Government Regulation No. 208 / 2015 Coll.
Government Regulation on technical requirements for pyrotechnic articles and their placing on the market
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Regulation
Effective from 04.09.2015
Text versions:
04.09.2015
20.08.2015
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208
GOVERNMENT REGULATION
of 29 July 2015
on technical requirements for pyrotechnic articles and their placing on the market
The Government hereby orders, pursuant to § 7 (3), § 8 (3), § 9 (4) and § 10 (3) of Act No. 206 / 2015 Coll., on pyrotechnic articles and on the modification of certain laws (pyrotechnic Act) ("the Act '):
Subject matter
This Regulation implements the relevant European Union1 Regulation and provides for
(a) the description and content of each conformity assessment procedure, including the documentation to be kept for each conformity assessment procedure and the procedure of the manufacturer and the notified body for each conformity assessment procedure;
(b) the scope and description of the documentation belonging to each conformity assessment procedure;
(c) the description and particulars of the EU type-examination certificate and the conformity assessment certificate;
(d) a model of the EU declaration of conformity.
Conformity assessment procedures
The description and content of each conformity assessment procedure, including the documentation to be kept for each conformity assessment procedure and the procedure of the manufacturer and the notified body for each conformity assessment procedure, are set out in Annex 1 to this Regulation.
Documentation
The documentation accompanying the application for conformity assessment shall consist of:
(a) EU type-examination
1. technical documentation; and
2. supporting evidence of the adequacy of the technical design solution; supporting evidence shall refer to documents which have been used, in particular where harmonised standards have not been applied in full; where necessary to demonstrate the adequacy of the technical solution, the supporting evidence shall also include the results of the tests carried out in accordance with other technical specifications by the manufacturer's laboratory or another testing laboratory on its behalf and under its responsibility;
(b) conformity with the type based on quality assurance of the production process
1. information on the expected category of pyrotechnic articles;
2. documentation of the quality system; and
3. the technical documentation of the approved type and a copy of the EU-type examination certificate;
(c) conformity with the type based on product quality assurance
1. information on the expected category of pyrotechnic articles;
2. documentation of the quality system; and
3. the technical documentation of the approved type and a copy of the EU-type examination certificate;
(d) conformity based on comprehensive quality assurance
1. technical documentation for one model of each category of pyrotechnic articles to be manufactured; and
2. documentation of the quality system.
Technical documentation
(1) The technical documentation must enable the assessment of the conformity of a pyrotechnic article with the requirements of the law and include an appropriate analysis and risk assessment.
(2) The technical documentation shall include at least:
(a) the overall description of the pyrotechnic article;
(b) conceptual design, manufacturing drawings and diagrams of components, sub-assemblies, circuits and, where appropriate, other parts of the product, including their descriptions and explanatory notes;
(c) a list of harmonised standards which have been applied in whole or in part and to which references have been published in the Official Journal of the European Union and a description of the solutions chosen to meet the essential safety requirements of the law; a list of other relevant technical specifications which have been applied where the harmonised standards have not been applied; in the case of partly applied harmonised standards, the technical documentation shall specify the parts used;
(d) the results of the design calculations, the examinations carried out and, where appropriate, other data necessary for the conformity assessment of the product; and
(e) reports of tests carried out.
Documentation of the quality system
(1) The quality system documentation shall allow a uniform interpretation of the quality programmes, plans, manuals and records.
(2) The quality system documentation shall include:
(a) a description of the quality objectives, organisational structure, responsibilities and powers of management as regards product quality;
(b) a description of the examination and tests to be carried out before, during and after manufacture, indicating their frequency;
(c) a description of the quality records, in particular the inspection reports, the records from the tests carried out, the calibration records and the qualification reports of the relevant personnel; and
(d) a description of the means of monitoring the effective functioning of the quality system.
(3) The quality system documentation for conformity assessment with the type based on quality assurance of the production process shall include, in addition to the data referred to in paragraph 2, a description of the corresponding methods, procedures and systematic measures to be used in the manufacture and control and quality assurance.
(4) The quality system documentation for conformity assessment based on comprehensive quality assurance shall include, in addition to the data referred to in paragraph 2:
(a) a description of the relevant methods, procedures and systematic measures to be used in the manufacture, control and quality assurance;
(b) a description of the means of monitoring the achievement of the required quality of the product design;
(c) the specifications of the technical proposal, including the standards to be applied; where the relevant harmonised standards are not fully applied, a description of the means to be used to ensure compliance with the essential safety requirements of the law; and
(d) a description of the methods of control of design and verification of design, procedures and systematic activities to be used in the design of pyrotechnic articles belonging to the relevant pyrotechnic articles category.
EU type-examination certificate
(1) The EU-type examination certificate and its annexes shall contain information enabling:
(a) evaluate whether the pyrotechnic articles manufactured are in conformity with the type which has undergone the conformity assessment of the EU type-examination; and
(b) carry out checks on the manufacturer for the verification of the requirements laid down.
(2) The EU-type examination certificate shall contain:
(a) the business firm and the address of the registered office or the name, surname and address of the manufacturer's residence;
(b) the conclusions of the examination;
(c) the conditions of validity of the certificate, if any; and
(d) the data necessary to identify the approved type.
(3) Where modifications are made to an approved type of pyrotechnic article which may affect its conformity with the essential safety requirements of the law or the conditions of validity of this certificate, the EU type-examination certificate shall include an addendum to which such modifications are subject.
Certificate of conformity assessment
The certificate of conformity shall contain:
(a) information that the quality system guarantees compliance of the pyrotechnic article with the type assessed by the EU-type examination conformity assessment procedure;
(b) the business name and address of the registered office or the name, surname and address of the manufacturer's residence;
(c) the company and the address of the registered office or the name, surname and address of the importer in the case of imports of the pyrotechnic article;
(d) the particulars necessary to identify the approved quality system, the certificate holder and the notified body which issued the certificate;
(e) the conclusions of the conformity assessment; and
(f) its period of validity.
Model EU declaration of conformity
The EU model declaration of conformity is set out in Annex 2 to this Regulation.
Efficacy
This Regulation shall enter into force on the 15th day following its publication.
Prime Minister:
Sobotka v. r.
Minister for Industry and Trade:
Ing. Mládek, CSc., v. r.
Příloha č. 1
Annex No 1 to Government Regulation No 208 / 2015 Coll.
CONFORMITY ASSESSMENT PROCEDURES
1. EU type-examination (Module B)
1.1. The EU type-examination is part of a conformity assessment procedure in which the notified body will review the technical design of the pyrotechnic article and verify that the technical design of the pyrotechnic article meets the requirements of the law.
The EU type-examination shall be carried out to assess the suitability of the technical design of the pyrotechnic article by reviewing the technical documentation and supporting evidence and by checking the complete product sample corresponding to the intended product (combination of the production type and design type).
1.3. The notified body shall examine the technical documentation and supporting evidence for the pyrotechnic article in order to assess the adequacy of the technical design of the pyrotechnic article.
1.4. Notified body of sample
1.4.1 examine whether the sample has been produced in accordance with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the harmonised standards and those which have been designed in accordance with other technical specifications;
1.4.2 shall carry out or have the examinations and tests performed to verify that, where the manufacturer has chosen a solution according to harmonised standards, these standards have been applied correctly;
1.4.3 carry out or have carried out examinations and tests to verify that, in the absence of harmonised standard solutions, the solutions used by the manufacturer, including other technical specifications used, meet the essential safety requirements of the law;
1.4.4 shall agree with the manufacturer where the examinations and tests will be carried out.
1.5 Where the type meets the requirements of the law applicable to the pyrotechnic article, the notified body shall issue an EU-type examination certificate to the manufacturer. If the type does not comply with the requirements of the law, the notified body shall not issue an EU-type examination certificate and shall inform the applicant accordingly, stating the reasons for not issuing the certificate.
1.6 The notified body shall monitor changes in generally accepted scientific knowledge on the basis of which the approved type may no longer comply with the requirements of the law and shall inform the manufacturer if such changes require further investigation. The manufacturer shall inform the notified body which keeps the technical documentation relating to the EU-type examination certificate of any modifications to the approved type which may affect the conformity of the pyrotechnic article with the essential safety requirements of the law or the conditions of validity of that certificate. These adaptations require further approval in the form of an addendum to the original EU-type examination certificate.
The notified body shall inform its notifying authorities of the EU type-examination certificates or additions thereto it has issued or withdrawn and shall make available, on a regular basis, to its notifying authorities, on request, a list of such certificates or additions which it has refused, suspended or otherwise restricted. The notified body shall inform the other notified bodies of the EU type-examination certificates or additions which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of those certificates or additions it has issued. The notified body shall provide the Commission, the Member States or other notified bodies with a copy of the EU-type examination certificates or additions thereto at their request. The notified body shall provide the Commission or the Member States, at their request, with a copy of the technical documentation and the results of the examinations it has carried out. By the end of the period of validity of the EU-type examination certificate, the notified body shall keep a copy of the certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer.
The manufacturer shall keep, for the purposes of Article 18 (4) of the law, a documentation of the EU type-examination, a copy of the EU type-examination certificate, its annexes and additions.
2. Conformity to type based on internal control of the production and testing of the product under supervision at random intervals (Module C2)
2.1. Assessment of conformity to type based on internal control of the production and testing of the product under supervision at random intervals is part of the conformity assessment procedure which the manufacturer fulfils the obligations set out in points 2.2, 2.3 and 2.4 and declares on his own responsibility that the pyrotechnic articles in question are in conformity with the type described in the EU-type examination certificate and comply with the requirements of the law.
2.2. Production
The manufacturer shall take measures to ensure that the production process and its control ensure compliance of the pyrotechnic articles manufactured with the type described in the EU-type examination certificate and with the requirements of the law.
2.3. Product tests
The notified body selected by the manufacturer shall carry out the tests of the product or have such tests carried out at random intervals which it shall itself determine to verify the quality of the internal tests of the pyrotechnic article, taking into account, inter alia, the technological complexity of the pyrotechnic articles and the quantity produced. Before placing on the market, the notified body shall take an appropriate sample of finished products on the spot, which shall be examined and subjected to the appropriate tests provided for in the harmonised standards or equivalent tests specified in other technical specifications, in order to verify the conformity of the pyrotechnic article with the type described in the EU-type examination certificate and with the requirements of the law. If the sample does not reach an acceptable level of quality, the notified body shall take the necessary measures.
The sampling procedure for the acceptance is to verify that the production process of the pyrotechnic article is carried out within acceptable limits ensuring the conformity of the pyrotechnic article.
The manufacturer shall, during the manufacturing process, affix the product under the responsibility of the notified body with the identification number of the notified body concerned.
2.4. CE marking and EU declaration of conformity
2.4.1. The manufacturer shall affix the CE marking to each individual pyrotechnic article which complies with the type described in the EU-type examination certificate and meets the requirements of the law.
2.4.2. The manufacturer shall draw up a written EU declaration of conformity for each product model. The EU declaration of conformity shall indicate the pyrotechnic article for which it has been drawn up. A copy of the EU declaration of conformity shall be provided by the manufacturer on request to the competent control authorities.
3. Conformity with the production process quality assurance type (module D)
3.1. A conformity assessment based on the quality assurance of the production process is part of a conformity assessment procedure which the manufacturer fulfils the obligations set out in points 3.2 and 3.5 and declares under its responsibility that the pyrotechnic articles in question are in conformity with the type described in the EU-type examination certificate and comply with the requirements of the law.
3.2. Production
The manufacturer shall use the approved quality system for the production, output control and testing of the pyrotechnic articles concerned in accordance with point 3.3 and shall be subject to supervision in accordance with point 3.4.
3.3 Quality system
3.3.1. The notified body shall assess whether the quality system complies with the requirements laid down by law. For the elements of the quality system which comply with the provisions of the harmonised standard, the notified body shall presume compliance with these requirements. Persons who, on behalf of a notified body carrying out a quality system assessment (audit team), must have experience with quality management systems and knowledge of the requirements of the law and at least one of its members must have experience in evaluating the relevant product area and the relevant product technology. The audit shall include an evaluation visit at the manufacturer's premises. The audit team shall review the technical documentation in order to verify that the manufacturer complies with the requirements of the law for the type of conformity assessment and carry out all necessary examinations to ensure compliance of the pyrotechnic article with those requirements. The audit conclusions, including their justification, shall be notified to the manufacturer.
3.3.2. The manufacturer shall comply with the obligations arising from the approved quality system and maintain it in order to remain proportionate and effective.
3.3.3. The manufacturer may change the quality system for which the quality system documentation has been drawn up only with the prior approval of the notified body. The notified body shall assess the proposed changes and whether the changed quality system will continue to meet the same requirements as the existing quality system or whether a new assessment is needed. The notified body shall notify the manufacturer of its assessment, including its justification.
3.4. Supervision under the responsibility of the notified body
3.4.1 The purpose of supervision is to ensure that the manufacturer complies properly with the obligations arising from the approved quality system.
3.4.2. In order to exercise supervision, the manufacturer shall allow the notified body access to the premises intended for production, inspection, testing and storage and shall provide it with all necessary documents, in particular:
(a) documentation of the quality system;
(b) the quality records, in particular the inspection reports, the records of the tests carried out, the calibration records and the qualification reports of the persons responsible for the conformity assessment.
3.4.3. The notified body shall carry out regular audits to verify that the manufacturer maintains and uses the quality system and shall submit an audit report to the manufacturer.
3.4.4. The notified body may carry out an inspection without prior notification to the manufacturer. Where necessary, the notified body may carry out or have the product tested to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a control report and a test report if the test has been carried out.
3.5 CE marking and EU declaration of conformity
3.5.1. The manufacturer shall affix the CE marking to each individual pyrotechnic article which is in conformity with the type described in the EU-type examination certificate and meets the requirements of the law and shall, under the responsibility of the notified body for which he has submitted an application for conformity assessment with the type based on quality assurance of the production process, attach the identification number of that notified body.
3.5.2. The manufacturer shall draw up a written EU declaration of conformity for each product model. The EU declaration of conformity shall indicate the pyrotechnic article for which it has been drawn up. A copy of the EU declaration of conformity shall be provided by the manufacturer on request to the competent control authorities.
3.6 The manufacturer shall keep at the disposal of the national authorities, pursuant to Article 18 (4) of the Act, documentation which, in conformity with the type based on quality assurance of the production process, consists of:
(a) information on the approved quality system change;
(b) the conclusions of the examination and the reasoned assessment decision, reports and protocols of the notified body referred to in points 3.4.3 and 3.4.4.
3.7. The notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall make available, on a regular basis, to its notifying authorities a list of quality system approvals refused, suspended or otherwise restricted. The notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended, revoked or otherwise restricted and, upon request, of the quality system approvals it has issued.
4. Conformity to type based on product quality assurance (module E)
4.1 A conformity assessment based on product quality assurance is part of the conformity assessment procedure which the manufacturer fulfils the obligations set out in points 4.2 and 4.5 and declares under its responsibility that the pyrotechnic articles are in conformity with the type described in the EU-type examination certificate and comply with the requirements of the law.
4.2. Production
The manufacturer shall use the approved quality system for the exit inspection and testing of the pyrotechnic articles concerned in accordance with point 4.3 and shall be subject to supervision in accordance with point 4.4.
4.3. Quality system
4.3.1. The notified body shall assess whether the quality system complies with the requirements laid down by law. For the elements of the quality system which comply with the specifications of the harmonised standard, the notified body shall presume compliance with those requirements. The audit team shall have experience with quality management systems and knowledge of the requirements of the law and at least one of its members shall have experience in evaluating the relevant product and product technology. The audit shall include an evaluation visit at the manufacturer's premises. The audit team shall review the technical documentation in order to verify that the manufacturer is following the requirements of the law for the type of conformity assessment and carry out the necessary checks to ensure compliance of the pyrotechnic article with those requirements. The audit conclusions, including their justification, shall be notified to the manufacturer.
4.3.2. The manufacturer shall comply with the obligations arising from the approved quality system and maintain it in order to remain proportionate and effective.
4.3.3. The manufacturer may change the quality system for which the quality system documentation has been drawn up only with the prior approval of the notified body. The notified body shall assess the proposed changes and whether the changed quality system will continue to meet the same requirements as the existing quality system or whether a new assessment is needed. The notified body shall notify the manufacturer of its assessment, including its justification.
4.4. Supervision under the responsibility of the notified body
4.4.1 The purpose of supervision is to ensure that the manufacturer complies properly with the obligations arising from the approved quality system.
4.4.2. In order to exercise supervision, the manufacturer shall allow the notified body access to the premises intended for production, inspection, testing and storage and shall provide it with all necessary documents, in particular:
(a) documentation of the quality system;
(b) the quality records, in particular the inspection reports, the records of the tests carried out, the calibration records and the qualification reports of the persons responsible for the conformity assessment.
4.4.3. The notified body shall carry out regular audits to verify that the manufacturer maintains and uses the quality system and shall submit an audit report to the manufacturer.
4.4.4. The notified body may carry out an inspection without prior notification to the manufacturer. The notified body may, if necessary, carry out or have products tested in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a control report and a test report if the test has been carried out.
4.5 CE marking and EU declaration of conformity
4.5.1. The manufacturer shall affix the CE marking to each individual pyrotechnic article which is in conformity with the type described in the EU-type examination certificate and meets the requirements of the law and shall, under the responsibility of the notified body for which he has submitted an application for conformity assessment with the product quality assurance type, attach the identification number of the notified body.
4.5.2. The manufacturer shall draw up a written EU declaration of conformity for each product model. The EU declaration of conformity shall indicate the pyrotechnic article for which it has been drawn up. A copy of the EU declaration of conformity shall be provided by the manufacturer on request to the competent control authorities.
4.6 The manufacturer shall keep at the disposal of the national authorities, pursuant to Article 18 (4) of the Act, documentation which, in conformity with the type based on product quality assurance:
(a) information on the approved quality system change;
(b) the conclusions of the examination and the reasoned assessment decision, reports and protocols of the notified body referred to in points 4.4.3 and 4.4.4.
4.7. The notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall make available, on a regular basis, to its notifying authorities a list of quality system approvals refused, suspended or otherwise restricted. The notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended or revoked and, upon request, of the quality system approvals it has issued.
5. Conformity based on verification of each individual product (Module G)
5.1. The conformity assessment based on the verification of each product shall be a conformity assessment procedure whereby the manufacturer fulfils the obligation to draw up and submit to the notified body the technical documentation and the obligations set out in points 5.2 and 5.4 and declares on his own responsibility that the pyrotechnic article in question, which has been verified in accordance with point 5.3, is in conformity with the requirements of the law.
5.2. Production
The manufacturer shall take measures to ensure that the production process and its control ensure compliance of the pyrotechnic article produced with the requirements of the law.
5.3 Verification
The notified body which has chosen the manufacturer shall carry out, or have it carried out, the examinations and tests referred to in the harmonised standards, or equivalent tests referred to in other technical specifications to verify the conformity of the pyrotechnic article with the requirements of the law. In the absence of such a harmonised standard, the notified body shall decide which tests are to be carried out.
The notified body shall issue a certificate of conformity with regard to the examinations and tests carried out and shall, under its responsibility, affix or have the approved pyrotechnic article bearing its identification number.
5.4. CE marking and EU declaration of conformity
5.4.1. The manufacturer shall affix the CE marking to each pyrotechnic article complying with the requirements of the law and shall, under the responsibility of the notified body referred to in point 5.3, attach the identification number of that body.
5.4.2. The manufacturer shall draw up a written EU declaration of conformity. The EU declaration of conformity shall indicate the pyrotechnic article for which it has been drawn up. A copy of the EU declaration of conformity shall be provided by the manufacturer on request to the competent control authorities.
5.5 The manufacturer shall keep at the disposal of the national authorities, pursuant to Article 18 (4) of the Act, documentation which, for conformity based on verification of each product, constitutes a certificate of conformity.
6. Conformity based on complete quality assurance (module H)
6.1 The conformity assessment based on comprehensive quality assurance shall be a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 6.2 and 6.5 and declares on his own responsibility that the pyrotechnic articles in question comply with the requirements of the law.
6.2 Production
6.2.1. The manufacturer shall apply an approved quality system for the construction, production, exit inspection and testing of the pyrotechnic articles concerned as referred to in point 6.3.
6.2.2. The manufacturer shall be subject to supervision in accordance with point 6.4.
6.3 Quality system
6.3.1. The notified body shall assess whether the quality system complies with the requirements laid down by law. For the elements of the quality system which comply with the specifications of the harmonised standard, the notified body shall presume compliance with those requirements. The audit team shall have experience with quality management systems and knowledge of the requirements of the law and at least one of its members shall have experience in evaluating the relevant product area and the relevant product technology. The audit shall include an evaluation visit at the manufacturer's premises. The audit team shall review the technical documentation in order to verify that the manufacturer complies with the requirements of the law for the type of conformity assessment and carry out all necessary examinations to ensure compliance of the pyrotechnic article with those requirements. The audit conclusions, including their justification, shall be notified to the manufacturer.
6.3.2. The manufacturer shall comply with the obligations arising from the approved quality system and maintain it in order to remain proportionate and effective.
6.3.3. The manufacturer may change the quality system for which the quality system documentation has been drawn up only with the prior approval of the notified body. The notified body shall assess the proposed changes and whether the changed quality system will continue to meet the same requirements as the existing quality system or whether a new assessment is needed. The notified body shall notify the manufacturer of its assessment, including its justification.
6.4. Supervision under the responsibility of the notified body
6.4.1 The purpose of supervision is to ensure that the manufacturer fulfils the obligations arising from the approved quality system.
6.4.2. In order to exercise supervision, the manufacturer shall allow the notified body access to the premises for design, manufacture, inspection, testing and storage and shall provide it with all necessary documents, in particular:
(a) documentation of the quality system;
(b) the quality records referred to in the section of the quality system relating to the design, in particular the results of analyses, calculations and tests;
(c) the quality records referred to in the manufacturing part of the quality system, in particular the inspection reports, the records of the tests carried out, the calibration records and the qualification reports of the persons responsible for the conformity assessment.
6.4.3. The notified body shall carry out regular audits to verify that the manufacturer maintains and uses the quality system and shall submit an audit report to the manufacturer.
6.4.4. The notified body may carry out an inspection without prior notification to the manufacturer. Where necessary, the notified body may carry out or have the product tested to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a control report and a test report if the test has been carried out.
6.5. CE marking and EU declaration of conformity
6.5.1. The manufacturer shall affix the CE marking to each individual pyrotechnic article complying with the requirements of the law and, under the responsibility of the notified body for which he has submitted an application for conformity assessment based on comprehensive quality assurance, shall attach the identification number of that notified body.
6.5.2. The manufacturer shall draw up a written EU declaration of conformity for each product model. The EU declaration of conformity shall indicate the pyrotechnic article for which it has been drawn up. A copy of the EU declaration of conformity shall be provided by the manufacturer on request to the competent control authorities.
6.6. The manufacturer shall keep at the disposal of the national authorities, pursuant to Article 18 (4) of the Act, documentation which, for conformity based on comprehensive quality assurance, consists of:
(a) information on the approved quality system change;
(b) the conclusions of the examination and the reasoned assessment decision, reports and protocols of the notified body referred to in paragraphs 6.4.3 and 6.4.4.
6.7. The notified body shall inform its notifying authorities of quality system approvals issued or cancelled and shall make available, on a regular basis, to its notifying authorities a list of quality system approvals refused, suspended or otherwise restricted. The notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended or revoked and, upon request, of the quality system approvals it has issued.
Příloha č. 2
Annex No 2 to Government Regulation No 208 / 2015 Coll.
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Regulation Information
| Citation | Government Regulation No. 208 / 2015 Coll., on technical requirements for pyrotechnic articles and their placing on the market |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.08.2015 |
|---|---|
| Effective from | 04.09.2015 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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