New Serialization Guidance Published in Brazil

Brazilian drug regulator ANVISA has published the country’s new guidance for its pharmaceutical track-and-trace system, revealing what specific information will have to be submitted to ANVISA and distributed between parties in the supply chain.

The new guidance has been four years in the making. A more general outline of the National Drug Control System (SNCM) was published in December 2013.  As described in the most current requirements, the serialization of medicine packs will be accomplished using 2D data matrix and human-readable codes. More specifically, the unique medicines identifier (UMI) will incorporate a 13-digit serial number, the product's ANVISA registration number, batch number, and expiry date. Each supply chain organization must maintain its own database of drug product and downstream transaction tracking data, according to Securing Industry.

In addition, transaction reporting must be uploaded to ANVISA via XML files to its website, highlighting key events, such as 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,” Securing Industry says.

Here is a breakdown of the key provisions:

• Pharma manufacturers will be required to maintain a real-time database of all transactions – from manufacture to dispensing. Companies must include details of the recipients, transport companies, and transport packaging.
• Distributors must report serialized transaction data to the manufacturer as well as keep a real-time database of suppliers, medicine recipients, along with packaging and logistics companies.
• Dispensers/Pharmacies have to provide serialized product information back to the manufacturer and distributor and maintain their own detailed transaction database.

In addition, this data must be archived one year after the expiration date of the drug product, Trace Link reported.

All pharma manufacturers must serialize and track three batches of product through the supply chain by December 10, 2015, which is the first step toward the mandatory track-and-trace regulations that will require all pharmaceuticals to be serialized in 2016.

ANVISA has said its complete serialization requirements will be fully published online in 2016.