Recent serialisation legislation movements – Part 1

Recent serialisation legislation movements – Part 1

It’s been a long time since I did an update on serialisation legislation activity, so over the next two weeks I will give you a summary of some of the main things that are happening. If you want to know more details then just drop me an email.


  • Draft regulations under development.
  • Decree expected imminently.
  • Thought to be considering serialised sticker model with price on it, which is clearly causing concern.


  • The existing serialisation law RDC54 still stands, so there is a risk that come the end of 2016, all product will need to be serialised.
    • Many companies have reported that they have stopped activity at present.
  • However, a new draft law PLS 276/2015 has been approved by the Senate and is due to go to public consultation from ANVISA shortly with an expected publishing in September. This should nullify RDC54.
    • Scope of products up to ANVISA, so hope that can remove samples and OTC products which were in RDC54.
  • Proposed timelines: Pilot for 3 batches in 1 year, then approximately a year’s consideration and publishing final requirements, then 3 years to enforcement.
  • The new draft law is still under evolution, but appears to have a number of positive points over the existing law, e.g.
    • Manufacturers will not be responsible for data collection down the supply chain.
    • Serial numbers will be unique to GTIN, not MAH.
    • Serial numbers will up to 20 digit alphanumeric.


  • Issued a suspension letter for the current requirements, stating they wish to change the drug tracing system.
  • Responses have been fed back to the new China proposals.
  • Scope of new proposals includes Medical Devices and Food Safety.


  • The Egypt MoH have signed an implementation plan for serialisation that will be published soon.
  • Timelines appear to be:
    • 1st July 2016: 17 master data fields for all products need to be provided to GS1 Egypt, who are coordinating the maintenance of that data in the national product master database for a small annual fee.
      • GS1 Egypt are also managing the taking of photographs of product secondary packs, which is also a master data requirement.
    • 1st September: GLNs required.
    • 1st July 2018: GTIN, Lot & Expiry.
    • 1st July 2019: Serialisation.


  • Considering serialisation and holding a workshop in July.


  • FMD Delegate Act published, setting deadline at February 2019.
  • National system moving forward as soon as possible.


  • Exemptions for export products are coming through from the Indian authorities, but as per the law are only for secondary packs, one tertiary level must have an SSCC.
  • Product images required for master data.
  • Single database being used/developed for the Export and emerging domestic market legislation which is causing issues.
    • An Industry / Ministry working group is being established to handle issues.


  • A draft serialisation legislation is currently out for public review until the 24th June.
    • Non-biologics deadline proposed of 2021 for serialisation.

More to follow next week.

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