Full text of Act No. 402 / 2000 Coll.
The full text of Act No. 79 / 1997 Coll., on Medicines, as follows from the amendments made by Act No. 149 / 2000 Coll.
Valid
Declared full text
Text versions:
24.11.2000
Contents
ČÁST PRVNÍ
HLAVA PRVNÍ
§ 1
§ 2
§ 3
§ 4
§ 5
HLAVA DRUHÁ
Díl první
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
Díl druhý
§ 15
§ 16
§ 17
Díl třetí
§ 18
§ 19
§ 20
§ 21
§ 22
HLAVA TŘETÍ
§ 23
§ 24
§ 25
§ 26
§ 27
§ 28
§ 29
§ 30
§ 31
§ 32
HLAVA ČTVRTÁ
Díl první
§ 33
§ 34
§ 35
§ 36
§ 37
§ 38
§ 39
§ 40
Díl druhý
§ 41
§ 42
§ 43
Díl třetí
§ 44
§ 45
§ 46
§ 47
Díl čtvrtý
§ 48
§ 49
Díl pátý
§ 50
§ 51
HLAVA PÁTÁ
§ 52
§ 53
HLAVA ŠESTÁ
Díl první
§ 54
§ 55
§ 56
§ 57
§ 58
Díl druhý
§ 59
§ 60
§ 61
§ 62
§ 63
HLAVA SEDMÁ
§ 64
§ 65
§ 66
§ 67
§ 68
§ 69
§ 70
ČÁST TŘETÍ
§ 75
§ 76
§ 77
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402
PRESIDENT OF THE GOVERNMENT
Announces
full text of Act No. 79 / 1997 Coll., on Medicines, as is apparent from the amendments made by Act No. 149 / 2000 Coll.
THE LAW
o
Parliament has decided on this law of the Czech Republic:
THE PROVISIONS
INTRODUCTORY PROVISIONS
Purpose of the law
That law lays down the conditions for:
(a) research, production, preparation, distribution, control and disposal of medicines;
(b) the registration, prescription and supply of medicinal products and the sale of reserved medicines;
(c) documentation of the activities referred to in points (a) and (b).
Interpretation of terms
(1) Medicinal products are active substances or mixtures thereof or medicinal products intended for administration to humans or animals, not for additives and premixy1)
(2) Active substances are substances of natural or synthetic origin, generally having a pharmacological or immunological effect, or affecting metabolism, which serve to prevent, treat and mitigate diseases, diagnose and influence physiological functions.
(3) Medicinal products are products obtained by the technological treatment of active substances and excipients, as well as plants used for pharmaceutical and therapeutic purposes, either alone or in a mixture, in a specific pharmaceutical form, packed in appropriate packaging and labelled appropriately, intended for human administration ("human medicinal products') or for animal administration (" veterinary medicinal products'). They are also
(a) veterinary medicinal products containing active substances or mixtures thereof intended for use in feedingstuffs or beverages and medicated feed and medicated premixtures;
(b) disinfectants and disinfectants intended for direct contact with the organism
1. man,
2. animals and feedingstuffs, if they are liable to endanger animal health or the health of animal products, 2)
(c) diagnostic preparations intended for direct contact with a human or animal organism;
(d) immunobiological products;
(e) transfusion preparations and blood derivatives,
(f) radiopharmaceuticals,
(g) homeopathic products, even if they do not fully possess the characteristics of the medicinal products listed in the first sentence, in particular substances contained therein, are not always substances of medicinal products which have a proven medicinal effect;
(h) medicinal teas and medicinal teas;
(i) therapeutic dietetics.
(4) Immunobiological products are mass-produced medicinal products intended to protect against the development and spread of infectious diseases and to reduce their occurrence acting by affecting the immune system.
(5) Transfusion products shall mean human blood and its components and medicinal products made from human blood or its constituents, from a maximum of 10 donors per recipient. Transfusion products shall not be considered mass-produced medicinal products.
(6) Blood derivatives are mass-produced medicinal products made from or from human blood.
(7) Radiopharmaceuticals are medicinal products which contain at least one intentionally integrated radionuclide in the form intended for administration to a person or animal.
(8) A homeopathic preparation means a specific process diluted by one or more substances which, in concentrated quantities, would be able to produce similar symptoms in a healthy individual as those for which it is administered.
(9) Medicinal dietetics are oral medicinal products intended for human or animal consumption in the event of disease treatment.
(10) The other ingredients are substances that are in the quantities used without their own therapeutic effect, and
(a) enable or facilitate the manufacture, preparation and storage of medicinal products or their application;
(b) affect favourably the pharmacokinetic properties of the active substances contained in medicinal products.
(11) The mass-produced medicinal products are those manufactured by the manufacturer in batches. Intermediate products intended for further processing by the manufacturer shall not be considered mass-produced medicinal products.
(12) The lot is the quantity of product produced or prepared at the same time in a single production cycle (process) or homogenised during preparation or manufacture. The essential feature of the lot is its homogeneity.
(13) The summary of product characteristics is a written summary of all information on the medicinal product relevant for its proper use by healthcare professionals, which contains in particular therapeutic indications, contraindications, dosage and storage conditions of the medicinal product.
(14) Withdrawal period means the period after the administration of the veterinary medicinal product, during which the product may be adversely affected by the health of animal products.
(15) The undesired effect of the medicinal product is an adverse and unintended response to its administration, which occurs after a dose commonly used for prophylaxis, treatment or diagnosis of the disease or to affect physiological function.
(16) A serious adverse effect of a medicinal product is the death of a treated person or animal, such an adverse effect that endangers their life, seriously harms their health, has permanent consequences for their health or results in hospitalisation of the treated person or animal, a disproportionate extension of their hospitalisation, or a congenital anomaly in their offspring.
(17) The unexpected adverse effect of a medicinal product shall be that which is not listed in the summary of product characteristics referred to in paragraph 13.
(18) Medicines shall not be considered as
(a) food and feed;
(b) cosmetic products,
(c) plant protection products,
(d) laboratory diagnostics;
(e) disinfectant and disinsecting preparations, not for the products referred to in paragraph 3 (b);
(f) tissues and grafts intended for transplantation.
The said products must not be labelled with a therapeutic indication.
(19) Reserved medicines are mass-produced medicinal products for human use that can be sold without a prescription and outside pharmacies according to the marketing authorisation.
(20) The investigational medicinal products are those active substances, their mixtures, medicinal products or products obtained by the technological treatment of excipients which are evaluated or used as comparators in clinical trials; medicinal products may be already authorised.
(21) Medicated feed means a mixture of medicated premixture or a mixture of a veterinary medicinal product with a feed or feed placed on the market in final presentation which is intended for direct skinning by the animal without further modification.
(22) A medicated premixture means any mass-produced veterinary medicinal product manufactured for the preparation of medicated feed.
(23) Monitoring means the examination of the veterinary medicinal product in a wide clinical practice, such as the systematic collection and analysis of effects related to the use of the medicinal product, including monitoring of resistance of disease agents and drug residues in animal products.
(1) Treatment of medicinal products means research, production, preparation, distribution, supply, sale of reserved medicines, use of medicines in the provision of and disposal of health and veterinary care.
(2) Drug research means pre-clinical testing and clinical evaluation of drugs to demonstrate their effectiveness, safety and quality.
(3) The manufacture of pharmaceuticals shall mean all activities, including individual activities, leading to the formation of a medicinal product, in particular the provision of raw materials, including blood and its constituents, the processing of raw materials, further filling, packaging and labelling, including the control and keeping of documentation in those activities, even if such activities are carried out for the purpose of exporting medicines. The manufacture of medicinal products shall also mean the storage by the manufacturer, and, in the case of establishments, their supply.
(4) The preparation of medicinal products means the manufacture of medicinal products at a pharmacy or at the workplace of nuclear medicine at a medical facility.
(5) The distribution of medicines shall mean their purchase, storage, transport and supply, including the control and documentation of such activities, even if such activities are carried out for the purpose of importing or exporting medicines.
(6) The supply of medicinal products shall mean the provision of medicinal products to natural persons or medical establishments under the conditions set out in Section 48 (3).
(7) The use of medicinal products in the provision of medical care means the use of medicinal products in the exercise of such care, or the provision of the patient with the necessary quantities of medicinal products. The provision of the necessary amount of medicinal products on release from the institution into home care or on the provision of medical care by a medical practitioner, a medical practitioner for children and adolescents, a emergency care doctor or a emergency emergency medical practitioner in the event that the patient's medical condition requires the immediate use of the medicinal product and that the timely delivery of the medicinal product to a medical prescription is not achievable due to the local or temporal availability of medical care.
(8) The use of medicinal products in the provision of veterinary care means the provision of such medicinal products to caregivers or directly to animals, except for the supply of medicinal products, by persons authorised to provide veterinary care under specific regulations.4)
(9) The supply of medicines to persons referred to in § 20 (2) (b) to (e), (g) and (h), the supply of medicinal products, the sale of reserved medicines and the use of medicinal products in the provision of health care and veterinary care shall be understood as being a supply of medicines.
(1) Operator means:
(a) the manufacturer of medicines;
(b) the distributor of medicines;
(c) a natural or legal person authorised to provide health care under special regulations (3) (hereinafter referred to as "health care facilities");
(d) the natural or legal person authorised to provide veterinary care under specific rules, 4)
(e) a natural or legal person conducting research on medicinal products;
(f) a natural or legal person who has obtained a trade authorisation (5) for the purchase, storage and sale of reserved medicinal products (hereinafter referred to as "dealers of reserved medicinal products").
(2) A producer is a natural or legal person who, by virtue of authorisation, provides for the manufacture of pharmaceuticals and, where appropriate, individual manufacturing activities (§ 3 (3)).
(3) Distributor means any natural or legal person who, by virtue of authorisation, ensures the distribution of medicines.
(4) A qualified person shall mean a natural person designated by the manufacturer or the distributor, who shall:
(a) in the case of the manufacturer, for each batch of the medicinal product being manufactured and controlled in accordance with this Law and the implementing rules; if the device manufacturer is a transfusion service, it is considered that each transfusion product is manufactured and controlled in accordance with this Act and its implementing rules,
(b) the distributor for the distribution of the medicinal product in accordance with this Law and the implementing provisions.
(5) Good manufacturing practice means a set of rules ensuring that the manufacture and control of medicinal products are carried out in accordance with quality requirements, the intended use and the relevant documentation.
(6) Good distribution practice means a set of rules ensuring that the distribution of medicines is carried out in accordance with quality requirements, intended use and appropriate documentation.
(7) Good laboratory practice means a set of rules constituting a system of work in conducting preclinical studies on the safety of medicinal products; These rules concern the organisation process and the conditions under which such studies are planned, implemented, controlled, recorded, submitted and archived.
(8) Good clinical practice means a set of rules for the design, implementation, processing, evaluation and documentation of clinical trials of medicinal products, established to ensure the accuracy of the data obtained, as well as for the maintenance of the rights and integrity of persons covered by the evaluation and confidentiality of data on those persons.
(9) The control laboratory shall be a laboratory verifying the quality of medicinal products, excipients, intermediate products and packaging. The control laboratory shall comply with the conditions of good manufacturing practice.
(10) The correct practice of dealers of reserved medicinal products is a set of rules that ensure the quality, safety and efficacy of the reserved medicinal products in accordance with their intended use.
Basic provisions
(1) Persons handling medicines are obliged to:
(a) to minimise the adverse effects of medicines on humans, animals and the environment;
(b) comply with the instructions for handling the medicinal product established in accordance with the Summary of Product Characteristics (Section 2 (13)).
(2) Prescription, putting into circulation and use in the provision of health care and veterinary care, unless otherwise provided, may be carried out only:
(a) 1. authorised medicinal products;
2. medicinal products authorised by the Ministry of Health pursuant to § 7 (c) (1) or by the State Veterinary Administration pursuant to § 11 (a) (1),
3. medicinal products prepared in a pharmacy or at the workplace of nuclear medicine in a medical facility;
4. transfusions manufactured in a transfusions service facility;
(b) active substances and excipients listed in accordance with § 75 (2) (f) or authorised by the Ministry of Health under § 7 (c) (2) or by the State Veterinary Administration under § 11 (a) (2);
(c) plants used for pharmaceutical and therapeutic purposes listed in the Decree.
(3) When providing health care, medicinal products not authorised under this law may also be prescribed or used unless the corresponding authorised medicinal product is distributed or circulated. This will be communicated by the treating physician to the patient to whom this unauthorised medicinal product is prescribed or recommended to be used. The treating physician shall be fully responsible for the use of such a medicinal product. The prescribed medicinal product may be supplied by the distributor, or by other distributors, on the basis of a prescription for a particular patient to the operators referred to in § 20 (2) (b), (c) and (e) who may issue it. The use of an unauthorised medicinal product shall be notified immediately to the State Institute for Drug Control by the treating physician.
(4) The purchase, storage and sale of reserved medicines is a business which can be operated by eligible dealers of reserved medicines.
SECURITY
Tasks of the authorities in the field of pharmaceuticals
Performance of state administration
(1) State administration in the field of medicinal products for human use
(a) Ministry of Health,
(b) Ministry of Interior, Justice and Defence,
(c) State Institute for Drug Control.
(2) State administration in the field of veterinary medicinal products
(a) Ministry of Agriculture,
(b) State Veterinary Administration;
(c) Institute for State Control of Veterinary Bioprafts and Medicines,
(d) county and municipal veterinary administrations.
(3) State administration in the field of pharmaceuticals is also carried out by the State Office for Nuclear Safety.
Ministry of Health
Ministry of Health
(a) process the concept of the protection of medicinal products for human use;
(b) by decree, lay down the rules for:
1. research, production, preparation and distribution of human medicines,
2. the registration, prescription, supply of medicinal products and the sale of reserved medicines,
(c) authorise the use of:
1. after requesting the opinion of the State Institute for the Control of Medicinal Products, non-authorised medicinal products for human use (§ 31 (1)), in the event of a serious threat to human health, unless the corresponding authorised medicinal product is distributed or is in circulation and lays down the conditions for the supply, supply and use of such medicinal product;
2. active substances and excipients for human uses not listed in the list provided for in Article 75 (2) (f);
(d) decide on appeals against decisions of the State Institute for Drug Control;
(e) process the concept of the operation of pharmacies, transfusions and nuclear medical facilities;
(f) is expressed on the issue of import and export authorities6) of medicinal products for human use;
(g) declare measures (7) to notify medicinal products for human use whose use in the provision of health care has been discontinued for additional defects of their quality, effectiveness and safety;
h) ensure the publication in the Ministry of Health Bulletin of marketing authorisations issued for medicinal products, their changes, extensions and cancellations, the publication of permitted exceptions, the publication of a list of reserved medicines and the publication of a list of persons authorised to dispose of useless medicines;
(i) establish an Ethics Commission which gives its consent to the clinical evaluation of medicinal products for human use under § 35 (1) (b);
j) issue a decree after consultation with the Ministry of Agriculture and the Ministry of Industry and Trade of the Czech Pharmacopoeia, which sets out the requirements for the quality, procedure for the preparation, testing, storage and dosage of medicines;
(k) submit comments on the registration of immunobiological products and disinfectant and disinsecting products in contact with human organisms and on the authorisation of a clinical evaluation of immunobiological products; these tasks are performed by the head hygienist of the Czech Republic in the Ministry of Health,
(l) entrusts legal persons to conduct professional courses for natural persons or for legal persons who, under the Special Law 7a, purchase, store and sell reserved medicines.
Ministry of Interior, Justice and Defence
Ministry of Interior, Justice and Defence
(a) establish the conditions for ensuring effective, safe and quality medicines used by public health establishments in their field of competence; to that end, carry out checks on compliance with this law and impose penalties for infringements;
(b) they are entitled, in their field of competence, to regulate, by way of derogation from this law, the security of their medicinal components
1. in the field of their distribution and control, subject to the requirements on the efficacy, safety and quality of medicines laid down by this law;
2. in the field of their use in life-threatening cases where the corresponding authorised medicinal product is not distributed or is not in circulation.
State Institute for Drug Control
(1) State Institute for Drug Control in the field of medicinal products for human use
(a) issue:
1. marketing authorisations for medicinal products, changes, extensions and cancellations, keeps a register of authorised medicinal products and ensures publication of decisions issued in the Bulletin of the State Institute for Drug Control; Where immunobiological products or disinfectant and disinsecticide products come into contact with a human organism are involved, the decision shall be based on the positive expression of the leading hygienist of the Czech Republic and on radiopharmaceuticals, and shall do so on the positive expression of the State Office for Nuclear Safety,
2. permit to operate (§ 42), decides on its amendment or revocation;
3. certificates for the quality of medicinal products, auxiliary substances, if required by operators;
4. certificates to operators and control laboratories certifying compliance with the conditions of good manufacturing practice or good distribution practice or the good practices of dealers of reserved medicines;
5. certificates to laboratory test operators for pre-clinical testing or clinical trial of medicinal products that certify compliance with good laboratory practice;
6. certificates to the procuring entities of the clinical trial of medicinal products certifying compliance with the conditions of good clinical practice;
7. opinions on the authorisation granted under Article 7 (c);
(b) authorise the clinical trial of medicinal products, comment on the reported clinical trial and decide whether to terminate or suspend the clinical trial,
(c) orders, in the event of a threat to the life or health of persons, in particular in the event of the detection of an adverse effect of the medicinal product or a suspicion of an adverse effect thereof, or in the event of a defect or suspicion of a defect in the quality, efficacy or safety of the medicinal product, in particular:
1. the suspension of the use of the medicinal product and its putting into circulation;
2. the putting into circulation of the medicinal product only after its prior consent,
3. recall of the medicinal product, including determination of the extent of withdrawal;
4. the disposal of the medicinal product;
the appeal against the decision referred to in point 1 shall not have suspensory effect;
(d) carry out random laboratory checks on medicinal products;
(e) checks for operators and other medicinal persons:
1. the quality, efficacy and safety of medicines;
2. the quality and safety of the excipients, intermediate products and packaging,
3. compliance with this law, good manufacturing practice, good distribution practice, good laboratory practice, good practice of dealers of reserved medicinal products, the conditions laid down in the permit to operate (§ 42) or in a decision issued under special regulations; 3) and if it identifies deficiencies in the persons to whom it has granted the certificate, it may revoke the validity of the certificate issued by it,
4. compliance with technical and material requirements for the equipment of medical devices provided for in a specific regulation, 8)
(f) checks compliance with this law, good clinical practice and the conditions set out in the application for authorisation of the clinical trial or in its notification for persons involved in the clinical trial;
(g) decide in contentious cases whether it is a medicinal product, a mass-produced medicinal product or another product, or whether it is a homeopathic product;
(h) impose fines, within the limits of its scope, for infringements of the obligations laid down by this law.
(2) The State Institute for the Control of Medicinal Products in the Field of Human Medicines
(a) monitor the adverse effects of medicinal products;
(b) implement and maintain a fund of expert information on medicinal products; to that end, the operators shall, upon request, provide him with professional information free of charge; the information obtained is required to protect against misuse in such a way that the legitimate interests of the persons concerned cannot be jeopardised,
(c) inform the competent district authorities or, where appropriate, the Municipality of the capital of Prague and the Municipality of Brno, Ostrava and Pilsen (hereinafter referred to as the "district authorities") of the authorisations for activities granted under paragraph 1 (a) (2) to persons having their registered office or permanent residence in their territorial districts;
(d) report and communicate the data requested by the Ministry of Health to the extent specified by the special regulation, 9)
(e) publish in the Bulletin of the State Institute for Drug Control in each calendar year a list of medicines that may be issued without prescription, including the indication of reserved medicines;
(f) carry out further professional activities in its field of competence upon request;
g) prepares Czech Pharmacopoeia.
Ministry of Agriculture
Ministry of Agriculture
(a) process the concept of veterinary medicinal products;
(b) carry out checks on the implementation of international veterinary medicinal contracts;
(c) ensure, in the Bulletin of the Ministry of Agriculture, the publication of marketing authorisations issued for veterinary medicinal products, their amendments, extensions and cancellations, the publication of permitted exceptions and the publication of a list of persons authorised to dispose of unused medicinal products.
State Veterinary Administration
State Veterinary Administration
(a) authorise the use of:
1. after requesting the opinion of the Institute for State Control of Veterinary Bioprafts and Medicines, non-authorised veterinary medicinal products (Section 31 (1)), unless the corresponding authorised medicinal product is distributed or is in circulation and lays down the conditions for the supply, supply and use of such medicinal product,
2. active substances and excipients for veterinary uses not listed in the list issued pursuant to Article 75 (2) (f);
(b) decide on appeals against decisions of the Institute for State Control of Veterinary Bioprafts and Medicines;
(c) report and communicate the information requested by the Ministry of Agriculture to the extent provided for in the special regulation, 9)
(d) agree to the registration of applicants for the production and import of additives from growth promoters, anti-coccidic agents and chemotherapeutic agents groups according to specific regulations. 10)
Contents
ČÁST PRVNÍ
HLAVA PRVNÍ
§ 1
§ 2
§ 3
§ 4
§ 5
HLAVA DRUHÁ
Díl první
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
Díl druhý
§ 15
§ 16
§ 17
Díl třetí
§ 18
§ 19
§ 20
§ 21
§ 22
HLAVA TŘETÍ
§ 23
§ 24
§ 25
§ 26
§ 27
§ 28
§ 29
§ 30
§ 31
§ 32
HLAVA ČTVRTÁ
Díl první
§ 33
§ 34
§ 35
§ 36
§ 37
§ 38
§ 39
§ 40
Díl druhý
§ 41
§ 42
§ 43
Díl třetí
§ 44
§ 45
§ 46
§ 47
Díl čtvrtý
§ 48
§ 49
Díl pátý
§ 50
§ 51
HLAVA PÁTÁ
§ 52
§ 53
HLAVA ŠESTÁ
Díl první
§ 54
§ 55
§ 56
§ 57
§ 58
Díl druhý
§ 59
§ 60
§ 61
§ 62
§ 63
HLAVA SEDMÁ
§ 64
§ 65
§ 66
§ 67
§ 68
§ 69
§ 70
ČÁST TŘETÍ
§ 75
§ 76
§ 77
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Regulation Information
| Citation | The full text of Act No. 402 / 2000 Coll., Act No. 79 / 1997 Coll., on Medicines, as shown by the amendments made by Act No. 149 / 2000 Coll. |
|---|---|
| Regulation Type | Declared full text |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 24.11.2000 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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