Unofficial transfer (c) Soyuzpravoinform LLC
of July 28, 2022 No. 2469-IX
This Law regulates the legal relationship in the field of medicines connected with creation, pharmaceutical development, preclinical researches, clinical trials (testing), state registration of medicines, production, production (production) in the conditions of drugstore, appointment, use, import, wholesale and retail trade, remote trade, quality control of medicines, implementation of pharmakonadzor and also determines the rights and obligations of legal entities and physical persons, powers of public authorities and officials in the respective sphere.
The purpose of this Law is ensuring public health care by ensuring access to effective, high-quality, modern and safe medicines, and also implementation of separate provisions of the European Union law concerning medicines for application by the person.
1. The legislation on medicines consists of the Constitution of Ukraine, Bases of the legislation of Ukraine on health protection, this Law and other acts of the legislation adopted according to this Law and also the industry standards adapted for the European Union law.
1. In this Law terms are used in such value:
1) active pharmaceutical ingredient (medicinal substance, active ingredient, active substance) (further - active ingredient or AFI) - any substance or mix of substances, held for use in medicine production which at the same time becomes its active ingredient. Active ingredient is intended for implementation of pharmacological, immunological or metabolic actions for the purpose of recovery, correction or change of physiological functions of organism or for establishment of the medical diagnosis;
2) drugstore - the healthcare institution which is the place of implementation of activities of subjects of managing for retail trade by medicines which main objective is providing the population, other healthcare institutions, companies, organizations and organizations with medicines;
3) bioequivalence - the characteristic of similarity of two or more medicines containing identical active ingredient. Medicines are considered bioequivalent if they are pharmaceutical equivalent or pharmaceutical alternative, and their bioavailability (indicators of speed and extent of absorption) after introduction in identical molar dose is in the established eligibility criterions. Eligibility criterions are established for ensuring comparison of characteristics of in vivo medicines, that is for establishment of similarity from the point of view of safety and efficiency;
4) biological medicine - the medicine containing AFI of biological origin (the substance or substances made by biological source or from biological source for assessment and which determination of quality (which) carrying out fiziko-chemical and biological testing in combination with technological assessment of production process and its control is necessary).
Medicines of the advanced therapy, immunological medicines and medicines which receive from blood or plasma of blood of the person, and also the medicines made by means of one of such bioengineering procedures belong to biological medicines:
technology of recombinant DNA;
controlled expression of the genes coding biologically active proteins at prokariot and eukaryotes including the transformed cages of mammals;
methods of hybridoma and monoclonal antibodies;
5) brokerage (activities of the broker, trade mediation) in the field of drug circulation - the actions directed to sale or purchase of medicines except wholesale trade by medicines which do not provide their physical movement and consist in negotiating independently and on behalf of other legal entity or physical person;
6) medicine issuance - the actions connected with:
for the medicines imported on the territory of Ukraine - certification and release of series of medicine by the authorized person of the producer or importer of this medicine or quality check of series by the responsible person of the distributor, and also provision of the relevant information to state control body about the medicine series introduced into circulation;
for medicine which is made in the territory of Ukraine, - certification and release of series of medicine by the authorized person of the producer;
7) production (production) of medicines in the conditions of drugstore - individual production of medicines according to the recipe of the doctor to order treatment and prevention facilities of health care and production of intra pharmaceutical procurements, concentrates, semifinished products, and also the medicines made for emergency;
8) producer of medicines - the subject of managing which is performing one or more production phases of medicines and having the license for production of medicines;
9) production of medicines (industrial) - the activities connected with serial release of medicines which include one or more stages of their production (transaction on engineering procedure, quality control, packaging and repacking, marking and remarking, certification of series and issue of permission to release), and also the activities connected with purchase of materials and products, storage, wholesale trade (distribution) of self-produced medicines;
10) the owner of registration for medicine - the legal entity or physical person entrepreneur (the subject of managing) registered in the procedure established by the legislation of Ukraine or registered in established by the legislation of the respective member state of the European Union or the European Free Trade Association which is agreement party about European Economic Area, procedure person who submits the corresponding application for state registration of medicine (further - the applicant) or who already acquired the status of the owner of such registration (further - the owner of registration).
The owner of registration for the medicine intended for treatment of rare (orphan) diseases in the countries with strict regulatory bodies (SRAs), orphan, innovative medicine, medicine of the advanced therapy, medicine for prevention and/or treatment of HIV, treatment of hemophilia, oncological diseases, vaccines the legal entity or physical person entrepreneur (the subject of managing) or person registered in the country established by the legislation with strict regulatory bodies (SRAs) can be registered in the procedure established by the legislation of Ukraine.).
The legal entity or physical person entrepreneur (the subject of managing) or person registered in other country registered in the procedure established by the legislation of Ukraine can be the owner of registration of the medicine which is subject to purchase by the specialized organizations which conduct procurement and person authorized on implementation of purchases in the field of health care;
11) secondary package - packaging in which the primary package is placed;
12) generic medicine - the medicine having the same high-quality and quantitative composition of active ingredients and the same dosage form, as reference medicine, and also bioequivalence of which with reference medicine it is proved as a result of carrying out the corresponding researches. Different salts, esters, ethers, isomers, mixes of isomers, complexes or derivatives of active ingredient are considered as the same active ingredients if their properties significantly do not differ regarding safety and/or efficiency. In such cases the Applicant provides the additional information which contains proofs of safety and/or efficiency of different salts, ethers or derivatives of active ingredient which is authorized to use. Different peroral dosage forms reckon with immediate release as the same dosage form. Carrying out researches of bioavailability is not required if the applicant proves that generic medicine answers the criteria determined by the industry standard on bioequivalence approved by the central executive body which provides forming and realizes state policy in the field of health care;
13) homeopathic medicine - any medicine made of homeopathic raw materials according to the procedure of production of homeopathic medicine, certain state pharmacopeia of Ukraine or the European pharmacopeia or in case of lack of such description - the operating official pharmacopeias of member states of the European Union, Great Britain, homeopathic pharmacopeia of the United States of America;
14) ready medicine - the dosed medicine in the type and condition intended for application which passed all production stages including final packaging and marking;
15) the State pharmacopeia of Ukraine - approved by the central executive body which provides forming and realizes state policy in the field of health care, the regulation which determines the general quality standards of medicines and contains requirements in the form of monographs and general clauses by methods of the analysis, testings, testing, packagings of medicines;
16) the State register introduced into drug circulation, imported on the territory of Ukraine, - the electronic database containing data on series of the medicines arriving in the address in the territory of Ukraine and persons responsible for input in turnover of medicines in the territory of Ukraine. Data in the State register introduced into drug circulation, imported on the territory of Ukraine, are introduced in the mode of the information message;
17) the State register of clinical trials (testing) of medicines (further - the State register of clinical trials) - the single state information system containing urgent and historical data on all clinical trials (testing) permitted to carrying out in Ukraine in accordance with the established procedure, access to which is open. The procedure for maintaining the State register of clinical trials affirms the central executive body providing forming and realizing state policy in the field of health care;
18) the State register of medicines - the single state information system containing urgent and historical data on the medicines registered in accordance with the established procedure, data on all changes to materials of the registration file of medicines and also provides collection, accumulating, processing, accounting, protection and provision of information about such medicines. The procedure for maintaining the State register of medicines affirms the central executive body providing forming and realizing state policy in the field of health care;
19) the State register of the medicines in parallel imported on the territory of Ukraine - the single state information system which contains urgent and historical data on the permissions to parallel import provided in accordance with the established procedure and provides collection, accumulating, processing, accounting, protection and provision of information on such medicines. The procedure for maintaining the State register of the medicines in parallel imported on the territory of Ukraine affirms the central executive body which provides forming and realizes state policy in the field of health care;
20) source of radionuclides - any system containing the fixed primary radionuclide from which the secondary radionuclides extracted by eluating or different way and used in radio pharmaceutical medicine are made;
21) well studied medical application of medicine - well studied medical application of active ingredient which is part of medicine which efficiency and satisfactory degree of safety are acknowledged that it is confirmed by detailed bibliographic references to the published data on post-registration, epidemiological and other researches if there passed at least 10 years from the moment of the first systematic and documented use of active ingredient as medicine, within the European Union and/or in Ukraine;
22) excipient - any component of medicine, except active ingredients and packaging materials;
23) studied or the subject of research (the patient, the healthy volunteer) (further - the subject of research) - the physical person which participates in clinical trial (testing) and/or accepts the researched medicine, or joins in control group;
24) the researched medicine - the dosage form of active ingredient or the studied or used placebo for comparison in clinical trial (testing), including the registered medicines which are used or produced (constituted or packed) otherwise, than medicines with the registered dosage form, or are used according to the unregistered indications or for more information on the registered medicine form;
25) the commonly accepted name - the international unlicensed name recommended by the World Health Organization or if there is no that, the regular commonly accepted name;
26) use of the registered medicine not to destination ("off-label use") - use of medicine according to indications or in age group, or in dosage, or the introduction method which is not specified in the short characteristic of medicine;
27) abuse of medicines - permanent or sporadic deliberate excessive and/or not according to indications the use of medicines which is followed by dangerous physical or mental effects;
28) obligations of the manufacturer on realization of medicines - the obligations assigned to the producer of medicines which consist in realization on equal terms of self-produced goods to all licensees which have the license for wholesale trade by medicines and addressed producer of medicines according to the conclusion of the purchase and sale agreement of medicines;
29) obligations on servicing of the population - the obligations assigned to subjects of managing who perform activities for wholesale trade by medicines consist in ensuring permanent availability of the necessary range of medicines with them for requirements satisfaction of the population of certain administrative and territorial unit and in opportunity to deliver necessary amount of medicines in a short space of time on the corresponding territory;
30) import of medicines - the activities performed by licensed importers of medicines and connected with import to the territory of Ukraine of medicines (except AFI), including the studied medicines, from the countries which are not member states of the European Union or the European Free Trade Association which is the agreement party about the European Economic Area for the purpose of their further realization, wholesale trade or use in production of finished pharmaceutical products, clinical trials (testing) or medical practice including storage, quality control, certification and release of series of medicine.
Import of medicines, including the researched medicines, does not include import to the territory of Ukraine made and introduced into circulation for export to Ukraine by the Authorized person of the producer which carries out the related licensed activity in the territory of the member state of the European Union or the European Free Trade Association which is agreement party about the European Economic Area. Import to Ukraine of such medicines is performed by the subjects of managing performing economic activity on wholesale trade by medicines licensed in Ukraine;
31) the importer of medicines (further - the importer) - the subject of managing registered in the procedure established by the legislation of Ukraine, which is performing activities for import of medicines and having the import license of medicines;
32) immunological medicine - medicine which is vaccine, toxin, serum or medicine of allergen.
The agents used for treat vaccines, toxins and serums, in particular:
developments of active immunity;
diagnostics of condition of immunity;
developments of passive immunity;
33) the indicator of unauthorized opening - the means of safety allowing to be convinced that packaging of medicine was not opened;
34) multicenter clinical trial - the clinical trial conducted under the single protocol more than in one center of carrying out researches and more than one researcher in whom the centers of research can be placed in Ukraine, in one or in several member states of the European Union and other countries which are not members of the European Union;
35) clinical trial (testing) of medicine - any research with participation of the person as the subject of research intended for identification or confirmation clinical and/or pharmacological and/or phracodynamic of effects and/or identification of undesirable reactions, and/or studying of pharmacokinetics of one or several researched medicines for the purpose of assessment of its safety and/or efficiency;
36) the short characteristic of medicine - information on medicine for health and pharmaceutical workers;
37) the countries with strict regulatory bodies (Stringent Regulatory Authorities (SRAs) - the countries which correspond to one of the following criteria:
the countries which regulatory bodies till October 23, 2015 were members or observers of the International council on harmonization of technical requirements to medicines for application by people (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH);
the countries which signed with Ukraine or with the European Union the agreement on mutual recognition (Mutual Recognition Agreements (MRA) in the field of medicines;
the countries which signed with Ukraine or with the European Union the agreement on assessment of conformity and the acceptability of manufactured goods (Agreement on Conformity Assessment and Acceptance of industrial products (ACAA) in the field of medicines.
The list of the countries with strict regulatory bodies (SRAs) constituted based on such criteria affirms and, in the presence of the corresponding bases, is updated by the central executive body which provides forming and realizes state policy in the field of health care;
38) medicine leaf insert - the document containing information on medicine for consumers and accompanying medicine;
39) medicine - any substance or combination of substances which have pharmacological, immunological or metabolic action and are applied or entered to the person in the corresponding dosage form for treatment or prevention of diseases of the person or for the purpose of recovery, improvement or change of physiological functions of organism, or for establishment of the medical diagnosis.
Treat medicines: AFI, products of "in bulk"; homeopathic remedies; means which are used for identification of causative agents of diseases, and also fight against causative agents of diseases or parasites; medicinal cosmetics and medicinal additives to foodstuff; finished pharmaceutical products (medicines, drugs, medicines) and made (made) in the conditions of drugstore finished pharmaceutical products;
40) medicine of gene therapy - biological medicine to which the following characteristics are inherent:
AFI of such medicine contains or consists of recombinant nucleic acid which is used or entered to the person for the purpose of streamlining, recovery, replacement, addition or removal of the genetic sequence;
therapeutic, preventive or diagnostic effect of medicine is connected directly with the sequence of recombinant nucleic acid which it contains, or with product of genetic expression of such sequence.
Vaccines for prevention of infectious diseases do not belong to medicines of gene therapy;
41) medicine for kompassionatny use (rendering from compassion) - the medicine provided and applied to the patient is non-paid (without any cash, material or other types of compensations) is exclusive for ethical and humane reasons and corresponds to the following criteria:
it is provided for application to the patient with chronic or serious wearisome disease or rare (orphan) disease, or with disease or serious medical condition which poses threat of life and requires treatment, however the patient cannot well be treated by the registered medicines or has no access to alternative methods of treatment by the registered medicines, or cannot be included in clinical trials (testing) of such medicine;
medicine shall be or is at stage of execution of the statement for state registration in Ukraine or in other country with strict regulatory bodies (SRAs) or to be applied in the current clinical trials (testing) in Ukraine or other countries with strict regulatory bodies (SRAs) or in clinical trials (testing) which just ended in Ukraine;
42) medicine for pediatric use - the medicine allowed for use in parts or in full for pediatric group of persons, the indications allowed for use for which are provided in the short characteristic of medicine;
43) medicine of the advanced therapy - medicine of gene therapy or somatic cellular therapy, fabric engineering;
44) medicine of somatic cellular therapy (medicine of somatokletochny therapy) - biological medicine in which such characteristics are inherent:
contains or consists of cages or fabrics, biological characteristics, physiological functions or structural properties of which are important for clinical application, were changed as a result of essential manipulations, or from cages or fabrics, not held for use with the same purpose at the donor or the recipient;
it is provided as having the properties applied or entered to the person for the purpose of treatment, prevention or diagnosis of disease by pharmacological, immunological or metabolic action of its cages or fabrics.
Manipulations, such as cutting, crushing, forming, centrifuging, soaking in antibiotic or antimicrobic solutions, sterilization, radiation, cell fission, concoction or cleaning, filtering, lyophilizing, freezing, cryopreservation, vitrifications, are not considered as essential;
45) medicine of fabric engineering - medicine which contains or consists of the cages or fabrics created by cellular or fabric engineering provided as means which has properties, is applied or entered to the person for the purpose of regeneration, recovery or replacement of human fabric. Medicines of fabric engineering may contain cages or fabrics of human and/or animal origin which are viable or impractical, and also additional substances, in particular, products of cages, biological molecules, biomaterials, chemicals, cellular matrixes or skaffolda;
46) the medicine made according to the approved copy-book - medicine which includes active ingredient with the medical application which is well studied in the territory of Ukraine, with certain efficiency, satisfactory degree of safety which copy-book is approved by the central executive body which provides forming and realizes state policy in the field of health care;
47) the medicine made from blood or plasma of blood of the person - the medicine made on the basis of blood components by industrial method. Albumine, fibrillation factors, immunoglobulins of human origin belong to such medicines, in particular;
48) low-intervention clinical trial - clinical trial (testing) which corresponds to all such criteria:
the researched medicines, except placebo, are registered;
according to the protocol of clinical trial (testing) the researched medicines are used according to the approved short characteristic of medicine or use of the researched medicines is based on the facts and is confirmed by the published scientific proofs on safety and efficiency of the researched medicines in any of the countries with strict regulatory bodies (SRAs);
supplementary procedures of diagnostics or monitoring in comparison with customary clinical practice represent no more than minimum additional risk or load of safety of subjects of research;
49) marking - information specified on primary and secondary packagings of medicine;
50) the master file of system of pharmakonadzor - the detailed description of the system of pharmakonadzor used by the owner of registration concerning one or several medicines;
51) proper pharmaceutical practice (Good Pharmacy Practice, Good Pharmaceutical Practice, GPP) - approved by the central executive body which provides forming and realizes state policy in the field of health care, the industry standard adapted for the European Union law which determines set of rules of realization of pharmaceutical services and the help in the field of pharmaceutical activities, including in case of retail trade by medicines, their storage, quality control, production (production) of medicines in the conditions of drugstore, leaves which observance provides efficiency of pharmacotherapy and quality of medicines at stages of their purchase, production (production), storage and retail trade;
52) proper production practice (Good Manufacturing Practice, GMP) - the approved by the central executive body which provides forming and realizes state policy in the field of health care, industry standard adapted for the European Union law, determining set of organizational and technical actions which is part of quality management, and guarantees that products are constantly made and controlled on the quality standards and answers its appointment according to requirements of materials of the registration file or the file of the researched medicine for clinical trials (testing), or the specification such products;
53) proper clinical practice (Good Clinical Practice, GCP) - approved by the central executive body which provides forming and realizes state policy in the field of health care, the industry standard adapted for the European Union law, containing set of the ethical and scientific quality requirements recognized in the world to which it is necessary to adhere during planning, accomplishment, monitoring, audit, documentation, carrying out the analysis and creation of reports of clinical trials (testing) providing participation of people. Observance of proper clinical practice ensures confidence in protection of the rights, safety and wellbeing of subjects of research and reliability of results of clinical trials (testing);
54) proper laboratory practice (Good Laboratory Practice, GLP) - the approved central executive body providing forming and realizing state policy in the field of health care, the industry standard adapted for the European Union law which determines set of organizational and technical actions for the organization of process and conditions of planning, carrying out, monitoring, data recording, provision of results and storage of materials of preclinical researches on toxicity and safety of medicines;
55) proper practice of distribution (Good Distribution Practice, GDP) - the approved by the central executive body providing forming and realizing state policy in the field of health care, industry standard adapted for the European Union law, determining set of the available organizational and technical actions part of quality assurance also guarantees that quality of medicines is maintained on all sites of supply chain from production site to drugstore or the person having permission or appointed to deliver medicines to the population;
56) proper practice of pharmakonadzor (Good pharmacovigilance practices, GVP) - approved by the central executive body which provides forming and realizes state policy in the field of health care, the industry standard adapted for the European Union law which determines features of planning, the organization of implementation of pharmakonadzor, its documentary registration;
57) narcotic (psychotropic) medicines - the medicines and AFI containing the drugs, psychotropic substances or precursors included in the List of the drugs, psychotropic substances and precursors which are subject to control in Ukraine according to the legislation of Ukraine;
58) national system of verification of medicines - the automated system providing identification and authentication of medicines by check of the medicines having the security aids determined according to this Law and directed to control of drug circulation only for the purpose of prevention and counteraction to the address of counterfeited medicines;
59) undesirable reaction - any reaction, inadvertent and harmful to human body, to medicine;
60) not intervention research - research in which medicine is appointed usual method according to the approved short characteristic of medicine.
Reference of the patient to group with the treatment method determined in the protocol of clinical trial (testing) is not provided in advance, and prescription of medicine is performed according to modern practice and does not depend on the decision on involvement of the patient to testing. Within not intervention research supplementary diagnostic procedures or procedures of observation are not applied to patients, and during the analysis of collected data epidemiological methods are used.
Also researches in which the biomedical indicators, results or changes of the state of health of the person caused by disease or the carried-out treatment during which medicine was appointed usual according to the approved short characteristic of medicine are estimated belong to not intervention researches;
61) unexpected undesirable reaction - undesirable reaction which nature, weight and effects will not be approved with information provided in the short characteristic of medicine;
62) drug circulation - types of activity which are performed during production (industrial) and production (production) of medicines in the conditions of drugstore, storage, transportation, import, import, export, wholesale and retail trade, appointment and application, quality control, implementation of pharmakonadzor, utilization and/or destruction of medicines;
63) wholesale trade by medicines (distribution) - activities of subjects of managing (except physical persons entrepreneurs) on acquisition of medicines at subjects of managing which have the corresponding license (producers, importers or distributors), storages, transportations, deliveries, import, export and sale of medicines from pharmaceutical warehouses (bases) to other subjects of wholesale or retail trade by medicines which obtained on it the corresponding licenses to producers of medicines, it is direct to treatment and prevention facilities or legal entities whose structural divisions are treatment and prevention facilities of health care;
64) state control body - the central executive body with the special status realizing state policy in the field of creation, the admission on the market, quality control, safety and efficiency of medicines;
65) original (innovative) medicine - the medicine registered for the first time in the world on the basis of the complete registration file concerning its efficiency, safety and quality;
66) orphan medicine (medicine of limited application or "orphan medicine") - medicine concerning which the owner can show that:
means is intended for diagnosis, prevention or treatment of rare disease, that is life-threatening disease or chronic condition which threatens life or leads to disability usually no more than five people on each 10 thousand people in Ukraine at the time of filing of application about its state registration;
means is intended for diagnostics, prevention or treatment of disease which threatens life or seriously weakens immunity, the serious or chronic exhausting diseases and without the state stimulation the probability that such medicines will be registered in the market of Ukraine is insignificant. In that case the medicine intended for treatment of the diseases which are found in Ukraine more than at five people on each 10 thousand people can be recognized as orphan;
in Ukraine there is no satisfactory method of diagnostics, prevention or treatment of the corresponding rare disease or if such method exists - medicine will have big advantage for patients with such rare disease;
67) poisonous medicines - the medicines carried by the central executive body providing forming and realizing state policy in the field of health care to poisonous medicines;
68) pediatric committee on questions of clinical trials (testing) (further - pediatric committee) - independent body which is effective under state control body and draws the conclusion about possibility of performing clinical trials (testing) with the assistance of juveniles and minors and includes medical/scientific specialists, the representative of the central executive body which provides forming and realization of state policy in the field of social policy, the representative of guardianship and custody body and persons of other specialties, the public representatives which exercise supervision of observance of the rights, safety, wellbeing of juveniles or minors. The structure and powers of pediatric committee determines the central executive body providing forming and realizing state policy in the field of health care;
69) primary package - any packaging which is directly contacting to medicine;
70) the risk management plan - the detailed description of risk management system;
71) similar biological medicine (биосимиляр) - biological medicine, characteristics on quality which efficiency and safety are similar to characteristics on quality, efficiency and safety of the registered reference biological medicine;
72) post-registration researches of safety of medicine - any research on safety of the registered medicine conducted after its state registration for the purpose of determination, the characteristic or assessment of safety hazard, confirmation of profile of safety of medicine or efficiency evaluation of measures for risk management;
73) the representative of the owner of registration for medicine in Ukraine (further - the representative in Ukraine) - the legal entity or physical person registered in the procedure established by the legislation of Ukraine - the entrepreneur (the subject of managing) which was authorized according to the relevant agreement and/or the power of attorney by the owner of registration registered in the member state of the European Union or the European Free Trade Association which is the agreement party about the European Economic Area for representation of its interests in Ukraine and implementation of the requirements established by the legislation of Ukraine during action of state registration;
74) radionuclide precursor - any other radionuclide intended for introduction of radioactive tag in other substance before its application;
75) allergen medicine - any medicine intended for identification or stimulation of manifestation of the specific acquired change of immune reaction to the substance causing allergy;
76) products of "in bulk" - any medicine intended for production of ready medicine which took place all stages of engineering procedure, except stage of packing and/or final packaging and marking;
77) medicine promotion - information on medicine widespread in any form and in any manner, intended for forming or maintenance of awareness of health and pharmaceutical workers, rehabilitation specialists on such medicine and directed to promotion of appointment, leave, sale or use of medicine;
78) radionuclide set - any medicine which shall be connected or mixed with radionuclides in ready radio pharmaceutical medicine, as a rule, before application;
79) radio pharmaceutical medicine - any medicine which contains one or several radionuclides (radioactive isotopes) which are entered into it in the medical purposes in condition, ready to application;
80) rekonstitution - manipulation for the purpose of obtaining ready for introduction or medicine, ready to use, from registered in accordance with the established procedure and entered in the State register of medicines or permitted to turnover and use of medicine in the cases provided by this Law according to medicine leaf insert. Rekonstitution is not considered production (production) of medicines if such actions are performed by medical personnel during medical interventions;
81) reference medicine - the medicine registered in Ukraine according to the complete registration file or, in the absence of state registration in Ukraine, - according to the complete registration file competent authority of the European Union and/or the member state of the European Union to which generic medicine for the purpose of state registration on condition of bioequivalence confirmation shall be compared;
82) the recipe - the document which form is established by the central executive body which provides forming and realizes state policy in the field of health care, constituted by the health worker who has the right to it according to the legislation based on which the subject of managing which has the corresponding license releases ready medicine to the patient or makes medicine and releases it to the patient;
83) the risks connected using medicine - any risks connected with quality, safety and efficiency of medicine for health of patients and public health and also any risks of undesirable influence on the surrounding environment;
84) retail trade by medicines - activities of subjects for acquisition, storage and sale (to realization, leaves), including remote sale (electronic retail trade) of the finished pharmaceutical products including made (made) in the conditions of drugstore, through drugstore and its structural divisions directly to citizens for private consumption, to healthcare institutions (except pharmaceutical institutions) and also to the companies, organizations and the organizations without the right of their further resale;
85) vegetable substance - everything, generally whole, crushed or cut off parts of plants, seaweed, mushrooms, lichens in raw, usually dried up, form, and also exudates which were not exposed to special processing. Vegetable substances are precisely determined by means of the used part of plant and the Botanical name according to the binomial nomenclature (sort, type, version and the author);
86) herbal remedy - any medicine containing in quality of active ingredient one or several vegetable substances, one or several vegetable medicines, one or several vegetable substances in combination (combination) to one or several vegetable medicines;
87) vegetable medicines - the medicines received from vegetable substances by extraction, distillation, expression, fractionation, cleaning, concentration and fermentation. The crushed or powdery vegetable substances, tinctures, extracts, essential oils, the wrung-out juice, the processed exudates belong to vegetable medicines;
88) serious undesirable reaction - undesirable reaction which leads to death poses threat for life, requires hospitalization or prolongation of term of hospitalization, causes resistant or essential disability or disability, or inborn anomaly / malformation or has other important medical assessment;
89) the certificate of series of medicine (the quality certificate of series) - the document which is issued by the producer and/or the importer on each series of medicine in the form established by it and certifies compliance of such series of the approved specification of medicine;
90) force of effect of medicine - content of active ingredients in quantitative expression per unit of dosing or unit of volume, or unit of mass according to dosage form;
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