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MS-activities in Bulgaria Svetlozar TOLEV DG”Market surveillance”- SAMTS

MS-activities in Bulgaria Svetlozar TOLEV DG”Market surveillance”- SAMTS UNECE “MARS” Group meeting 24 – 26 September 2006 Bratislava, Slovakia. MARKET SURVEILLANCE AUTHORITIES. FOODSTAFFS Ministry of Health Ministry of Agriculture and Forestry PHARMACEUTICALS Ministry of Health

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MS-activities in Bulgaria Svetlozar TOLEV DG”Market surveillance”- SAMTS

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  1. MS-activities in Bulgaria Svetlozar TOLEV DG”Market surveillance”- SAMTS UNECE “MARS” Group meeting 24 – 26 September 2006 Bratislava, Slovakia

  2. MARKET SURVEILLANCE AUTHORITIES • FOODSTAFFS Ministry of Health Ministry of Agriculture and Forestry • PHARMACEUTICALS Ministry of Health • NEW APPROACH DIRECTIVES State Agency for Metrological and Technical Surveillance(SAMTS) Ministry of Regional Development and Public Works (MRDPW) • GENERAL PRODUCT SAFETY - 2001/95/EC Commission on Consumer Protection

  3. MARKET SURVEILLANCE (New Approach) LEGISLATIVE FRAMEWORK • Law on Technical Requirements to Products (LTRP): • adopted in 1999; • amendments : first - October 2002 last - May 2005; • Ordinance on Market Surveillance: • adopted in June 2003 • amendment: October 2005

  4. New Approach market surveillance authorities According to the LTRP market surveillance is carried out for products under New Approach Directives as follows: • by SAMTS: 1. DG ”Market surveillance” (LVD, EMC, CPD, TOYS, MD, PPE, RTTE, GAD, PED – end consumers products) 2. DG ”High Risk Equipment Inspection” (high risk equipment – non end consumers product) 3. DG ”Metrological Supervision”(NAWI, MID) • by SAMTS and MRDPW - for construction products • The law on medical devices (adopted in August 2006) will regulate the market surveillance on medical devices

  5. DG ”Market surveillance”activities • Checks and monitoring according to theAnnual plan • Proactive checks of products (Thematically, Big Chains, Cheap products, etc.) • Monitoring – for new products • Campaigns (Instruction for use in Bulgarian language, Season products, etc.) • Non-scheduled checks • Notifications and complaints from citizens and institutions • Notifications received under the RAPEX • first notifications – November 2005 • Testing of samples of products

  6. DG ”Market surveillance”activities2005 - 2006 (I and II quarter)

  7. DG ”Market surveillance”activities2005 - 2006 (I and II quarter) Total number of:2005 2006 till July • Checked and monitored products 2 750 4 193 • non – compliant products 1 137 1 366 • Non-scheduled checks770 560 • Tested products 12 48 • confirmed as non – compliant11 30 (+10?)

  8. The number products: checked and monitored /non – compliant Year: 2005 2006 till July • LVD & EMC 958/254822/268 • Machinery 262 /108628/184 • Toys 498 /283543/198 • Construction products 544 /189570/280 • Gas appliances114 /29459/124 • R&TTE 48 /9352/111 • Preassure equipment & vessels246 /245103/ 55 • Personal protective equipment 56 /20 156/ 40

  9. Administrative and penal actions2005 - 2006 (I and II quarter) 2005 2006 till July Acts for administrative infringements 2974 51 • in respect of traders198336 ( 682 prod.) • in respect of importers/producers99115 ( 183 prod.) Penal acts issued 147246 Orders for temporary suspension of the distribution/use 4263 Orders for prohibition of the distribution/use of the product & withdrawalfrom the market9 26

  10. MARKET SURVEILLANCE COOPERATION • Agreementfor joint activities with the Commission on Trade and Consumer Protection • Agreementfor cooperation and joint activities in the field of construction products with the Directorate for National Construction Controlfrom the MRDPW • Common Instruction covering the regulations and procedures of interaction between the Customs authorities and SAMTS • Council for cooperation and exchange of information between market surveillance authorities

  11. Efficient and effective market surveillanceProblems • “Working” documents • Cooperation • Optimal structure (institutions) • Competent personnel (experts, inspectors, lawyers) • Appropriate Annual plan • Efficient non-scheduled checks(on the basis of notifications received) • Experts and inspectors with sound experience (max specific knowledge under particular directives) • Operative managers • Principle of ”proportionality” • Team working! • Finance • Samples/specimens testing • Standards (BDS) • IT equipment/data base/information exchange system – RAPEX • Travel expenditures • Training • ADCO, seminars, workshops • Joint activities and projects

  12. Thank you!

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