Regulation

LEGAL IDENTITY

The Institute of Public Health of the Republic of North Macedonia (referred to as IPH RNM) is registered as Public Health Institution in the Central Registry of the Republic of North Macedonia by Decision of 2 November, 2009. The legal acts, the Statute and Rulebook for internal organization and systematization of workplaces regulate the organization, tasks, authorizations, mutual relationship and responsibilities of employees.

PRINCIPLES OF PUBLIC HEALTH

Public health is a system of knowledge and skills for preventing diseases, prolonging life and promoting health by the organized efforts of the society. The Institute of Public Health of the Republic of North Macedonia in accordance with the Law on Health Care and the Law on Public Health and as a national health institution is on the first line in the realization of this goal. Ensuring an appropriate level of excellence in the process of providing its services, based on the highest level of knowledge available and applicable in the Republic of North Macedonia, is based on the principles of:

  1. Responsibility for the health of entire community and the leading role of the country in preserving and improving population’s health;
  2. Comprehensiveness of measures and activities focusing on the entire population and on separate social groups as well as on socioeconomic determinants of health and the most important risk factors;
  3. Intersectoral cooperation, multidisciplinary and interdisciplinary approach to health promotion, which is achieved by continuous improvement of cooperation with health institutions involved in public health and with other participants in public health;
  4. Scientific basis and comprehensives in collecting data using quantitative and qualitative methods, which means activity of public health based on scientifically proved and tested methods and procedures used to promote and preserve the population’s health;
  5. Partnership with the population and strengthening civil initiatives in the field of public health, realized by raising awareness about the importance of care for our own health;
  6. Efficiency and effectiveness of public health are realized by achieving the best possible results depending on the available financial resources that is, achieving the highest possible health level with the lowest expenditure of resources.

QUALITY POLICY

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ACCREDITATION AND CERTIFICATION

Recognizing the importance of application of the quality standards in its activity/work, IPH started to implement them a long time ago. The laboratories within IPH, which are part of the Center for Reference Laboratories, were among the first in Macedonia to be accredited according to the requirements of the ISO 17025:2006 standard. The first certificate for accreditation of laboratories regarding testing and calibration according to ISO 17025:2006, IPH received on 25.12.2006, awarded by the Accreditation Institute of the Republic of Macedonia. Since then, the IPH has regularly improved its work and has followed the new requirements for quality procurement in the work, which is also confirmed on the basis of regular annual inspections by the Accreditation Institute of the Republic of North Macedonia. The laboratories’ expertise and competence are also confirmed by regular successful participation in competencies testing schemes and inter-laboratory comparisons in the country and abroad. The main purpose of the established quality system is to satisfy the requirements of the regulations and other normative documents as well as to meet the requirements of the users of services, which is reflected by issuing accurate and high-quality test results, as well as compliance with deadlines and timely performance of activities. All employees of IPH are acquainted with the quality policy and are included in the document management system; they use procedures and work instructions that they consistently implement in their work. A representative appointed by the management - Quality Manager - is responsible for the proper functioning of the certified quality system. In this way, the management of PHI IPH emphasizes its dedication and commitment to development, and each of the employees, in line with her/his own powers and responsibilities, contributes to improving the effectiveness of the institution’s work. The Institute of Public Health strives to follow the world’s achievements in the field of analytics and to be always prepared to respond to the requests and needs of the users of services and inspection bodies.

The testing laboratories that function within the Department of Chemical and Radiological Testing, the Department of Microbiology and the Department of Testing and Quality Control of Drugs in IPH are accredited for food testing (quality and safety - microbiology, pesticides, heavy metals, mycotoxins, radiology), drinking water, mineral water and surface water (quality and safety, content of gamma-radionuclides, alpha and beta activity), soil and atmospheric sediments, building materials, medicines and items of general use (toys, plastic objects and ceramics) and materials that come into contact with food. The calibration laboratory is accredited for the calibration of instruments for detection of ionizing radiation. The scope of accreditation includes about 100 test methods and 4 calibration methods; the list of methods accredited according to laboratories can be found on the website of the Accreditation Institute of R.N. Macedonia (LT-005 and LK-008).

FINANCING

The financing of the activities of the Institute is provided out by realization of the program activities anticipated in the government preventive programs, from services to citizens and patients from the laboratory activity based on an agreement with the Health Insurance Fund of the RNM, funds that are provided by donations for research projects, other funds provided by the services that the Institute performs for manufacturers, importers and exporters of medicines, food, items for general use, as well as other services resulting from the professional competencies of the Institute’s employees.

LEGAL REGULATION

  1. Health Care Law;
  2. Public Health Law;
  3. Law on the Protection of the Population from Infectious Diseases;
  4. Law on records in the field of healthcare;
  5. Law on Abortion (Termination of Pregnancy);
  6. Health Insurance Law;
  7. The Law on Medicines and Medical Devices ("Official Gazette of the Republic of Macedonia" No. 106/07, 88/10, 36/11, 53/11, 136/11, 11/12, 147/13, 164/13, 27 /14, 43/14, 88/15, 154/15, 228/15, 7/16, 53/16, 83/18, 113/18, 245/18" and "Official Gazette of RNM" No. 28/21) as well as by-laws;
  8. Rulebook on the method and procedures for the analytical testing of medicines ("Official Gazette of RSM" No. 37/12.02.2021);
  9. Rulebook on the method of quality control of medicines and the method of recognition of the analyzes of the batches of medicines ("Official Gazette of RSM" No. 37/12.02.2021);
  10. Monographs from European, British or American Pharmacopoeia;
  11. Approved quality specifications and validated analytical procedures of the drug manufacturer;
  12. The Law on the Safety of Cosmetic Products Official Gazette no. 55/07; Regulation 1223/2009;
  13. List of products that are considered cosmetic products Official Gazette No. 156/2007;
  14. List of substances used in the production of cosmetic products Official Gazette No. 89/2010;
  15. List of preservatives whose use is allowed in cosmetic products Official Gazette No. 89/2010;
  16. Rulebook on the content and method of labeling cosmetic products Official Gazette No. 98/2010;
  17. Rulebook on the criteria for microbiological and chemical purity of cosmetic products and on the methods for checking those criteria Official Gazette No. 94/2010;
  18. Rulebook for putting into circulation items of general use Official Gazette 26/83;
  19. Rulebook on the data on the contents of the detergents that should be listed on the packaging, as well as the general and special rules for labeling the packaging of the detergents Official Gazette no. 84/2011;
  20. Rulebook on the list of data on the content of detergents Official Gazette no. 84/2011, Order prohibiting the production, sale and use of detergents for machine washing of textile products with phosphorus content in organic or inorganic form with more than 0.5% by weight;
  21. Food Safety Law;
  22. Water Law;
  23. Law on Safety and Health at Work;
  24. Law on protection against ionizing radiation and radiation safety;
  25. Law on primary education;
  26. Child Protection Law;
  27. Chemicals Law;
  28. Mental Health Act;
  29. Law on precursors;
  30. Law on protection of patients' rights;
  31. Law on protection against ionizing radiation and radiation safety;
  32. Law on protection from smoking;
  33. Law on tobacco, tobacco products and related products;
  34. Law on protection against environmental noise.