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.
- 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.
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.
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