Guidelines for participants of the drug labeling pilot project were issued in Russia

| By | Drug Marking, Drug Quality Control
News, Pharmaceutical Regulatory

The Federal Service for Surveillance in Healthcare has published guidelines for participants of the pilot project on drug labeling with control (identification) signs (CIS) and monitoring of certain types of drugs for medical use.

One of the document sections outlines the requirements for equipment used for code application:

  • Within the framework of the pilot project CIS shall be applied by the subject of circulation of medicinal products onto the secondary (consumer) MP packaging and tertiary (factory, transport) packaging using printing methods, labeling, or any other techniques at the discretion of the subject of circulation of MPs without any restrictions and by means of any equipment.
  • The equipment used for the application of CIS shall be designed for the pharmaceutical manufacture and meet all the requirements of the Russian and international Good Manufacturing Practices, which shall be confirmed by appropriate documents.
  • The recommended range of individual dot-matrix characters comprising the two-dimensional DataMatrix barcode applied to the secondary (consumer) MP packaging is the 0.255 mm – 0.615mm size range of DataMatrix dot-matrix symbols.
SOURCE: gmpnews.ru
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