Decree No. 217 / 2024 Coll.
Ordonnance on Good Veterinary Clinical Practice and Closer Conditions of Clinical Evaluation of Veterinary Medicinal Products
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Order
Effective from 01.08.2024
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01.08.2024
16.07.2024
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217
DECLARATION
of 28 June 2024
on good veterinary clinical practice and closer conditions for the clinical evaluation of veterinary medicinal products
The Ministry of Agriculture provides, pursuant to Article 114 (3) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act on Medicines), as amended by Act No. 66 / 2017 Coll., Act No. 262 / 2019 Coll. and Act No. 314 / 2022 Coll., ("the Act ') for the implementation of § 60 paragraphs 1, 4 and 11, § 61 paragraph 2 (a) and (b) points 1 and 6, § 61 paragraph 2 (c) and § 61 paragraph 3 (e) of the Act:
Subject matter
This decree provides
(a) the structure of the data contained in the application for approval of the clinical trial of the veterinary medicinal product;
(b) the rules of good veterinary clinical practice;
(c) the content of the clinical trial protocol (hereinafter referred to as "the protocol"), the extent and breakdown of the data contained therein and the manner in which it is conducted;
(d) how the clinical trial is initiated,
(e) changes in the contact details of the contracting authority which may be made and reported without delay to the Veterinary Institute;
(f) the method of labelling veterinary medicinal products in the clinical trial;
(g) the extent of the data reported in the clinical trial termination report; and
(h) evidence of clinical trial kept by the examiner.
Preliminary provisions
(1) For the purposes of this decree:
(a) an audit of the systematic and independent assessment of the conformity of the activities carried out in the framework of the clinical trial of the veterinary medicinal product (hereinafter referred to as the "clinical trial") and its documentation;
(b) the investigational medicinal product of which the therapeutic, preventive or diagnostic effect or the ability to affect physiological function is examined in a study conducted in accordance with the approved conditions of the clinical trial;
(c) the approved veterinary medicinal product used in accordance with the conditions of its registration, placebo or any other product which complies with the conditions of the study used to compare its effects with the product under assessment;
(d) residues of a pharmacologically active substance defined as residues by a directly applicable regulation laying down procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (1),
(e) a withdrawal period from the administration of the investigational or control product under the conditions laid down in the study to animals from which products for human consumption are obtained until the food obtained from such animals is safe for their consumers with regard to the residue content of the pharmacologically active substance (s);
(f) primary records of all original working sheets, calibration records, other original records, minutes or notes of observations or study activities necessary for the reconstruction and assessment of the study;
(g) by a contractual research organisation, a natural or legal person in a contractual relationship to a contracting entity or to an examiner who, in the course of a study, ensures that one or more of the activities or functions of the contracting entity or the investigator are carried out;
(h) by standard working procedures, detailed procedures for the uniform implementation of the relevant actions in the study;
(i) by blinding the procedure whereby the breeder and, where appropriate, the examiner or other persons involved in the study do not have access to information on the assignment of the evaluated product and control product to the evaluated animals;
(j) by the current text of the Protocol, the Protocol as amended by its subsequent amendments in accordance with the law;
(k) an amendment to the Protocol amending the current version of the Protocol amending the objectives of the study or the conditions for carrying out or managing the study; and
(l) a derogation from the Protocol on the application of procedures or conditions other than those laid down in the current version of the Protocol.
(2) The clinical trial is initiated at the time when the first act under the Protocol is carried out after the decision on its approval has become final.
(3) The clinical trial may be discontinued for a reason that allows the clinical trial to be continued after the interruption in accordance with the conditions under which it was approved.
(4) The clinical trial is concluded
(a) at the moment specified in the Protocol;
(b) the moment when the contracting authority notifies the Veterinary Institute that it has decided not to proceed with the clinical trial before its completion in accordance with point 1; or
(c) the date on which the decision given by the Veterinary Institute pursuant to Article 60 (10) or Article 61a (9) of the Act became final.
Structure of data contained in the application for approval of a clinical trial
(1) The information referred to in Section 60 (3) of the Act is provided by the applicant in the application for approval of a clinical trial in the following structure:
(a) the general elements of the application under the administrative rules;
(b) scientific documentation,
1. Protocol drawn up in accordance with this Order, including any amendments thereto,
2. written information addressed to the examiner in accordance with Annex 1 to this Decree, unless that information is part of the Protocol,
3. written information for breeders as referred to in Annex 2 to this Decree, unless that information is part of the Protocol; and
4. information on the quality of the products under assessment as referred to in Annex 3 to this Regulation, unless this information is part of the protocol,
(c) administrative data,
1. proof of the insurance policy of the contracting authority and the investigator, through which compensation is provided for the breeder of the animal in the clinical trial;
2. whether the clinical trial has already been approved in another European Union State or in a third country, under the conditions laid down in the protocol submitted in the application, specifying the countries concerned,
3. information on whether or not a dissenting opinion has already been delivered by the foreign supervisory authority, including where the clinical trial has been terminated by such an authority; and
4. data pursuant to § 60 (3) (b) to (d) of the Act.
(2) In the case of a verification clinical trial, the applicant shall submit the documentation referred to in Section 60a (2) of the Act in part of the scientific documentation.
Rules of good veterinary clinical practice
The rules of good veterinary clinical practice are set out in Annex 4 to this Decree.
Scope and breakdown of data provided in the Protocol
(1) The Protocol contains data on all the objectives set for the study in question and provides detailed details of the conditions under which the study is to be conducted and managed, including post-study conditions.
(2) The Protocol shall include its Annexes and Appendices and records of any derogations from the Protocol.
(3) The Protocol must comply with the conditions of the decision approving the study.
(4) The detailed scope and breakdown of the data contained in the Protocol are set out in Annex 5 to this Decree.
Method of implementation of the Protocol
(1) The contracting authority shall draw up and maintain a paper-based or electronic protocol. The paper or electronic form of the management of the Protocol shall be secured in such a way that the particulars contained in the Protocol cannot be modified by unauthorised persons or by unauthorised procedure.
(2) The contracting authority shall draw up a report in cooperation with the investigator. The contracting authority and the examiner must approve the protocol. In the event that the examiner is unable to participate in the drawing up of the protocol, the contracting authority shall ensure the agreement of the examiner with the protocol, on the basis of a detailed and documented familiarity of the examiner with the protocol and in such a way as not to derogate from the protocol.
(3) The contracting authority shall maintain the protocol in such a way as to enable the identification of the protocol, including the identification of its version. It must be clear from the protocol whether it is a protocol at the preparation stage or a valid version of the protocol. The date of its approval and the date from which the relevant version is valid shall be indicated for each version of the protocol.
(4) Where new facts are known that may affect the course of the study, the ability to achieve the specified objective of the study, or as a result of which foreseeable risks and difficulties may outweigh the expected benefit of the study for the animals included in the study, the sponsor shall ensure that the protocol is updated by means of its amendment.
(5) Amendments to the Protocol shall be made by the contracting entity by the adoption of a new version of the Protocol which is deemed to be its version for the purposes of the identification of the Protocol or by the Appendix to the Protocol. The method of making amendments is set out in the Protocol.
(6) Any deviation from the protocol shall be recorded by the examiner or, where applicable, by another person who is to perform the relevant action under the protocol in the form of an alert containing the date of creation of the alert, a description of the derogation and the reason for the derogation. If the reason for the derogation cannot be determined, this indication shall be entered in the alert. The alert shall contain the particulars by which the person who made the alert can be clearly identified. Paragraph 2 shall apply mutatis mutandis to the keeping of records of derogations.
Information on the initiation of a clinical trial
The sponsor shall inform the Veterinary Institute of the initiation of the clinical trial without undue delay at least to the extent that:
(a) contact details of the contracting authority;
(b) unique study identification data as provided for in the current Protocol,
(c) name of the study;
(d) the starting date of the study;
(e) information on the veterinary centres or on the animals where the study will be carried out, if these sites were not known before the study started; and
(f) information on investigators who will participate in the study, if the investigator concerned has not been known before the study is started.
Changes in the contact details of the contracting entity that may be made and reported without delay to the Veterinary Institute
A change in the contact details of the contracting authority which the contracting authority may make and notify the Veterinary Institute without delay shall be the change:
(a) the contact details of the contracting entity, including the address of the place of permanent residence, registered office or place of business;
(b) the person designated by the contracting authority as his representative in the Protocol; and
(c) the contact details of the contractor's representative.
Method of labelling veterinary medicinal products in clinical trials
(1) The labelling on the inner and outer packaging of the veterinary medicinal product must ensure that:
(a) the safety of animals and persons involved in the study, as well as the protection of the environment during the conduct of the study; and
(b) the quality of the data and study results in accordance with the conditions and requirements set out in the Protocol.
(2) The inner and outer packaging of the veterinary medicinal product contains:
(a) the contact details of the person designated by the contracting authority to deal with urgent issues which may occur during the study;
(b) identification of the study;
(c) the identification of the medicinal product in accordance with the conditions laid down in the Protocol; if possible, given the special conditions of the study, such as blindness, it should be reported:
1. the labelling of the medicinal product,
2. identification of the active substance,
3. the strength or, in the case of an immunological veterinary medicinal product, its potency,
4. Pharmaceutical form, route of administration, pack size or amount of doses, and
5. batch number or code to identify the content and the adjustment operation;
(d) storage conditions,
(e) the expiry date of the product;
(f) the warning "Keep out of the reach and sight of children!,"
(g) information related to the use of the medicinal product, including dose, dosage and method of use data, which may be replaced by a reference to another appropriate source of information;
(h) the designation "For use in veterinary clinical trials only"; and
(i) the designation "For animal treatment only."
(3) Veterinary medicinal products with small inner packaging shall bear on the inner packaging at least the particulars referred to in paragraph 2 (a), (b), (c) (1) and (4), (e), (h) and (i).
(4) If the product used in the study is a registered veterinary medicinal product and if it complies with the conditions laid down in the protocol, it shall be identified in accordance with the conditions of its marketing authorisation and the particulars referred to in points (a), (b) and (h) of paragraph 2.
Scope of data reported in the clinical trial termination report
(1) The clinical trial termination report ("the final report") contains data providing a comprehensive and detailed description of the study. The final report shall be drawn up jointly by the contracting authority, the investigator or the contracting authority and the investigator. For the sake of completeness, the final report shall be drawn up only after the study has been completed.
(2) The final report contains a description of the materials and methods used in the study, the results of the study and their evaluation, the statistical analysis of the data obtained in the study and the critical evaluation of clinical data, the scientific procedure used in the study and the methods used for the statistical evaluation of data.
(3) The final report contains details of all its authors. Where the examiner does not participate in the production of the report, the final report shall provide the author with the following information:
(a) all documentation of the study relating to the location at which the relevant investigator carried out the study; and
(b) a document dated and signed by the examiner, annexed to the final report, detailing the documentation of the study transmitted to the author of the report and certifying its accuracy and completeness.
(4) Additional data to the final report, changes to or modifications to the data contained in the report or to be deleted from the report shall be included in the Appendix to the final report drawn up by the author of the final report referred to in paragraph 3. The Appendix defines the data to be supplemented, amended or deleted and is dated and signed by the author.
(5) The final report may contain minor administrative corrections to the data made in the report by its author or authors, indicating for each correction the date of the correction, the reason for the correction and the signature of the author.
(6) The structure of the data shall be drawn up in a manner consistent with the structure of the study protocol.
(7) The detailed scope of the data provided in the final report is set out in Annex 6 to this decree.
Evidence of clinical trial kept by the examiner
The clinical trial documents kept by the examiner under Section 61 (3) (e) of the Act are listed in Annex 7 to this Decree.
Technical Regulation
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Repeal
Decree No. 139 / 2018 Coll., on Good Clinical Practice and Closer Conditions of the Clinical Evaluation of Veterinary Medicinal Products, is repealed.
Efficacy
This Decree shall take effect on 1 August 2024.
Minister for Agriculture:
Mgr. Excellent v. r.
Příloha č. 1
Annex No 1
Written information to the examiner
1. The written information to be provided to the examiner (hereinafter referred to as "the investigator's information file ') shall include the information on the contracting entity and the contact persons designated by it, the study name and its unique identification code and the protocol identification data, including its version and the date of approval and validity of that version.
2. A set of information for the examiner shall be processed in accordance with the current text of the Protocol and the current state of scientific knowledge, the requirements of legislation and technical and ethical standards in the field of veterinary medicine and the regulation of veterinary medicinal products.
3. The purpose of the investigator's information set is to provide the investigator and other persons involved in the conduct of the study under the lead of the investigator with information that will facilitate them to understand the intention and key conditions of the protocol, such as the objective of the study with regard to a specified hypothesis, the conditions of use of medicinal products such as dose size, frequency of administration, route and route of administration, safety monitoring procedures, efficacy monitoring procedures and other information, if necessary to ensure the proper conduct of the study, the ability to achieve the objectives of the study and to ensure the quality of data collected in the study. Data reporting shall take into account the scope and mode of blindness and other relevant study conditions.
4. The information shall be provided in a short, simple, objective, balanced and non-promotional form in the investigator's information file, allowing them to be assessed impartially by a practical veterinarian as an examiner or by persons who are under the supervision of the investigator in carrying out the study, understand and be able to assess the risks and benefits of the proposed clinical trial on the basis of the submitted information file. The file shall be drawn up on the basis of all available information and documents supporting the justification of the proposed clinical trial and the safe use of the investigational medicinal product in the context of the clinical trial and shall be translated in the form of summaries.
5. If the investigational medicinal product is registered and used in accordance with the terms of the marketing authorisation, the investigator's data set is set out in the approved SPC. If the conditions of use in the clinical trial differ from those of the marketing authorisation, a summary of the relevant preclinical and clinical data shall be provided to support the use of the investigational medicinal product in the study. Where a marketing authorisation is granted only in a third country, the terms of the marketing authorisation may be used as part of the product safety data or its clinical effects.
6. In the case of an international clinical trial where the medicinal product to be used in each of the Member States concerned is authorised at national level and the summary of product characteristics varies from one Member State to another, the contracting authority shall choose one summary of product characteristics for the entire clinical trial. This summary of product characteristics is the one best suited to the study conditions.
7. If the information set for the investigator is not the data contained in the approved summary of product characteristics, the data set for the investigator shall contain a separate section containing information on the safety of the product, including information on adverse reactions, may be considered as expected.
8. The information file for the investigator contains this basic information about the evaluated veterinary medicinal product
(a) the identification of the active substance or substances with their international non-proprietary name, if any, of another common name or other appropriate method of identification of the active substance or substances, including the CAS number, if any, or the chemical formula of the active substance or substances, where possible;
(b) the composition of the product with regard to the active substance or substances content;
(c) data on the excipients contained in the product which are of relevance for the safety of the product or which may influence the course or results of the study; the particulars referred to in points (a) and (b) shall be given to the appropriate relevance of the excipients; in the case of an excipient having the characteristics of the first sentence and being used simultaneously in the veterinary medicinal product for the first time, this information shall also be provided;
(d) data on the physical, chemical, microbiological, pharmaceutical or biological properties of the product which are of importance for the safety of the product or which may influence the course or results of the study;
(e) guidance on the correct storage and handling of the product under assessment;
(f) the pharmaceutical form of the product,
(g) the anatomical-chemical-therapeutic classification of the preparation, if any; and
(h) additional information on the quality of the product which is of relevance for the safety of the product or which may influence the course or results of the study, such as information on the manufacture or control of the product or the specifications set out for the product.
9. Part of the investigator information set containing product safety information, data on pre-clinical studies performed in the field of pharmacodynamic effects, pharmacokinetics and toxicological tests, and data on residues testing for animals from which human nutrition products are derived. The data shall be presented as summaries of individual studies, including a description of the assessment methodologies used, indicating the results of the studies and their interpretations in relation to the safety of the use of the investigational medicinal product in animals included in the clinical trial, human and environment. The study results shall also be provided, including the calculation method used, on the basis of which the dose and frequency of dosing were proposed for use in the clinical trial. In the case of an immunological veterinary medicinal product, data on preclinical safety and efficacy tests shall be provided, including those used for the design of the vaccination schedule or dosage to be used in the clinical trial, depending on the nature of the immunological veterinary medicinal product. The safety section also contains data on adverse reactions or other hazards that can be expected during the course of a study proposing measures to minimise the risk of these adverse reactions or other hazards. If other clinical trials have been conducted with the evaluated product, which are completed, safety data shall also be provided from these studies.
10. In the case of an animal product from which products intended for human consumption are to be obtained during or after the study, the safety part of the product shall also include information on the basis of which the withdrawal period has been proposed. This information shall include data on pharmacologically active substances contained in the preparation, the residues left in the tissues of treated animals and animal products, including their metabolites, the rate of reduction of residues in animal tissues and products (also kinetics or residue depletion), the residue safety limit applied, the analytical methods used for the determination of residues in animal tissues and products, including their validation parameters, and the determination of the withdrawal period, including the variables used and the method of calculating the withdrawal period. If certain data are not known at the time of the study, the reasons shall be given, including the justification why even with limited data a safe withdrawal period may be established. In addition, it shall be indicated how the examiner is to proceed with the establishment of a withdrawal period in cases where the product has been used contrary to the terms of the Protocol in force.
11. The information set for the investigator contains information on the therapeutic or preventive potential of the evaluated veterinary medicinal product. Comprehensive information shall be provided on the effects of the evaluated veterinary medicinal product that have been identified in other completed clinical trials using the evaluated veterinary medicinal product and any further experience in the use of the evaluated veterinary medicinal product in veterinary clinical practice.
12. For a veterinary medicinal product containing several active substances, the potential interactions between the components shall be indicated. In addition, potential interactions with other products or the influence of feed or drinking water on the quality, safety or efficacy of the evaluated veterinary medicinal product shall be indicated in the investigator's information file.
13. Overall assessment of preclinical and clinical data on the evaluated veterinary medicinal product from various sources and interpretation of available data, including consequences for future clinical trials. Evaluation of published reports on related medicinal products, which will enable the adverse effects of the evaluated veterinary medicinal product or other risks related to the clinical trial to be predicted.
Příloha č. 2
Annex No 2
Written information for breeders
Written information for breeders contains:
1. details of the contracting entity and contact persons designated by it, which provide the breeder with information on the conditions of the study and, if necessary, the need to cooperate with the resolution of potential problems arising from the course of the study;
2. data on the examiner,
3. the study name and its unique identification code and protocol identification data, including its version and date of approval and validity,
4. the purpose and objective of the clinical trial;
5. up-to-date summary information on the disease to which treatment or prevention is the subject of the study and the current treatment or prevention method; if the study is not the subject of treatment or prevention of animal disease, similar information justifying the subject of the study shall be provided;
6. information on the entry and exclusion criteria, including the tests and procedures to which the animal will be subjected, and information on the conditions for which the animal will be taken out of the study prematurely and the conditions to be applied in such cases,
7. information on the possibility of not including the animal in the study and the consequences of such a decision;
8. Information on the possibility of early removal of the animal from the study on the basis of the breeder's decision and the conditions to be applied in such a case,
9. the scope of the clinical trial, indicating the minimum number of animals included in the clinical trial, description of the groups used in the study, information on the use of medicinal products such as the number of administration of the veterinary medicinal product, dose and dose, route of administration of the veterinary medicinal product, treatment of unused medicinal products, indication of the overall duration of the study,
10. Warning for accidental inclusion of animals in treatment / untreated groups where this is a randomized clinical trial,
11. laboratory and clinical monitoring indicators, indicating the frequency of their monitoring, as well as data on tests, tests or procedures to be carried out in the animal in the study;
12. foreseeable risks to animals in clinical trials, breeders or other persons coming into contact with the animal, or to the environment,
13. foreseeable benefits to the animal in the clinical trial,
14. information on the suspected adverse event procedure and the conditions for reporting changes in health or behaviour in an animal included in the study;
15. information on the withdrawal period and, where appropriate, information on other restrictions to ensure consumer safety where animal products intended for human consumption are obtained from an animal included in the clinical trial;
16. description of the breeder's activities before, during and after the clinical trial, such as participation in the selection of animals, ensuring zoogygienic conditions, feeding and drinking regime, monitoring of animal health, recording of data and keeping records and providing them to the examiner,
17. data on financial issues related to the inclusion of the animal in the study, such as cost or benefit data for animal breeders, intellectual property as a result of the clinical study and, where appropriate, other issues;
18. Information on the treatment and conditions of compensation to be provided by the sponsor of the clinical trial in the event of injury to the health arising from the participation of the animal in the clinical trial; and
19. Information on confidentiality.
Příloha č. 3
Annex No 3
Quality data on products evaluated
1. Data on the quality of an unauthorised veterinary medicinal product evaluated shall include:
(a) the name or other form of identification of the product and its pharmaceutical form;
(b) the qualitative and quantitative composition of the product in accordance with the conditions laid down for veterinary medicinal products in Annex II to the Regulation on veterinary medicinal products (*), and its strength;
(c) the firms and addresses of the premises of all manufacturers involved in the manufacture of the product, where appropriate, blinding the samples, indicating their function in the production process;
(d) the firm and the address of the manufacturer's premises for final release,
(e) proof of compliance with the conditions of good manufacturing practice throughout the manufacture of the investigational veterinary medicinal product (e.g. certificate of good manufacturing practice of the manufacturer of veterinary medicinal products or authorisation for the manufacture of veterinary medicinal products),
(f) additional information on the active substance or substances: name and address or registered office of the manufacturer, quality criteria for a new substance which has not yet been included in any authorised veterinary medicinal product, identity card of the active substance and its structure, analytical methods used to control the quality of the active substance, stability data, data on batch or batch of active substance used for pre-clinical studies and intended for use in a clinical study;
(g) a brief description of the manufacture of the active substance and the veterinary medicinal product,
(h) the specification of the veterinary medicinal product, including the control methods for the veterinary medicinal product, for medicinal products administered in feed, as well as methods for the determination of the active substance in feed, analytical certificates;
(i) data on the stability of the veterinary medicinal product, the proposed shelf life, the proposed storage conditions,
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Regulation Information
| Citation | Decree No. 217 / 2024 Coll., on Good Veterinary Clinical Practice and Closer Conditions of Clinical Evaluation of Veterinary Medicinal Products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.07.2024 |
|---|---|
| Effective from | 01.08.2024 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Agriculture
The regulation text is for informational purposes only.
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