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 (Official Gazette of the Republic of Slovenia, Nos. 17/14 and 66/19);   

Medical Devices Act (Official Gazette of the Republic of Slovenia, No. 98/09);

Production of and Trade in Illicit Drugs Act (Official Gazette of the Republic of Slovenia, Nos.  108/99, 44/00, 2/04 – ZZdrI-A and 47/04 – ZdZPZ);

Decree on the classification of illicit drugs (Official Gazette of the Republic of Slovenia, Nos.  69/19, 157/20 and 162/21)

Blood Supply Act (Official Gazette of the Republic of Slovenia, No. 104/06);

Act on quality and safety of human tissues and cells, for the Purposes for medical treatment (Official Gazette of the Republic of Slovenia, Nos.  61/07 and 56/15 – ZPPDČT)

Pharmacy Practice Act (Official Gazette of the Republic of Slovenia, Nos. 85/16, 77/17, 73/19 in 186/21)

Inspection Act (Official Gazette of the Republic of Slovenia, Nos. 43/07 – official consolidated version and 40/14)

Chemicals Act (Official Gazette of the Republic of Slovenia, Nos. 110/03 – official consolidated version, 47/04 – ZdZPZ, 61/06 – ZBioP, 16/08, 9/11 and 83/12 – ZFfS-1)

Minor Offences Act (Official Gazette of the Republic of Slovenia, Nos. 29/11 – official consolidated version, 21/13, 111/13, 74/14 – odl. US, 92/14 – odl. US, 32/16, 15/17 – odl. US, 73/19 – odl. US, 175/20 – ZIUOPDVE and 5/21 – odl. US)

General Administrative Procedure Act (Official Gazette of the Republic of Slovenia, Nos. 24/06 – official consolidated version, 105/06 – ZUS-1, 126/07, 65/08, 8/10, 82/13, 175/20 – ZIUOPDVE and 3/22 – ZDeb)

Debureaucratisation Act (Official Gazette of the Republic of Slovenia, No. 3/22)

Public Finance Act (Official Gazette of the Republic of Slovenia, Nos. 11/11 – official consolidated version, 14/13 – popr., 101/13, 55/15 – ZFisP, 96/15 – ZIPRS1617, 13/18 and 195/20 – odl. US)

Public Procurement Act (Official Gazette of the Republic of Slovenia, Nos. 91/15, 14/18, 121/21 and 10/22)

Act Regulating the Obtaining and Transplantation of Human Body Parts for the Purposes of Medical Treatment (Official Gazette of the Republic of Slovenia, Nos. 56/15 and 186/21 – KZ-1I)

Public Agencies Act (Official Gazette of the Republic of Slovenia, Nos. 52/02, 51/04 – EZ-A and 33/11 – ZEKom-C)

Decision on the establishment of the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (Official Gazette of the Republic of Slovenia, Nos. 115/06 and 70/17)

Decree on administrative operations (Official Gazette of the Republic of Slovenia, Nos. 9/18, 14/20, 167/20 and 172/21)

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 (Official Gazette of the Republic of Slovenia, No. 67/19)

Decree on the implementation of the Regulation (EU) on medical devices (Official Gazette of the Republic of Slovenia, No. 16/18)

Decree on the implementation of the Regulation (EU) on in vitro diagnostic medical devices (Official Gazette of the Republic of Slovenia, No. 16/18)

Decree on the implementation of the Regulation (EU) on market surveillance and compliance of products (Official Gazette of the Republic of Slovenia, No. 194/21)

Administrative Fees Act (Official Gazette of the Republic of Slovenia, Nos. 106/10 – official consolidated version, 14/15 – ZUUJFO, 84/15 – ZZelP-J, 32/16, 30/18 – ZKZaš and 189/20 – ZFRO)

Public Use of the Slovene Language Act (Official Gazette of the Republic of Slovenia, Nos. 86/04 and 8/10)

Act on Additional Measures to Stop Spreading and Mitigate, Control, Recover and Eliminate the Consequences of COVID-19 (Official Gazette of the Republic of Slovenia, No. 206/21)

1.2  IMPLEMENTING REGULATIONS

Tariff of the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (unofficial translation)

Tariff of the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (Official Gazette of the Republic of Slovenia, Nos. 9/18 and 209/21)

Rules on the marketing authorization of medicinal product for human use (Official Gazette of the Republic of Slovenia, Nos. 57/14, 41/17 and 44/19)  

Rules on authorization of a medical product for veterinary use (Official Gazette of the Republic of Slovenia, Nos. 16/11 and 17/14 – ZZdr-2)

Rules on the labelling and instructions for medicinal products for human use (Official Gazette of the Republic of Slovenia, No. 57/14)

Rules on the identification and use instructions of veterinary medicinal products (Official Gazette of the Republic of Slovenia, Nos. 101/09 and 17/14 – ZZdr-2)

Rules on pharmacovigilance of medicinal products for human use (Official Gazette of the Republic of Slovenia, Nos. 57/14 and 27/17)

Rules on pharmacovigilance of veterinary medicinal products (Official Gazette of the Republic of Slovenia, Nos. 53/06 and 17/14 – ZZdr-2)

Order on the determination of the national centre for pharmacovigilance (Official Gazette of the Republic of Slovenia, No. 30/17)

Rules on the classification, prescribing and dispensing of medicinal products for human use (Official Gazette of the Republic of Slovenia, Nos. 86/08, 45/10, 38/12 and 17/14 – ZZdr-2)     

Rules on the classification, prescription and administering of veterinary medicinal products (Official Gazette of the Republic of Slovenia, Nos. 86/00, 33/01 – ZVet-1, 91/08 and 38/09)    

Rules on the production of medicinal products (Official Gazette of the Republic of Slovenia, No. 81/16)

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 (Official Gazette of the Republic of Slovenia, Nos. 46/09 and 17/14 – ZZdr-2)

Rules on the manufacture, wholesale distribution and import of active substances and on registers of manufacturers, wholesalers and importers of active substances (Official Gazette of the Republic of Slovenia, No. 79/16)

Rules concerning the requirements to be met by specialized shops for retail trade in medicinal products and on the procedure for ascertaining their compliance (Official Gazette of the Republic of Slovenia, Nos. 64/09 and 17/14 – ZZdr-2)

Regulations on the conditions and procedures for granting import permit for medicinal products for human use (Official Gazette of the Republic of Slovenia, Nos. 65/12, 20/13 and 17/14 – ZZdr-2)    

Rules on conditions, mode and procedure of entries and imports of individual groups of medicinals for use in veterinary medicine (Official Gazette of the Republic of Slovenia, No. 90/11)

Regulations on authorization of parallel imported product and parallel distribution of medicines (Official Gazette of the Republic of Slovenia, Nos. 49/09, 17/14 – ZZdr-2 and 26/18)

Rules on the system for the receipt, storage and traceability of medicinal products (Official Gazette of the Republic of Slovenia, Nos. 82/15 and 70/16)  

Rules on the traceability of distribution and use, and on storage, of veterinary medicinal products (Official Gazette of the Republic of Slovenia, No. 38/09)

Rules on clinical testing of medicinal products (Official Gazette of the Republic of Slovenia, Nos. 54/06 and 17/14 – ZZdr-2)

Rules on the traditional medicinal products of plant origin (Official Gazette of the Republic of Slovenia, Nos. 55/06 and 17/14 – ZZdr-2)

Rules concerning the procedure of edition and of the revocation of permission for performing the activity of supply with blood (Official Gazette of the Republic of Slovenia, No. 6/08)

Regulations on conditions for performing the activity of supply with blood (Official Gazette of the Republic of Slovenia, No. 6/08)

Rules on hemovigilance (Official Gazette of the Republic of Slovenia, No. 9/07)

Rules on tissue vigilance (Official Gazette of the Republic of Slovenia, No. 47/17)

Rules on the manner and form of access to the documentation (Official Gazette of the Republic of Slovenia, No. 9/07)

Rules concerning the method of storing, delivery, transport and elimination / removal of unused blood and blood preparations (Official Gazette of the Republic of Slovenia, No. 100/02 and 104/06 – ZPKrv-1)

Rules on the requirements for the organization and carrying out of blood donation sessions (Official Gazette of the Republic of Slovenia, Nos. 92/03 and 104/06 – ZPKrv-1)

Rules concerning requirements for the acquisition of one’s own blood, collecion oft individual types of cells andblood plasm (Official Gazette of the Republic of Slovenia, Nos. 118/03 and 104/06 – ZPKrv-1)

Rules on the content of records kept on any use of blood, blood preparations and medicinal products made of blood, including biotechnological blood substitutes (Official Gazette of the Republic of Slovenia, Nos. 70/03, 104/06 – ZPKrv-1 and 9/07)

Rules on the compulsory testing of human blood and blood components (Official Gazette of the Republic of Slovenia, Nos. 9/07 and 62/18)

Rules on the standards and technical requirements of the blood transfusion quality system (Official Gazette of the Republic of Slovenia, Nos. 9/07 and 21/18)

Rules on the methodology for determining the price of blood and blood products (Official Gazette of the Republic of Slovenia, No. 24/09)

Rules on the collection, processing, storage, distribution and transportation of human blood and blood components (Official Gazette of the Republic of Slovenia, Nos. 9/07, 58/11 and 21/18)

Rules on the technical and medical requirements for blood collection (Official Gazette of the Republic of Slovenia, Nos. 9/07, 107/09, 91/13 and 91/15)

Rules on the conditions for granting licenses to perform the activity of supplying human tissue and cells (Official Gazette of the Republic of Slovenia, No. 31/17)

Rules on the conditions and methods of the import / export and entry / exit of human tissues and cells ((Official Gazette of the Republic of Slovenia, No. 47/18)

Rules on donation and procurement of human tissues and cells (Official Gazette of the Republic of Slovenia, Nos. 70/08, 67/14 and 79/14)

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 (Official Gazette of the Republic of Slovenia, No. 43/18)

Rules on the reception, processing, storage, release and distribution of human tissues and cells (Official Gazette of the Republic of Slovenia, Nos. 70/08 and 46/18)

Rules on the exceptional use of medicinal products for the treatment of animals and on animal treatment records (Official Gazette of the Republic of Slovenia, Nos. 53/06 and 17/14 – ZZdr-2)

Rules on united national naming of medicinal active ingredients and system of arranging treated for round anatomically-therapeutic-chemical classification (Official Gazette of the Republic of Slovenia, Nos. 86/08 and 17/14 – ZZdr-2)

Rules on radiopharmaceuticals (Official Gazette of the Republic of Slovenia, No. 61/18)

Rules on coloring matters that may be added to medicinal products (Official Gazette of the Republic of Slovenia, No. 51/17)

Rules on more exact donditions and procedure for determining interchangeable medicinal (Official Gazette of the Republic of Slovenia, Nos. 102/10 and 17/14 – ZZdr-2)

Rules on homeopathic medicines for human use (Official Gazette of the Republic of Slovenia, Nos. 94/08 and 17/14 – ZZdr-2)

Rules on recall of medicines (Official Gazette of the Republic of Slovenia, Nos. 105/08 and 17/14 – ZZdr-2)

Rules on advertising of medicines (Official Gazette of the Republic of Slovenia, Nos. 105/08, 98/09 – ZMedPri, 105/10 and 17/14 – ZZdr-2) 

Rules on the assessment and procedures for compliance monitoring of the principles of good laboratory practice (Official Gazette of the Republic of Slovenia, Nos. 38/00 and 14/13)  

Rules on the principles of good laboratory practice (Official Gazette of the Republic of Slovenia, Nos. 38/00 and 2/04) 

Rules determining the prices of medicinal products for human use (Official Gazette of the Republic of Slovenia, Nos. 32/15, 15/16, 19/18, 11/19, 26/20, 51/21 and 52/21 – corrigendum)

Rules on the use of potassium iodine (Official Gazette of the Republic of Slovenia, Nos. 59/10 and 17/14 – ZZdr-2)  

Rules on the central database of medicinal products for human use (Official Gazette of the Republic of Slovenia, No. 21/17)

Rules on Medical Devices (Official Gazette of the Republic of Slovenia, Nos. 37/10 and 66/12)     

Rules on the manufacturing and trade with medical devices (Official Gazette of the Republic of Slovenia, No. 37/10)

Rules on the vigilance of medical devices (Official Gazette of the Republic of Slovenia, No. 61/10)  

Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19)

Order on list of standards, when applied, create the presumption of conformity of medical device in accordance with the Act on medical devices (Official Gazette of the Republic of Slovenia, Nos. 28/11 and 15/17)

Rules on the definition of national addition to European pharmacopaeia (Official Gazette of the Republic of Slovenia, Nos. 118/06 and 17/14 – ZZdr-2)

Rules on the method and procedure for analytical, non-clinical pharmaco-toxicological and clinical testing of medicinal products for human use (Official Gazette of the Republic of Slovenia, No. 16/18)

Rules on expanded professional boards (Official Gazette of the Republic of Slovenia, Nos. 44/17 and 187/21)

Order on list of standards, when applied, create the presumption of conformity of medical device in accordance with the Act on medical devices (Official Gazette of the Republic of Slovenia, Nos. 28/11 and 15/17)

Decree on management with waste medicines (Official Gazette of the Republic of Slovenia, Nos. 105/08 and 84/18 – ZIURKOE)

Rules on the membership, responsibilities and working methods of the Commission for Medical Ethics (Official Gazette of the Republic of Slovenia, No. 11/20)

Decree on fees for the Medical Ethics Committee of the Republic of Slovenia (Official Gazette of the Republic of Slovenia, No. 48/18)

Rules on the conditions for providing pharmacy practice (Official Gazette of the Republic of Slovenia, Nos. 28/18, 71/18 and 5/20)

Rules on the conditions for providing radiopharmaceutical services ((Official Gazette of the Republic of Slovenia, No. 82/18)

Rules on the provision of pharmacy services by hospital pharmacies (Official Gazette of the Republic of Slovenia, No. 28/18)

Rules on the provision of pharmacy practice within the military healthcare of the Slovenian Armed Forces (Official Gazette of the Republic of Slovenia, No. 73/18)

Rules concerning mode of action of the Expert Council for blood, blood derivatives and blood products supply (Official Gazette of the Republic of Slovenia, No. 52/21)

Notice on the Validation of the Fifth Edition of the Slovenian National Formulary to the European Pharmacopeia – Formularium Slovenicum 5.0 (Official Gazette of the Republic of Slovenia, No. 145/20)

Notice on the Validation of the First Addendum to the Fifth Edition of the Slovenian National Formulary to the European Pharmacopeia – Formularium Slovenicum 5.1 (Official Gazette of the Republic of Slovenia, No. 178/21)

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 (Official Gazette of the RS, No. 178/21)

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 (Official Gazette of the Republic of Slovenia, No. 178/21)

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 (Official Gazette of the Republic of Slovenia, No. 178/21)

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