Brazil’s ANVISA update their serialisation track and trace requirements

Brazil’s ANVISA update their serialisation track and trace requirements

In a press release from ANVISA dated 8th December 2011, the results of the Brazil Government Integrated Task Force review of the serialisation legislation (Law No. 11.903/2009) were announced. An intention to implement full tracking of serialised product through the supply chain is still at the heart of the requirements. Whilst not explicitly mentioned, I would think that the requirement to track product through the supply chain will bring with it an explicit requirement for association/aggregation in the fullness of time.

A number of onerous requirements on the government have been withdrawn, namely: government issued security labels and the government supply of special authentication devices for use by the public in pharmacies.

Notably, no indication of the implementation timing of the legislation was given in the press release.

Our interpretations of the highlights from the press release are as follows:

• Tracking drugs at the secondary pack level through the Brazil supply chain.
• 2D data matrix code and associated text to be put on all secondary packaging.
• Information in 2D data matrix to include: product registration number; batch identification; validity (interpreted by us to mean expiry date); IUM (serial number).
• 13 digit IUM (serial number) will be generated and managed by ANVISA.
• ANVISA to provide a central system to capture, store and manage data on the flow of products through the supply chain.
• Supply chain nodes responsible for updating the ANVISA system with product movement information.
• There will be the ability for consumers to access information in the ANVISA system, but no details were given.
• Detailed guidance will be provided at a later date.

Whilst this information clarifies some things about the legislation, we are a long way from actionable implementation information at this point.

If you have any other information or thoughts on this topic, please do not hesitate to comment on this blog.

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