Serialization 2014-2023. Where Things Stand

April 28, 2014 6:08 am | Posted by Admin

We all know that serialization deadlines are looming.  Some of you have serialization projects well under way while others are waiting to get their projects started. Either way, you have questions that you need answers to and, according to people we are talking to, these answers are proving pretty hard to find.

So we decided to help you out. We sat down with two of our lead serialization consultants – Liam O’Riordan and Linda Murphy, to ask them the questions you have asked us in the past few months. We hope that this interview will give you some valuable insights into serialization requirements around the world and to help you decipher your DQSA from your NHRN.

Before we begin, it’s important to point out that the views expressed in this interview are based on ESPs understanding of current legislation and our experience in this market. We would strongly advise that you carry out your own research into legislation in your relevant markets before undertaking any serialization project.

Let’s start with the US…

Q: “How are manufacturers preparing for the US 1st Jan 2015 lot tracing TI/TH/TS deadline?”

LM: Typically we see our clients assessing how they currently communicate with downstream trading partners whether that is by email, fax, hard copy or electronically from the impacted sites. Clients are assessing the impact on current warehouse and distribution operations such as the impact to shipping processes, impact to master data and determining how best to manage the different communication mediums to distribution partners. The DSCSA gives some details on the data that needs to be included in the TH/TI and TS but manufacturers are also watching closely for guidance from the FDA on standards for the interoperable exchange of transaction information/history/ statement in paper or electronic form. The FDA have less than one year i.e. to the 27th November 2014 to publish this guidance but the sooner the better as far as manufacturers are concerned!

Q: What guidance is currently in the DSCSA on TH/TI and TS?

LOR: The act states that the transaction history is a statement in paper or electronic form which includes the transaction information for all prior transactions going back to the manufacture of the product. The act lists the information to be included in the transaction information including items that were also required in California ePedigree requirements:

  1. The name of the product
  2. The strength and dosage form of the product
  3. The NDC of the product
  4. The container size and number of containers
  5. The lot number of the product
  6. Date of the transaction
  7. Date of shipment if more than 24 hours after the Date of Transaction
  8. Business name and address of person transferring ownership
  9. Business name and address of person receiving ownership

The transaction statement is a statement in paper or electronic form that the entity transferring ownership in a transaction:

  1. Is authorized under the DSCSA
  2. Received the product from person that is authorized under DSCSA
  3. Received TI and a TS from prior owner of the product
  4. Did not knowingly provide false information or ship a suspect or illegitimate product
  5. Did not knowingly alter the transaction history

Essentially, it is a statement asserting the legitimacy of the transaction.

Q: “What are the implications of the recent change in US legislation concerning Track & Trace for lot level packaging after 2017?”

LM: After November 27th 2017, lot level transaction information must be electronic. Lot level transaction information is still required but the manufacturer will no longer have the option of using a paper based method. The required information i.e. transaction information, transaction history and transaction statement does not change. Potentially, this means that EDI (Electronic Document Interchange) can be used for the electronic transaction of lot level information but this is be clarified when the FDA publish their draft guidance establishing standards for the interoperable exchange of transaction history/information and statement later this year (2014).

Q: “What exactly is the National Healthcare Reimbursement Number (NHRN)?”

LOR: GS1 developed the NHRN to meet the needs of global supply chain participants who need to cater for national numbers. The NHRN allows association of the national number to the global GTIN of the product in databases and data carriers in a GS1 compliant fashion. Thus, when necessary the national number and the GTIN can be captured in the same barcode in a single scan.

At this stage GS1 has allocated AI’s for 4 NHRN: NHRN AI for Germany PZN AI 710, France CIP AI 711, Spain CN AI 712, Brazil DRN AI 713 and have stated that if additional NHRN AIs are required a request for a new NHRN AI needs to be made to GS1. There are other known NHRNs in use today and this gives the flexibility to add additional NHRN at a later date. Brazil, in their serialization requirements, have stipulated that AI713 must be encoded in the Unique Medication Identifier on each pack and current EFPIA pack coding guidelines (who are the European Federation of Pharmaceutical Industries and Associations based out of Brussels whose membership is made up of national organizations and pharmaceutical manufacturers) recommend that the NHRN is included in the 2D DataMatrix.

It’s probably wise to note that the NHRN should only be used for compliance with regulatory requirements where the GTIN on its own in the barcode does not meet requirements.

Q: “One piece of legislation mentioned in Brazil legislation is the “code identifier” of the transport packaging. Have you come across this and can you explain what this is?

A full transcript of this interview including details on South Korea, Saudi Arabia and how to streamline your serialization approach is available here  Global Q&A 2014

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