NATIONAL LEGISLATION
General online access to legislation: Pravno-informacijski sistem Republike Slovenije (Legal-information System of Republic of Slovenia)
1.1. ACTS/REGULATIONS
Production of and Trade in Illicit Drugs Act
Decree on the classification of illicit drugs
Act on quality and safety of human tissues and cells, for the Purposes for medical treatment
General Administrative Procedure Act
Decree on administrative operations
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
Public Use of the Slovene Language Act
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)
Rules on the marketing authorization of medicinal product for human 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
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
Regulations on conditions for performing the activity of supply with blood
Rules on the manner and form of access to the documentation
Rules on the requirements for the organization and carrying out of blood donation sessions
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 technical and medical requirements for blood collection
Rules on donation and procurement of human tissues and cells
Rules on the reception, processing, storage, release and distribution of human tissues and cells
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 advertising of medicines
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 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 expanded professional boards
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
