UNITED NATION ECONOMIC COMMISSION FOR EUROPE First meeting of regulators from South East European countries

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UNITED NATIONECONOMIC COMMISSION FOR
EUROPEFirst meeting of regulators from South
East European countries

• Technical regulation
• in the Republic of Moldova
• Aurelia Alexandrova, Deputy Heard of
  General
• Standardization Division,
• Department of Standards
• and Metrology
• Ljubljana
• 8 June 2004

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• Oficial dates
• about Republic of Moldova
• Oficial name Republic of Moldova
• Population 4228,9 thousand
• Capital Chisinau, over 750 thousand
• Political system The President,
• Government, Parliament

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Moldavian Trade Volume with Balkan Countries
4
Moldavian Export-Import in Albania

• Export

Import
5
Moldavian Export-Import in Bulgaria
Export
6
Moldavian Export-Import in Bulgaria
Import
7
Moldavian Export-Import in Bosnia and Herzegovina

• Export Import

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Moldavian Export - Import in Croatia

• Export Import

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Moldavian Export-Import in FYR of Macedonia

Export Import
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Moldavian Export-Import in Serbia and Montenegro
Export Import
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Moldavian Export Import in Romania
Export
12
Moldavian Export Import in Romania
Moldavian Export Import in Romania
Export
13
Moldavian Export Import in Romania
Import
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Moldavian Export-Import in Slovenia
Export Import
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Restrictions of Trade between Moldova and South
East Europe Countries

• The following trade barriers are known
• A high level of competitiveness on the world
  market
• Sanitary, fitosanitary and ecological
  restrictions
• Strict observance of packaging standards
• Appliance of old technological processes and
  standards by Moldavian companies, which prevents
  them from producing goods that would meet the
  requirements of the market
• High requirements to the quality of products
• The fact that Moldova is not famous on the world
  market
• Lack of trade delegations for promoting the image
  of the country and informing producers about
  conditions of access to the markets of countries
• Low purchasing capacity of Moldavian population
• Not corresponding of national standardization
  systems and conformity assessment system
  international requirements
• Cultural, linguistic and demographic conditions

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Factors, Which Have Defined Priorities of Moldova
in Field of Technical Regulation

• 1. Moldova is member of WTO (on May, 8 2001, in
  Geneva it was signed the report on the
  introduction of Republic Moldova in WTO).
• 2. Orientation of Moldova for integration in EU
  (It is signed the report between the Republic of
  Moldova and EU about partnership and
  co-operation).
• 3. Necessity of promotion of Moldavian export in
  EU and Central and the East Europe countries.
• 4. Maintenance of Moldavian export markets
  in NIS countries.
• 5. Protection of Moldavian market from the
  inappropriate production imported in Republic
  Moldova.

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Stakeholders in Technical Legislation

• Quality infrastructure

• National Standardization System
• National Standardization Body
• Technical Committees
• Standardization services.
• National Metrology System
• -National Metrology Body
• -Metrology services.
• National System of Conformity
• Assessment of products
• -National Body of Conformity Assessment of
• products
• Conformity assessment bodies (26 Body of
• certification products 2 Body of Services
  certification
• 2 Body of certification of Quality
• Managements Systems 2 Inspection Body
• 156 Test laboratories).
• Accreditation System.

Ministries (legislator), Responsible for
development of technical regulations
Market surveillance
Industry and trade
Consumers
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Legal and Normative Framework in Moldova for
Technical Regulation Development

• Law on Standardization
• Establishes legal, social, economic and
  organizational basis of standardization, is
  stated the term technical regulation and period
  for transition to the voluntary application of
  standards.
• Law on Technical Barriers to Trade
• Establishes juridical bases for elimination of
  technical barriers to trade during the process of
  the development, adoption and application of
  technical regulations, standards and conformity
  assessment procedures and notification
  obligations during development of technical
  regulation and procedures of an estimation of
  conformity .
• Law on Products Conformity Assessment
• Establishes requirements to structure of
  technical regulation, introduction of the modular
  approach for the varies phases of the conformity
  assessment procedures and minimal requirements to
  notifies bodies for work in regulated area.

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Legal and Normative Framework in Moldova for
Technical Regulation Development

• The Government Decision on Transition to the
  Voluntary Standardization
• Establishes central authorities
  (ministries, departments and agencies),
  responsible for development of technical
  regulations in specific areas. Department of
  Standardization and Metrology coordinates the
  activity related to technical regulation
  development.
• Mandatory standards of National Standardization
  System
• Moldavian Standard SM 1-13 Principals and
  methodology of standardization. Technical
  regulation. General principles
• Establishes the general principles of technical
  regulation development, requirements for the
  basic structural elements of technical
  regulation, the responsibility during
  development.
• Moldavian Standard SM 1-17 Principals and
  methodology of standardization. Rules and
  procedures of notifications preparation in
  conformity with Agreement on Technical Barriers
  to trade
• It is developed according to Recommendations of
  World Trade Organization notification
  requirements.

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Rules for the National Adoption of ISO, IEC, EN
Standards and of National Standards of the Other
States as Moldavian National Standards

• Mandatory standards of National Standardization
  System
• Moldavian Standard SM 1-12 Principals and
  methodology of standardization. Adoption of
  international standards in Moldavian standards
  (according to Guide ISO/IEC 211999)
• Moldavian Standard SM 1-20 Principals and
  methodology of standardization. Order of
  application of other states normative documents
  in Republic Moldova
• Moldavian Standard SM 1-21 Principals and
  methodology of standardization. Adoption of
  European standards in Moldavian standards

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The Responsibility During Development of
Technical Regulation

• Role of Ministries
• Development of technical regulation
• Implementation of EU Directives
• Export promoting
• Withdrawal conflicting regulation
• Implementation of standards
• Technical regulations-referred standards
• Role of Department of Standardization and
  Metrology
• Coordination the activity of technical regulation
  development
• Standardization development Technical work
• Affiliation to ISO membership

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Technical Regulation in Moldova

• In the Republic of Moldova the following
• are considered as technical regulations
• Legislations acts, Decrees of the President and
  Decision of the Government, containing
• requirements for products
• Normative acts of public authorities, in whose
  competence is establishing mandatory requirements
  for products
• Medical standards, medical and biological
  requirements, sanitary norms, sanitary and
  hygienic norms and rules
• Norms and rules in construction field
• Norms and rules in field of environment, energy,
  transport, and telecommunication
• Norms and rules in field of industrial security
•  Norms and rules in field of labour safety
• Other documents with mandatory technical
  requirements in respective field.

• Technical regulation objects to which obligatory
  demands can be applied
• Products
• Processes of production
• Operations
• Storage
• Transportation
• Marketing
• Utilization

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National Program on Technical Regulation
Development (over 74 technical regulations)
Horizontal technical regulations

General product safety (Directive 2001/95/EC)
Liability for detective product (Directive
85/374/EEC)

• The priority of technical regulations
• Safety of main group of food staff
• Safety of main group of industrial products
• Sanitary veterinary norms for milk and
• meat products
• Safety on tobacco and tobacco articles
• Norms and rules in transport field
• Safety of pharmaceutical products
• Safety of cosmetic products
• Safety of textile
• Labelling of food and industrial products
• Packing

Modules for the various Phases of the
conformity Assessment procedures (Directive
85/374/EEC)
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Main Problems Impeding Regulatory Work on
National and Regional Level

• 1. Insufficient experience in development of
  technical regulations which transposes EU
  Directives.
• 2. Insufficient experience in identifying the
  essential requirements (There is a necessity of
  experts, which would be able to specify
  requirements for each group of products. But it
  is also important the knowledge of
  standardization bases, the knowledge of
  conformity assessment for each group of products,
  knowledge of horizontal technical regulations) .
• 3. The necessity to improve the Conformity
  Assessment System of Products (its necessary to
  apply conformity assessment procedures based on
  modular approach, the technical regulation body
  must develop technical regulations for groups of
  products, which would set essential requirements,
  procedures of conformity assessment and market
  surveillance. Conformity Assessment bodies must
  switch to the conformity assessment procedures,
  which are established in technical regulation).
  These and other problems in Moldova will be
  realized on the basis of the Law on Products
  Conformity Assessment, which was applied in
  January, 2004 and now replaces the Law on
  Certification which was in force.
• 4. The language barriers in applying
  International and European standards, as well as
  European directives.