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Review of changes in pharmaceutical legislation by Golaw

31/ 01/ 2018
  WHAT’S NEW: TYPICAL VIOLATIONS DETECTED BY STATE SERVICE ON MEDICINES AND DRUGS CONTROL Background State Service on Medicines and Drugs Control (the Service) after obtainment of authorities of market supervision over medical devices that were grated by the decree of Cabinet of Ministers of Ukraine On approval of the list of types of products in respect of which bodies of state market supervision carry out state market supervision dated December 28, 2016 No. 1069 started to carry out audits of the producers and distributors of medical products. Notwithstanding that such audits have been carried out only for last 11 months it became possible to detect to which violations the Service pays attention the most. Principal breaches that were revealed by the Service: Products marked with identification number of conformity assessing body on medical devices in a “short” format (YYY), without indication of UA.TR. The Service insisted, that the “full” format (UA.TR.YYY) of identification number must be indicated. Non-indication of sign of conformity with technical regulations and instructions of use of medical products. Sign of conformity with technical regulations does not comply with requirements of the decree of Cabinet of Ministers of Ukraine 1184 dated December 30, 2015. Absence of instructions for use in Ukrainian. Absence of identification number of conformity assessing body on medical devices. Absence of necessary information for consumers for their accurate identification of the product and packaging content. Absence of information about the name and location of the Authorized Representative on the outer packaging of medical product. Absence of Declaration of conformity of medical product. Information indicated in Declaration of conformity and on the packaging is different.   REQUIREMENTS FOR INDICATION OF THE IDENTIFICATION NUMBER OF CONFORMITY ASSESSING BODY WERE SPECIFIED The Decree of Cabinet of Ministers of Ukraine No. 1027 dated December 20, 2017 came into force on January 04, 2018. According to the aforementioned Decree the conformity sign must be accompanied with the identification number of the assigned conformity assessment body, if such an body has been involved at the control stage of production, in the format UA.TR.YYY or YYY, where: UA – identification mark of Ukraine in Latin letters; TR – identification mark which means that the conformity assessment body is appointed to carry out works of conformity assessment to the requirements of technical regulations; YYY – identification mark of the assigned conformity assessment body. The identification number of the assigned conformity assessment body must be indicated by such body or by the manufacturer or an authorized representative.

WHAT’S NEW: TYPICAL VIOLATIONS DETECTED BY STATE SERVICE ON MEDICINES AND DRUGS CONTROL

Background

State Service on Medicines and Drugs Control (the Service) after obtainment of authorities of market supervision over medical devices that were grated by the decree of Cabinet of Ministers of Ukraine “On approval of the list of types of products in respect of which bodies of state market supervision carry out state market supervision” dated December 28, 2016 No. 1069 started to carry out audits of the producers and distributors of medical products.

Notwithstanding that such audits have been carried out only for last 11 months it became possible to detect to which violations the Service pays attention the most.

Principal breaches that were revealed by the Service:

  • Products marked with identification number of conformity assessing body on medical devices in a “short” format (YYY), without indication of UA.TR. The Service insisted, that the “full” format (UA.TR.YYY) of identification number must be indicated.
  • Non-indication of sign of conformity with technical regulations and instructions of use of medical products.
  • Sign of conformity with technical regulations does not comply with requirements of the decree of Cabinet of Ministers of Ukraine 1184 dated December 30, 2015.
  • Absence of instructions for use in Ukrainian.
  • Absence of identification number of conformity assessing body on medical devices.
  • Absence of necessary information for consumers for their accurate identification of the product and packaging content.
  • Absence of information about the name and location of the Authorized Representative on the outer packaging of medical product.
  • Absence of Declaration of conformity of medical product.
  • Information indicated in Declaration of conformity and on the packaging is different.

 

REQUIREMENTS FOR INDICATION OF THE IDENTIFICATION NUMBER OF CONFORMITY ASSESSING BODY WERE SPECIFIED

The Decree of Cabinet of Ministers of Ukraine No. 1027 dated December 20, 2017 came into force on January 04, 2018.

According to the aforementioned Decree the conformity sign must be accompanied with the identification number of the assigned conformity assessment body, if such an body has been involved at the control stage of production, in the format UA.TR.YYY or YYY, where:

UA – identification mark of Ukraine in Latin letters;

TR – identification mark which means that the conformity assessment body is appointed to carry out works of conformity assessment to the requirements of technical regulations;

YYY – identification mark of the assigned conformity assessment body.

The identification number of the assigned conformity assessment body must be indicated by such body or by the manufacturer or an authorized representative.

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