Recent serialisation legislation movements – Part 2

Recent serialisation legislation movements – Part 2

It’s been a long time since I did an update on serialisation legislation activity, so last week I did part one and this week is part two of a summary of some of the main things that are happening. If you want to know more details then just drop me an email.


  • Requirements published which are fully aligned with global standards.
    • 1st July 2018: 2d with GTIN, Lot and Expiry.
    • 1st July 2020: addition of serial number.
  • JFDA want everything in scope, i.e. samples, tenders, named patients – this is clearly causing concern.
  • No news on data exchange requirements.


  • The local manufacturers appear to be working to get rid of the holographic label and move to more global serialisation standards.


  • Work is under way to define a global standards based serialisation requirement to follow up on the current SMS messaging system used in the country.


  • New legislation drafted for Tenders.
    • 1st January 2017 serialisation deadline.
    • Pharma and medical devices at present.
    • Based on the Saudi Arabia legislation, but originating from the central purchasing organisation rather than the MoH, and is aimed at helping product flow.
    • A circular was sent to many companies, but the MoH only got two responses stating they would have issues complying.


  • No dates set yet for their new requirements being published, but expected soon.


  • New serialisation regulation in draft with very short timelines, e.g. Jan 2017.


  • Regulation still being finalised, no recent new Concept Paper has been published.
    • Microchip (RFID?) being rumoured.
    • QR codes rumoured to be being considered.
    • Pilots being discussed for the first half of 2017 – an email has been issued naming a number of companies that are apparently going to be involved, although without clear understanding of the objectives and scope of the pilot, there is some concern.
    • January 2017 still believed to be the date for the first group of products.
  • The MoH was leading this initiative, but it has switched to the Ministry of Finance and Taxes, who are already implementing some very strict rules on other products.

Saudi Arabia

  • New Decree was circulated which ratified older requirements.
    • Packaging size/quantity dropped.
    • New Saudi drug code requirement dropped.
  • Scope clarified.
    • All marketed product including tenders in scope.
    • Samples and named patient products out of scope.
  • Stakeholder group formed to work on reporting standards.
  • No news on reporting requirements yet, except for verbal assurances from government representatives that it will be easy.
    • The Saudi authorities have visited Turkey several times, so it is not unlikely that their solution will be similar.
  • Track and trace with aggregation is on the way in a 3rd wave.
    • SFDA reported at a recent conference that they were building the database.
  • There are some apparently conflicting requirements between the serialisation legislation requirements and the Saudi customs and import regulations:
    • SFDA are not specific about where product is serialised.
    • Customs authority seem to require product to come directly from the manufacturing origination source.


  • Requirements being drafted, some publication expected imminently.
  • 1st July 2017 to 1st Jan 2018 have been stated as deadlines in various conflicting communications.


  • Intend to move from recommendations to regulation.
    • 2d for traceability.
    • QR code for traceability – concern that this will cause confusion.
  • GS1 attempt to start a pilot to demonstrate requirements could be met with global standards did not get off the ground, unfortunately.


  • FDA pilot scoping workshop held, but pilot scope not yet clear.
  • Growing support for EPCIS 1.1 standards to be used, as supported by the likes of McKesson.
  • Big wholesalers published requirements which effectively bring deadlines forward.

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