2003-07-23
2003-07-17
Article 2
For the purposes of this Act, the following terms bear the following meanings:
1. Medicinal product: Any substance or combination of substances intended for treatment or prevention of human diseases as well as any substance or combination of substances which may be administered to human beings with a view of restoring, correcting or modifying their physiological functions or making a medical diagnosis,
2. Substance referred to in item 1 of this Article may be of the following origins:
– human, e.g. human blood and human blood products,
– animal, e.g. microorganisms, including genetically modified organisms, animals, parts of organs, animal secretions, toxins, extracts, blood products,
– vegetable, e.g. plants, parts of plants, vegetable secretions, extracts,
– chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by a chemical change or synthesis,
3. Active substance: Any matter conferring a drug product action,
4. Excipient: Any substance that instead of conferring a drug product action:
– assists in giving a pharmaceutical form to a drug product,
– protects, supports and improves stability, bioavailability and tolerance of a medicinal product,
– assists in drug product identification,
5. Raw material: Any substance of specified quality intended for a drug product manufacture,
6. Drug product: Any medicinal product that is industrially manufactured in order to be placed on the market,
7. Galenical preparation: Any medicinal product from the List of Galenical Preparations issued by the Minister for Health, manufactured in a galenical laboratory according to the procedure provided in the current pharmacopoeia and GMP (Good Manufacturing Practice) standards for galenical laboratories,
8. Magistral formula: Any medicinal product prepared in a pharmacy from active substances and excipients of prescribed and verified quality, in accordance with a prescription for an individual patient,
9. Name of the medicinal product: The name given to a medicinal product, which may be either an invented name or a common or scientific name. The common or scientific name must be followed by a trademark or the name of the manufacturer. The invented name shall not be liable to confusion with the common name,
10. Common name: The international non-proprietary name (INN) recommended by the World Health Organisation or, if one does not exist, the usual common name,
11. Immunological medicinal product: Any medicinal product that is or consists of vaccines, toxins, serums or allergen products.
Vaccines, toxins and serums shall cover in particular:
– agents used to produce active immunity,
– agents used to diagnose the state of immunity,
– agents used to produce passive immunity.
“Allergen product” means any medicinal product that is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.
12. Medicinal products derived from human blood or human plasma: Medicinal products based on blood constituents including, in particular, albumin, coagulating factors and immunoglobulin,
13. Radiopharmaceutical: Any medicinal product that contains one or more radionuclides,
14. Radionuclide generator: Any system incorporating a fixed parent radionuclide from which a particular radionuclide is produced for fresh preparation of a radiopharmaceutical,
15. Radionuclide in a sealed radiation source: Any radioactive substance in a tightly sealed container used for external radiation treatment,
16. Radionuclide kit: Any preparation to be reconstituted or combined with radiounuclides in the final radiopharmaceutical, usually prior to its administration,
17. Radiopharmaceutical precursor: Any radionucliude produced for the radiolabelling of another substance prior to administration,
18. Medical device:
Any product used for the purpose of making a medical diagnosis, prevention, monitoring, treatment or alleviation of disease and compensation for an injury or handicap; for investigation, replacement or modification of the anatomy or of a physiological process; for administration of medicinal products and control of conception.
Medical devices do not achieve their principal intended action in or on the human body by pharmacological, metabolic or immunological means, although in their function they may be assisted by such means,
19. Homeopathic medicinal product: Any medicinal product prepared from substances or compositions of substances used as homeopathic stocks, in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or by other currently used pharmacopoeias in the EU Member States,
20. Quality of the medicinal product: The acceptable physical, chemical, biological, pharmaceutical and technological, as well as other property of a medicinal product,
21. Safety of the medicinal product: The acceptable relation between efficacy and harmfulness of a medicinal product.
22. Efficacy of the medicinal product: The ability of a medicinal product verified in clinical trials conducted in compliance with this Act,
23. Testing of the medicinal product: The procedure for establishing quality, safety and efficacy of a medicinal product which is performed for the purpose of obtaining a marketing authorisation,
24. Clinical trial: Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic activities of one or more investigational medicinal product(s); and/or to discover any adverse reactions to one or more investigational medicinal product(s); and/or to study absorption, distribution, metabolism and excretion of one or more investigational product(s) for the purpose of defining its (their) safety and/or efficacy.
Clinical trials may be conducted at one or several places,
25. Laboratory testing of medicinal products: The testing by which the quality of a medicinal product is determined,
26. Pharmacological and toxicological testing of medicinal products: The testing of pharmacodynamic, pharmacokinetic and toxicological properties of a medicinal product on animals and other appropriate models,
27. The Central Ethics Committee: An independent body consisting of medical professionals and other non-medical members whose responsibility is to ensure the protection of rights, safety and well-being of clinical trial subjects and to provide assurance of that protection by, among other things, giving opinions on trail protocols, suitability of investigators, legal persons on whose premises trials are conducted, equipment, methods and documents to be used for informing the trial subjects and obtaining their informed consents. The Minister for Health shall appoint the Central Ethics Committee,
28. Bioavailability: The rate and the degree of availability of the active substance from a drug product (dosage form) determined according to the concentration-time curve in general circulation or excretions,
29. Bioequivalent drugs: Pharmaceutical equivalents or pharmaceutical alternatives whose bioavailability after administration of the same molar dose is to such extent similar that it may be expected to produce basically the same effect, including efficacy and safety,
30. Pharmaceutical equivalents: Drug products containing the same active substance(s) in the same quantity and of the same dosage form, administered by the same route and complying with the same or comparable standards,
31. Pharmaceutical alternatives: Drug products containing the same active substance but in the form of a different salt, ester and the like, or in the same pharmaceutical form but of a different strength,
32. Good Laboratory Practice: The standard for organising, designing, conducting, monitoring, reporting and documenting of laboratory studies,
33. Good Clinical Practice: The standard for designing, conducting, completing, monitoring, analysing, reporting and documenting human clinical trials, which ensures that the trials are scientifically and ethically founded and that clinical properties of the medicinal product tested for diagnostic, treatment or prevention purposes have been appropriately documented,
34. Informed consent: A signed and dated consent of a trial subject given in writing, which proves the subject’s willingness to participate in a clinical trial, after having received appropriately documented information on the nature and significance, as well as involved consequences and risks. If a subject is incapable of giving such consent or is a minor, his legal representative or a guardian may sign an informed consent,
35. Immediate packaging: The container or other form of packaging immediately in contact with the medicinal product,
36. Outer packaging: The packaging into which the immediate packaging is placed,
37. Summary of product characteristics: Expert information on a drug product approved in an authorisation procedure and intended for physicians, stomatologists and pharmacists. Also used as a source of information for drawing up package leaflets for end users, labelling of medicinal products, and for verification of advertising,
38. Labelling: Any set of data provided on the immediate or outer packaging,
39. Package leaflet: A leaflet containing information for the user, which accompanies the medicinal product,
40. Original medicinal product: The first world-wide version of a medicinal product authorised for placing on the market on the grounds of complete efficacy, safety and quality documentation which complies with requirements in force,
41. Essentially similar medicinal product: A drug product which has the same active amount of the active substance in the same dosage, form as well as equal bioavailability/bioequivalence as the original product. A medicinal product of a different dosage form than another product of the same composition (capsules/tablets) intended for oral administration is also considered to be an essentially similar medicinal product, with the exclusion of dosage forms with controlled active substance release,
42. Marketing authorisation: An authorisation issued by the competent authority of the Republic of Croatia after completion of the procedure for establishing that a medicinal product meets the quality, efficacy and safety requirements,
43. Marketing authorisation holder: A legal person seated in the Republic of Croatia holding an authorisation for the marketing of a drug product in the Republic of Croatia,
44. Manufacturing authorisation: A document issued by the competent authority confirming that the manufacturer meets the conditions imposed on premises, equipment and staff of a drug product manufacturing plant(s) and applies principles and guidelines of Good Manufacturing Practice in accordance with this Act and regulations derived therefrom,
45. Manufacturer of the medicinal product: A legal person responsible for production and development as well as quality, safety and efficacy of a medicinal product, regardless of whether it was manufactured by him or some other person on his behalf,
46. Manufacturer with respect to manufacturing site: A legal person holding the manufacturing authorisation for a plant or plants for drug product manufacturing,
47. Manufacture of medicinal products: Comprises the whole process or individual parts of pharmaceutical and technological preparation of a drug product, including production of a substance or acceptance of substances and materials, technological processing and packaging as well as quality control, storage and delivery,
48. Good Manufacturing Practice: The part of the quality assurance system which ensures that medicinal products are consistently produced and controlled in accordance with requirements and procedures relevant to the marketing authorisation issuance,
49. Qualified person for medicinal products manufacture: A master of pharmacy specialised in pharmaceutical technology or with at least five years of experience in the manufacture of medicinal products,
50. Qualified person for release of a medicinal product batch: A master of pharmacy specialised in testing and control of medicinal products or with at least five years of experience in medicinal products quality control,
51. Pharmacovigilance: Activities comprising detection, assessment, understanding and prevention of adverse reactions as well as other reactions caused by medicinal products,
52. Responsible person of the marketing authorisation holder responsible for pharmacovigilance: A physician specialised in clinical pharmacology or having at least five years of experience in the field,
53. Adverse reaction: Any noxious and unintended response to a medicinal product taken at normal and correctly administered doses for an approved indication,
54. Unexpected adverse reaction: Any adverse reaction that is not consistent with the summary of product characteristics,
55. Adverse event: Any noxious and undesired sign, symptom or disease (including changes in laboratory findings) that coincides with the use of a medicinal product or a medical device,
56. Serious adverse event: Any adverse event or adverse reaction that is fatal, life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, congenital anomaly/birth defect,
57. Wholesale distribution of medicinal products and medical devices: All activities including procurement, storage, supply or import/export of a medicinal product or medical device,
58. Good practice in wholesale distribution of medicinal products and medical devices: The standard for storage and transportation of medicinal products and medical devices which ensures organisation, performance and control over storage in line with prescribed conditions, as well as transport from the manufacturer to the end user,
59. Qualified person for acceptance, storage and supply of medicinal products and medical devices in wholesale: A master of pharmacy holding the necessary authorisation to operate independently,
60. Specialised stores for retail sale of medicinal products and medical devices: A store selling medicinal products in line with this Act and regulations derived therefrom,
61. Croatian pharmacopoeia: A regulation that lays down requirements for preparation of medicinal products and medical devices, as well as their quality and quality control procedures, and is appropriately referenced to and harmonised with the European Pharmacopoeia,
62. Agency: A legal person established by the Republic of Croatia whose competencies in the field of medicinal products, medical devices and homeopathic products are regulated by this Act.
