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Territory – SloveniaMinistrstvo za zdravje/ Ministry of Health (S MOH) Primary Language s – –
Territory – SloveniaAgency for Medicinal Products and Medical Devices Language – English
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EUROPEAN LEGISLATION General online address for access to legislation: EUR Lex – acces s to European Union Law (when searching set the language in the upper right corner)
EU LEGISLATION CONNECTED TO MEDICINAL PRODUCTS FOR HUMAN AND VETERINARY USE
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products
Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93
EU LEGISLATION CONNECTED TO MEDICINAL PRODUCTS FOR HUMAN USE Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises
Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products
Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council
Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’
Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring
Commission Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required
Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity
Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast)
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast)
Commission Implementing Decision of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council
2013/51/EU: Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council
1.2 EU LEGISLATION CONNECTED TO MEDICINAL PRODUCTS FOR VETERINARY USE Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance
Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products
Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans
Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals
Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation
Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products
Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
2. EU LEGISLATION CONNECTED TO MEDICAL DEVICES
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices
Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices
Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose
Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices
Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices
Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices
Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
3. EU LEGISLATION CONNECTED TO BLOOD, TISSUE AND CELLS
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events
Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components
Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments
Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life
Commission Directive 2014/110/EU of 17 December 2014 amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations
Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells
4. OTHER
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
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 authorization of a medical product for veterinary use
Rules on the labelling and instructions for medicinal products for human use
Rules on the identification and use instructions of veterinary medicinal products
Rules on pharmacovigilance of medicinal products for human use
Rules on pharmacovigilance of veterinary medicinal products
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 classification, prescription and administering of veterinary medicinal products
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 the exceptional use of medicinal products for the treatment of animals and on animal treatment records
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
Order on list of standards, when applied, create the presumption of conformity of medical device in accordance with the Act on 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 Fifth Edition of the Slovenian National Formulary to the European Pharmacopeia – Formularium Slovenicum 5.0
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
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
MEDICINAL PRODUCTS FOR HUMAN USE
Proper regulation of medicinal products for human use is an important part of efforts to protect public health. In the Republic of Slovenia, medicinal products are regulated by the Medicinal Products Act (Official Gazette of the Republic of Slovenia, No 17/2014 and No 66/2019 , hereinafter: the Act) and the related implementing regulations, and they fall under the competence of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP).
In accordance with the legislation relating to medicinal products, a medicinal product is any substance or a combination of substances presented as having properties for treating or preventing disease in human beings. A medicinal product is also any substance or a combination of substances that may be used in humans in order to establish a diagnosis or to restore, correct or modify physiological functions by exerting pharmacological, immunological or metabolic action.
HTA (Information on Health Technology Assessment)MEDICINAL PRODUCTS FOR VETERINARY USE
DESCRIPTION
MARKETING AUTHORISATION
Medical devices
MEDICAL DEVICE VIGILANCE
Blood, tissues and cells
TISSUES AND CELLS SUPPLYADVANCED THERAPY MEDICINAL PRODUCTS PREPARED ON A NON-ROUTINE BASIS
Regulation of activities
Inspection
