulfilment of preventive and counter-epidemic measures for infectious diseases specified in laws and regulations;

3.13. to control the fulfilment of the requirements for ensuring the safety of drinking water in public drinking water supply facilities from the place of water extraction to the consumer, as well as to control the fulfilment of the requirements for the protection of drinking water extraction sites;

3.14. to control conformity with the permissible regulatory and noise limit values for acoustic noise of the acoustic noise caused by machinery for economic activity and vehicles, as well as conformity with the permissible vibration levels in residential and public buildings;

3.15. to carry out the tasks provided for the competent authority in accordance with the requirements laid down in:

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. [24 April 2012];

3.16. to control the validity of the use of medicinal products, including narcotic medicinal products and psychotropic medicinal products, in the medical treatment process;

3.17. to control whether medical treatment institutions conform to the mandatory requirements laid down in laws and regulations and whether medical practitioners have certificates of a medical practitioner issued by the certification institution;

3.18. [24 April 2012];

3.19. [24 April 2012];

3.20. to register medical treatment institutions in the Register of Medical Treatment Institutions and medical practitioners and medical treatment support personnel in the Register of Medical Practitioners and Medical Treatment Support Personnel;

3.21. according to its competence to control the implementation of the laws and regulations in the field of health care, including procedures for the operation and technical supervision of medical devices, as well as to supervise the market in the field of healthcare and pharmacy.

[8 September 2009; 21 December 2010 / Amendment regarding deletion of Sub-paragraph 3.15.7 shall come into force on 12 October 2012. See Paragraph 2 of Cabinet Regulation No. 284 of 24 April 2012]

4. In order to carry out the specified functions, the Inspectorate shall have the following tasks:

4.1. to perform expert-examinations and to provide opinions on the quality of health care and expert-examination of the capacity for work in a medical treatment institution regardless of the form of the property or subordination thereof, on the quality of medical treatment, if the medical practitioner has performed medical treatment outside the medical treatment institution, and to evaluate whether the unauthorised medical treatment performed by a person without medical education has caused a health disorder to the person;

4.2. [8 September 2009];

4.3. according to its competence to examine the complaints, submissions, and proposals of natural persons and legal persons;

4.4. upon request of a court or a person directing criminal proceedings to provide opinions on the quality control of health care and expert-examination of the capacity for work;

4.5. according to its competence to issue administrative acts;

4.6. to ensure access to information regarding supervised undertakings and institutions;

4.7. to create and maintain a database of ingredients of cosmetic products;

4.8. to compile the information obtained during examinations regarding conformity with laws and regulations, as well as to submit proposals to the Ministry of Health regarding the development of the laws and regulations in the fields within the competence of the Inspectorate;

4.9. in the cases provided for in the Latvian Administrative Violations Code review cases of administrative violations and impose administrative sanctions;

4.10. to inform the public regarding activities of the Inspectorate;

4.11. according to its competence to order rectification of the discrepancies identified and to control carrying out of the tasks;

4.12. to supplement and maintain the Register of Medical Treatment Institutions and the Register of Medical Practitioners and Medical Treatment Support Personnel;

4.13. to organise and perform monitoring of the quality of drinking water and bathing waters;

4.14. in the cases specified in laws and regulations or upon request of a natural person or legal person to evaluate the conformity of a building design and facility with the hygiene requirements, as well as to evaluate the risks of chemical substances to human health;

4.15. [24 April 2012];

4.16. according to its competence to participate in the fulfilment of the International Health Regulations;

4.17. to participate in the management of such emergency situations which are related to threats to public health;

4.17.¹ according to its competence to provide support to the National Health Service for ensuring the functioning of the cross-border health care contact point;

4.18. to perform the tasks specified in other laws and regulations.

[8 September 2009; 24 April 2012; 22 October 2013]

5. The Inspectorate has the following rights:

5.1. to request and receive free of charge the information and documents necessary for carrying out of the tasks from State and local government institutions, medical treatment institutions, as well as in accordance with the procedures specified in laws and regulations from natural persons and legal persons governed by private law (including medical documentation);

5.2. according to its competence to request and receive oral and written explanations of such persons who are responsible for complying with the requirements of laws and regulations or have provided the relevant service;

5.3. in the cases provided for in law, without prior warning, special permit, fee, and other restrictions, to visit and control without hindrance any facility throughout the territory of the Republic of Latvia regardless of the regime of subordination and attendance thereof, except for prisons and other restricted access institutions and territories specified in laws and regulations, the attendance of which shall be co-ordinated with the management of the relevant authority or the administration of the territory;

5.4. according to its competence to submit proposals to the competent authorities regarding the need to suspend or withdraw special permits (licences) and certificates of professional activity, if violations have been established in the fields of activity within the competence of the Inspectorate;

5.5. in the cases provided for in law to prohibit or suspend the distribution of products, medicinal products and veterinary narcotic and psychotropic medicinal products, as well as to take the following decisions:

5.5.1. to suspend the activity of a merchant or an undertaking owned by such merchant which operates on the basis of a special permit (licence) and which deals with the production, standardisation, quality control, or distribution of medicinal products;

5.5.2. to suspend the operation of the premises, buildings, parts thereof, structures, engineering communications, as well as equipment or equipment systems which are subject to the requirements laid down in the laws and regulations governing epidemiological safety;

5.5.3. to suspend the operations of medical treatment institutions or their structural units;

5.6. to take samples of goods and the environment in accordance with the procedures laid down in laws and regulations and to organise laboratory or other type of expert-examination thereof, if a non-conformity has been established or there are justified suspicions regarding non-conformity of the relevant facility, product, or service with the requirements laid down in laws and regulations, or an expert-examination is necessary in order to establish the hygienic condition and counter-epidemic measures taken;

5.7. to perform an inspection without hindrance of medicinal products, veterinary narcotic and psychotropic medicinal products and other products, productions, goods, assets, vehicles, premises, equipment, devices, and other objects during the period of control;

5.8. to request that the natural persons and legal persons to be controlled ensure the presence of the head of the facility, the responsible official of the facility, or another representative during the period of control;

5.9. to perform control without the presence of the representative of the facility if the person to be controlled fails to comply with the requirement referred to in Sub-paragraph 5.8 of this Regulation;

5.10. to assign legal persons and natural persons in the cases provided for in law to cease actions or inactions harmful to the interests, health, and life of inhabitants and consumers;

5.11. if necessary, upon carrying out an expert-examination, to invite specialists of professional associations;

5.12. to co-operate with State administration institutions, private individuals, as well as with foreign public administration institutions, international and non-governmental organisations, their representatives and experts;

5.13. to withdraw documents or receive certified copies thereof in the cases specified in laws and regulations;

5.14. to organise seminars, conferences, and congresses according to its competence;

5.15. in the cases provided for in law, to publish in full or in part in the official gazette Latvijas Vēstnesis and on the website of the Inspectorate the decisions of the Inspectorate, in conformity with the requirements laid down in laws and regulations (expenses related to publication shall be covered by the addressee of the unfavourable administrative act);

5.16. in the cases provided for in law to request that the natural persons and legal persons terminate the committed violations within a specified time period, attesting the undertaking in writing, and to post such personal attestations on the website of the Inspectorate;

5.17. to perform measurements with an instrumental method in order to ensure supervision;

5.18. to perform control purchases;

5.18.¹ to collect payment for the public services provided;

5.19. to carry out other activities specified in laws and regulations.

[8 September 2009; 21 December 2010]

III. Organisation of the Activities of the Inspectorate

6. The work of the Inspectorate is led by the head of the Inspectorate. The head of the Inspectorate shall perform the functions of the head of an institution of direct administration specified in the State Administration Structure Law.

7. The head of the Inspectorate shall be appointed to and removed from the office by the Minister for Health. The head of the Inspectorate has deputies.

8. The head of the Inspectorate shall determine the organisational structure of the Inspectorate.

9. The following officials shall have control and supervision powers: the head of the Inspectorate, the deputy head, the heads of the Control and Supervision Departments and deputy heads, senior inspectors, inspectors, junior inspectors, senior experts, experts, and junior experts.

IV. Ensuring the Lawfulness of the Operation of the Inspectorate and Submission of Reports

10. The head of the Inspectorate shall ensure the lawfulness of the activities of the Inspectorate. The head of the Inspectorate is responsible for the establishment and operation of the system for examination of management decisions.

11. The decisions and actual action of the officials of the Inspectorate may be contested by submitting a relevant submission to the head of the Inspectorate. A decision of the head of the Inspectorate may be appealed in court.

12. The decisions issued by the head of the Inspectorate (except for the decision referred to in Paragraph 11 of this Regulation) and his or her actual action may be contested in the Ministry of Health. A decision of the Ministry of Health may be appealed in court.

13. The Inspectorate shall, at least once a year, provide the Minister for Health with a report on the performance of the functions of the administration and the utilisation of the State budget resources allocated to the Inspectorate.

V. Closing Provisions

14. The following are repealed:

14.1. Cabinet Regulation No. 227 of 29 April 2003, By-laws of the State Sanitary Inspectorate (Latvijas Vēstnesis, 2003, No. 66);

14.2. Cabinet Regulation No. 218 of 29 March 2005, By-laws of the Quality Control Inspectorate of Medical Care and Expert-Examination of the Capacity for Work (Latvijas Vēstnesis, 2005, No. 53);

14.3. Cabinet Regulation No. 232 of 28 March 2006, By-laws of the State Pharmacy Inspectorate (Latvijas Vēstnesis, 2006, No. 52).

15. Sub-paragraphs 3.20 and 3.21 of this Regulation shall come into force on 1 October 2009.

[8 September 2009]

Prime Minister I. Godmanis

Minister for Health I. Eglītis

Translation © 2019 Valsts valodas centrs (State Language Centre)