NATIONAL LEGISLATION
General online access to legislation: Pravno-informacijski sistem Republike Slovenije (Legal-information System of Republic of Slovenia)
1.1. ACTS/REGULATIONS
Medicinal Products Act;
Medical Devices Act;
Production of and Trade in Illicit Drugs Act
Decree on the classification of illicit drugs
Blood Supply Act;
Act on quality and safety of human tissues and cells, for the Purposes for medical treatment
Pharmacy Practice Act
Inspection Act
Chemicals Act
Minor Offences Act
General Administrative Procedure Act
Debureaucratisation Act
Public Finance Act
Public Procurement Act
Act Regulating the Obtaining and Transplantation of Human Body Parts for the Purposes of Medical Treatment
Public Agencies Act
Decision on the establishment of the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices
Decree on administrative operations
Decree on the implementation of the Delegated Regulation (EU) on laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
Decree on the implementation of the Regulation (EU) on medical devices
Decree on the implementation of the Regulation (EU) on in vitro diagnostic medical devices
Decree on the implementation of the Regulation (EU) on market surveillance and compliance of products
Decree on the implementation of the Regulation (EU) on clinical trials on medicinal products for human use
Administrative Fees Act
Public Use of the Slovene Language Act
Act on Additional Measures to Stop Spreading and Mitigate, Control, Recover and Eliminate the Consequences of COVID-19
Act Ratifying the Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health
1.2 IMPLEMENTING REGULATIONS
Tariff of the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (2022-2023) SI – Unofficial translation (EN)
Tariff of the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (2018-2021)
Rules on the marketing authorization of medicinal product for human use
Rules on the marketing authorization of medicinal product, paralel product autorisation and registration of homeopatic medicinal product for veterinary use
Rules on the labelling and instructions for medicinal products for human use
Order on the determination of the national centre for pharmacovigilance
Rules on the classification, prescribing and dispensing of medicinal products for human use
Rules on the production of medicinal products
Rules on detailed conditions of wholesale of medicinal products and determining of fulfilment of these conditions and procedure of gain the permission for traffic of wholesale of medicinal products
Rules on the manufacture, wholesale distribution and import of active substances and on registers of manufacturers, wholesalers and importers of active substances
Rules concerning the requirements to be met by specialized shops for retail trade in medicinal products and on the procedure for ascertaining their compliance
Regulations on the conditions and procedures for granting import permit for medicinal products for human use
Rules on conditions, mode and procedure of entries and imports of individual groups of medicinals for use in veterinary medicine
Regulations on authorization of parallel imported product and parallel distribution of medicines
Rules on the system for the receipt, storage and traceability of medicinal products
Rules on the traceability of distribution and use, and on storage, of veterinary medicinal products
Rules on clinical testing of medicinal products
Rules on the traditional medicinal products of plant origin
Rules concerning the procedure of edition and of the revocation of permission for performing the activity of supply with blood
Regulations on conditions for performing the activity of supply with blood
Rules on hemovigilance
Rules on tissue vigilance
Rules on the manner and form of access to the documentation
Rules concerning the method of storing, delivery, transport and elimination / removal of unused blood and blood preparations
Rules on the requirements for the organization and carrying out of blood donation sessions
Rules concerning requirements for the acquisition of one’s own blood, collection of individual types of cells andblood plasm
Rules on the content of records kept on any use of blood, blood preparations and medicinal products made of blood, including biotechnological blood substitutes
Rules on the compulsory testing of human blood and blood components
Rules on the standards and technical requirements of the blood transfusion quality system
Rules on the methodology for determining the price of blood and blood products
Rules on the collection, processing, storage, distribution and transportation of human blood and blood components
Rules on the technical and medical requirements for blood collection
Rules on the conditions for granting licenses to perform the activity of supplying human tissue and cells
Rules on the conditions and methods of the import / export and entry / exit of human tissues and cells
Rules on donation and procurement of human tissues and cells
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 the reception, processing, storage, release and distribution of human tissues and cells
Rules on united national naming of medicinal active ingredients and system of arranging treated for round anatomically-therapeutic-chemical classification
Rules on radiopharmaceuticals
Rules on coloring matters that may be added to medicinal products
Rules on more exact donditions and procedure for determining interchangeable medicinal
Rules on homeopathic medicines for human use
Rules on recall of medicines
Rules on advertising of medicines
Rules on the assessment and procedures for compliance monitoring of the principles of good laboratory practice
Rules on the principles of good laboratory practice
Rules determining the prices of medicinal products for human use
Rules on the use of potassium iodine
Rules on the central database of medicinal products for human use
Rules on Medical Devices
Rules on the manufacturing and trade with medical devices
Rules on the vigilance of medical devices
Rules on fees in the field of medical devices
Rules on the definition of national addition to European pharmacopaeia
Rules on the method and procedure for analytical, non-clinical pharmaco-toxicological and clinical testing of medicinal products for human use
Rules on expanded professional boards
Order on list of standards, when applied, create the presumption of conformity of medical device in accordance with the Act on medical devices
Decree on management with waste medicines
Rules on the membership, responsibilities and working methods of the Commission for Medical Ethics
Decree on fees for the Medical Ethics Committee of the Republic of Slovenia
Rules on the conditions for providing pharmacy practice
Rules on the conditions for providing radiopharmaceutical services
Rules on the provision of pharmacy services by hospital pharmacies
Rules on the provision of pharmacy practice within the military healthcare of the Slovenian Armed Forces
Rules concerning mode of action of the Expert Council for blood, blood derivatives and blood products supply
Notice on the Validation of the Sixth Edition of the Slovenian National Formulary to the European Pharmacopeia – Formularium Slovenicum 6.0
Notice on the Validation of the First Addendum to the Sixth Edition of the Slovenian National Formulary to the European Pharmacopeia – Formularium Slovenicum 6.1
Notice on the suppression of the monographs Barbital (0170), Aminoglutethimide (1291), Cod liver oil (type B) (1193) and Technetium (99mTc) for colloidal sulfur injection (0131) from the European Pharmacopoeia
Notice on the implementation of the Supplements 7 and 8 of the 10th Edition of the European Pharmacopoeia and the 11th Edition of the European Pharmacopoeia
Notice on the rapid implementation of revised versions of the monographs on Candesartan cilexetil (2573), Irbesartan (2465), Losartan potassium (2232), Olmesartan medoxomil (2600) and Valsartan (2423) in the European Pharmacopoeia
Notice on the implementation of the Supplements 1 to 3 of the 11th Edition of the European Pharmacopoeia
Notice on the suppression of the monographs Diethylstilbestrol (0484), Diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed) (2062), Diphtheria, tetanus, pertussis (acellular, component) and hepatitis B (rDNA) vaccine (adsorbed) (1933), Diphtheria, tetanus, pertussis (whole cell), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2066) and Ether anaesthetic (0367) from the European Pharmacopoeia
Notice on the Validation of the Second Addendum to the Fifth Edition of Slovenian National Formulary to the European Pharmacopeia – Formularium Slovenicum 5.2
