ORDER promulgating the Medicinal Products Act (ZZdr-2) MEDICINAL PRODUCTS ACT (ZZdr-2)

Transcription

1 539. The Medicinal Products Act, page Pursuant to the second indent of the first paragraph of Article 107 and the first paragraph of Article 91 of the Constitution of the Republic of Slovenia, I hereby issue an ORDER promulgating the Medicinal Products Act (ZZdr-2) I hereby promulgate the Medicinal Products Act (ZZdr-2), adopted by the National Assembly of the Republic of Slovenia at its session held on 24 February No / Ljubljana, 4 March 2014 Borut Pahor President of the Republic of Slovenia MEDICINAL PRODUCTS ACT (ZZdr-2) I. GENERAL PROVISIONS Article 1 (Scope and responsibility) (1) This Act regulates the field of medicinal products for human use and veterinary medicinal products, the conditions and measures to ensure their quality, safety and efficacy, conditions and procedures for their testing, the production, distribution and use of medicinal products, the prices of medicinal products, official controls, advanced therapy medicinal products prepared on a non-routine basis, and supervision of the implementation of this Act with the aim of public health protection for medicinal products that are industrially produced or manufactured in a manner involving an indus trial process, including pre-mixes for preparing medicated compound feeding stuffs, with active substances used as starting materials, and for certain substances which may be used as veterinary medicinal products, and having anabolic, anti-infection, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties, and the tasks and competences of the Public Agency of the Republic of Slovenia for Medicines and Medical Devices (hereinafter referred to as: JAZMP). (2) This Act shall also apply to homeopathic medicinal products, unless otherwise specified herein. Article 2 (Transposition and implementation of EU legislation) (1) By this Act the following EU directives shall be transposed into the legislation of the Republic of Slovenia: Council Directive of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, , p. 8, hereinafter: Directive 89/105/EEC); Commission Directive of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, , p. 70; hereinafter: Directive 91/412/EEC); 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 (OJ L 121, , p. 34), as last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny Part Four (OJ L 188, , p. 14; hereinafter: Regulation 596/2009/EC), (hereinafter: Directive 2001/20/EC); Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for veterinary use (OJ L 311, , p. 1), last amended by

2 Regulation 596/2009/EC (hereinafter: Directive 2001/82/EC) except in the part relating to the use of medicinal products and use-related traceability of medicinal products, which is regulated by the law on veterinary compliance criteria; 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 (OJ L 311, , p. 67), as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, , p. 1), (hereinafter: Directive 2001/83/EC); 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 (OJ L 262, , p. 22; hereinafter: Directive 2003/94/EC); Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, , p. 13; hereinafter: Directive 2005/28/EC). (2) This Act shall regulate the implementation of the following regulations: Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, , p. 1), as last amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (OJ L 316, , p. 38), (hereinafter: Regulation 726/2004/EC); 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) N o 726/2004 (OJ L 324, , p. 121), as last amended by Regulation (EU) No.1235/2010 of the European Parliament and of the Council of 15 December 2010 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products, as regards pharmacovigilance of medicinal products for human use (OJ L 348, , p. 1), (hereinafter: Regulation 1394/2007/EC); 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 (OJ L 334, , p. 7), as last amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 209, , p. 4), (hereinafter: Regulation 1234/2008/EC); Regulation (ES) 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 (OJ L 152, , p. 11, hereinafter: Regulation 470/2009/EC). Article 3 (Competent authority) (1) The minister for the area of medicinal products governed by this Act shall be the minister competent for health (hereinafter: the Minister), unless stipulated otherwise by this Act. (2) The implementing regulations in the field of veterinary medicinal products shall be issued by the Minister in agreement with the Minister responsible for veterinary medicine (hereinafter: the Minister responsible for veterinary medicine). (3) The body responsible for medicinal products covered by this Act is JAZMP. (4) JAZMP shall act in administrative matters in accordance with the Act governing the general administrative procedure, unless otherwise stipulated by this Act. (5) Unless otherwise provided by this Act, in administrative matters, JAZMP must request that any incomplete application be supplemented within five days of its receipt and notify the applicant of the deadline by which the applicant must supplement such application.

3 (6) In the matters in which JAZMP shall decide under this Act, JAZMP may by way of an order request the applicant to submit additional documentation or information by a specified deadlin e. The finality of this Decision shall suspend the time limit for taking a decision under this Act, which shall start again upon the expiry of the deadline for the submission of documents or data or the presentation of these, whichever is earlier. Article 4 (Strategic Council for Medicinal Products, commissions and external experts of JAZMP) (1) The Strategic Council for Medicinal Products is an advisory body of the Minister that deals with strategic issues in the field of medicines. Members of the Strategic Council for Medicinal Products shall be appointed by the Minister, who shall determine their responsibilities and method of work. (2) JAZMP may, in dealing with matters within its competence, include external experts (hereinafter: external experts) if in the performance of its tasks it assesses that the implementation of the tasks requires expert knowledge that JAZMP does not possess. Persons or organisations that possess the expert knowledge necessary for elucidating a state of affairs shall be appointed external experts. If an organisation is appointed as an external expert, one or more than one authorised persons shall participate in procedures on its behalf. (3) Individual external experts may be included in expert committees, expert working groups a nd other expert groups of the European Medicines Agency and the European Commission, and may participate in the activities of other bodies and institutions as well as other international networks in dealing with professional matters in the areas stipulated by this Act. (4) The list of external experts referred to in the second and third paragraphs of this Article shall be determined by the Minister from among experts in the fields of pharmacy, medicine, veterinary medicine and other areas, whereas the list of experts in the field of veterinary medicinal products is laid down by the Minister in agreement with the Minister responsible for veterinary matters. In exceptional cases and with the consent of the Minister, JAZMP may, in order to ensure smooth implem entation of the work process, use an external expert who is not included in the current list of external experts. (5) The Minister shall appoint the commissions, committees and groups that include JAZMP representatives and external experts referred to in the preceding paragraph for the purpose of resolving issues within the competence of JAZMP. Commissions, committees and groups shall draft opinions and proposals on: procedures for obtaining marketing authorisation; procedures for obtaining authorisation for a clinical trial of medicinal products; drafting the list of essential medicines and indispensable medicinal products; determining extraordinary higher approved prices of medicinal products for human use; the Pharmacopoeia. (6) The criteria for determining the proficiency and conflicts of interests of candidates for the job of an external expert, the method of work of individual external experts and the working methods of the committees and commissions referred to in the preceding paragraph shall be determined by JAZMP upon the prior consent of the Minister. (7) External experts shall be impartial in carrying out their work and shall respect the confidentiality of data. (3) They must have no conflict of interest in a manner that would allow undue advantage or favour certain parties in procedures. (8) JAZMP shall appoint an expert commission to assess compliance with the conditions of manufacturing and marketing of medicinal products and active ingredients, and of advanced therapy medicin al products prepared on a non-routine basis. (9) The Minister responsible for veterinary medicine shall appoint commissions for doctrinaire issues regarding veterinary medicinal products. Article 5 (Definition of a medicinal product) (1) A medicinal product is any substance or a combination of substances presented as having properties for treating or preventing disease in human beings or animals.

4 (2) A medicinal product is also any substance or a combination of substances that may be used in humans or animals, and is administered to humans or animals, in order to establish a diagnosis or to restore, correct or modify physiological functions by exerting pharmacological, immunological or metabolic action, or to provide diagnosis. (3) A substance referred to in the first and second paragraphs of this Article may be: of human origin; of animal origin; of herbal origin; of microbial origin; of chemical origin; chemical products obtained by chemical change or synthesis; or obtained by biotechnological procedures. Article 6 (Definitions) The terms used in this Act shall have the following meanings: 1. Analysis of the quality of a medicinal product is a qualitative analysis of all components, quantitative analysis of at least all the active ingredients and all other tests that are needed to determine the quality of the medicinal product in accordance with the requirements of the marketing authorisation or testing methods that are in accordance with the provisions of Article 28 hereof or developed and validated for the purpose of determining the quality of the medicinal product. 2. A biological medicinal product is a medicinal product that contains as an active ingredient a biological substance or a substance obtained by a process that includes biological systems. A biological substance is one that is obtained from or through the use of a biological source, and needs a combination of physicochemical and biological testing in order to determine its quality, together with the production procedure and its supervision. These are, for example, medicinal products produced by biological or biotechnical processes, including cell cultures, etc. 3. The centralised procedure is the procedure for obtaining marketing authorisation for a medicinal product in the European Union, as laid down in Regulation 726/2004/EC. 4. Placing medicinal products on the market means supplying the market with medicinal products or making them available against payment or free of charge in the Republic of Slovenia. 5. The decentralised procedure is the procedure for obtaining medicinal product marketing authorisation that is started simultaneously in the Reference Member State and in the Concerned Member States. It is compulsory for medicinal products that are not subject to the centralised procedure, have not yet obtained marketing authorisation in the EU and will be marketed in more than one EU Member State, as laid down in Directive 2001/83/EC and Directive 2001/82/EC. 6. Good distribution practice is a quality system relating to the organisation, implementation and control of product storage in a specific order before further use or placement on the market and the transport of products from the manufacturer to the end-user in accordance with the principles and guidelines for m edicinal products and active ingredients, which are adopted and laid down by the European Commission. 7. Good pharmacovigilance practices are guidelines on the implementation of pharmacovigilance activities in accordance with Article 108 of Directive 2001/83/EC. 8. Good clinical practice in the conduct of clinical trials (of medicinal products) for human use is an international ethical and scientific system of quality in the planning, implementation, recording, monitoring and reporting of clinical trials in humans that ensures the credibility of the data obtained in the trial, and protects the rights and safety of subjects under study in accordance with the Declaration of Helsinki of the World Health Organisation on medical research involving human subjects (1964), published on the website with this Act, the regulations adopted on the basis thereof, and the rules of the European Union.

5 9. Good clinical practice in the conduct of clinical trials in veterinary medicine is an international ethical and scientific system of quality the in planning, implementation, recording, monitoring and reporting of clinical trials in target animals, which ensures the credibility of the data obtained in the trial, and protects the safety of animals under study in compliance with this Act, the regulations adopted on the basis thereof, and the regulations on the protection of animals. 10. Good laboratory practice is a system of quality control for the implementation of analytical testing of medicinal products, which may also be part of good manufacturing practice carried out for the purpose of the product quality control. 11. Good laboratory practice is a quality control system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported in accordance with the principles and guidelines adopted and published by the European Commission. 12. Good manufacturing practice is a quality control system that ensures strict quality control in the production of medicinal products and active substances in compliance with the quality standards appropriate for their intended use and in accordance with the principles and guidelines adopted and p ublished by the European Commission. 13. A possible adverse effect of a medicinal product is a suspected adverse reaction in which a causal relationship between the medicinal product and the adverse event is at least reasonably possible. 14. The European Pharmacopoeia is a pharmacopoeia provided for by the Convention on the Elaboration of a European Pharmacopoeia of the Council of Europe (1964), published on the website and published by the European Directorate for the Quality of Medicines (EDQM). 15. Pharmaceutical form is the form of a medicinal product in which an active ingredient or ingredients are incorporated by means of technological procedures to facilitate their use, having regard to the physiological conditions and physicochemical properties of the active ingredient and excipients. 16. The Pharmacopoeia is a collection of monographs and other provisions for the development, preparation and manufacturing of medicinal products, authentication, identification of purity and testing of other parameters of the quality of medicinal products and their ingredients, as well as other information on medicinal products. 17. Pharmacovigilance is the system of detection, assessment, understanding and prevention of adverse reactions to medicinal products and other information about the safety of medicines and actions taken to manage and reduce risks associated with medicinal products. 18. An officinal formula for use in human medicine is a medicinal product prepared as a medicinal product k ept in stock at the pharmacy, or in a galenic laboratory of the pharmacy, from ingredients that are active substances or excipients in accordance with the applicable pharmacopoeias or in accordance with prescriptions (for the needs of hospital services) that shall be confirmed by JAZMP on the joint proposal of the extended expert panel for the relevant therapeutic domain and the extended expert panel for pharmacy, and is intended to be dispensed to end-users of the relevant pharmacy services in accordance with the regulations governing pharmacy. 19. An officinal formula for veterinary use is a medicinal product prepared as a medicinal product kept in stock at the pharmacy, or in a galenic laboratory of the pharmacy, from ingredients that are active substanc es or excipients in accordance with the applicable pharmacopoeia and the prescriptions thereof. An officinal formula may also be prepared in accordance with prescriptions confirmed by JAZMP on the joint proposal of the expert body for veterinary medicine and the extended expert panel for pharmacy, and is intended to be dispensed to users of the relevant pharmacy services in accordance with the regulations governing pharmacy. 20. A generic medicinal product is a medicinal product that has the same qualitative and quantitative composition and pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference product has been established by suitable bioavailability studies. Different salts, esters, ethers, isomers, mixed isomers, active substance complexes or derivatives shall be regarded as the same active substance, unless they differ significantly in terms of safety or efficacy or both. 21. The pharmacovigilance system master file is a detailed description of the pharmacovi gilance system used by marketing authorisation holders for one or more medicinal products that have obtained marketing authorisation. 22. A homeopathic medicinal product is a medicinal product prepared from substances called homeopathic stocks in accordance with homeopathic manufacturing described by the European Pharmacopoeia or, in the

6 absence thereof, by the pharmacopoeias currently used officially in the EU Member States. A homeopathic medicinal product may contain several essential ingredients. 23. The name of a medicinal product may be an invented name that must not lead to confusion with a common name, or a common or scientific name, accompanied by a trade name or the name of the holder (hereinafter: the holder) of the marketing authorisation for the medicinal product. 24. Immunological medicinal products are vaccines, toxins and serums that are used for: triggering active immunity; activating passive immunity; or diagnosing the state of immunity; and allergens that are intended to reveal or initiate a specific acquired change in the immunological response to allergy causing agents. 25. An intermediate is an intermediate product of a multi-stage synthesis of an active ingredient, which is generally subject to further molecular changes, or purification, and can be isolated or not, before it becomes an active ingredient This definition applies to substances produced by the level of synthesis specified by the manufacturer of the active ingredient as the initial synthesis of the active ingred ient. 26. The dispensing of medicinal products in retail trade is the sale and delivery of medicinal products in retail trade, chargeable partly or totally to public funds, or the delivery of medicinal products that are donated or provided for from budget funds to end-users, and which are accompanied by appropriate independent expert support and advice. 27. Off-label use is the use of a veterinary medicinal product that is not compliant with the summary of the medicinal product characteristics but is perm itted under the conditions laid down by this Act and the law governing veterinary compliance criteria. 28. Exit shall mean the wholesale of a medicinal product from the Republic of Slovenia to another EU Member State. Exit of a medicinal product shall als o mean the transfer of a medicinal product from the Republic of Slovenia to another EU Member State by an individual either for his/her personal use or the use of his/her close family members or based on an authorisation for the personal use of not more th an one individual who is not his/her close family member or for the needs of his/her animal. 29. Export of a medicinal product shall mean the wholesale of a medicinal product from the Republic of Slovenia to third countries. Export of a medicinal product shall also mean the transfer of a medicinal product from the Republic of Slovenia to third countries by an individual either for his/her personal use or the use of his/her close family members or based on an authorisation for the personal use of not more than one individual who is not his/her close family member or for the needs of his/her animal. 30. Health care providers are public health institutions and other legal entities and natural persons carrying out health care activities in accordance with the regulations governing health care services, with the exception of pharmacy. 31. Veterinary service providers are veterinary organisations and other organisations carrying out veterinary activities in accordance with the regulations governing veterinary services. 32. The strength of a medicinal product is the content of the active ingredient expressed quantitatively per dosage unit, per unit of volume or weight, according to pharmaceutical form. 33. A withdrawal period is the period that must elapse after the last administration of the veterinary medicinal product to animals under normal conditions of use in accordance with this Act and with the regulations issued thereof, pending the acquisition or production of foodstuffs from such animals, in order to e nsure that such foodstuffs do not contain residues exceeding the maximum levels laid down by Regulation 470/2009/EC and Commission Regulation (EU) No. 37 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, , p. 1) as last amended by Commission Implementing Regulation (EU) No 489/2013 of 27 May 2013 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance double stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the Israel Acute Paralysis Virus (OJ L 141, , p. 4), (hereinafter: Regulation 37/2010/EU).

7 34. The end-user of a medicinal product for human use is an individual who was prescribed or dispensed the medicinal product (hereinafter: patient) or a health care service provider who uses the medicinal product in carrying out health care services. 35. The end-user of a veterinary medicinal product is the owner or caretaker of the animal for which the medicinal product was prescribed or dispensed, or a legal entity that uses the medicinal product in carrying out veterinary services. 36. A magistral formula for human use is a medicinal product that has been produced in a pharmacy in accordance with a medical prescription for an individual patient or a group of pa tients and dispensed directly after its manufacture, when for the purpose of achieving a particular therapeutic effect there is no industrially produced or officinal medicinal product of the same strength and the same composition of active ingredients and excipients or pharmaceutical form available on the market. 37. A magistral formula for veterinary use is a medicinal product manufactured in a pharmacy according to a veterinary prescription for a particular animal or a smaller group of animals and disp ensed directly after its manufacture. 38. A disruption in the supply of a medicinal product is a state of the market where business entites responsible for market supply in the Republic of Slovenia fail to provide the required amounts of medicinal products at the appropriate time. 39. The National Centre for Pharmacovigilance is a legal entity performing statutory tasks in the field of pharmacovigilance of medicinal products for human use and meeting the requirements regarding personnel, premises and equipment for this activity that have been determined by the Minister. 40. The national identifier of a medicinal product under which the medicinal product is marketed in the Republic of Slovenia is a unique code assigned to the medicinal product by JAZMP with respect to the active ingredients, pharmaceutical form, strength, packaging and marketing authorisation holder. 41. The national procedure for the acquisition of marketing authorisation in the Republic of Slovenia is a procedure for the acquisition of m arketing authorisation for those medicinal products for which the centralised procedure is not mandatory and which will be granted marketing authorisation only in the Republic of Slovenia. 42. A risk management plan in the area of pharmacovigilance is a detailed description of the risk management system. 43. The maximum residue limit is the maximum residue level of medicinal products after their use in veterinary medicine as laid down in Regulation 470/2009/EC. 44. An error in the use of a medicinal product is any unintended incorrect prescribing or dispensing or incorrect use of a medicinal product by a health care professional, patient or end-user. 45. Package leaflet shall mean the written information for end-users that is enclosed with the medicinal product. 46. A non-interventional trial is a clinical trial in which the selection of patients, treatment modality, choice of medicinal product and its prescription, as well as the assignment of diagnostic procedures and patient follow -up, are consistent with the established treatment approach, which is in compliance with the approved or prescribed dosing, method of use or indications. 47. Off-label use of a medicinal product is any intentional use of a product for medical purposes that is not consistent with its marketing authorisation. 48. Incorrect use of a medicinal product is any intentional use of a product that is not consistent with its marketing authorisation. 49. An unexpected side effect is an adverse reaction whose nature, severity or consequ ence is not consistent with the summary of product characteristics. 50. An advanced therapy medicinal product is any medicinal product for advanced therapy prepared on a non - routine basis in the Republic of Slovenia in accordance with the quality standard s laid down by this Act and used in the Republic of Slovenia by a health care provider or a veterinary service provider who: performs a health care activity under the exclusive professional responsibility of a physician in accordance with an individual order for an individual advanced therapy medicinal product prepared on a non -routine basis for an individual patient; or

8 performs a veterinary service under the exclusive professional responsibility of a veterinarian in accordance with an individual order for an individual animal or a group of animals from the same property. 51. An adverse effect of a medicinal product for human use is a reaction of the patient to a medicinal product that is noxious and unintended. 52. An adverse effect of a veterinary medicinal product is a harmful and unexpected reaction that can occur at doses that are normally used in animals for the prevention, diagnosis or therapy of diseases, or for restoring. improving or modifying physiological functions. 53. An adverse effect of a medicinal product in a clinical trial is any harmful and unexpected response to the investigational medicinal product associated with the dose administered. 54. The obligation to provide services in the public interest shall mean the obligation of wholesalers to provide a permanent and adequate range of medicinal products to meet the demand in the Republic of Slovenia throughout its territory in an accordingly short period of time as specified by health care service providers on the basis of demonstrable health needs or health documentation, and to deliver the supplies required in the Republic of Slovenia. 55. Recall of a certain batch of medicinal product shall mean any activity related to the intent of withdrawing the batch from the market and from use due to inadequate quality of the medicinal product batch or due to a pharmacovigilance measure. 56. Medicinal product labelling shall mean information appearing on the immediate or outer packaging. 57. Parallel distribution of medicinal products is the entry of medicinal products that have obtained marketing authorisation via the centralised procedure from one EU or EEA Member State (hereinafter: EEA) in another, and is carried out in accordance with the applicable regulations by a wholesaler whose business regarding this medicinal product is unrelated to the marketing authorisation holder. 58. A biosimilar medicinal product is a medicinal product that is similar to a biological reference product with marketing authorisation. The active ingredient in a biosimilar medicinal product is comparable to the active ingredient in a reference medicinal product. The similarity of the reference medicinal product must be demonstrated in terms of quality, biological activity, safety and efficacy on the basis of comparative research. The posology and route of administration should be the same as for the reference biological medicinal product. Any deviation in the form of a medicinal product or its excipients must be duly justified and supported by additional research. 59. Parallel import shall mean the entry of medicinal products with marketing authorisation in the state of export that are sufficiently similar to products that have obtained marketing authorisation in Slovenia via the national procedure or the mutual recognition procedure or the decentralised procedure, and that enter the Republic of Slovenia on the basis of marketing authorisation for a parallel imported medicinal product issued by JAZMP, where the parallel import is carried out by a wholesaler whos e business regarding this medicinal product is unrelated to the marketing authorisation holder. 60. Occupational exposure to a medicinal product is exposure to the medicinal product in the workplace. 61. A semi-finished product is a product that has pass ed all stages of production, with the exception of packaging in the outer packaging. 62. A falsified medicinal product is any medicinal product with false presentation of: identity, including its packaging and labelling or name or composition of any of the ingredients, including excipients, and strength; its source, including the manufacturer, country of manufacture, country of origin or the marketing authorisation holder; or history, including records and documentation on the distribution channel s used. This definition shall not apply to unintentional quality defects and is without prejudice to the infringement of intellectual property rights. 63. An excipient is any component of the medicinal product that is not an active ingredient or packagin g. 64. An individual person (hereinafter: an individual) is an identified or identifiable natural person who can be identified directly or indirectly.

9 65. An individual production site is a limited space that, in relation to its surroundings, constitutes a whole, and within which the manufacturing authorisation holder carries out medicinal product manufacturing activities. 66. Individual production activities are the medicinal product manufacturing activities that are defined as the production of semi-finished products, the production of final forms in the strict sense, primary packaging, outer packaging, a batch release or the finished medicinal product, quality control and the import of medicinal products. They are divided according to the intended use of the medicinal products, manufacturing activity involving medicinal products for human and veterinary use, and, with respect to the level of development, according to medicinal product manufacturing activities and activities involving the manufacture of medicinal products for a clinical trial. The activities entailing the manufacturing of final forms in the strict sense are divided according to pharmaceutical forms. Quality control activities are divided according to the type of tests performed, the production of medicinal products for human and veterinary use, and, with respect to the level of development, according to medicinal product manufacturing activities and the activities of manufacturing medicinal products for a clinical trial. The activities of manufacturing final forms in the strict sense are divided according to pharmaceutical forms. Quality control activities are divided according to the type of tests performed. 67. Business entities are domestic and foreign legal entities, sole proprietors, individuals who independently perform activities, and other natural persons performing registered activities or activities laid down by a regulation or an act establishing a certain activity. 68. Brokering medicinal products or active substances or both s hall mean all activities in relation to the sale or purchase of medicinal products or active substances or both, except for wholesale distribution and sale that do not include physical handling and that consist of negotiating independently on behalf of ano ther business entity. 69. A mutual recognition procedure is the procedure for obtaining marketing authorisation for a medicinal product, which shall be initiated in the Concerned Member States after approval is granted by the Reference Member State of the European Union, and is compulsory for medicinal products that are not subject to the centralised or decentralised marketing authorisation procedure and will be marketed in more than one EU Member State, as laid down in Directive 2001/83/EC and Directive 2001/82/EC. 70. A premix for the preparation of medicated feed is a medicinal product for veterinary use prepared in advance for further manufacture of medicated feed. 71. The priority supply of industrially manufactured medicinal products from Slovenian plasma (i.e. fresh-frozen plasma collected for processing in the Republic of Slovenia) is the underlying principle that regulates the provision of medicinal products in the EU from foreign plasma based on marketing authorisation when medicinal products from Slovenian plasma cannot cover all the needs for these products in the Republic of Slovenia, except where the entry or importation of certain medicinal products from foreign plasma is scientifically founded or there is a strategic reason that has been considered by the Strategic Council for Medicinal Products and the Expert Council for the Supply of Blood and Plasma-derived Medicinal Products. 72. An overdose is the use of such quantities of medicinal products in either a single dose or cumulatively that, with respect to the marketing authorisation and taking into account the clinical assessment, exceed the maximum permitted dose. 73. Placing a medicinal product on the market means the first activity undertaken in the marketing of a medicinal product that allows the market to be supplied with this product and its availability to end -users. 74. The wholesale of active substances and excipients means the purchase, storage, sale, entry, import, exit or export of active substances. 75. The wholesale of medicinal products means the purchase, entry, storage, exit, export and sale of medicinal products, except medicinal products dispensed to retail end-users. 76. The retail sale of medicinal products means the purchase, storage and dispensing of a medicinal pr oduct or its use within a medical or veterinary service. 77. Radiopharmaceutical products are radiopharmaceuticals, radionuclide precursors, radionuclide generators and kits for the preparation of radiopharmaceuticals, namely: a radiopharmaceutical is a medicinal product that, when ready for use, contains one or more radionuclides (radioactive isotopes) intended for use in human and veterinary medicine; a radionuclide generator is a system incorporating a solid-fixed parent radionuclide generating offspring radionuclide that can be separated by rinsing or some other method, and used as a radiopharmaceutical or radionuclide precursor;

10 a radionuclide precursor is a radionuclide used in the process of radiopharmaceutical preparation for labelling other substances, whereby the labelling takes place before application to the patient; a kit for a radiopharmaceutical preparation is any product that is reconstituted or combined with radionuclides (or radionuclide precursor) to make a final radiopharmaceutical, generally before application to the patient. 78. A risk-benefit ratio is an evaluation of the positive effects of treatment with the medicinal product compared with the risks as laid down in this Act. 79. A Reference Member State is the Member State that, in the mutual recognition procedure or decentralised procedure, draws up an assessment report on the basis of which EU Member States decide on the acceptability of the risk-benefit ratio or the evaluation of the quality, safety and efficacy of the medicinal product in accordance with Directive 2001/83/EC and Directive 2001/82/EC. 80. A reference medicinal product is a medicinal product that has obtained marketing authorisation in accordance with Article 44 of this Act and whose documentation serves as a reference to other applicants, taking into account Article 59 thereof. 81. A serious adverse effect of a medicinal product for human use is an adverse effect that causes death, is life threatening, requires hospitalisation or prolongation of the existing hospitalisation treatment, causes persistent or significant disability or incapacity, or a congenital anomaly or birth defect. 82. A serious adverse effect of a medicinal product for veterinary use is an adverse effect that causes death, is life threatening, causes persistent or significant disability or incapacity, a congenital anomaly or birth defect or permanent or prolonged pathological symptoms in treated animals. 83. A batch is a specified quantity of the medicinal product with the expected ho mogeneity, which is created within a single process or a series of processes and is identified with a clearly defined combination of characters, i.e. numbers or letters. It includes all the units of a pharmaceutical form that have been produced from the sa me initial quantity of material and were included in the same sequence of the production process or the same process of sterilisation. In the case of an interrupted production process, it contains all the units produced in the specified time period. 84. A pharmacovigilance system is the monitoring and reporting system managed by marketing authorisation holders and EU Member States for the implementation of tasks and responsibilities pursuant to this Act intended to monitor the safety of authorised medicinal products and to detect any changes in the risk-benefit ratio related to the use of medicinal products. 85. The Rapid Alert System is a communication system used by the competent authorities of the EU Member States responsible for medicinal products and by the European Union established for the purpose of immediate mutual, and where necessary, broader dissemination of information on emerging new risks to public health associated with the safety and quality of a medicinal product and in order to reduce thi s risk. 86. A risk management system is a range of pharmacovigilance activities and measures to identify, define, prevent or minimise medicinal product-related risks, as well as to assess the efficacy of these activities. 87. Compassionate use is the application of a medicinal product with a new active substance that represents a significant therapeutic, scientific and technical innovation and is pending marketing authorisation or is in clinical trials, and is made available to a group of patients with a chronic or severely disabling disease that cannot be satisfactorily treated with medicinal products that have already obtained marketing authorisation as laid down in Article 83 of Regulation 726/2004/EC. 88. A specialised store for the sale of medicinal products is a facility where a business entity under a JAZMP licence carries out retail trade in medicinal products that pursuant to this Act are dispensed in pharmacies and specialised stores without prescription. 89. A common name of a medicinal product is an international non-proprietary name recommended by the World Health Organisation, or if one does not exist, the usual common name. 90. A sponsor is a legal entity or an individual who assumes responsibility for the commencement, management and financing of a clinical trial of a medicinal product. 91. Immediate packaging is a container or any other form of packaging that is in direct contact with a medicinal product. 92. A study on the safety of a medicinal product after the latter has obtained marketing authorisation for use in human medicine shall be any study of this medicinal product aimed at identifying, defining or quantifying a safety risk, confirming the safety profile, or measuring the effectiveness of risk management measures.

11 93. A study on the safety of a medicinal product after the latter has obtained marketing authorisation for veterinary use is a pharmaco-epidemiological study or a clinical trial carried out in accordance with marketing authorisation in order to identify and investigate any risk regarding the safety of the medicinal product. 94. A traditional herbal medicinal product is a medicinal product of herbal origin whose properties can be identified on the basis of its traditional use and which fulfils the conditions laid d own in this Act and Directive 2001/83/EC. 95. Third countries shall mean countries that are not Member States of the European Union or the EEA. 96. A risk associated with the use of a medicinal product is: any risk of the onset of an adverse effect on the environment; or any risk to the health of the patient or animal or public health that is associated with the quality, safety or efficacy of the medicinal product. 97. An active ingredient or active substance is any substance or mixture of substan ces intended for use in the manufacture of medicinal products that in the course of the manufacturing process becomes an active ingredient of the medicinal product aimed at exerting a pharmacological, immunological or metabolic action to restore, improve or modify physiological functions or to facilitate diagnosis. 98. The official quality control of a medicinal product shall mean the determination of the quality of the medicinal product in accordance with the marketing authorisation or with the provisions of this Act, including analytical testing of the medicinal product or verifying the identity of the labelling and package leaflet, or both. 99. An official control laboratory is a laboratory that carries out official control of the quality of medicinal products and is included in the General European OMCL Network (GEON) The import of a medicinal product is the marketing of a medicinal product from third countries in the territory of the Republic of Slovenia, which may only be performed by medicinal product manufacturing authorisation holders if the authorisation covers the activity of importing such product. The import of a medicinal product shall also mean the transfer of a medicinal product from third countries to the territory of the Republic of Slovenia by an individual either for his/her personal use or the use of his/her close family members or based on an authorisation for the personal use of not more than one individual who is not his/her close family member or for the needs of his/her animal A wholesaler of medicinal products is a business entity who has been authorised by JAZMP to perform the activity of wholesaling medicinal product with a profitable or non-profitable intent An intermediate product is partially processed material that requires further processing before it becomes a semi-finished product Entry of a medicinal product shall mean the wholesale of a medicinal product from another EU Member State in the territory of the Republic of Slovenia. Entry of a medicinal product shall also mean the transfer of a medicinal product from another EU Member State to the territory of the Republic of Slovenia by an individual either for his/her personal use or the use of his/her close family members or based on an authorisatio n for the personal use of not more than one individual who is not his/her close family member or for the needs of his/her animal A security element is data on the outer packaging of a medicinal product for human use that enables wholesalers and competent persons responsible for the retail sale of medicinal products in pharmacies and specialised shops to verify the authenticity of the product and identify each individual package A Concerned Member State is the Member State that in the mutual re cognition procedure or the decentralised procedure decides on the acceptability of the risk-benefit ratio or the evaluation of the quality, safety and efficacy of the medicinal product on the basis of an assessment report drawn up by the Reference Member State of the European Union Blood- or plasma-derived medicinal products are industrially produced medicinal products, such as pharmaceuticals that contain, in particular, albumins, blood-clotting factors and human immunoglobulin, derived from blood components obtained in accordance with the regulations governing the supply of blood and blood products and regulations governing medicinal products that are manufactured by business entities specialised in this activity A medicated feed mix or medicated feed is any mixture of veterinary medicinal product and feed that is prepared for marketing and intended to be fed to animals without further processing, for healing, prevention or other properties of the medicinal product.

12 108. A medicinal product of herbal origin is a medicinal product that contains as an active ingredient one or more plant materials, one or more herbal preparations, or one or more plant materials in combination with one or more herbal preparations An orphan medicinal product is a medicinal product intended for the treatment of a very serious and very rare disease for which there is no other permitted method of treatment, prevention or diagnosis, with regard to which, however, without incentives, its marketing is insufficiently profitable to justify the necessary investment into its development and marketing, and is thus designated as an orphan medicinal product in accordance with the conditions laid down in Regulation (EC) No 141/2000 of the European Parliament and of the Coun cil of 16 December 1999 on orphan medicinal products (OJ L 18 of ), as last amended by Regulation 596/2009/EC A medicinal product for advanced treatment is a medicinal product as defined in Article 2 of Regulation 1394/2007/EC A medical or veterinary prescription is a document issued by an expert qualified and authorised to prescribe medicinal products in accordance with regulations Abuse of a medicinal product means constant or sporadic intentional excessive use of a medicinal product, accompanied by harmful physical or psychological effects Outer packaging is packaging that contains a medicinal product in the immediate packaging. II. MARKETED MEDICINAL PRODUCTS Article 7 (Differentiation between medicinal products and other products) (1) If a product by definition, and taking into account all of its properties, may be classified among medicinal products as well as among products that are subject to other regulations, in the case of ambiguity the provisions of this Act shall apply. (2) The definition referred to in the preceding paragraph is subject to a decision taken by JAZMP in an administrative procedure by a special declaratory procedure, on the basis of the application of the manufacturer or business entity that markets or intends to market the product referred to in the preceding paragraph or ex officio. In considering this, it shall take into account: the qualitative and quantitative composition of the product; the intention and manner of its use; whether the product or its components have pharmacological, immunological or metabolic effects; whether the product is believed to have any direct or indirect therapeutic, preventive or diagnostic effects; a presentation of the product and its impact on the end-user or customer; potential adverse effects and the related risks for the individual and for public health; knowledge of the product by end-users or customers; the latest scientific findings; and the guidelines of the European Union, which are published by JAZMP, and the national guidelines, which are prepared and published by JAZMP on its website. (3) An application referred to in the preceding paragraph shall contain information on the qualitative and quantitative composition of the product, its safety, a presentation of the product for end-users or customers on the packaging, enclosed leaflets or brochures, websites, orally or in some other manner, and on the status of the product in the Member States of the European Union. (4) The costs of the procedure based on an application referred to in the second paragraph of this Article shall be covered by the manufacturer or business entity that markets or intends to market the product referred to in the first paragraph of this Article. Article 8