ANVISA And The SSCC Controversy

GS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations.  I’ll cover these controversies in multiple essays—in this one, Brazil. This controversy started when ANVISA, the pharma regulator in Brazil, indicated

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One thought on “ANVISA And The SSCC Controversy”

  1. This blog post (especially its headline) gives the impression that a “SSCC controversy” was caused by Anvisa. I was a participant in the discussions here in Brazil and I can say this is not the case.

    The Brazilian industry associations previously indicated to Anvisa that SSCC would be enough to identify “transportation packages”. Then, the Anvisa team incorporated SSCC in its data format for communicating traceability information.

    Months later, a multinational industry justifiably asked GS1 Brazil (by e-mail) whether GTIN+SN could be used for identifying packages in some scenarios, rather than SSCC. A discussion ensued, with a lot of people in different organizations (esp. industries and solution providers) being added in the e-mail “CC:” field, including Anvisa, which was asked to participate in the discussion.

    After some e-mail message exchanges, the Anvisa team proposed a data format solution that was flexible enough to acomodate a) SSCC, b) GTIN+SN, and c) other formats. Some messages later, and a consensus was reached on that proposal: after some analysis, the proposed solution was perceived as acceptable to GS1 Brazil, and the original multinational industry that started the discussion was very happy with the outcome on this particular issue.

    The situation was perceived as a “SSCC controversy” just because it took about 2 months from the start of the discussion to its conclusion, with everybody agreeing. Of course, before an agreement was reached, industry was afraid an acceptable outcome wouldn’t occur; since the perspectives were initially diverging, no one could be sure at that time. Since the discussion involved a variety of stakeholders, with many details to be sorted out, and with the discussions happening by e-mail (instead of teleconference or presential meeting), the time to reach the consensus was not that long.

    While this issue has been overcome, many other topics are under discussion today, however. Supply chain traceability is *very* challenging, and many details need to be sorted out by all stakeholders for it to become an operational reality in Brazil.

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