Brazil issues reporting guidance for drug traceability scheme

Brazil's regulatory authority ANVISA has published guidance on the reporting requirements for its medicine track-and-trace system, which is due to come fully online in 2016.

After four years in development, the broad outline of the National Drug Control System (SNCM) was published last December and - like many similar approaches around the world - is based on the serialization of medicine packs using 2D datamatrix and human-readable codes.

The unique medicines identifier (UMI) incorporate a 13-digit serial number, the product's ANVISA registration number, batch number and expiry date, and each organisation in the supply chain is required to maintain its own database of drug product and downstream transaction tracking data.

By December 10, 2015, pharma manufacturers are required to have serialised and tracked three batches of product through the supply chain, and a year later this will be mandatory for all pharmaceuticals.

There is also a requirement in the legislation for information to be reported back to ANVISA, although until now the details of that have been sketchy.

The latest guidance finally fleshes out what information will have to be submitted to ANVISA and between parties in the supply chain.

It specifies that the transactions will have to be reported to the regulator by uploading XML files to its website detailing events such transport packaging (case) identifiers, receiving and delivery (including free samples), production, importing, completing the supply chain (e.g. via dispensing, loss or discard of medicines, and corrections to erroneous transaction data.

The tracking requirements apply from the point of manufacture through to dispensing of the medicine pack at pharmacy, as well as reverse logistics, and records must be retained for one year after a product's expiration date. Any amendments to or removal of past records will be considered tampering, according to ANVISA.

As previously disclosed, pharma manufacturers will have to maintain a real-time database of all transactions through to dispensing, including details of the recipients, transport companies and transport packaging.

Distributors must report serialised transaction data back to the manufacturer and maintain a real-time database of suppliers and recipients of medicines, as well as transport companies, along with transport packaging.

Finally, the dispenser should provide serialised product information back to the manufacturer and distributor and once again maintain a database of all transactions.

[Ed: The notification in the official gazette (in Portuguese) can be downloaded here by inputting the code '00012014081900043'.Make sure your pop-up blocker is disabled!]