Serialization Regulations

USA
  • 2D Datamatrix on packages, 2D or linear on cases by Nov. 27, 2017 (2018 for repackagers)
  • Barcodes encode: NDC, Unique SN, Lot #, expiration date
  • NDC+Serial Number “verification” by Mfr. & Repackager
  • Packaging records must be retrievable for six years
  • GS1 barcode & identifier standards will satisfy the law
  • No serial number randomization required
  • No serial numbers in exchanged data until November 2023
  • No aggregation requirement until perhaps 2023
Italy
  • 2D Datamatrix on packages, 2D or linear on cases by Nov. 27, 2017 (2018 for repackagers)
  • Barcodes encode: NDC, Unique SN, Lot #, expiration date
  • NDC+Serial Number “verification” by Mfr. & Repackager
  • Packaging records must be retrievable for six years
  • GS1 barcode & identifier standards will satisfy the law
  • No serial number randomization required
  • No serial numbers in exchanged data until November 2023
  • No aggregation requirement until perhaps 2023
EU
  • Falsified Medicines Directive effective in 2013
  • “Delegated Act” now due in 2015 to define technical specifications expected to take effect in 2018
  • Countries with existing serialization requirements (Italy) will have an additional 3 years to switch to the EU approach
  • Mfr is required to serialize at the individual pack level, encoding GTIN, unique SN, Lot # and expiration date
  • Serial numbers must be “randomized”
  • GS1 barcode and product identifier standards will comply
  • Product identifier authentication at pharmacy counter
  • Industry stakeholder data repositories
  • No aggregation required
Turkey
  • 2D Datamatrix on packages, linear GS1 SSCC on cases
  • Applied by importer or manufacturer
  • Package barcodes encode: GS1 GTIN, Unique SN, Lot #, expiration date
  • NDC+Serial Number “verification” by dispensers
  • GS1 barcode and product identifier standards comply
  • Changes of ownership must be documented in government-funded data repository via web services
  • No aggregation

http://itsportal.saglik.gov.tr/index.php?run=document&category=1&mp=28

China
  • Most drug packages and cases will be serialized by end of 2015
  • Mfr must obtain serial number codes from government service and update status
  • Serial number codes are “pre-randomized”
  • Linear barcodes containing the serial number code must be applied to all levels (except pallet)
  • Aggregation data must be supplied to government repository
  • Changes of custody must be updated in government repository
  • GS1 standards are NOT used

http://www.sda.gov.cn/WS01/CL0844/78215.html

South Korea
  • Specified list of drugs (30%) must be serialized as of January 2015, remainder by January of 2016
  • 2D Datamatrix on packages, linear GS1 SSCC on cases
  • Applied by manufacturer
  • Package barcodes encode: GS1 GTIN, Unique SN, Lot #, expiration date
  • GS1 barcode and identifier standards comply
  • Future requirements may include aggregation data and writing data to a government data repository
Brazil
  • Drugs containing specified APIs must be serialized as of 2011 and 2012 with more to be added in future years
  • Type of barcode on packages is left up to Mfr
  • Package barcodes encode: GS1 GTIN, Unique SN
  • GS1 barcode and identifier standards comply
  • No aggregation required
  • Changes of ownership must be documented and sent to a government data repository
Agentina
  • Drugs containing specified APIs must be serialized as of 2011 and 2012 with more to be added in future years
  • Type of barcode on packages is left up to Mfr
  • Package barcodes encode: GS1 GTIN, Unique SN
  • GS1 barcode and identifier standards comply
  • No aggregation required
  • Changes of ownership must be documented and sent to a government data repository

 

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