What is Act No. 129 / 2003 Coll.?

Act No. 129 / 2003 Coll., amending Act No. 79 / 1997 Coll., on Medicinal Products, and amending and supplementing certain related laws, as amended, and Act No. 368 / 1992 Coll., on Administrative Charges, as amended — Act amending Act No. 79 / 1997 Coll., on Medicines and on Amendments and Additions to Certain Related Acts, as amended, and Act No. 368 / 1992 Coll., on Administrative Charges, as amended.

When it became Act No. 129 / 2003 Coll. effectiveness?

Act No. 129 / 2003 Coll. became effective 05.06.2003.

Is Act No. 129 / 2003 Coll. still valid?

Yes, Act No. 129 / 2003 Coll. is still valid and effective.

Act No. 129 / 2003 Coll. - Act amending Act No. 79 / 1997 Coll., on...

129

THE LAW

of 2 April 2003

amending Act No 79 / 1997 Coll., on medicinal products and amending and supplementing certain related laws, as amended, and Act No 368 / 1992 Coll., on administrative fees, as amended

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

Amendment to the Drug Act

Čl. I

Act No. 79 / 1997 Coll., on Medicines and on Amendments and Additions to Certain Related Acts, as amended by Act No. 149 / 2000 Coll., Act No. 153 / 2000 Coll., Act No. 258 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 138 / 2002 Coll., Act No. 309 / 2002 Coll. and Act No. 320 / 2002 Coll., is amended as follows:

1. in Article 1, the following point (c) is inserted after point (b):

"(c) post-registration monitoring and international cooperation in ensuring the protection of public health and the creation of a single market for medicinal products of the European Communities (hereinafter referred to as the Community),"

Point (c) shall be renumbered (d).

2. in Article 1 (d), "(a) and (b)" shall be replaced by "(a) to (c)";

3. In Article 2 (1), the words "and premixtures' are deleted.

4. the following shall be added to Article 2 (2) to (20), including footnote 2a:

"(2) Medicinal product means any substance or combination of substances intended to treat or prevent disease in humans or animals. Any substance or combination of substances that may be administered to humans or animals for the purpose of establishing a medical diagnosis or for the renewal, modification or alteration of their physiological functions shall also be considered a medicinal product.

(3) A medicinal product for human use is a medicinal product for human use. A veterinary medicinal product means a medicinal product intended for administration to animals.

(4) A mass-produced medicinal product means any medicinal product finally placed on the market under a specific name and in a specific packaging.

(5) 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, whole animals, parts of organs, animal secretions, toxins, extracts or preparations of blood;

(c) vegetable or chemical.

(6) Human immunological medicinal product means any medicinal product consisting of vaccines, toxins, serum or allergenic products. A decree provides for a closer definition of vaccines, toxins, sera and allergen products.

(7) The veterinary immunological medicinal product means any veterinary medicinal product administered to animals to induce active or passive immunity or to diagnose the immune status.

(8) Human autogenic vaccine means a medicine prepared for a particular patient from pathogens or antigens obtained exclusively from that patient.

(9) A veterinary autogenic vaccine means an inactivated immunological veterinary medicinal product which is made from pathogens and antigens derived from animals or animals in breeding and which is used for the treatment of animals or animals in that breeding in the same location.

(10) A homeopathic preparation means any preparation made up of preparations, substances or mixtures, called essential homeopathic substances, according to the homeopathic manufacturing process described by the European Pharmacopoeia (2a) or, if not mentioned therein, by certain pharmacopoeia officially used in the Member States of the Community. The homeopathic product may contain several ingredients. The 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.

(11) Radiopharmaceuticals are any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) incorporated for medical purposes.

(12) A radionuclide generator means any system containing bound parent radionuclide from which a subsidiary radionuclide is formed, separated by elution or by other means, and used as or for the preparation of radiopharmaceuticals. The kit for radiopharmaceuticals means any preparation for reconstitution or association with radionuclide into the final radiopharmaceuticals usually prior to administration. Radionuclide precursor means radionuclide produced for the radioactive labelling of another substance prior to administration.

(13) A blood derivative means an industrially manufactured medicinal product derived from human blood or human plasma; these medicinal products include albumin, coagulation factors and immunoglobulins of human origin.

(14) A transfusion product means human blood and its components and a medicinal product made from human blood or its components, not more than 10 donors, intended to treat or prevent the disease of one recipient.

(15) Reserved medicinal product means a medicinal product for human use that can be sold without a prescription and outside pharmacies according to the marketing authorisation.

(16) Premix for medicated feed (hereinafter referred to as medicated premixture) means any veterinary medicinal product subject to registration which is intended for subsequent manufacture of medicated feed.

(17) Medicated feed means any mixture of medicated premix or medicated premixes and feed or feed intended for putting into circulation and feeding to animals without further processing or treatment, showing therapeutic or preventive properties or other properties of the medicinal product in accordance with paragraph 2 and produced and put into circulation in accordance with Sections 41j and 41k.

(18) 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.

(19) The lot means the quantity of product produced or prepared in a single production cycle (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.

(20) The summary of product characteristics is a written summary of all information on the medicinal product which is relevant for its proper use and which is intended either to health professionals, if it is for a medicinal product for human use, or to veterinary surgeons, if it is for a veterinary medicinal product.

2a) Communication from the Ministry of Foreign Affairs No. 255 / 1998 Coll., on the adoption of the Convention for the Development of the European Pharmacopoeia and the Protocol to the Convention for the Development of the European Pharmacopoeia. '

footnote 2 is deleted, including the footnote reference.

5. In Article 2, paragraphs 21 to 23 are deleted.

6. the following paragraphs 21 to 34 are added to Paragraph 2, including footnote 2b:

"(21) A withdrawal period shall mean the period between the last administration of the veterinary medicinal product to animals under normal conditions of use of the product concerned and the time when food may be obtained from such animals in order to ensure that those foodstuffs do not contain residues of pharmacologically active substances in excess of the maximum levels laid down in a specific legislation. 2b)

(22) The undesired effect of the medicinal product is the adverse and unintended response to its administration, which occurs after a dose commonly used for prophylaxis, treatment or diagnosis of the disease or for the renewal, modification or other influence of physiological functions; in the case of a clinical trial of medicinal products, this is a negative and unintended response after any dose.

(23) The non-desirable effect that has occurred in humans with respect to the veterinary medicinal product is an adverse effect that is harmful and unintended and occurs in humans after exposure to the veterinary medicinal product.

(24) An adverse event means any adverse change in the state of health affecting the patient or the subject of the assessment receiving the medicinal product, even if it is not known whether it is related to the cause of the treatment.

(25) A serious adverse event means an adverse event that results in death, endangers life, requires hospitalisation or prolongation of the ongoing hospitalisation, results in permanent or significant damage to health or incapacity for work, or is manifested as a congenital anomaly or birth defect in offspring, regardless of the dose of the medicinal product used.

(26) A serious adverse reaction is that which results in death, endangers life, requires hospitalisation or prolongation of the ongoing hospitalisation, results in permanent or significant harm to health or incapacity for work, or is manifested as a congenital anomaly or birth defect in offspring.

(27) The unexpected adverse effect of a medicinal product shall mean an adverse effect 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 which is contrary to the available information, such as a set of information for the examiner of the investigational medicinal product which is not authorised.

(28) For the purposes of this Regulation, the following definitions apply:

(29) The name of the medicinal product is the name of the medicinal product, which may be either a fictional name or a common or scientific name in conjunction with the manufacturer's or marketing authorisation holder's name; the intended name must not be confused with the normal name.

(30) 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 normal common name.

(31) 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.

(32) 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. The formalities for labelling the packaging of medicinal products are governed solely by the provisions of Section 7 (a) (2) of this Act.

(33) Package leaflet means the enclosed written information for the user accompanying the medicinal product.

(34) The active substance is any substance intended to be part of a medicinal product that causes its activity; This effect is generally pharmacological, immunological, or it involves affecting metabolism.

2b) Decree No. 273 / 2000 Coll., laying down the maximum permitted residues of veterinary medicinal products and bioactive substances used in animal production in food and food materials, as amended by Decree No. 106 / 2002 Coll. Regulation (EEC) No 2377 / 90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of foodstuffs of animal origin for veterinary medicinal products, as amended. '

7. Sections 3 to 5, including the title, read:

„§ 3

(1) Treatment of medicinal products means their research, preparation, modification, production, distribution, supply, sale of reserved medicines, provision of advertising samples, use of medicines in the provision of health care and veterinary care and disposal.

(2) For the purposes of this Act, research on medicinal products means non-clinical safety assessment (§ 4 (4), § 18 (5)) and clinical evaluation of medicinal products to demonstrate their effectiveness, safety and quality.

(3) The preparation of medicinal products shall mean the manufacture by the person referred to in Article 43 (2).

(4) The preparation of medicinal products means the procedure to be followed for:

(a) medicinal products subject to marketing authorisation prior to their use in the provision of health care in accordance with the Summary of Product Characteristics or the manufacturer's data in the case of a procedure under § 5a (3) or the conditions laid down by a specific treatment programme under § 31a;

(b) investigational medicinal products prior to their use in a clinical trial, in accordance with the protocol and approved clinical trial procedures.

The adjustment provided for in the Decree as excessively demanding or dangerous shall be considered as preparation.

(5) The distribution of medicinal products shall mean all activities consisting of the provision, storage, supply, import or export of medicinal products, including relevant commercial transfers, regardless of whether they are activities performed for payment or free of charge. The distribution is not considered to be the supply of medicinal products, their sale by the seller of reserved medicines and their use in the provision of health care and veterinary care. Distribution activities shall be carried out in cooperation with manufacturers or their warehouses, other distributors or pharmacists and other persons authorised to supply medicinal products to the public, where appropriate, to use medicinal products.

(6) Imports of medicinal products from countries other than the Member States of the Community (hereinafter referred to as "third countries') pursuant to Paragraph 41 (3) shall not be considered as distributing medicinal products as referred to in paragraph 5.

(7) 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 (2).

(8) The use of medicinal products in the provision of health 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 (§ 5a). 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.

(9) The use of medicinal products in the provision of veterinary care shall be understood as providing them to breeders for subsequent administration to animals or direct administration to animals.

(10) The supply of medicines to persons referred to in § 42b (1) (c) (2) to (4), the supply of medicinal products, the sale of reserved medicines and the use of medicinal products in the provision of health or veterinary care.

(11) The placing into circulation of medicated feed shall mean the holding of medicated feed for the purpose of selling or any other means of providing to third parties, or the actual sale or supply of medicated feed to third parties, whether or not they are activities performed for remuneration or free of charge.

(12) For the purposes of this Act, the use of medicinal products for human use is understood to be permanent or occasional, intentional over-use of medicinal products, accompanied by harmful effects on the body, including psychological.

(13) The use of a veterinary medicinal product outside the scope of the marketing authorisation means the use of a veterinary medicinal product which does not comply with the summary of product characteristics, including incorrect use or serious misuse of the product.

(14) Medical prescription means any prescription issued by an expert authorised to prescribe medicinal products (§ 44).

(15) The risk to human health or public health, animal health or the environment means any risk related to the quality, safety and efficacy of the medicinal product.

(16) Pharmacovigilance means the supervision of medicinal products after their registration to ensure maximum safety and the most favourable benefit-benefit ratio of the medicinal product to its risks. Pharmacovigilance 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.

(17) The placing on the market of a medicinal product in the Czech Republic means handing it over or offering it to be delivered after production or import, which is carried out for the purpose of distributing the medicinal product, dispensing it, selling it by the seller of the reserved medicines or using it as well as distribution of the medicinal product, dispensing it, selling it by the seller of the reserved medicines or using it in the provision of medical or veterinary care.

§ 4

(1) Operator means:

(a) the manufacturer of medicinal products, the person importing medicinal products from third countries (§ 41 (3)), the holder of the authorisation for the manufacture of transfusion products and raw materials for further production (hereinafter referred to as the "equipment of the transfusion service"), the control laboratory and the manufacturer of the active substances;

(b) a distributor of medicinal products, including distributors with extended authorisation pursuant to § 42b (5) or (7);

(c) a natural or legal person authorised to provide healthcare under special legislation3 (hereinafter referred to as "health care facilities");

(d) the natural or legal person authorised to provide veterinary care under specific legislation, 4)

(e) a natural or legal person conducting research on medicinal products;

(f) a natural or legal person who has obtained a trade licence (5) for the purchase, storage and sale of reserved medicines (hereinafter referred to as "the seller of reserved medicines").

(2) 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.

(3) 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.

(4) 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) Good pharmacological practice means a set of rules ensuring that the preparation, storage and supply of medicines are carried out in accordance with the requirements for their quality, safety, efficacy and information of patients, in accordance with the intended use of the medicines and the relevant documentation.

(6) The correct practice of dealers of reserved medicines means a set of rules ensuring that the sale of reserved medicines is carried out in accordance with the quality, safety and efficacy requirements of the reserved medicines in accordance with their intended use.

§ 5

Basic provisions

Persons handling medicines are obliged to:

(a) to minimise the adverse effects of medicines on human health and public health, animal health and the environment;

(b) comply with the instructions for handling the medicinal product established in accordance with the Summary of Product Characteristics (Section 2 (20)); This shall not apply to the use of medicinal products in the provision of health care under the conditions laid down in § 5a (3) and in the provision of veterinary care under the conditions laid down in § 5b (2). '

8. The following Sections 5a and 5b are inserted after Section 5, including the headings and footnotes Nos 5a to 5d:

„§ 5a

Use of medicinal products in the provision of healthcare

(1) Only authorised medicinal products for human use may be prescribed, put into circulation and used in the provision of health care, unless otherwise provided. The patient may be supplied with the necessary amount of medicinal products in the provision of medical care (§ 3 (8)), provided that the patient's health status is strictly required for the immediate use of the medicinal product and that the early dispensation of the medicinal product is not feasible due to local or time-sensitive medical care.

(2) In addition to the products referred to in paragraph 1, medicinal products prepared in a pharmacy and other establishments authorised to prepare under this Act (Section 43 (2)) and transfusions manufactured in a transfusions service facility may be prescribed and used in the provision of healthcare.

(3) When providing healthcare to individual patients, the treating physician may prescribe or use medicinal products not authorised under this law for the purpose of providing optimal healthcare if:

(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) it is a medicinal product already authorised abroad by the competent authorities,

(c) such a method is sufficiently justified by scientific evidence; and

(d) it is not a medicinal product containing a genetically modified organism.

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. If the treating physician follows this paragraph, the patient or, where appropriate, his legal representative shall be informed thereof and shall be fully responsible for the use of the medicinal product. If the patient's medical condition does not allow him to be informed in advance of the use of the unregistered product or the use of the product not mentioned in its summary, the treating physician shall do so immediately after the use of the medicinal product, as soon as the patient's health allows. The use of an unauthorised medicinal product shall be notified immediately by the treating physician to the State Institute for Drug Control in accordance with a decree. 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.

(4) The purchase, storage and sale of reserved medicines is a business which can only be run by qualified dealers of reserved medicines. 5)

(5) The provisions of this Act shall be without prejudice to the provisions of specific legislation governing radiation protection for persons undergoing medical examination or treatment, or to the rules laying down basic safety standards for the protection of public health and workers against the dangers of ionising radiation. (a)

§ 5b

Use of medicinal products in the provision of veterinary care

(1) In the provision of veterinary care, only:

(a) registered veterinary medicinal products (§ 23);

(b) veterinary autogenic vaccines which comply with the requirements of this law;

(c) medicated feed complying with the requirements of this Law;

(d) medicinal products prepared in a pharmacy for an individual patient in accordance with the veterinary prescription;

(e) medicinal products prepared in accordance with the Articles of the Czech Pharmacopoeia and under the conditions laid down in the Decree;

(f) medicinal products for which the State Veterinary Administration has granted an exemption pursuant to Article 31,

(g) authorised medicinal products for human use (§ 23).

(2) The medicinal products referred to in paragraph 1 may be prescribed, issued or used in the provision of veterinary care only under the conditions laid down in the Decree.

(3) For animals producing foodstuffs intended for human consumption, only medicinal products containing pharmacologically active substances listed in Annexes I, II or III to the specific legislation may be prescribed, issued and administered when providing veterinary care; (2b) where this specific legislation provides for restrictions with regard to the category of animal, method of administration or other restrictions, these restrictions must be respected when prescribing, dispensing and using medicinal products to animals producing foodstuffs intended for human consumption.

(4) The person administering the medicinal product to animals producing food for human consumption must comply with the withdrawal period laid down in the marketing authorisation.

(5) (c) in the case of homeopathic veterinary medicinal products containing active substances in dilution equal to or greater than one in a million, no withdrawal period shall be set.

(6) The prescription, supply or use of medicinal products in the provision of veterinary care shall be kept by persons who prescribe, issue or use medicinal products in accordance with the requirements laid down in the Decree; such records shall be kept for at least 5 years.

(7) When providing veterinary care, only veterinary surgeons who comply with the requirements for professional veterinary activity under specific legislation may prescribe, issue or use medicinal products where activities are carried out for business purposes. (c)

(8) Persons residing or established 5d) in a Member State of the Community other than the Czech Republic who are authorised to provide veterinary care in accordance with special legislation5c) are entitled to use medicinal products in accordance with the conditions laid down in the Decree. the use of medicinal products shall be recorded in accordance with paragraph 6. To this end, these persons are entitled to import medicinal products in the territory of the Czech Republic in quantities which do not exceed the overnight requirement.

(9) For the use of medicinal products, not for veterinary immunological medicinal products, in the form of mass medications using feed on a given holding, only technological equipment which is part of the holding concerned and for which the competent regional veterinary administration has established animal health conditions and measures in accordance with specific legislation may be used; 5c. If such measures have not been laid down for the relevant technological establishment, the breeder may use such equipment for the purpose of medication only after laying down the animal health conditions and measures of the competent regional veterinary authority requesting such conditions and measures.

5a) Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionizing Radiation (Atomic Law) and on the amendment and addition of certain laws, as amended.

5b) For example, Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended, Act No. 91 / 1996 Coll., on Feed, as amended.

5c) Act No. 166 / 1999 Coll., as amended.

5d) Article 43 et seq. of the Treaty establishing the European Community. '

9. Article 7, including the title and footnote 7b, reads:

„§ 7

Ministry of Health

(a) by decree, lay down 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,

(b) issue consent to and control specific treatment programmes (§ 31a);

(c) authorise the use for human use of an active substance and an excipient not included in the list issued pursuant to Article 75 (2) (f);

(d) participates in the preparation of the European Pharmacopoeia 2a) and is responsible for ensuring its preparation and publication in the Czech Republic; Articles of the European Pharmacopoeia on individual active substances, pharmaceutical forms and medicinal products ("the European Pharmacopoeia monograph ') shall be binding; the use of European Pharmacopoeia procedures and requirements for medicinal products subject to registration is provided for in the Decree,

e) is responsible for ensuring the preparation and issue of the Czech Pharmacopoeia, which provides for binding procedures and requirements for:

1. the manufacture of active substances and excipients,

2. the manufacture and preparation of medicinal products,

3. testing and storage of active substances, excipients and medicinal products;

the use of the procedures and requirements of the Czech Pharmacopoeia for medicinal products subject to registration is laid down in the Decree,

(f) decide on appeals against decisions of the State Institute for Drug Control;

g) publishes in the Ministry of Health Bulletin a list of persons authorised to remove useless medicines,

(h) identify ethical committees issuing opinions on multicentre clinical trials (§ 35 (2)) and may establish an ethics committee (§ 35 (1)) giving opinions on the clinical evaluation of a medicinal product for human use;

(i) submit comments on the registration of immunological products and on the authorisation of the clinical trial of immunological products;

j) Instructs legal entities to conduct professional courses for natural persons or for legal persons who purchase, store and sell reserved medicaments under special legislation7a;

(k) take measures to promote the research, development and availability of orphan medicinal products and products which may be established as such;

(l) establish the conditions for the introduction of measures and coordination of measures necessary to prevent the transmission of infectious diseases, taking into account the use of human blood or human plasma as a starting source for the manufacture of medicinal products,

(m) involved in the provision of pharmacovigilance pursuant to § 52;

(n) ensure the necessary measures to promote Community self-sufficiency in the field of human blood or human plasma. To this end, it shall ensure the promotion of voluntary unpaid blood and plasma donation and shall ensure the implementation of the measures necessary for the development of the production and use of products derived from human blood and human plasma of voluntary unpaid donors. These measures are notified to the European Commission ("the Commission '),

(o) agree to appoint representatives proposed by the State Institute for the Control of Medicinal Products to the Committee for Bulk Produced Medicinal Products, the Committee for Orphan Medicinal Products and the Management Board of the European Medicines Agency ("the Agency").

(b) Council Regulation (EEC) No 2309 / 93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, as amended by Commission Regulation No 649 / 98. ';

footnotes 6 and 7 are deleted, including the footnotes.

10.

„§ 8

Ministry of Interior, Justice, Defence and Finance

(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 for the efficacy, safety and quality of the medicines laid down by this Act, they may, where appropriate, extend the period of application of the medicinal product in the event of a war or other emergency conditions after laboratory inspections;

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.

By way of derogation from the conditions laid down in this Act or by derogation from those laid down by the manufacturer in the case of non-authorised medicinal products, the authority which has modified the use of the medicinal product shall be liable for damage resulting from changes in the use of the medicinal product and shall be liable mutatis mutandis to it under Paragraph 26 (9) (b). ';

11. Article 9 to 13, including the headings and footnotes 7c and 8a, read:

„§ 9

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 to them, extensions, transfers, suspensions and cancellations, decisions authorising parallel imports, keeps a register of authorised medicinal products and ensures publication of the decisions issued in its information medium,

2. authorisations for the manufacture of medicinal products, authorisations for the manufacture of transfusion products and raw materials for further production, authorisations for the operation of the control laboratory and for distribution, decisions to amend or revoke the authorisations issued (Sections 41 to 42b);

3. certificates to operators certifying compliance with the conditions of good manufacturing practice, good distribution practice, good pharmaceuticals practice or good practices of dealers of reserved medicines;

4. certificates to operators carrying out non-clinical studies on the safety of medicinal products, whether or not they are intended for human or veterinary use, certifying compliance with good laboratory practice;

5. Opinion on a medicine which is an integral part of a medical device, at the request of an authorised person under specific legislation, 7c)

6. an opinion on the conditions for the use, distribution, distribution and monitoring of the medicinal product and its quality, safety and efficacy under a specific treatment programme; it exercises control over these elements of the approved programme (Section 31a),

7. an opinion on the use of the active substance or of the excipients for human uses not listed in Article 75 (2) (f);

(b) authorise the clinical trial of medicinal products, comment on the reported clinical trial and decide to terminate or, where appropriate, suspend the clinical trial;

(c) decide, 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 a 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 of the medicinal product, on:

1. the suspension of the use of a medicinal product or an additive intended for the preparation of medicinal products and the suspension of the putting into circulation of a medicinal product or such an additive; the appeal against the decision does not have suspensory effect,

2. restrictions on the placing into circulation of medicinal products, consisting of the obligation to put into circulation individual batches of medicinal products only after the consent of the State Institute for Drug Control has been given,

3. Withdrawal of a medicinal product from circulation, including determination of the extent of withdrawal, even if the medicinal product is marketed as another product,

4. the removal of the medicinal product,

5. the adoption of provisional urgent safety restrictions pursuant to Article 26a (6);

(d) carry out random laboratory checks on medicinal products and is entitled to issue quality certificates for medicinal products and excipients;

Citation	Act No. 129 / 2003 Coll., amending Act No. 79 / 1997 Coll., on Medicinal Products, and amending and supplementing certain related laws, as amended, and Act No. 368 / 1992 Coll., on Administrative Charges, as amended
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	06.05.2003
Effective from	05.06.2003
Effective until	-
Status	Valid

Act No. 129 / 2003 Coll.

Act amending Act No. 79 / 1997 Coll., on Medicines and on Amendments and Additions to Certain Related Acts, as amended, and Act No. 368 / 1992 Coll., on Administrative Charges, as amended

Contents

ČÁST PRVNÍ

Čl. I

„§ 3

§ 4

§ 5

„§ 5a

§ 5b

„§ 7

„§ 8

„§ 9

Contents

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