Legislation and Strategic Documents

National Strategy For quality and safety in Healthcare (2023 - 2031)

Strategies and programmes

National Strategy for Quality and Safety in Healthcare - angleška različica strategije(pdf, 711 KB)

Legislation

Alcohol

Restrictions on the Use of Alcohol Act
Rules on warnings as regards consuming alcoholic beverages at public sports events
Act Regulating the Sanitary Suitability of Foodstuff, Products and Materials Coming into Contact with Foodstuffs
Road Traffic Rules Act

Transplantation of Human Body Parts for the Purposes of Medical Treatment

Act Regulating the Obtaining and Transplantation of Human Body Parts for the Purposes of Medical Treatment
Rules on the Transplant Ethics Committee
Rules on preservation methods and transport procedures for human organs
"Rules on duties of transplantation coordinators"
Rules on declarations regarding the donation of human body parts
Rules on reporting and managing serious adverse events and reactions in use of human organs
Rules on the traceability of human tissues and cells and products as well as products and materials coming into contact with these tissues and cells
Rules on placing a person on the waiting list for treatment with human body parts
Rules on education and training programmes for the procedures regarding the supply of organs
Act on quality and safety of human tissues and cells, for the Purposes for medical treatment
Rules on donation and procurement of human tissues and cells
Rules on tissue vigilance
Rules on medical criteria, methodology and procedures for certification of the brain death and on thecomposition of the Commission for the certification of the brain death
Rules on the conditions and methods of the import/export and entry/exit of human tissues and cells
Rules on the mode of operation and conditions for the development of the national programme of treatment with transplantation of hematopoietic stem cells and the mode of operation of the register for unrelated hematopoietic stem cells donors
Rules on the mode of integration with related foreign and international organizations and the exchange of human body parts with other countries
Rules on personal data protection of the donors and receivers of human body parts for treatment purposes
Rules on the conditions for granting licences to perform the activity of supplying human tissue and cells
Rules on the procedures for collection, storage and use of hematopoietic stem cells
Rules stablishing notification procedures for the deceased persons being potential organ donors ofhuman body parts for transplantation purposes
Rules on the reception, processing, storage, release and distribution of human tissues and cells

Drugs

Criminal Code
Production of and Trade in Illicit Drugs Act
Rules on method and form of record-keeping and of reports on illicit drugs
Rules governing the procedures for the issue o flicences for illicit drugs marketing
Rules on technical and sanitary conditions and on the mode of protection of the facilities for storage and dispensing of illicit drugs from Groups I and II
Act on the Prevention of the Use of Illicit Drugs and on the Treatment of Illicit Drug Users
Rules on supervising the work activity of centres for the prevention of and treatment of illicit drug addiction
Rules on the structure and method of work of services co-ordinating the Centres for the prevention and treatment of addiction to illicit drugs

Mental Health

Mental Health Act
Rules on the implementation of security measures of compulsory psychiatric treatment and care in a health establishment of compulsory psychiatric treatment at liberty and compulsory treatment of alcoholics and drug addict
Rules on the staff, technical and spatial conditions, which must meet the performers of psychiatric care, and the process of verification
Rules on staff, technical and premises requirements for institutional care providers and Social Work Centres providing mental health services, and on the verification procedure thereof
Rules on criteria determining the amount of remuneration for work and the reimbursement of the mental health advocate's expenses
Rules on performing Community treatment of people with long-standing Mental Health problems
Rules on the cooperation between medical staff and rescue service and police
Rules on providing representative service on the field of mental health
Rules on content, conditions and the method of examination coordinator for the controlled treatment

Smoking and Tobacco Control

Restriction on the Use of Tobacco Products and Related Products Act
Act Ratifying the WHO Framework Convention on Tobacco Control

Prevention and Control of Hospital Infections

Communicable Diseases Act
Pravilnik o pogojih za pripravo in izvajanje programa preprečevanja in obvladovanja bolnišničnih okužb
Rules on expert supervision over implementation of the programme on prevention and control of hospital infections
Rules on drinking water

Patients’ Rights

Patients’ Rights Act
Rules on the method for appointment of patient's representatives and on the advance healthcare directive
Rules on forms for written healthcare directives
Rules on the direct cost rate of hospitalisation incurred by healthcare service providers
Rules on the organisation and provision of spiritual care in hospitals and at other healthcare service providers
Rules on healthcare mediation
Rules on the internal supervision of healthcare providers subject to a second request
Rules on determination of measures of compensation and the reimbursement of actual costs for representative of patient's rights
Rules on remuneration rates for the president and members of the Commission for the protection of patient rights and mediators
Decree on officiation with users in public health care

Drinking Water

Rules on drinking water
Rules on minimum hygiene requirements to be met by baths and bathing water in swimming pools

Health and Safety at Work

Health and Safety at Work Act
Rules on the Evaluation of Health Ability for the Military Service
Rules on preventive medical examinations of workers
Rules on the list of occupational diseases
Rules on the protection of workers from risks related to exposure to asbestos at work
Rules on the protection of workers from risks related to exposure to chemical substances at work
Rules on the protection of workers from risks related to exposure to noise at work
Pravilnik o varovanju zdravja pri delu nosečih delavk, delavk, ki so pred kratkim rodile ter doječih delavk
Rules on Protection of Health at Work of Children, Adolescents and Young Persons
Rules on safety and health requirements for work with display screen equipment
Rules on ensuring safety and health in manual handling of loads
Rules concerning medical examinations establishing health requirements of an individual carrying orpossessing fire-arms
Rules setting out the health requirements to be met by workers coming in contact with foodstuffs

Regulating the Sanitary Suitability of Foodstuff, Products and Materials Coming into Contact with Foodstuffs

Act Regulating the Sanitary Suitability of Foodstuff, Products and Materials Coming into Contact with Foodstuffs
Rulesrepealing the Rules on hygiene of foodstuffs
Rules on official temperature control of fast frozen food
Rules setting out the health requirements to be met by workers coming in contact with foodstuffs
Agriculture Act
Rules on the safety of quick-frozen foodstuffs
Act Amending Certain Acts in the Field of Health
Regulation on coordination of the ministries and their bodies with the responsibilities for food and feed safety, animal health, animal welfare and plant health
Decree on the implementation of certain Regulations (EC) concerning official control and obligations of food business operators in primary production of foodstuffs and feed
Decree on the implementation of certain Regulations (EC) concerning foodstuffs, hygiene of foodstuffs and official control of foodstuffs
Decree on the management of waste edible oils and fats

Data Collections

Personal Data Protection Act
Healthcare Databases Act
Rules on the conditions, deadlines and method of integration and use of the eHealth system for mandatory users
Rules on the prohibition of access to the patent’s data in the Central Register of Patients
Order determining the uniform definition of key concepts in health
Order establishing uniform methodological principles, common standards and standard operating procedures to ensure uniformity of data collection management system in the field of health care
Order determining the types and retention periods of medical documentation in the Central Register of Patients

Medicinal Products

Medicinal Products Act
Rules on colouring matters that may be added to medicinal products
Rules on the central database of medicinal products for human use
Rules determining the prices of medicinal products for human use
Rules on marketing authorisation for parallel imported medicinal products and for the parallel distribution of medicinal products for human use
Rules on the marketing authorisation of medicinal products for human use
Rules on pharmacovigilance of medicinal products for human use
Rules on the on-line dispensing of medicinal products
Rules on the method and procedure for analytical, non-clinical pharmaco-toxicological and clinical testing of medicinal products for human use
Rules on the labelling and instructions for medicinal products for human use
Rules on the manufacture, wholesale distribution and import of active substances and on registers of manufacturers, wholesalers and importers of active substances
Rules on the production of medicinal products
Rules on radiopharmaceuticals
Rules on the system for the receipt, storage and traceability of medicinal products
Rules on the manufacturing and trade with medical devices
Medical Devices Act
Rules on Medical Devices
Rules on fees in the field of medical devices
Rules on the vigilance of medical devices
Order on list of standards, when applied, create the presumption of conformity of medical device in accordance with the Act on medical devices

Complementary and Alternative Medicine

Complementary and Alternative Medicine Act
Rules determining complementary and alternative medicine (CAM) systems and methods, and on the procedure for the register, acknowledgment and supervision of CAM systems and the methods to be introduced in CAM services
Rules on conditions for performing activities on Alternative medicine
Rules on the medical examination for healers who have not completed medical education
Decision on costs of test from health contents for medicine

Medical Services

Medical Services Act
Act on Recognition of Professional Qualifications for Medical Doctors, Specialist Doctors, Doctors of Dental Medicine and Specialist Doctors of Dental Medicine
Decree on the performance-related bonus paid to public employees for increased workload
Decree on standards for the level of Slovene language skills for typical work posts in health care
Pravilnik o strokovnem nadzoru s svetovanjem
Rules on the Register of Physicians
Rules on the conditions under which a physician is not required to perform turn of duty
Rules concerning the employment and financing of physicians interns
Decision determining the Medical Chamber of Slovenia membership fee
Decision on insurance against damage that may be caused by physicians and dentists during their work for 2019

Health Services

Health Services Act
Rules on professional supervision and counselling for certain health professional groups not organised in professional chambers or organisations with public authority
Rules on minimum training conditions and acquired rights for medical doctors, specialist doctors, general practitioners, doctors of dental medicine, specialist doctors of dental medicine, graduate nurses, graduate midwifes and masters of pharmacy
Rules on carriage of patients
Rules on requirements to be met by laboratories performing laboratory medicine tests
Rules on the verification procedure concerning healthcare programmes and services carried out in health care and health resort services
Rules on emergency medical service
Rules on the specialisation of healthcare and allied professionals
Rules on the professional training of medical and non-medical professionals
Rules concerning curriculum and requirements of the phramacists' specialization programmes
Rules concerning the Health Council
Rules on carrying out preventive health care at the primary level
Rules on professional supervision and counselling in nursing and midwifery services
Rules on helicopter emergency medical service
Rules on the register of laboratory medicine providers
Rules on the register and licences of nursing and midwifery providers
Rules on professions for which professional qualifications are examined before the first provision of services
Rules on conditions for the issuance of certificates of attained professional qualifications
Rules on specialisation in medical biochemistry
Rules on the medical dispatch service
Rules on professional supervision and counselling in the field of laboratory medicine
Rules on expanded professional boards
Rules on the criteria for determining the amount of payment for medical services under work contracts or other civil law contracts
Rules on awarding the title of head physician
Rules on the method of providing funds for traineeships, secondments and specializations
Rules on administrative supervision in healthcare
Rules on the systemic supervision in healthcare services
Rules concerning the employment and financing of physicians interns
Rules concerning requirements to be met by the laboratories examining the uterus tube smears
Rules on the criteria for the classification of hospitals
Rules on drawing up and adoption of technical guidelines in health care and health resort services
Rules concerning the requirements to be met and the procedure to obtain the title of a councillor or a higher councillor
Rules on licence in the field of laboratory medicine
Rules on the conditions to be met by healthcare institutions and private healthcare professionals for the provision of specialisation programmes
Rules on the requirements to be met by health institutions providing practical clinical instruction of pupils attending secondary schools and of students attending advanced educational institutions in order to be awarded the title educational institution
Rules concerning the employment and financing of health professionals interns other than physicians and dentists

Health Care and Health Insurance

Health Care and Health Insurance Act
Rules on compulsory health insurance
Rules on inclusion of medicines on the list
Rules on classification of foods for special medical purposes
'Rules on the form of the medical confirmation on the legitimate absence from the hearing or other procedural act before the court
Rules concerning the health insurance card
Rules on write-off, instalment payment and deferred payment of outstanding amounts arising from compulsory health insurance contributions
Rules on forms and documents needed to implement compulsory health insurance
Pravilnik o sofinanciranju strokovnega tiska, organizacije in udeležbe na kongresih in drugih strokovnih srečanjih
Pravilnik o volitvah in imenovanju članov v organe upravljanja Zavoda
Rules on carrying out preventive health care at the primary level
Pravilnik o izdajanju zdravniških spričeval in potrdil v zdravstvenih delovnih organizacijah
Rules on the inclusion of medical devices on the Medical Devices List, and their exclusion from the List
Decision concerning composition and functioning of the Health Council of the Republic of Slovenia
Rules setting references for price standards of medical devices and devices covered by compulsory health insurance
Order on the list of health services, for which prior authorisation is required
Instructions on preparation of the report on execution of supplementary health insurance for the period of compensation
Instructions for completing the insurance application form for the disabled
Decision concerning flat-rate contributions for compulsory health insurance
Decision on detailed instructions for accounting and presentation of transactions as regards offsets in supplementary health insurance

Food for Special Groups

Rules of processed cereal-based foods and baby foods for infants and young children
Rules on special requirements for labelling and presentation of prepackaged foodstuffs

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