New Global Pharma Serialisation Legislation Developments Roundup – Part 1

New Global Pharma Serialisation Legislation Developments Roundup – Part 1

This is the first of a 3-part update on serialisation legislation developments since my last update in mid-2016.

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Argentina

  • ANIMAT published a new regulation in September 2017 which increases the scope of products covered by the traceability requirements, including all new drugs that are registered in Argentina

Australia

  • Serialisation requirements are in place for blood products
  • New medicine labelling guidelines have been issued for Rx and OTC products which come in to effect in September 2020
    • This is a batch variable requirement only, with no serialisation

Algeria

  • No further update since my last summary in mid-2016

Brazil

  • Late in 2016, ANVISA finally officially withdrew their 2016 pilot requirements
  • A new track and trace law 13410 was signed by the President in December 2016, which also gave ANVISA the power to define the product scope of the legislation
    • In public presentations in late 2016, ANVISA seemed to be suggesting that they would exclude the likes of OTC, vaccine, parenteral products and Samples when the new RDC is published
    • The effective date of the law is 29 December 2016. This sets the dates for the implementation milestones
  • The model will be full track and trace, with a government run central database and extensive reporting requirements for supply chain participants
  • ANVISA are currently developing the revised RDC54, which will contain the details of the new system
    • The document is expected to be released for public comment in the late March timeframe
    • Pack marking and the number of data elements contained in barcodes will be defined in the RDC
  • As before, a Pilot is required and a cross-stakeholder pilot committee was approved recently
  • A service bulletin is expected shortly, which should lay out the scope and participants of the pilot

China

  • As I previously reported, in February 2016, the Electronic Drug Monitoring System (EDMS) was suspended pending new regulations which, it is hoped, will align with international standards. In the meantime, GS1 are preparing a position paper on the migration from the current system to international standards
  • The CFDA issued new Good Supply Practice for Pharmaceutical Product guidelines in July 2016, that also calls for the building of track and trace systems for pharma product
  • In September 2016, the CFDA published opinions that further reinforced their view that manufacturers should uniquely identify individual product packs.
  • In January 2017, the CFDA issued a new notice advising that the Chinese National Drug Code, which has been in use since 2009 for the likes of product approvals, is to be used for pack marking and traceability in future
  • Ali Health are ceasing support of their EDMS portal in March, although it appears it will still be possible to download serial numbers for use on product. Ali Health appear to be trying to encourage use of a newer system they are providing
  • A working group has been set up in China to make recommendations on the replacement track and trace system in China

Egypt

  • Requirements for marking of secondary packs in two phases were published in January 2016. The initial phase was for batch variable marking, then for the addition of serialisation
  • Final phasing and timing requirements have not yet been published by the local committee tasked with defining this in the law
  • There are no clear reporting requirements at this time
  • GS1 Egypt is contracting with organizations to manage the master data for the new government system

Ethiopia

  • No further update since my last summary in mid-2016

EU FMD

  • The deadline of February 2019 to serialise product still stands
  • The use of GTIN, NTIN and NHRN codes by the different member states continues to play out. The main issue here is that it is not possible to have an NTIN and a GTIN on the same pack. Therefore, there will be implications on the ability for companies to use multi-market packs for some combinations of countries.
  • An updated version of the EU Hub is due to be released imminently
  • Member states are continuing to select their National Systems which will connect to the EU Hub and provide local product authentication

GCC Countries

  • Apart from those GCC countries I mention specifically, I understand that the likes of Bahrain and Kuwait will follow the lead of the larger countries. Qatar has already done so.
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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