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New regulatory package

New regulatory package. October 2008 Author Steinlová Kvetoslava MARS 2.10.2008. NARIADENIE EURÓPSKEHO PARLAMENTU A RADY (ES) č. 764/2008

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New regulatory package

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  1. New regulatory package October 2008 Author Steinlová Kvetoslava MARS 2.10.2008

  2. NARIADENIE EURÓPSKEHO PARLAMENTU A RADY (ES) č. 764/2008 ktorým sa ustanovujú postupy týkajúce sa uplatňovania určitých vnútroštátnych technických pravidiel na výrobky, ktoré sú v súlade s právnymi predpismi uvedené na trh v inom členskom štáte, a ktorým sa zrušuje rozhodnutie č. 3052/95/ES NARIADENIE EURÓPSKEHO PARLAMENTU A RADY (ES) č. 765/2008 ktorým sa stanovujú požiadavky akreditácie a dohľadu nad trhom v súvislosti s uvádzaním výrobkov na trh a ktorým sa zrušuje nariadenie (EHS) č. 339/93 ROZHODNUTIE EURÓPSKEHO PARLAMENTU A RADY č. 768/2008/ES o spoločnom rámci na uvádzanie výrobkov na trh a o zrušení rozhodnutia Published 9. July 2008 Journal Official of the EU

  3. Scope: • Non harmonized area • Articles 28 -30 of the Treaty • Non applicable for measures adopted under: • Article 8.1 letter d) to f) and Article 8.3 GPSD - 2001/95/EC; • Article 50.3 letter a) and Article 54 of the EC Regulation No. 178/2002; • Article 54. of the EC Regulation No.882/2004 • Article 14 of the Directive 2004/49/EC Regulation of EP and Council 764/2008: Mutual Recognition Regulation

  4. Mutual Recognition concerns also accreditation • Need for notification channel • Need to differentiate what should be notified under this scope and what is under other Communities notification tools • One-stop-shops? • . Common application tools Regulation of EP and Council 764/2008: Mutual Recognition Regulation

  5. Accreditation - without Market Surveillance – harmonized area Lex specialis under Article 2.2 – Regulation is not applicable if there is a lex specialis Complimentarily to the GPSD Limits for theScope of application Regulation of EP and Council 765/2008 Accreditation and Market Surveillance

  6. ICSMS ? • RAPEX extension? • Sharing test results? • Market surveillance programmes • Notification obligations Supporting tools Regulation of EP and Council 765/2008 Accreditation and Market Surveillance

  7. transfer know how • Training • Joint programmes? • Co-operation with 3rd countries • Financial support also for ADCO and „safeguard clause“ Sharing resources and co-operation Regulation of EP and Council 765/2008 Accreditation and Market Surveillance

  8. Open Question Related to the notification Regulation of EP and Council 765/2008 Accreditation and Market Surveillance

  9. Thank you for your attention

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