Global Pharma Serialisation Legislation Developments Roundup: Part 3

Global Pharma Serialisation Legislation Developments Roundup: Part 3

This the final instalment of a 3-part update on serialisation legislation developments since my last update in mid-2016. You can read Part 1 here and Part 2 here.

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Qatar

  • Hamad Medical Corporation (HMC) have published requirements for batch variable coding of product moving through their warehouse.
  • A barcode label containing the purchase order reference (400) is also required on shipments to HMC.
    • This needs to be done at point of shipment dispatch, which for some manufacturers, may be outside of Qatar
  • Requirements not GS1 compliant at present, so work is going on locally to try to bring the requirements in line with other GCC member states.
  • Serialisation implementation dates are not yet published, but it is hoped that they will align with other GCC countries.

Russia

  • A Decree published in late 2016 lays out the requirements for a complex track and trace system, including aggregation.
  • The scope of the legislation includes Rx and OTC products.
  • Full serialisation of all products is required by the end of 2018.
  • An interview with the Prime Minister emphasised his views that this legislation was key to public safety.
  • A decree was published at the end of January laying out the requirements of the pilot, which will run in 2017.

Saudi Arabia

  • See my previous update for more details on the requirements.
  • Whilst aggregation is not required in the law, it may be necessary for the supply chain to meet the event-reporting requirements throughout the supply chain.
    • A local poll recently indicated that only a few companies are planning initial aggregation.
  • It has been confirmed that a list of serial numbers does not need to be included with delivery shipment paperwork.

South Korea

  • Reporting of serialisation information started in July 2017, although there was a grace period to the end of 2016 during which non-compliant companies would not be penalised.
    • Reporting is required, at the latest, the day after the transaction occurs.
  • Aggregation is voluntary in the law, however, a significant number of manufacturers are aggregating to make the reporting requirements in the supply chain practical.
  • The South Korean authorities seem to be stepping back from RFID, which is good news.
  • The reporting system requirements are expected imminently.

Turkey

  • The comprehensive serialised track and trace system in Turkey continues to operate.
  • The Turkish authorities have been visited or invited to key events of a number of other nations developing serialisation, e.g. Saudi Arabia, so we can expect similar requirements emerging elsewhere.

Taiwan / Chinese Taipei

  • Draft legislation has been published for comment.
  • Complex pack marking and serialisation model affecting primary, secondary and tertiary pack marking and comprehensive reporting.
  • Six-stage phased implementation, including:
    • 1st January 2019: Serialisation of a list of high priority products.
    • 1st January 2010: Serialisation of all prescription drugs.
    • 1st January 2021: Serialisation of sales packs of all active pharmaceutical ingredient packs.

Tunisia

  • The Tunisia health authority are developing requirements.

UAE

  • The Dubai Health Authority have published requirements for a GS1 Datamatrix to be applied to all secondary packs sold to DHA(?) by 1st January 2017 containing batch variable data. They are no longer accepting unmarked product.
  • The three other health authorities in the UAE have yet to publish their requirements.
  • Companies can meet this requirement, at least in the short term, by having local converters apply appropriately marked stickers, although issues with the quality of these stickers have caused the HDA to require an additional barcode verification report to be sent with each shipment.

US DSCSA

  • The November 2017 deadline for serialising all product is approaching fast. Worryingly, there still seems to be a large proportion of smaller Pharma companies and contract manufacturers who have not made significant progress.
  • The need to aggregate product continues to be a significant debate.
    • The FDA, in a consultation workshop in October 2016, essentially stated that they will not be legislating on this and it was up to the supply chain to define what was necessary to meet the requirements.
    • The big wholesalers are calling for aggregation.
    • A significant number of manufacturers are planning to aggregate US product from day one.
    • Other manufacturers, in particular the generic companies, are not planning to aggregate and, in the case of the generic manufacturers, are pushing to never have too aggregate.
  • The HMA (wholesalers organisation) ran pilots in 2016, with one of the areas of focus being how they will be able to meet their 2019 requirements to authenticate product returned to them for sale. They concluded that two options are practical and pilots will run in 2017 to investigate them. The two models are:
    • Manufacturers reporting serialisation information to the wholesalers when product is shipped to them. This effectively moves much of the 2023 requirement on manufacturers forward to 2018/9.
    • The establishment of information exchange hub(s) to allow wholesalers to “ask” for real time authentication of packs they are holding. Like the EU hub, this system would have the advantage that each company only needs to connect to one system. However, there is a long way to go before such a system becomes real.
  • I wonder what, if any, impact President Trump’s desire for reduced regulation on industry will have on the DSCSA in the long term.
If you would like to discuss your particular situation with regard to aggregation, or other aspects of serialization, please do not hesitate to contact me at Stephen.McIndoe@be4ward.com

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