_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ * Republished pursuant to art. III b) of the law No. 186 from 22.07.2016-Official Gazette of the Republic of Moldova, by 2016. 315-328, art. 684. Amended by the laws of the Republic of Moldova: LP186 from 22.07.16, MO315-328/23.09.16 art. 684; force 23.12.16 LP184 from MO166 11.07.12, 16.08.12-169a/art. 571; force LP66 from 16.11.12 07.04.11, MO110-112/08.07.11 art. 299, LP109 from MO131-134 04.06.10/30.07.10 art. 443 LP131-XVIII from 23.12.09, MO23-24/12.02.10 art. 35-XVI dated 14.12.07 LP280, 96/MO94-30.05.08 art. 349; in effect this law Parliament adopted 30.05.08.
This Act establishes the legal bases of technical and regulatory activity is intended to remove technical barriers to trade.
Chapter I.GENERAL PROVISIONSARTICLE 1 GENERAL Article. Scope of application (1) the present law establishes general requirements concerning the content and mode of development, approval and implementation of technical regulations in the field of trade, as well as the duties of the regulatory authorities of the regulatory process to ensure transparency and the free movement of products aimed at defending public interests on the domestic market.
(2) the technical regulation constitutes a prerogative of the State being exercised by the regulatory authorities.
(3) this law shall not apply to products: (a)) subject to law. 78-XV of 18 March 2004 concerning foodstuffs;
b) plant protection products and fertilizer;
c) plants, feed and live animals;
d products of human origin) and the products of plant and animal origin that are directly related to their future reproduction;
e) substances, psychotropic drugs and precursors;
f) medicinal products for human and veterinary use;
g) aircraft and equipment in the field of aviation;
h) products are made available on the market as antiques or Museum purposes;
I) products in category of armaments and military equipment, special equipment, involving national defense and safety;
j) services;
k) sanitary and phytosanitary regulations, norms and veterinary requirements whose legal framework is established by special laws.
Article 11. The purpose of the law this law aims at ensuring the free movement of products, creation of conditions for the harmonization of national technical legislation with European Union laws, requirements, and conditions for placing on the market of Republic of Moldova to secure and compliant products that foster a competitive marketplace and to eliminate technical barriers to trade.
In article 2. Notions for purposes of this law, shall use the following notions: technical-regulatory activity overview of activities relating to the establishment of requirements towards products in terms of their security, the conditions for the marketing and use of them, also determining the rules of market surveillance and conformity assessment;
regulatory authority-central specialised body of public administration, within the limits of its competence, elaboration of technical regulations;
technical barriers to trade-the difference between the requirements of national technical regulations, national standards and procedures for assessment of conformity and of those used in international practice or their non-recognition, which implies, in comparison with ordinary commercial practice, additional expenses and/or for the marketing of products on the domestic and external markets;
essential requirements-requirements stipulated in national technical regulations transposing the harmonisation legislation what has the European Union and ensuring national security and the safety of products for life and health of humans, for the animal and the plant, environmental and material possessions in order to protect the interests of the consumer, including practices in order to prevent misleading the consumer as regards the composition of the , destination, origin, quality and safety of products;
technical documentation-documentation drawn up by the manufacturer, which allows conformity assessment of the product and is intended to provide information on the design, manufacture and operation of the product;
area covered-overview of economic activities and associated products for which specific technical regulations are issued on the conditions for placing on the market and/or make available on the market;
module-overview of applied rules and procedures for conformity assessment of the product according to the European practices;
interested party-authority, operator or other entity applying times they intend to apply a national technical regulation;
presumption of conformity-assumption, in force until the demonstration to the contrary, that a product meets the requirements specified in the applicable technical regulation;
conformity assessment procedure-any procedure used, directly or indirectly, to determine if the product meets the requirements. The term "conformity assessment procedure" shall include, as appropriate, procedures for sampling, testing and inspection, evaluation, verification and assurance of conformity, registration, approval, and their combinations;
product-any good material, including a provision of services intended for distribution, consumption or use on the market in the context of commercial activities, in return for payment or free of charge;
technical regulation-regulatory action which provides, directly and/or by reference to certain standards, technical requirements for a product relating to its security, including the relevant administrative provisions, the observance of which is mandatory in the case of introductions or available on the market of this product;
technical specification-document that lays down the technical requirements which must be fulfilled by a product; technical specification may be a standard part of a standard or a document independent of a standard;
the harmonised european standard-standard, adopted following a request from the European Commission for the implementation of the harmonisation of the laws of the European Union and that transforms the essential requirements of such legislation in the technical specifications for the products scope;
equal treatment-conditions of employment granted to import products that is no less favourable than that accorded to like products of indigenous in a comparable situation.
Chapter II REQUIREMENTS for the REGULATION of TRADE in article 3. General requirements concerning technical regulations (1) in order to ensure the safety of products for life and health of humans, for the animal Kingdom, at environmental and, in order to protect the interests of consumers, including for the prevention of practices liable to mislead them, and for other public order considerations, regulatory authorities shall prepare technical regulations under this law.
(2) For the matters covered in that there is legislation on the harmonisation of the European Union, national technical regulations transposing this legislation. The list of areas covered is given in the annex. 3 the law nr. 235 of 1 December concerning the activities of accreditation and conformity assessment.
(3) For areas where there is legislation on the harmonisation of the European Union, regulators may issue technical regulations for the marketing of national products.
(4) the placing on the market and use of certain products in areas where there is no harmonization of the legislation of the European Union, shall be permitted only if these products are marketed lawfully in another Member State of the European Union and if they offer a degree of protection of consumers ' interests equivalent to that required by the rules applicable in the Republic of Moldova.
(5) National Technical Regulations for the areas in which there is legislation on the harmonisation of the European Union may have direct or indirect effects as a prohibition on placing on the market of a product or type of product, or withdrawal from the market of that product or type of product, or change the times seeking additional product testing/or that type of product.
(6) technical regulations shall be approved by law or by regulatory acts of the Government and complies with the principles laid down in this law.
Article 4. Requirements regarding the content of technical regulations (1) technical regulations shall not be more trade restrictive than is necessary to achieve the following objectives: (a) national security;)
b) protection of life, health, and safety of heredity;
c) asset protection materials;
d) protection of the animal and plant Kingdom;
e) environmental protection;
f) rational use of natural resources and energy;
g) prevention practices that mislead consumers with regard to composition, destination, origin, quality and safety of products.
(2) Technical Regulations: a) to provide for equal treatment of imported products from countries with which treaties;
b) to grant imported products treatment no less favourable than that accorded to like products, imports from countries with which treaties;
d)-have been repealed.
(3) repealed.
(4) technical regulation provides, where appropriate, but not limited to) the following: defining the scope regulated: Describes a group of products referred to in the respective technical regulation and the nature of the risks to be avoided, as well as, where applicable, of groups of products which do not apply the provisions of the technical regulation;
b) product groups from areas covered subject to conformity assessment: specify the products subject to mandatory conformity assessment with the requirements of the technical regulation in question;
c) product groups from the regulated areas are not subject to conformity assessment: specify the products which are not subject to mandatory conformity assessment with the requirements of the technical regulation in question;
d) essential requirements for the groups of products in the scope in which there is legislation on the harmonisation of the European Union: the essential requirements shall be established which shall ensure a high level of safety of the product, taking into account the specific hazards associated with it, or requirements that relate to its performance. The essential requirements constitute a fundamental part of the technical regulation and allow the application of harmonised standards adopted as standards, to remain voluntary. In the absence of harmonised standards or where the manufacturer decide not to resort to such standards, essential requirements must allow assessment of the conformity of the product to be used;
D1) the requirements for the product groups in the area where there is no harmonization of the legislation of the European Union: shall establish requirements for products to be identified and placed on the market. Requirements constitute a fundamental part of the technical regulation, and the standards to which reference is made must presume conformity with these requirements in products;
e) conformity assessment procedures: specify, where appropriate, for products of the fields covered, one or more appropriate procedures for conformity assessment;
f) requirements for the content of the technical documentation and the documents certifying the conformity with essential requirements;
g scope of rules) the CE marking of conformity: shall be set to the respective rules under the provisions of laws and other normative acts in force;
h) specific requirements towards metrological assurance: specifying, where appropriate, gauges, measuring instruments, reference materials used, the procedures for carrying out measurements, such measurements with uncertainty estimation, etc.;
I) requirements for accredited bodies for conformity assessment which are recognized and notified for activity in that area, in accordance with the legislation in force, including the specific requirements laid down by the regulatory authority;
j) obligations of the manufacturer, the authorised representative, the importer and the Distributor;
k) corrective measures, prohibitions, or withdrawals from the market for consumer recalls of nonconforming product;
l) traceability requirements: product identification elements (type, batch, serial number, etc.) and of the manufacturer/importer (name, trade name or registered trade mark, mailing address etc.);
m) authorities in charge with market surveillance.
(41) the regulators will determine the structure and content of the technical regulation for each case separately.
(42) the essential requirements of national technical regulations transposing the harmonisation of legislation of the European Union to be removed even from the point of view of technical content, structure and numbering.
(5) The technical regulations in the areas for which there is no harmonization of the legislation of the European Union, the regulatory authorities shall determine: (a) extra) the frequency or the criteria for determining the frequency of periodic assessment of products certified by the certification bodies and accredited inspection and recognized in the manner established by law;
b) criteria for the suspension or revocation of certificates and declarations of conformity;
c)-repealed.
(6) the list of areas covered by the regulatory authorities and market surveillance authorities is approved and, if necessary, updated by the Government.
Article 5. The way of development of technical regulations (1) regulatory authorities who shall prepare draft technical regulations placed on the official web page of the authority, no later than 2 weeks from the date of initiating the development, an opinion on such a development, to inform all interested parties.
(2) in order to ensure the transparency of the regulatory process (Amendment) regulations technical regulatory authority, through notification and Information Centre of the World Trade Organization: a) shall notify the signatory States of bilateral or multilateral agreements relating to mutual exchange of appropriate information, referred to as the States parties about the types of products which they will apply the common technical regulation under development , indicating the objective and motive of elaboration (notifications shall be submitted in English, French or Spanish);
b) provide States parties, on request, details of the technical regulation being prepared or copy thereof and, where possible, indicate the compartments that differ in substance from relevant international and European standards.
(3) The drafting of a regulation (modification) which can considerably influence the technical conditions of the import or export of the products, the regulatory authority shall, at the request of States parties justifies the need for technical regulation concerned and transmit those States supporting note through notification and Information Centre of the World Trade Organization as set forth in the agreements. When drawing up a regulation (modification) in accordance with the technical requirements of the relevant international and European standards, it conveys only information concerning the conformity of the technical regulation being developed with relevant international or european standard.
4. Regulatory authorities shall take into account the time limit of 6 months time limit set for the submission of objections on the draft technical regulation by States parties and interested parties of the Republic of Moldova. These objections should be examined together with their authors and other interested parties and the results of the examination shall be taken into account in the finalisation of the project.
(5) In cases where the achievement of the objectives specified in article 4 paragraph 2. (1) acquire an emergency character, developer technical regulation shall be entitled to omit as appropriate, some provisions of paragraphs 1 and 2. (2) and paragraphs 1 and 2. (4) of this article provided that: (a)) States parties notification about drafting technical regulation concerned, indicating the nature of the problems;
b) presentation, at request, States parties a copy of the technical regulation, giving them the possibility of exposure of objections in writing, to be examined, taking into account the results of the examination.
(6) technical regulations shall be published in the Official Gazette of the Republic of Moldova in the manner established by law. Between the date of adoption and the date of implementation of the technical rules, if necessary, will be provided for a period of at least 3 months, be determined by the regulatory authority in the field, for the implementation of measures of transition from the old procedures, requirements and standards to the new provisions and requirements laid down in the technical regulations and standards.
(7) if the circumstances or objectives that have conditioned the adoption of technical regulation are gone or have changed, the regulatory authority which has taken repeals or amends the technical regulation in question, by publishing the information. Where the authority has adopted the common technical and completed the work, the appropriate decision is taken by the successor of that authority. Where no successor is established, the appropriate decision is taken by Government.
(8) the elaboration, coordination and the adoption of technical regulations shall be established in accordance with the legislation in force.
(9) New Procedures for assessment of conformity shall be drawn up in case there are no guides or recommendations or relevant international organisations the European standards or if the content of a conformity assessment procedure in force does not meet the requirements of the guidelines or recommendations of international organisations or European standards.
In article 6. Coordination of elaboration of technical regulations (1) the elaboration of technical regulations by regulatory authorities, is administered and coordinated by the central body of the public administration specialist in charge of the quality infrastructure.
(2) repealed.
(3) repealed.
(4) repealed.
Article 7. References to standards in technical regulations (1) technical regulations transposing the harmonisation of legislation of the European Union refer to the Moldovan standards by adopting at the national level, the harmonised standards whose references have been published in the official journal of the European Union. They confer a presumption of conformity with the essential requirements laid down in the respective technical regulations.
(2) the Moldovan standards titles and Phrases by which it adopted the harmonized standards shall be published in the Official Gazette of the Republic of Moldova, and the standards are made available by the national standardization body according to law nr. 20 of March 4, 2016 with respect to national standardization.
(3) where there are Moldovan standards by adopting, at national, European and international standards, or conforming to the objectives of elaboration of technical regulations for groups of products in areas for which there is legislation on the harmonisation of European Union regulatory authorities, while respecting the copyright of the national body for Standardization, use these standards in the elaboration of appropriate technical regulations by inserting : a direct reference to standards) in the text of technical regulations to show that the only way to satisfy some conditions of technical regulation is to be in accordance with the standards to which reference is made;
b indirect references to standards) in the text of technical regulations to show that one of the means to satisfy some conditions of technical regulation is to be in accordance with the standards to which reference is made.
(4) compliance with the provisions of the standard to which reference is made in the regulation presumes conformity with technical requirements laid down in the respective technical regulation.
(5) the specialized central body of public administration in charge of the quality infrastructure provides the necessary budgetary funding for international and European standards, as Moldovan standards, including standards concerning test methods and sampling methods, applicable to conformity assessment procedures required for the implementation of appropriate technical regulations and for market surveillance.
Article 8. Conformity assessment procedures as part of the technical regulations (1) the conformity assessment of the products is carried out through the respective procedures for assessment, which represents the modules or other forms (schemes) on conformity assessment.
(2) the conformity assessment Procedures provided for in technical regulations, depend on the degree of complexity of the product in question and the risk that may arise from its use.
(21)-repealed.
3. the regulatory authorities shall lay down the rules for the technical phase of the project and/or for the production phase, prior to the placing on the market of products, possibilities for the use of conformity assessment procedures, which will ensure the required level of security of the products in question and the objective technical regulation.
(4) The technical rules to be established: a) for one and the same or product group-one or several conformity assessment procedures, which are identical as the supporting level, which would allow the applicant to choose the most suitable procedure for ensuring safety requirements;
b) criteria according to which the manufacturer may choose for their own products the most appropriate conformity assessment procedures, provided for by law;
(c)) usable test methods in the conformity assessment process.
(5) the conformity assessment Procedures must not be excessive in relation to the objectives of the technical regulation, referred to in art. "". (1) where a technical regulation shall be drawn up on the basis of the harmonization of the laws of the European Union, the regulatory authority shall be obliged, in the process of elaboration, to establish procedures for assessing the conformity which shall not be more restrictive than those laid down by Community law.
(6) repealed.
(61)-repealed.
(7) in the absence of standards, the regulatory authorities shall lay down in detail the requirements for the placing on the market and/or making available products on the market, including test methods and sampling methods, necessary for the implementation of technical regulations in the areas for which there is legislation of European Union harmonization and conformity assessment.
Article 9. The application of technical regulations, conformity assessment procedures and standards for domestic products and imported (1) National Technical Regulations, national procedures for conformity assessment and standards apply in Moldovan the same way for both domestic products and those for import.
(2) where the regulator is heeded, by an interested party, that a national technical regulation which was adopted by it is used or could be used as a technical barrier to trade, the authority must take emergency measures to prevent such use. Such measures relate to: (a) in case interpretation) if necessary, the technical regulation in question;
(b) publication of an official's comment), with the argumentation of the mode and the conditions of application of the restrictions established by the respective technical regulation shall, for the purpose of elimination of technical barriers to trade.
(3) repealed.
(4) If a product falls within the scope of several technical regulations, placing and making available on the market thereof shall take place only if the product complies with all technical regulations applicable to it.
(5) General technical regulations apply to products not limited itself to an exhaustive list thereof and shall, as a rule, requirements relating to the prevention of one or more risks characteristic of all products to which the rules in question apply to them.
(6) specific technical Regulations establish requirements for products or groups of products, the provisions of the General technical regulation concretizînd if it exists. The technical specific rulemaking will ensure compliance with the General safety requirement.
(7) where a product or group of products are applicable to them both general technical regulations, as well as specific technical regulations apply to specific technical regulations.
Article 10. The recognition of equivalence of technical regulations with those of other countries (1) national technical regulations of other members of the World Trade Organization or States with which the Republic of Moldova has agreements in question shall be regarded as equivalent to national technical rules where: (a) do not contravene the provisions of the legislation) of the Republic of Moldova;
b) contribute in the same way, to the achievement of the objectives of national technical regulations.
(2) the recognition of equivalence of technical regulations of other States with the competence of national regulatory authorities in the areas concerned.
(3) the procedure for taking charge of the technical regulations of other States, which are considered equivalent, is determined by the regulatory authority of the domain in question.
(4) In the case of products for which import is requested a confirmation of their compliance with technical regulations or standards, the results of the checks and tests carried out by the conformity assessment bodies of the exporting country are recognized and applied in the Republic of Moldova in accordance with the mutual recognition agreements concluded with that State.
Chapter IIIASIGURAREA of INFORMATION in the FIELD of TRANSPARENCY of TECHNICAL REGULATION in article 11. Notification and information centre of the World Trade Organization (1) in the Republic of Moldova information source in the field of technical barriers to trade is the notification and Information Centre of the World Trade Organization (hereinafter referred to as the Centre). The Centre carries out its activities in accordance with the agreements and procedures adopted in the framework of the World Trade Organization and its regulation approved by the Government, and, at the request of the parties concerned, provide information on: (a) technical standards) regulations or other regulations adopted or being prepared in the Republic of Moldova;
b) conformity assessment procedures, applied or planned for implementation in the Republic of Moldova;
c) and participation of regulatory authorities from international or regional organisations, as well as concerning bilateral and multilateral agreements in the areas concerned, already concluded or in the phase of negotiation;
d) publication of the notifications referred to in article 5 paragraph 1. (2) and (3).
(2) specialized central body of public administration in charge of relations with the World Trade Organization ensures the functioning of the Centre.
(3) the funds necessary for the support of the Centre's activity are provided from the State budget. Article 12. -repealed.
Chapter IV TASKS of REGULATORY AUTHORITIES by article 13. Powers of the regulatory authorities for the development and enforcement of technical regulations, regulatory authorities shall have the following powers: (a) international standards) used European and Moldovan in the elaboration of technical regulations by inserting references into the article. 7;
b) co-ordinates technical regulations developed with the specialized central body of public administration in charge of the quality infrastructure;
(c)) shall, subject to approval and updates the list of Moldovan standards by adopting harmonized standards for technical regulations transposing the harmonisation of legislation of the European Union;
d) presented for endorsement to the national body for standardization list of Moldovan standards by adopting harmonized standards;
e) requires national standardization body drafting the official version in the national language Moldovan standards by which international standards have been adopted, or in original version and intend to make reference in technical regulations;
f) published in the Official Gazette of the Republic of Moldova Moldovan standards list which presumes conformity with requirements of technical regulations;
g) participates as an observer in the process of accreditation of conformity assessment bodies to be or are recognized;
h) recognize, for the purpose of notification, the conformity assessment bodies accredited to operate in the area covered;
I respond to the request) by any State member of the World Trade Organization on the need for the adoption of a technical regulation which do not comply with the provisions of international or European standards, in the form of notifications through the Centre, in one of the working languages of the World Trade Organization (English, French or Spanish).
Article 14. Cooperation between regulatory authorities in the elaboration of technical regulations, regulatory authorities shall cooperate as follows: (a)) requires information Center technical regulations, conformity assessment procedures and standards relating to membership of international organizations participating in the times or the European standards, and on bilateral and multilateral agreements in the field of standardisation and conformity assessment;
b) participate in the elaboration of technical regulations initiated by other regulatory authorities;
c) calls to each other information on technical regulations and conformity assessment procedures.
Article 15. -repealed.
Chapter V chapter VI-repealed-repealed by Chapter VIIDISPOZIŢII FINAL and TRANSITORY Article 22 this Act comes into force more than six months from the date of publication.
Article 23 up to bringing the legislation into line with the present law, laws and other normative acts in force shall apply insofar as they do not contravene this law.
Article 24 the Government within 18 months of the date of publication of the present law:-will bring its normative acts in compliance with this law;
-approve the list of areas covered under art. "". (6) of this law;
-approve the procedures of conformity assessment pursuant to article 8 paragraph 3. (1) of this Act;
-on the basis of this law, shall adopt the necessary normative acts and other documents that will ensure regulatory technique and application of voluntary standards, as well as market surveillance.
Article 25
Date of entry into force of this law shall be repealed law No. 866-XIV of 10 March 2000 on technical barriers to trade (Official Gazette of the Republic of Moldova, 2000, no. 65-67, 462), article 19 of law No. 186-XV of 24 April 2003 on the evaluation of the conformity of products (Official Gazette of the Republic of Moldova, 2003, nr. 141-145, 564) and article II of law No 72-XV of 5 May 2005 for the modification and completion of the law # 590-XIII of 22 September 1995 on the standardization and the law No. 866-XIV of 10 March 2000 on technical barriers to trade (Official Gazette of the Republic of Moldova, 2005, no. 92-94, art. 433).
