Decree No. 159 / 2021 Coll.
Ordinance on veterinary preparations and veterinary technical devices
Valid
Effective from 01.07.2021
Text versions:
01.07.2021
08.04.2021
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159
DECLARATION
of 30 March 2021
on veterinary preparations and veterinary technical means
The Ministry of Agriculture provides, pursuant to Article 78 of Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended by Act No. 131 / 2003 Coll., Act No. 316 / 2004 Coll., Act No. 48 / 2006 Coll., Act No. 182 / 2008 Coll., Act No. 227 / 2009 Coll., Act No. 308 / 2011 Coll., Act No. 18 / 2012 Coll., Act No. 359 / 2012 Coll., Act No. 279 / 2013 Coll., Act No. 139 / 2014 Coll., Act No. 250 / 2014 Coll., Act No. 264 / 2014 Coll., Act No. 302 / 2017 Coll., and Act No. 368 / 2019 Coll. ("Act ') for the implementation of § 66a paragraph 4 and § 66b.
Subject matter
This decree provides
(a) quality requirements for veterinary products;
(b) the requirements of good manufacturing practice in the manufacture of veterinary products;
(c) the content of reports of adverse reactions or defects in the quality of veterinary products;
(d) a list of amendments subject to approval requiring expert evaluation;
(e) the contents of the particulars on the packaging or package leaflet of the veterinary medicinal product,
(f) quality requirements for veterinary technical means;
(g) the content of reports of adverse events or defects in the quality of veterinary technical means;
(h) the content of the particulars on the packaging or in the instructions for use of the veterinary technical device.
Quality requirements for veterinary products
(1) Only those substances which do not adversely affect the quality and safety of the veterinary medicinal product and which ensure that the veterinary medicinal product shows an effect on its packaging or package leaflet may be used for the manufacture of veterinary products. Substances used in the manufacture of veterinary medicinal products shall conform to the quality laid down for veterinary medicinal products by other legislation1) or to the quality corresponding to the particulars in the dossier for the application for approval of the veterinary medicinal product by which their quality, safety and performance are clearly demonstrated.
(2) Veterinary preparations
(a) it must not contain:
1. substances whose presence in the preparation excludes or adversely affects the safety of the preparation,
2. substances which, for animals whose products are intended for human consumption, are prohibited or pharmacologically active, including natural substances, requiring the fixing of withdrawal periods after their application in accordance with the provisions directly applicable (2),
3. narcotic and psychotropic substances (3); or
4. pathogenic micro-organisms, including pathogenic fungi, or micro-organisms conditionally pathogenic; and
(b)
1. meet the safety requirements relating to transmissible spongiform encephalopathies agents recommended in accordance with the principles of the European Pharmacopoeia when raw materials of animal origin are used;
2. have a described source of raw material of plant origin, if used, and the quality assurance system must be set in their manufacture; and
3. comply with the criteria characterising the quality of the preparation (hereinafter referred to as "the specifications"), including the criteria for feedstock, packaging material and, where appropriate, intermediate products, where these are verified using sensory, chemical, physical, microbiological and, where appropriate, other tests established by the manufacturer, including the methods used and limits for each test.
Good manufacturing practice
(1) Good manufacturing practice in the manufacture of veterinary products means the introduction of a quality management system ensuring that the veterinary product is processed and controlled in conformity
(a) quality requirements which correspond to its intended use,
(b) with a specification; and
(c) the decision approving the veterinary medicinal product.
(2) In good manufacturing practice,
(a) veterinary products shall be manufactured in such a way that:
1. compliance with the requirements laid down in the decision approving the veterinary medicinal product has been guaranteed; and
2. are suitable for the intended and indicated use and the animals have not been exposed to the risk caused by their lack of safety and efficacy;
it is implemented through a comprehensive system of quality assurance for veterinary products,
(b) the production of veterinary products shall be carried out in suitably large, suitably located, arranged and equipped premises, the corresponding type and extent of the activities carried out therein, such premises being such as to enable all manufacturing operations to be carried out correctly and the proper handling of raw materials, packaging materials as well as finished products such as income, separate storage of raw materials and packaging materials before their release into production, storage of input materials released into production, sampling, own production, quality control, dispatch, ensuring separate storage of returned products, minimising the possibility of substitution of materials entering and contamination of products;
(c) premises and equipment which may affect the quality, safety and efficacy of veterinary products shall be properly cleaned, maintained and regularly inspected in accordance with the principles of good manufacturing practice and the requirements arising from standard operating procedures; premises and equipment shall be arranged and maintained in a way that prevents contamination, cross-contamination or other adverse effects on the quality of veterinary products; where the starting substances, primary packaging, intermediate products or products are exposed to the external environment before they are filled into the primary packaging, the internal surfaces of the rooms shall be smooth, uncracked and free of any open clasps, the particles shall not be released from them and shall allow efficient cleaning and, where necessary, disinfection; in cases where dust is generated in manufacturing operations, the manufacturer shall take specific measures to avoid cross-contamination and to facilitate cleaning;
(d) production facilities which are critical for the quality of veterinary products shall be subject to appropriate verification of their competence, which shall be carried out at regular intervals to the appropriate extent and shall consist of verification of the accuracy of the installation, calibration of the instrumentation, verification of the operational functionality of the production equipment, verification of the operational functionality of the production equipment using the material produced or the simulated product under normal production conditions; measuring instruments, scales, recording and control equipment shall be tested metrologically at regular intervals;
(e) the operating conditions take into account the requirements of the product and must be monitored;
(f) the quality control premises shall be separated from the production premises in so far as they are not continuous production checks and shall be equipped with the necessary equipment subject to the specified control, maintenance and calibration;
(g) documentation to ensure the production, quality control and release of products into circulation, with the possibility of monitoring all stages of production of each lot, shall be clearly and clearly processed; records of the production and control of the lot must be legible, protected from damage, deterioration or loss; records of production and control of the lot shall include:
1. the name and batch number of the product,
2. the date and time of start of production, the date and time of start of each critical stage of processing defined by the manufacturer and the date and time of completion of production;
3. identification of personnel carrying out individual production steps during processing;
4. batch numbers or analytical protocols numbers and quantities of source substances actually established;
5. a list of production operations and production facilities used,
6. a record of the ongoing production controls carried out and their results;
7. records of the packaging of the lot, indicating the time of packing operations, the facilities used and the staff involved in the operations;
8. Where possible, samples of printed packaging materials used, indicating the batch number, the period of application and other printed particulars,
9. Notes on potential problems and deviations from the defined production rules,
10. records of the testing of the input raw materials, if any, and records of the testing of the final product, identifying the name of the material or product, batch numbers, by reference to the test procedure, by reference to the equipment used, indicating the results of the tests, the date of testing and the identification of the staff performing the test; and
11. record of release of the lot into circulation by the person responsible for release of the lot into circulation;
(h) production processes shall be carried out in accordance with the documentation submitted in the framework of the approval procedure and shall be defined in writing; only raw materials and materials which have been subject to an entry control and which comply with the specifications shall be used for production; the manufacturer must keep documentation in the form of:
1. specifications which serve as a basis for assessing the quality of raw materials and materials;
2. the production rules or instructions for production, packaging and testing which contain details of all the starting materials and equipment used and shall establish detailed procedures for the production activities, packaging, sampling and testing, procedures for the preparation of equipment and for checking the purity and suitability of the use of the equipment;
3. standard operating procedures containing instructions for carrying out certain activities;
(i) the documents defined in points (h) (1) to (3) shall be kept in the form of controlled documentation and shall be approved, signed and dated by the relevant authorised staff and distributed in such a way as to ensure that only valid versions of the documents are used; the documents must be revised and updated regularly; the retention period of the dossier depends on the activity that the dossier provides; the documentation, including the primary data, supporting the information in the approval documentation, in particular information relating to validation or stability, shall be kept for the duration of the approval; where data, in particular primary data supporting validation or stability reports, are replaced by a complete set of new data, they may be shredded, except for the original data, which must be kept for at least as long as records of the production and control of all batches released for circulation on their basis,
(j) manufacturer
1. validate each new production process, validation is also required in the event of a significant change in the production process, such as a change in production equipment or starting materials that could affect the quality or reproducibility of the production process,
2. verify that a new working procedure is in place, that such a working procedure is suitable for routine production;
3. demonstrate that the production process defined in the manufacturing regulation referred to in point (h) (2) will repeatedly provide a product of satisfactory quality when using prescribed starting materials and equipment; and
4. document the results and conclusions of validation studies;
(k) any handling of materials and products, in particular acceptance, quarantine storage, sampling, storage, labelling, delivery for processing, processing, packaging and distribution, carried out in accordance with written procedures; the raw materials and packing materials must be checked before they are released into production and placed separately in quarantine until their written release for further processing; the final products must be quarantined and stored in quarantine immediately after completion of production until their written release into circulation;
(l) the raw materials, packaging and products shall be stored under appropriate conditions laid down by the manufacturer, clearly so that the individual lots can be separated from each other and that the stocks can be replaced according to their shelf life; the processing of different products shall not take place in the same room in parallel or in close succession unless it is ensured that there is no risk of confusion or cross-contamination; at all stages of manufacture, materials and products shall be protected from microbial and other contamination;
(m) during manufacture, the materials shall be clearly marked and the production facilities and premises marked with the name of the product processed and the batch number;
(n) the manufacturer shall establish and maintain a quality control system to ensure that:
1. analytical methods have been validated to demonstrate that they are suitable for the intended purpose of their use;
2. laboratory equipment has been qualified to be carried out at regular intervals to an appropriate extent and consists of verifying the accuracy of the installation, calibration of the instrumentation and verifying the operational functionality of the equipment;
3. the manufacturer made records of the tests carried out; other primary data, in particular laboratory journals or records, shall be kept in addition to data contained in the batch documentation;
4. test reports or analytical certificates are available, test results including calculations, records of validation of analytical methods, records of calibration of equipment, qualification and maintenance of equipment, non-specification testing procedure, environmental monitoring data, if implemented;
5. the quality-critical data have been defined as primary data; and
6. reference substances have been established to be suitable for the intended purpose; the storage conditions must be monitored;
(o) the raw materials and finished products used shall be sampled in quantities ensuring that at least two complete analyses are carried out within the scope of the approved specification; samples of the starting materials, other than solvents, gases or water used in the manufacturing process, shall be kept by the manufacturer for a minimum period of 2 years from the release of the finished product on the market; that period may be shortened if the stability of the material is shorter; samples of final products must be kept by the manufacturer for at least 1 year after the expiry date of the products; a sample of each batch of the finished product must be kept in its final inner packaging or in a packaging of the same material as the inner packaging in which the preparation is put into circulation;
(p) the manufacturer shall carry out repeated internal controls and be shown to have continued application and compliance with the requirements of good manufacturing practice, in particular entry control of raw materials and materials, interoperational control and control of the specifications of finished products, and shall take measures to remedy the deficiencies identified; the manufacturer must have adequate material and personnel equipment and use approved procedures; the manufacturer shall keep and keep records of such internal controls and any corrective actions subsequently taken;
(q) the manufacturer shall have an adequate number and an adequate professional structure of qualified staff, which corresponds to the type and extent of production, and shall have a developed organisational scheme, from which, on the basis of a clearly defined work figure, the powers, responsibilities and links in employment relations are evident; in particular, the person responsible for releasing the lot and the management staff responsible for production, quality control and quality assurance shall be considered as key staff; sub-responsibilities must be understandable to individual employees and must be determined in writing; the staff member responsible for production and the staff member responsible for quality control shall be independent of each other; depending on the size and organisational structure of the company, the responsibilities of key employees may be cumulated,
(r) the manufacturer shall provide initial and continuous training for staff whose load is adapted to the needs, taking into account the nature and extent of the activities in the manufacture and putting into circulation of veterinary products, including guarantees of quality and good manufacturing practice, and lay down rules on the personal hygiene of workers;
(s) complaints and complaints against veterinary products shall be investigated in accordance with written procedures to determine whether a possible quality defect or any other problem is involved and a rapid and effective suspension of the placing into circulation and withdrawal from circulation of those veterinary products which do not comply with the requirements of the veterinary law, this decree or the decision approving the veterinary product must be ensured; in the case where a defect in the quality of a lot has been detected or suspected, care must be taken to check other batches and, where appropriate, other preparations to determine whether they are also affected; the manufacturer must introduce all available measures to reduce the risk to animal health; and
(t) the period of application shall be determined from the date of manufacture; the date of manufacture of the batch of the veterinary medicinal product for the purpose of determining the expiry date shall be the date on which the first manufacturing step occurs in which the active ingredient is combined with other raw materials.
Content of adverse reaction reports or defects in the quality of veterinary products
(1) The adverse reaction report shall include:
(a) name and surname or name, including address for delivery, telephone number or e-mail address, or other contact details (hereinafter referred to as "contact details") of the person reporting the adverse event, contact details of the owner of the animal, date of notification, type of animal, breed, age, sex of the animal, animal status, number of animals for which the veterinary medicinal product has been applied, number of animals for which the adverse event has been recorded;
(b) the name, approval number, batch number and expiry date or period of application of the veterinary medicinal product;
(c) the method of administration, the amount applied, the date of first administration and the time of administration of the veterinary medicinal product; and
(d) a description of the adverse effect, the time interval of occurrence of the adverse effect since the last application of the veterinary medicinal product, the duration of the adverse effect, information on the concomitant use of other veterinary medicinal products or medicinal products.
(2) In the event of an adverse event related to the use of the veterinary medicinal product in humans, the report shall contain the data referred to in points (a) to (d) of paragraph 1 as appropriate.
(3) The report of a defect in the quality of the veterinary medicinal product shall include:
(a) the contact details of the natural or legal person reporting the defect in the quality of the veterinary medicinal product;
(b) the particulars of the veterinary medicinal product, the name of the veterinary medicinal product, the manufacturer, if available, the holder of the decision approving the veterinary medicinal product, the batch number, if available, the expiry date or the expiry date; and
(c) details of the quality defect, including details of where the problem has been identified, extent, distribution data, if available.
Amendments to the decision approving the veterinary medicinal product
(1) When deciding on the approval of changes as compared to the documentation submitted in the context of the procedure for the approval of a veterinary medicinal product, amendments requiring a professional evaluation shall be considered as changes to:
(a) the composition of the preparation,
(b) the intended use of the preparation;
(c) concerning the addition of target species or removal of target species for safety reasons;
(d) how the product is used and the dosage thereof,
(e) extending the shelf life of the product in the sales pack, after first opening the immediate packaging, after dilution or reconstitution,
(f) conditions for storage of the finished product, the diluted or reconstituted product,
(g) the replacement or addition of the manufacturing site for the whole or part of the manufacturing process of the finished product;
(h) the immediate packaging of the finished product in semi-solid and liquid forms;
(i) the parameters or their limits specifying the quality of the finished product; or
(j) the number or content of the safety phrases or changes to the safety data sheet based on a change in the safety assessment of the product or change in the raw materials used.
(2) Amendments not referred to in paragraph 1 shall be deemed to be of an administrative nature.
Content of the information on the packaging or package leaflet of the veterinary medicinal product
(1) The holder of the decision approving the veterinary medicinal product must indicate on the packaging of the veterinary medicinal product:
(a) the trade name of the veterinary medicinal product, identical to that given in the application;
(b) the business name or registered office or place of business of the holder of the approval decision and, where appropriate, the manufacturer of the veterinary medicinal product, if different from the holder of the approval decision;
(c) the qualitative composition of the veterinary medicinal product or at least the main active ingredient where the package leaflet is included in the package leaflet,
(d) the nominal product content, expressed in particular by weight in grams, volume in millilitres, number in pieces, length in centimetres;
(e) target species;
(f) the purpose of the use of the veterinary medicinal product, where no claim which is contrary to the definition of the veterinary medicinal product, in particular the claim on the therapeutic effects of the veterinary medicinal product or its use for the purpose of treatment, may be made for use;
(g) the method and conditions of storage of the veterinary medicinal product,
(h) the expiry date or the period of application during which the product will retain the specific declared properties and be safe from that date of manufacture, subject to storage conditions;
(i) the identification of the production batch, such as the date of manufacture or the batch number;
(j) the approval number of the veterinary preparation allocated by the Institute;
(k) the warning "Keep out of the sight and reach of children,"
(l) the words "Veterinary medicinal product" and "For animal treatment only,"
(m) the words "Read the package leaflet before use" and
(n) further information on the basis of the reasoned requirements of the holder of the decision approving the veterinary medicinal product or the requirement of the Constitution resulting from the nature of the veterinary medicinal product and its purpose of use.
(2) If separate package leaflet is not included in the package leaflet, the holder of the decision approving the veterinary product must also indicate
(a) the quantitative composition of the preparation for ingredients which are essential to the declared effect of the preparation;
(b) the method of use of the veterinary medicinal product, including dosage and duration of application in each animal species;
(c) data which the manufacturer considers relevant for the correct and safe use of the veterinary medicinal product;
(d) details of how packaging, including residues, is disposed of; and
(e) shelf life after first opening the immediate packaging, if the nature of the product so requires.
(3) Where a separate package leaflet is included in the package of veterinary medicinal product, the holder of the decision approving the veterinary medicinal product must indicate:
(a) the business name or registered office or place of business of the holder of the approval decision and, where appropriate, of the manufacturer of the veterinary medicinal product, if different from the holder of the approval decision;
(b) the trade name of the veterinary medicinal product, identical to that given in the application;
(c) the complete qualitative composition of the veterinary preparation;
(d) the quantitative composition of the preparation for ingredients which are essential for the declared effect of the preparation;
(e) target species;
(f) the purpose of the use of the veterinary medicinal product, where no claim which is contrary to the definition of the veterinary medicinal product, in particular the claim on the therapeutic effects of the veterinary medicinal product or its use for the purpose of treatment, may be made for use;
(g) the method of use of the veterinary medicinal product, including dosage and duration of application in each animal species;
(h) data which the manufacturer considers relevant for the correct and safe use of the veterinary medicinal product;
(i) details of how packaging, including residues, is disposed of;
(j) the warning "Keep out of the sight and reach of children,"
(k) the expiry date after first opening the immediate packaging if the nature of the product so requires,
(l) the method and conditions of storage of the veterinary medicinal product,
(m) the words "Veterinary medicinal product" and "For animal treatment only,"
(n) a list of all approved packaging sizes; and
(o) further information on the basis of the reasoned requirements of the holder of the decision approving the veterinary medicinal product or the requirement of the Constitution resulting from the nature of the veterinary medicinal product and its purpose of use.
Quality requirements for veterinary technical means
(1) When designing and producing a veterinary technical device, the manufacturer shall choose such solutions as are consistent with the principles of safety and the current level of science and technology and shall ensure that the veterinary technical device is suitable for veterinary use.
(2) Veterinary technical device
(a) it must be designed and manufactured in such a way that, when used under the specified conditions and for the intended purpose of use, it does not jeopardise the clinical condition, health or safety of the animal, or the safety or health of the person serving or using the veterinary technical device, or other natural persons or environmental safety, as the case may be, and provided that any risks which may be related to the use of the veterinary technical device are acceptable compared to their benefit to the animal and correspond to a high level of health and safety protection;
(b) it must be designed in such a way that there are no infringements in the field of environmental or animal protection against abuse;
(c) it must be designed, manufactured and packaged in such a way that its characteristics, characteristics or efficacy for the intended use are not adversely affected by the conditions of transport or storage, while maintaining the instructions and information given on the label or in the instructions for use;
(d) it must be designed, including its manufacturing process, in the light of the current state of scientific knowledge and the purpose of use in such a way as to eliminate or minimise the risk of transmission of infection by veterinary technical means to animals, to persons serving or using the veterinary technical device or to other natural persons, or to the risk of contamination by those persons of another veterinary technical device;
(e) supplied in sterile form shall be designed, manufactured and packaged in disposable protective packaging, or, where appropriate, appropriate procedures shall ensure that it is sterile when the veterinary technical device is placed on the market and remains sterile under specified storage and transport conditions until the protective packaging is opened;
(f) intended for use in conjunction with a particular veterinary medicinal product must have the purpose of being used in accordance with the marketing conditions of that veterinary medicinal product,
(g) produced using raw materials of animal origin must meet the safety requirements relating to transmissible spongiform encephalopathy agents in accordance with the principles of the European Pharmacopoeia; and
(h) the measuring function shall be so designed and constructed as to provide sufficient accuracy and stability within the specified accuracy limits, taking into account the intended purpose of its use; the results of measurements carried out by a veterinary technical means with a measuring function shall be expressed in appropriate international units or other established scientific units.
(3) Where a veterinary technical device intended for use in conjunction with another veterinary technical device or equipment is used, the assembly resulting from such a connection, including the interconnection system, shall be safe and shall not interfere with the stated effectiveness of each veterinary technical device; any restriction on the applicability of another veterinary technical device shall be indicated on the label or in the instructions for its use.
Content of reports of adverse events or defects in the quality of veterinary technical means
(1) Reporting of an adverse event of a veterinary technical device contains:
(a) the contact details of the person reporting an adverse event of the veterinary technical device, the contact details of the owner of the animal, the date of the report, the type of animal, the breed, age, sex of the animal, the animal status, the number of animals in which the veterinary technical device has been used, the number of animals in which the adverse event of the veterinary technical device has been recorded;
(b) the name of the veterinary technical device, the identification details of the manufacturer, if available, and the holder of the registration decision, the batch number, if available, and the expiry date or period of validity of the veterinary technical device;
(c) the method of application, the quantity applied, the date of the first application and the time of application, depending on the nature of the veterinary technical device; and
(d) the time interval for the occurrence of an adverse event of a veterinary technical device since the last application of the veterinary technical device, the duration of the adverse event of a veterinary technical device, a description of the adverse event of a veterinary technical device, information on the simultaneous administration of other veterinary technical devices, and, where appropriate, veterinary products or veterinary medicinal products.
(2) Reporting of defects in the quality of the veterinary technical device contains:
(a) the contact details of the person reporting the defect in the quality of the veterinary technical device;
(b) the name of the veterinary technical device, the identification details of the manufacturer, if available, and the holder of the registration decision, the batch number, if available, and the expiry date or period of validity of the veterinary technical device;
(c) details of where the problem has been identified and its extent; and
(d) data on the distribution of the veterinary technical device, where available.
Content of the information on packaging or instructions for use of the veterinary technical device
(1) On the packaging of the veterinary technical device, the holder of the decision to register the veterinary technical device must indicate:
(a) the trade name of the veterinary technical device;
(b) the firm or the name and registered office or place of business of the holder of the registration decision and, where appropriate, of the manufacturer of the veterinary technical device, if different from the holder of the registration decision;
(c) the package size if it does not result directly from the nature of the veterinary technical device,
(d) the purpose of using the veterinary technical device;
(e) the unique identification mark of the veterinary technical device, such as production number, batch number, date of manufacture;
(f) the expiry date or the period of application, including the date of manufacture, where the nature of the veterinary technical device so requires;
(g) the number under which the Institute keeps the veterinary technical means in the list of veterinary technical means;
(h) the words "Veterinary technical means" and "For animal treatment only,"
(i) the words "Read the instructions for use before use," where a separate instructions for use are included in the packaging of the veterinary technical device; and
(j) further information on the basis of the reasoned requirements of the holder of the decision on the registration of a veterinary technical device or the requirement of the Constitution resulting from the nature of the veterinary technical device and its purpose of use.
(2) If the packaging of a veterinary technical device does not contain separate instructions for use, the holder of the decision on the registration of a veterinary technical device on the packaging must also indicate:
(a) a description of the method of use, where the nature of the veterinary technical device so requires;
(b) qualitative and quantitative composition, depending on the nature of the veterinary technical device; and
(c) other data relating to the use of a veterinary technical device which ensures its correct and safe use.
(3) Where the packaging of a veterinary technical device contains separate instructions for use, the holder of the decision on the registration of the veterinary technical device shall indicate:
(a) the business firm or the name and registered office or place of business of the holder of the registration decision, and, where appropriate, the manufacturer of the veterinary technical device, if different from the holder of the registration decision;
(b) the trade name of the veterinary technical device;
(c) the purpose of using the veterinary technical device;
(d) a description of the method of use, where the nature of the veterinary technical device so requires;
(e) qualitative and quantitative composition, depending on the nature of the veterinary technical device;
(f) other data relating to the use of a veterinary technical device which ensures its correct and safe use;
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Regulation Information
| Citation | Decree No. 159 / 2021 Coll., on Veterinary Products and Veterinary Technical Devices |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 08.04.2021 |
|---|---|
| Effective from | 01.07.2021 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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