Act No. 378 / 2007 Coll.

Law on medicinal products and on amendments to certain related laws (Law on medicinal products)

Valid Law Effective from 31.12.2007
Text versions: 01.01.2026 01.07.2025 01.01.2025 13.12.2024 23.08.2024 All versions (44)
Contents
ČÁST PRVNÍ HLAVA I Díl 1 § 1 Díl 2 § 2 § 3 § 3a § 4 § 5 § 6 § 7 Díl 3 § 8 § 9 § 9a § 9b HLAVA II Díl 1 § 10 § 11 § 12 § 13 § 14 § 15 § 16 § 17 § 18 § 19 § 19a Díl 2 § 20 § 21 § 22 Díl 3 § 23 § 24 § 24a HLAVA III § 25 § 26 § 27 § 28 § 28a § 29 § 30 § 30a § 30b § 30c § 31 § 31a § 32 § 32a § 32b § 33 § 33a § 33b § 33c § 34 § 34a § 35 § 36 § 37 § 38 § 39 § 40 § 41 § 42 § 43 § 44 § 45 § 45a § 46 § 47 § 48 § 48a § 49 § 49a § 49b § 50 HLAVA IV Díl 1 § 51 § 52 § 53 § 53a § 53b § 53c § 54 § 55 § 56 § 57 § 58 § 59 § 59a § 60 § 60a § 61 § 61a Díl 2 Oddíl 1 § 62 § 63 § 64 § 64a § 65 § 66 § 66a § 67 § 68 § 68a § 68b § 68c § 69 § 69a § 70 § 71 § 72 § 73 § 74 Oddíl 2 § 75 § 76 § 77 § 77a § 77b § 77c § 77d § 77e § 77f § 77g § 77h § 78 Oddíl 3 § 79 § 79a § 79b Díl 3 Oddíl 1 § 80 § 80a Oddíl 2 § 81 § 81a § 81b § 81c § 81d § 81e § 81f § 81fa § 81fb § 81fc § 81fd Oddíl 3 § 81g § 82 § 83 § 83a § 83b § 84 § 85 § 86 § 87 Oddíl 4 § 88 § 89 HLAVA V § 90 § 91 § 91a § 92 § 93 § 93a § 93b § 93c § 93d § 93e § 93f § 93g § 93h § 93i § 93j § 93k § 94 § 94a § 95 § 96 § 97 HLAVA VI Díl 1 § 98 § 99 § 100 § 100a § 101 § 101a § 101b § 101c § 101d § 102 § 102a § 102b § 102c § 102d § 102e Díl 2 § 103 § 104 § 105 § 106 § 107 § 108 § 109 HLAVA VII § 110 § 111 § 111a § 112 § 112a § 112b § 112c § 112d HLAVA VIII § 113 § 114 § 115 ČÁST DRUHÁ § 116 ČÁST TŘETÍ § 117 ČÁST PÁTÁ § 119 ČÁST ŠESTÁ § 120 ČÁST SEDMÁ § 121 ČÁST OSMÁ § 122 ČÁST DEVÁTÁ § 123 ČÁST DESÁTÁ § 124 ČÁST JEDENÁCTÁ § 125 ČÁST DVANÁCTÁ § 126
378
THE LAW
of 6 December 2007
on medicines and on changes to certain related laws (Law on medicines)
Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

SECTION A

HLAVA I

INTRODUCTORY PROVISIONS

Díl 1

Subject matter
§ 1
(1) This law incorporates the relevant European Unionregulations (1) and regulates, following the directly applicable European UnionRegulations (2)
(a) research, production, preparation, distribution, control and disposal of medicinal products and medicinal substances (hereinafter referred to as "medicines");
(b) registration, post-registration, prescription and supply of medicinal products, sale of reserved medicinal products and provision of information;
(c) international cooperation in ensuring the protection of public health and the creation of a single market for European Union medicinal products;
(d) documentation of the activities referred to in points (a) and (b).
(2) That law was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and rules and of rules on information society services, as amended by Directive 98 / 48 / EC.

Díl 2

Basic provisions
§ 2
(1) The medicinal product means
(a) a substance or a combination of substances presented having therapeutic or preventive properties in the event of human or animal diseases; or
(b) a substance or a combination of substances that can be used in humans or administered to humans or used in animals or administered to animals, either for the purpose of restoring, modifying or influencing physiological functions through pharmacological, immunological or metabolic effects, or for the purpose of establishing a medical diagnosis.
(2) The medicinal products referred to in paragraph 1 are:
(a) medicinal products for human use or use;
(b) veterinary medicinal products intended for use in animals or for administration to animals,
(c) human immunological medicinal products consisting of vaccines, toxins, serum or allergenic products; a list of vaccines, toxins, sera and allergen products is provided for in the implementing legislation,
(d) veterinary immunological medicinal products,
(e) human autogenic vaccines prepared for a particular patient from pathogens or antigens obtained exclusively from that patient;
(f) veterinary autogenic vaccines which mean inactivated immunological veterinary medicinal products produced from pathogens or antigens derived from animals or animals in one epidemiological unit (122) and which are used for the treatment of animals or animals in the same epidemiological unit or in an epidemiological unit which has the same disease situation with that epidemiological unit;
(g) homeopathic preparations made up of basic homeopathic substances according to the homeopathic manufacturing process described by the European Pharmacopoeia (4) or, if not indicated, by a pharmacopoeia officially used at present in at least one Member State of the European Union (hereinafter referred to as "the Member State"); a homeopathic medicinal product is considered to be a medicinal product even if it does not fully possess the properties of the medicinal products and the substances contained therein are not always substances with a proven medicinal effect,
(h) radiopharmaceuticals which, when ready for use, contain 1 or more radionuclides (radioactive isotopes) incorporated for medical purposes;
(i) radionuclide generators which are systems containing or preparing parent radionuclide from which a subsidiary radionuclide is produced, separated by elution or other means,
(j) kits by which products intended for reconstitution or use with radionuclide in the final radiopharmaceuticals are usually used prior to their administration,
(k) radionuclide precursors which mean radionuclides manufactured for the radioactive labelling of another substance prior to administration;
(l) blood derivatives which refer to industrially manufactured medicinal products of human blood or human plasma; blood derivatives include in particular albumin, coagulation factors and immunoglobulins of human origin,
(m) human herbal medicinal products containing as active ingredients at least 1 herbal substance or at least 1 herbal preparation or at least 1 herbal substance in combination with at least one herbal preparation;
(n) human blood transfusions and its components processed for human administration for the purpose of treating or preventing disease, except for blood derivatives; blood stem cells and lymphocytes of the haematopoietic stem cell donor intended for the recipients of these cells are not considered human blood and its components for the purposes of this Act,
(o) veterinary transfusions of animal blood and its constituents which have not undergone industrial processing;
(p) reserved medicinal products which, according to the marketing authorisation, may be sold without a prescription outside pharmacies,
(q) medicinal products for gene therapi86) which mean human biological medicinal products containing or consisting of recombinant nucleic acid, used or administered to humans for the control, repair, replacement, addition or elimination of a genetic sequence, the therapeutic, preventive or diagnostic effect of which relates directly to the recombinant nucleic acid sequence or to the genetic expression product of that sequence; gene therapy medicinal products do not include vaccines against infectious diseases,
(r) somatocellular therapy medicinal products which mean human biological medicinal products determined by or consisting of the pharmacological, immunological or metabolic action of their cells or tissues for the treatment, prevention or diagnosis of diseases in humans,
1. which have undergone a change in their physiological functions, biological or structural properties relevant to the intended clinical use, in particular where the manipulation referred to in Annex 1 to the directly applicable European Union regulation on advanced therapi87 medicinal products is not considered to be essential manipulation; or
2. which are not intended to be used by the recipient in the same basic function or functions as the donor,
(s) biological veterinary medicinal products.
(3) A substance means any substance, regardless of its origin, which may be:
(a) human blood, such as human blood, its constituents and preparations of human blood,
(b) animals such as micro-organisms, toxins, whole animals, parts of organs, animal secretions, extracts or preparations of blood;
(c) vegetable; or
(d) chemical.
(4) In particular, the substance referred to in paragraph 3 shall be:
(a) an active substance which means any substance or mixture of substances intended for use in the manufacture or preparation of a medicinal product which, after being used in that manufacture or preparation, becomes an active ingredient of a medicinal product intended to develop a pharmacological, immunological or metabolic effect for the purpose of restoring, modifying or influencing physiological functions or establishing a medical diagnosis;
(b) an additive which means any constituent of a medicinal product which is not an active substance or packaging material.
§ 3
(1) The summary of product characteristics is a written summary of the information on the medicinal product included in the marketing authorisation for the medicinal product and contains information relevant to its correct use.
(2) The withdrawal period for the purposes of this Act is the period referred to in Article 4 (34) of Regulation (EU) 2019 / 6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001 / 82 / EC ("the Regulation on veterinary medicinal products"). This also applies to other medicinal products used in accordance with Articles 113 and 114 of this Regulation.
(3) Pharmacovigilance of medicinal products for human use means the supervision of medicinal products to ensure the safety and the most favourable risk-benefit ratio of the medicinal product. Pharmacovigilance of veterinary medicinal products means the activities referred to in Article 4 (30) of the Regulation on veterinary medicinal products. Pharmacovigilance of medicinal products shall include in particular the collection of information relevant to the safety of the medicinal product, including information obtained through clinical trials, their evaluation and the implementation of appropriate measures.
(4) For the purposes of this Act, the undesired effect of a medicinal product for human use shall be the response to a medicinal product which is unfavourable and unintended. For the purposes of this Act, the undesired effect of a veterinary medicinal product shall be the adverse and unintended response that occurs after its use under the conditions of its registration or outside the conditions of its registration, usually after a dose commonly used for prophylaxis, treatment or diagnosis of disease or for the renewal, modification or other influence of physiological functions; in the case of a clinical trial of the veterinary medicinal product, this is an adverse and unintended response after any dose. This definition does not apply to human transfusion products. Adverse drug reactions are distinguished in particular from:
(a) serious adverse reactions resulting in death, life-threatening, requiring hospitalisation or prolongation of ongoing hospitalisation, resulting in permanent or significant harm to health or limitation of abilities, or manifesting itself as a congenital anomaly or birth defect in offspring;
(b) unexpected adverse reactions, the nature, severity or effect of which is contrary to the information contained in the summary of product characteristics of the authorised medicinal product or contravened with the available information, such as a set of information for the investigator of the investigational medicinal product which is not authorised;
(c) adverse reactions that have occurred in humans with the veterinary medicinal product.
(5) For the purposes of this Act, an adverse change in the state of health affecting the patient or the subject of the evaluation receiving a medicinal product for human use, other than a medicinal product for human transfusions, means that it is not known whether it is related to the cause of the treatment.
(6) For the purposes of this Act, a serious adverse event means an adverse event that results in death, endangers life, requires hospitalisation or extension of the ongoing hospitalisation, results in permanent or significant harm to health or limitation of abilities, or is manifested as a congenital anomaly or birth defect in offspring, regardless of the dose of the medicinal product used.
(7) For the purposes of this Act, a post-authorisation safety study for a veterinary medicinal product shall mean a pharmacoepidemiological study or clinical trial carried out in accordance with the marketing authorisation decision and for the purpose of identifying or quantifying the safety risk in relation to a authorised medicinal product.
(8) For the purposes of this Act, the risk associated with the use of a medicinal product means:
(a) the risk related to the quality, safety or efficacy of the medicinal product for human, public or animal health;
(b) the risk of adverse effects on the environment; or
(c) the risk of developing resistance if it is a veterinary medicinal product.
(9) Risk-benefit ratio means the assessment of the positive therapeutic effects of the medicinal product in relation to the risks referred to in paragraph 8. The risk-benefit ratio is favourable if the benefit outweighs the risks associated with its use.
(10) Hemovigilance means a set of systematic procedures for the supervision of human blood transfusions and blood raw materials and its components for further production (hereinafter referred to as "raw material for further production ') concerning serious adverse or unexpected events or reactions in donors or recipients, and epidemiological monitoring of donors.
§ 3a
(1) For the purposes of this Act, a safety pooling study for a medicinal product for human use means any study concerning a authorised medicinal product for human use carried out to identify, describe or quantify the safety risk, confirm the safety profile of the medicinal product or establish the effectiveness of the risk management measures.
(2) Non-interventional post-authorisation studies for a medicinal product for human use for the purposes of this Act are any study in which the authorised medicinal product is used in a normal manner and in accordance with the terms of its marketing authorisation and where the use of the medicinal product is not determined by the inclusion of the patient in such a study but by the decision of the treating doctor or dental practitioner (hereinafter referred to as the "doctor"), and no additional diagnostic or monitoring procedures are applied in patients and epidemiological methods are used for analysing the data collected; non-interventional post-registration studies shall include in particular epidemiological, pharmacological and research studies.
(3) Pharmacovigilance system means, for the purposes of this Act, a system of monitoring and reporting used by the marketing authorisation holder and by the authorities in the field of pharmaceuticals to perform the tasks and to ensure the duties referred to in Title Five of this Act in the pharmacovigilance section and to monitor the safety of authorised medicinal products and to identify any changes in their risk-benefit ratio.
(4) For the purposes of this Act, the basic pharmacovigilance system document shall mean a detailed description of the pharmacovigilance system used by the marketing authorisation holder for one or more authorised medicinal products.
(5) For the purposes of this Act, a risk management system shall mean a set of pharmacovigilance activities and interventions intended to identify, describe, prevent or reduce the risks associated with the medicinal product, including an assessment of the effectiveness of those activities and interventions.
(6) For the purposes of this Act, a risk management plan means a detailed description of the risk management system.
(7) For the purposes of this Act, a serious adverse reaction is an unintended response of a donor or a patient related to blood collection or its component or to a transfusion of a human transfusion product resulting in death, life-threatening, permanent or significant harm to health or limitation of the patient's ability, or requires hospitalisation or extension of ongoing hospitalisation.
(8) For the purposes of this Act, a serious undesirable event shall mean an adverse event related to blood collection or its components, testing, processing, storage and distribution of a released human transfusion product or raw material for the further manufacture or supply of a human transfusion product which could result in death, life-threatening, permanent or significant harm to the health or limitation of the patient's ability.
(9) For the purposes of this Act, reference substances shall mean substances with a defined purity which have a valid certificate indicating the quality and shelf life.
(10) For the purposes of this Act, the placing on the market of a medicinal product in the Czech Republic shall mean the transmission of a medicinal product after the completion of production, delivery from another Member State, or of imports carried out for the purpose of distributing the medicinal product, except for its use in a clinical trial.
§ 4
(1) The name of the medicinal product is a name which may either be unmistakable with a common name or a common or scientific name accompanied by a name or mark identifying the marketing authorisation holder. A common name means an international non-proprietary name recommended by the World Health Organisation or, in the absence of such an international non-proprietary name, a commonly used name.
(2) The strength of the medicinal product means the content of active substances, expressed quantitatively in relation to the unit of dose, volume or weight by pharmaceutical form.
(3) Internal packaging means a form of packaging in immediate contact with the medicinal product. The outer packaging means the packaging containing the inner packaging. Labelling on the packaging means the information given on the inner or outer packaging.
(4) Package leaflet means written information for the user who is part of the medicinal product.
(5) For the purposes of this Act, a lot shall mean the quantity of product produced or prepared in a single production cycle or process or homogenised during preparation or manufacture. The essential character of the lot is the uniformity of all units of the product constituting the lot.
(6) The provision of a transfusion service means a provider of health services for which the collection and testing of human blood or its constituents are carried out, if they are intended for transfusion or processing for any purpose, and in which the processing of human blood or its constituents is carried out to obtain human blood products or raw materials for the further manufacture of medicinal products for human use, including control and release, and their storage and distribution. A blood bank shall not be considered as a transfusion service.
(7) A blood bank means an organisational unit of the health service provider in which human blood transfusions are stored and issued, exclusively for use with the health service provider, or where pre-transfusion immunohematologic tests are carried out. The procedure for dispensing human transfusions shall be laid down in implementing legislation.
§ 5
(1) Treatment of medicinal products for the purposes of this Act means research, preparation, modification, control, production, distribution, storage and storage, supply and transport, offering for sale, supply, sale of possession for business purposes, provision of advertising samples, use of medicinal products in the provision of health services or veterinary care or disposal of medicines.
(2) For the purposes of this Act, research on medicinal products shall mean non-clinical evaluation of the safety of medicinal products and clinical evaluation of medicinal products to demonstrate their effectiveness, safety or quality.
(3) The preparation of medicinal products means the manufacture of medicinal products in a pharmacy or other workplaces where medicinal products may be prepared in accordance with Section 79 (2).
(4) The preparation of medicinal products means the procedure to be followed for:
(a) medicinal products subject to registration prior to their supply or use in the provision of health services or veterinary care in accordance with the summary of product characteristics or as specified by the manufacturer in the case of a procedure under § 8 (3) to (5) or the conditions laid down in a specific treatment programme;
(b) investigational medicinal products prior to their use in a clinical trial, in accordance with the protocol and approved clinical trial procedures;
the procedures referred to in points (a) or (b) which are disproportionately demanding or dangerous, even if otherwise meet the adaptation characteristics of those points, shall be considered as preparation; a list of such procedures shall be provided for in the implementing legislation.
(5) The distribution of medicines shall mean all activities consisting of the provision, storage, delivery, including the supply of medicines within the European Union and exports to countries other than Member States ("third countries') and relevant commercial transfers, regardless of whether they are activities performed for remuneration or free of charge. The distribution of medicinal products shall be carried out in cooperation with manufacturers, other distributors or pharmacies and other persons authorised to supply medicinal products to the public, where appropriate, to use medicinal products. The distribution of medicinal products shall not be considered to be the supply of medicinal products, their sale by the seller of the reserved medicinal products and their use in the provision of health services and veterinary care, as well as the distribution of human transfusions by transfusions and the distribution of raw materials for further production by transfusions and the distribution of veterinary transfusions and biological veterinary medicinal products. Imports of medicinal products from third countries are also not considered as distribution of medicinal products.
(6) The supply of medicinal products shall be understood as providing them under the conditions set out in Paragraph 82 (2). The supply of medicinal products shall also be considered to be the supply of their mail under the conditions set out in Sections 84 to 87. In the case of transfusion products, the supply of a human transfusion product to the provider of health services by means of a transfusion service or a blood bank, for the transfusion to a specific recipient. This provision is without prejudice to the laws governing value added tax and consumer protection (6).
(7) The sale of reserved medicinal products for human use means the purchase, storage or sale of such medicinal products. The sale of reserved veterinary medicinal products means the purchase, storage or sale to the final consumer.
(8) Use of medicinal products
(a) when providing health services:
1. their use to the patient in the provision of such services; or
2. equipping the patient in accordance with § 8 (1) with the necessary amount of medicinal products at the end of hospitalisation or at the time of transfer of the patient to another health service provider; or
3. the equipment of the patient referred to in Article 8 (1) by the provider of health services in the field of general medical practice, by a practitioner in the field of children and adolescents and by the provider of health care services; or
4. the equipment of the patient referred to in Article 8 (1) by the necessary amount of an individually prepared human medicinal product containing addiction40) by the provider of health services in the field of psychiatry, childhood and adult psychiatry, gerontopsychiatry or in the field of addictive illness in the context of the provision of treatment for an additive disorder in which the patient uses this medicinal product as a substitute for an addictive substance which has caused its additive disorder;
(b) veterinary care means the administration of animals or groups of animals or their use in an animal or group of animals and the provision of medicinal products to a breeder in the amount needed to complete the treatment or treatment in question, under the conditions laid down in this Act and the legislation (8).
(9) For the purposes of this Act, the supply of medicines to the persons referred to in points (2) to (6) and (9) of Paragraph 77 (1) (c), the supply of medicinal products, including the supply of human transfusions, the distribution of human transfusions, the supply of veterinary transfusions, the sale of reserved medicinal products and the use of medicinal products in the provision of health services or veterinary care.
(10) For the purposes of this Act, a veterinary special treatment programme shall mean the use of a veterinary medicinal product which is not authorised in the European Union or in a third country under the conditions laid down in this Act.
(11) The use of medicinal products for the purposes of this Act shall mean the deliberate excessive use of medicinal products or the intentional use of medicinal products in a manner contrary to the intended purpose of use, even after further processing, accompanied by harmful effects on the organism, including harmful effects on its psyche.
(12) The use of a veterinary medicinal product outside the scope of the marketing authorisation shall mean the use of a veterinary medicinal product which does not comply with the summary of product characteristics. For the purposes of checking the use, prescription and dispensation of medicinal products in the provision of veterinary care and pharmacovigilance, the use of the veterinary medicinal product outside the scope of the marketing authorisation shall also mean the misuse or misuse of the product.
(13) For the purposes of this Act, through the provision of medicinal products for human use, all activities linked to the purchase or sale of medicinal products for human use which do not involve the physical treatment or distribution of products and which are the subject of independent negotiations on the purchase or sale of medicinal products on behalf of another person.
(14) For the purposes of this Act, falsified medicinal product means any medicinal product,
(a) which contains false particulars of its identity, including packaging and labelling, name or composition in respect of any of its constituents, including the ingredients and the strength of those constituents;
(b) which contains false indications of its origin, including the manufacturer, the country of manufacture, the country of origin or the marketing authorisation holder; or
(c) which is accompanied by documentation containing false historical data, including records and documents relating to the distribution channels used.
(15) A medicinal product with unintended quality defects shall not be considered as a falsified medicinal product in accordance with paragraph 14.
(16) For the purposes of this Act, when used in investigational medicinal products for human use or veterinary medicinal products, the manufacturing, packaging, repackaging, labelling, marking, quality control or release of the active substance shall mean any complete or partial act of taking over the material, of manufacturing, packaging, repackaging, marking, remarking, quality control or release of the active substance, as well as any related control. The definition of what is meant by the production of the active substance, when applicable in medicinal products for human use, is laid down in a directly applicable European Union regulation governing good manufacturing practice for the active substance (101). The definition of the manufacturing of the active substance, when applicable in veterinary medicinal products, is laid down in the Regulation on veterinary medicinal products.
§ 6
(1) The operator for the purposes of this Act is:
(a) the manufacturer of medicinal products, the person importing medicinal products from third countries, the establishments of the transfusion service, the operator of the control laboratory and the manufacturer of the active substances;
(b) a drug distributor ("the distributor");
(c) a person authorised to provide health services under the Health Services Act (9) (hereinafter referred to as the "Health Service Provider");
(d) the person authorised to provide veterinary care under legislation (10);
(e) a person organising or conducting research into medicines; or
(f) dealers of reserved medicinal products.
(2) For the purposes of this Act, good manufacturing practice means a set of rules ensuring that the manufacture and control of medicines are carried out in accordance with quality requirements, intended use and appropriate documentation. In the case of medicinal products for human and veterinary use, good manufacturing practice rules shall apply mutatis mutandis to imports from third countries.
(3) For the purposes of this Act, proper distribution practice shall mean a set of rules ensuring that the distribution of medicinal products and, where appropriate, of excipients is carried out in accordance with quality requirements, intended use and appropriate documentation.
(4) For the purposes of this Act, good laboratory practice means a quality assurance system concerning the organisation process and the conditions under which non-clinical studies on the safety of medicinal products are planned, performed, controlled, recorded, submitted and archived.
(5) For the purposes of this Act, proper pharmacy practice means a set of rules ensuring that the preparation, modification, control, storage and supply of medicinal products are carried out in accordance with the requirements for their quality, safety, efficacy and information of patients, in accordance with the intended use of medicinal products and with the relevant documentation.
(6) For the purposes of this Act, the correct practice of dealers of reserved medicinal products means a set of rules ensuring that the sale of reserved medicinal products is carried out in accordance with the quality, safety and efficacy requirements of reserved medicinal products, in accordance with their intended use.
§ 7
(1) Persons handling medicines are obliged to:
(a) ensure the maximum benefit of medicines when used and minimise the adverse effects of medicines on human and public health, animal health and the environment;
(b) comply with the instructions for the treatment of a medicinal product in accordance with the Summary of Product Characteristics, as far as the use of medicinal products for human use is concerned, in accordance with § 8 (3) to (5) or in the provision of veterinary care under § 9 (1) (b) to (m).
(2) Only authorised persons may carry out medicinal activities under this law.

Díl 3

Use of medicinal products in the provision of health services and veterinary care
§ 8
Use of medicinal products for human use in the provision of health services
(1) Only authorised medicinal products for human use under § 25 may be prescribed, put into circulation or used in the provision of health services, unless otherwise specified. Medicinal products for the provision of medical services under Sections 5 (8) (a) (2) and (3) may only be supplied to the patient if the patient's medical condition necessarily requires the immediate use of the medicinal product and, due to the local or time-out of medical care, the timely dispensation of the medicinal product is not possible; the method of equipping the patient with medicinal products when providing the health services referred to in § 5 (8) (a) (2) to (4) shall be laid down in implementing legislation.
(2) In addition, medicinal products prepared in a pharmacy and other workplaces where medicinal products may be prepared in accordance with § 79 (2) can be prescribed and used in the provision of health services, and transfusion products produced in a transfusion service facility.
(3) When providing medical services to individual patients, the treating physician may prescribe or use medicinal products not authorised under this Act only in situations where:
(a) is not distributed or circulated in the Czech Republic a medicinal product corresponding to the composition or similar therapeutic properties which is registered;
(b) is a medicinal product which:
1. already registered in another State; or
2. a modern therapy product, the manufacturer of which holds an authorisation to manufacture a given pharmaceutical form to the extent appropriate to the authorisation to manufacture investigational medicinal products issued by the State Institute for Drug Control,
(c) such a method is sufficiently justified by scientific evidence; and
(d) it is not a medicinal product containing genetically modified organism11).
(4) The treating physician may, if the medicinal product is not distributed or the medicinal product of the necessary therapeutic properties is not in circulation, use the authorised medicinal product in a manner which does not comply with the Summary of Product Characteristics, but if such a method is sufficiently justified by scientific evidence.
(5) The health service provider shall be liable under the legislation (9) for damage to health or for the killing of a person resulting from the use of an unregistered medicinal product or the use of an authorised medicinal product as referred to in paragraph 4. If the treating physician intends to prescribe or use an unauthorised medicinal product or to use the authorised medicinal product in the manner referred to in paragraph 4, he shall inform the patient and, where appropriate, his legal representative of the consequences of treatment. If the patient 's medical condition does not allow for such familiarity, the treating physician will do so immediately after using the medicinal product as soon as the patient' s medical condition allows. If it is about the prescription of an unauthorised medicinal product, the doctor shall indicate this in the prescription. The prescribing or use of an unauthorised medicinal product by the treating physician shall be notified without delay to the State Institute for Drug Control. The manner and extent of notification of the prescription or use of an unauthorised medicinal product to the State Institute for Drug Control shall be laid down in the implementing legislation. In the case of radiopharmaceuticals, the State Institute for Drug Control shall inform the State Nuclear Safety Authority of the unregistered use of the non-authorised radiopharmaceuticals. The medicinal product referred to in paragraph 3 (b) (2) shall be labelled in at least the manner laid down in Paragraph 57 (2).
(6) In the case of suspected or confirmed spread of disease agents, toxins, chemicals, or in a suspected or confirmed radiological accident or accident that could seriously endanger public health, the Ministry of Health may exceptionally, by a decision issued on request by the State Institute for Drug Control, temporarily authorise the distribution, supply and use of an unregistered medicinal product for human use or the use of an authorised medicinal product in a manner which does not comply with the marketing authorisation decision. In such cases, marketing authorisation holders, manufacturers of medicinal products and health professionals shall not be liable for the consequences of such use of the medicinal product. This applies regardless of whether or not a marketing authorisation has been granted pursuant to Paragraph 25 (1). Liability for defects in medicinal products under special legislation12) is not affected. The Ministry of Health shall inform the State Institute for Drug Control of the measure. The Ministry of Health will post the measure on its official record and the State Institute for Drug Control will publish it in a way that allows remote access, and possibly in the Bulletin of the State Institute for Drug Control.
(7) The provisions of this Act shall be without prejudice to the provisions of the legislation governing radiation protection for persons undergoing medical examination or treatment or the rules laying down basic safety standards for the protection of public health and workers against the dangers of ionising radiation.
(8) It is prohibited to treat medicinal products for human use other than in accordance with this Act.
(9) In a situation where it is not possible to verify the safety features of the medicinal product to the extent that, in accordance with Article 10 of the directly applicable European Union Regulation, it is not possible to carry out a verification of the safety features on the packaging of medicinal products for human use (hereinafter referred to as "the Regulation on protective elements'), as this medicinal product does not comply with the requirements of this Regulation, the Ministry of Health may exceptionally authorise, at the request of the marketing authorisation holder, the distribution and supply of that medicinal product. In such a case, marketing authorisation holders, manufacturers of medicinal products, distributors and persons authorised to supply them shall comply with the obligations arising from the Regulation on protective elements mutatis mutandis. Liability for defects in medicinal products under special legislation12) is not affected. The Ministry of Health shall inform the State Institute for Drug Control of the measure. The Ministry of Health will post the measure on its official record and publish it in a way that allows remote access.
§ 9
Use of medicinal products in the provision of veterinary care
(1) In the provision of veterinary care, only:
(a) a veterinary medicinal product authorised in accordance with Section 25;
(b) the veterinary autogenic vaccine;
(c) a medicinal product prepared in a pharmacy for each animal in accordance with the veterinary prescription;
(d) a medicinal product prepared in accordance with the Articles of the Czech Pharmacopoeia and in the manner laid down in the implementing legislation at the pharmacy or at the workplace of another health service provider authorised under § 79 (2) to prepare medicinal products;
(e) a veterinary medicinal product authorised in another Member State in accordance with European Union14), for which the conditions laid down in Section 48 have been fulfilled for the placing into circulation in the Czech Republic,
(f) a medicinal product for human use authorised in accordance with Section 25;
(g) the veterinary medicinal product used in the framework of a veterinary special treatment programme approved by the Institute for State Control of Veterinary Bioprafts and Medicines (hereinafter referred to as the Veterinary Institute) for one animal or for a group of animals pursuant to Article 48a, having regard to Article 112, 113 or 114 of the Regulation on veterinary medicinal products,
(h) a veterinary medicinal product for which a clinical trial has been approved by the Veterinary Institute in accordance with § 60 or 60a;
(i) a biological veterinary medicinal product containing autologous or allogeneic cells or tissues;
(j) veterinary radiopharmaceuticals,
(k) the veterinary transfusion preparation,
(l) a veterinary medicinal product for which the Central Veterinary Administration of the State Veterinary Administration ("the Central Veterinary Administration") has issued an exemption under Paragraph 46; or
(m) an unregistered immunological veterinary medicinal product decided to be used by the European Commission ("the Commission").
(2) The medicinal products referred to in paragraph 1 may be used in the provision of veterinary care only if they comply with the conditions laid down in Chapter VII, Section 3 of the Regulation on veterinary medicinal products, Commission implementing acts or Commission delegated acts issued pursuant to the Articles of this Section, this Act and the implementing legislation. The implementing act shall impose restrictions on the use of the medicinal products referred to in paragraph 1 and the conditions for their availability with regard to authorised veterinary medicinal products under the directly applicable European Union Regulation.
(3) A veterinary medicinal product put into circulation under Article 34 of the Regulation on veterinary medicinal products or under this law is subject to medical prescription, a veterinary medicinal product which is not bound by a prescription but which is to be used outside the conditions of its authorisation and a medicinal product for human use used in the provision of veterinary care may only be used:
(a) a veterinarian authorised to carry out a veterinary medical and preventive activity in accordance with the conditions laid down in the Chamber of Veterinary Physicians or a university veterinarian authorised to carry out a veterinary medicinal and preventive activity in accordance with § 58 (3) (a) of the Veterinary Act (the "veterinarian"); or
(b) the breeder of the animal, if he / she is responsible for administering the medicinal product for the animal he / she is kept in accordance with the instructions given by the veterinarian and, in the case of an animal producing animal products intended for human nutrition, also in accordance with the conditions laid down in veterinary law (10).
Where a veterinarian intends to use an unregistered veterinary medicinal product in an animal, a veterinary medicinal product to be used outside the conditions of its registration, or a medicinal product for human use, he shall inform the keeper of the animal of the possible adverse consequences associated with the use of such a product.
(4) The veterinary surgeon shall use the medicinal product referred to in paragraph 3, or shall lay down instructions for the administration of such medicinal product only after diagnosis or other conclusion authorising it to use the medicinal product, on the basis of:
(a) a properly carried out and documented examination of the animal or animals in breeding normally carrying out a therapeutic and preventive veterinary activity and an assessment of any other conditions which may affect the safety or efficacy of the medicinal product to be used;
(b) a detailed and documented set of information on the health status of the animal or group of animals in the holding for which the conditions referred to in point (a) are met, in case of preventive use of medicinal products or a long-term programme of treatment in the holding; or
(c) on the basis of an immediate assessment of the health status of the animal or other information to the extent necessary to decide on the use of the medicinal product in such a way as to minimise the risk of its adverse effects, if there is an exceptional case of danger to the health or life of the animal;
taking further account of the conditions laid down in the Regulation on veterinary medicinal products.
(5) Only a veterinarian who has carried out the operations referred to in paragraph 4 may use:
(a) a veterinary medicinal product for which the Veterinary Institute has restricted the range of persons authorised to use the veterinary medicinal product by decision pursuant to Paragraph 40 (4);
(b) a medicinal product for human use as referred to in paragraph 1 which is associated with a high risk to public health, animal health or the environment, including the risk of developing resistance to antimicrobials; the implementing legislation establishes a list of such medicinal products for human use or groups thereof,
(c) the veterinary transfusion product referred to in Article 68a or 68b;
(d) the biological veterinary medicinal product for cellular or tissue therapy referred to in Article 68c;
(e) veterinary radiopharmaceuticals,
(f) a veterinary medicinal product for which the Central Veterinary Administration has so decided pursuant to Article 46,
(g) the medicinal product for which the Veterinary Institute has so decided pursuant to § 48, and
(h) an immunological veterinary medicinal product for which such a restriction has been provided for in the framework of protective or protective measures laid down by veterinary authorities under another legislation (18).
(6) A medicinal product containing thyrostatic substances, hormonal substances or beta-agonists may only be used for the purpose of providing veterinary care if its use is not contrary to the conditions laid down in this Act and other legislation17). A veterinarian intending to use the medicinal product according to the first sentence in an animal producing animal products intended for human consumption shall inform the breeder in advance and obtain the consent of the breeder to administer such medicinal product. However, if it is required to protect the health or life of an animal, the veterinarian may use the medicinal product according to the first sentence without obtaining the consent of the breeder, but shall immediately inform the breeder in a conclusive manner.
(7) An immunological veterinary medicinal product may only be used for veterinary purposes if its use complies with this law and the measures laid down by veterinary authorities under another legislation18).
(8) Following the administration of a veterinary medicinal product to an animal producing animal products intended for human consumption in accordance with the conditions of its registration, the breeder of such an animal shall comply with the withdrawal period laid down in the conditions for registration of the veterinary medicinal product, unless the veterinarian who has carried out the operations referred to in paragraph 4 provides for a longer withdrawal period.
(9) Following the administration of a medicinal product to an animal producing animal products intended for human consumption under conditions other than those referred to in paragraph 8, a withdrawal period shall be set taking into account the conditions laid down in Article 115 of the Regulation on veterinary medicinal products by a veterinarian who has carried out the operations referred to in paragraph 4, and the breeder shall comply with at least the withdrawal period laid down in this Regulation.
(10) The veterinarian who has carried out the operations referred to in paragraph 4 shall record any use of the medicinal product in the provision of veterinary care in accordance with the requirements laid down in the implementing legislation. Records of the use of medicinal products shall be kept by the veterinarian who carried out the operations referred to in paragraph 4 for at least 5 years. The implementing act shall lay down the manner in which such records are kept and the content thereof. Records of the use of medicinal products shall be provided by the veterinarian who carried out the operations referred to in paragraph 4 in electronic form to the Veterinary Institute in accordance with the conditions laid down in Sections 102a to 102e.
(11) Breeders who:
Zobrazit všechna ustanovení (3398)
Contents
ČÁST PRVNÍ HLAVA I Díl 1 § 1 Díl 2 § 2 § 3 § 3a § 4 § 5 § 6 § 7 Díl 3 § 8 § 9 § 9a § 9b HLAVA II Díl 1 § 10 § 11 § 12 § 13 § 14 § 15 § 16 § 17 § 18 § 19 § 19a Díl 2 § 20 § 21 § 22 Díl 3 § 23 § 24 § 24a HLAVA III § 25 § 26 § 27 § 28 § 28a § 29 § 30 § 30a § 30b § 30c § 31 § 31a § 32 § 32a § 32b § 33 § 33a § 33b § 33c § 34 § 34a § 35 § 36 § 37 § 38 § 39 § 40 § 41 § 42 § 43 § 44 § 45 § 45a § 46 § 47 § 48 § 48a § 49 § 49a § 49b § 50 HLAVA IV Díl 1 § 51 § 52 § 53 § 53a § 53b § 53c § 54 § 55 § 56 § 57 § 58 § 59 § 59a § 60 § 60a § 61 § 61a Díl 2 Oddíl 1 § 62 § 63 § 64 § 64a § 65 § 66 § 66a § 67 § 68 § 68a § 68b § 68c § 69 § 69a § 70 § 71 § 72 § 73 § 74 Oddíl 2 § 75 § 76 § 77 § 77a § 77b § 77c § 77d § 77e § 77f § 77g § 77h § 78 Oddíl 3 § 79 § 79a § 79b Díl 3 Oddíl 1 § 80 § 80a Oddíl 2 § 81 § 81a § 81b § 81c § 81d § 81e § 81f § 81fa § 81fb § 81fc § 81fd Oddíl 3 § 81g § 82 § 83 § 83a § 83b § 84 § 85 § 86 § 87 Oddíl 4 § 88 § 89 HLAVA V § 90 § 91 § 91a § 92 § 93 § 93a § 93b § 93c § 93d § 93e § 93f § 93g § 93h § 93i § 93j § 93k § 94 § 94a § 95 § 96 § 97 HLAVA VI Díl 1 § 98 § 99 § 100 § 100a § 101 § 101a § 101b § 101c § 101d § 102 § 102a § 102b § 102c § 102d § 102e Díl 2 § 103 § 104 § 105 § 106 § 107 § 108 § 109 HLAVA VII § 110 § 111 § 111a § 112 § 112a § 112b § 112c § 112d HLAVA VIII § 113 § 114 § 115 ČÁST DRUHÁ § 116 ČÁST TŘETÍ § 117 ČÁST PÁTÁ § 119 ČÁST ŠESTÁ § 120 ČÁST SEDMÁ § 121 ČÁST OSMÁ § 122 ČÁST DEVÁTÁ § 123 ČÁST DESÁTÁ § 124 ČÁST JEDENÁCTÁ § 125 ČÁST DVANÁCTÁ § 126

Sign in for notes, favorites and notifications

Register Free Sign In
Rating:

Comments 0

To write comments, please sign in.

Regulation Information

CitationAct No. 378 / 2007 Coll., on Medicines and Changes to Certain Related Acts (Law on Medicines)
Regulation TypeLaw
Author-
CollectionCode of Laws
Date of Promulgation31.12.2007
Effective from31.12.2007
Effective until-
Status Valid
Legal Areas: Taxes European law Finance Commercial law Labour law Industrial rights Self-administration Administrative offences Administrative law State (official) control Health Agriculture Eligibility for the pursuit of certain professions (activities)
The regulation text is for informational purposes only.

Partner Websites

Založení s.r.o. Virtual offices and company formation
MojeDatovka.cz Data box database and search
ČeskéFirmy.online Czech company directory and reviews
Favorites
Browsing History
This website uses cookies to ensure proper functionality, analyze traffic and display advertising. More information
Cookie Settings

Choose which cookie categories you want to allow.