May start for Brazil medicines traceability pilot

Brazil’s proposed traceability system for medicines will be put through its paces in the coming weeks as pilot testing gets underway.

The pilot of the long-awaited National Drug Control System (SNCM) will involve regulatory authority ANVISA and several pharmaceutical companies – initially Aché, Bayer, Boehringer Ingelheim, Janssen-Cilag and Libbs, with Roche and Eurofarma expected to participate later - and each will put three batches of product through the system.

It was officially started in September 2017 but will effectively get underway in May when the database for the project is fully up and running, according to Brazilian pharma industry trade body Sindusfarma.

The pilot is getting going more than eight years after medicines verification was first proposed in Brazil via Law 11,903 back in 2009. After years of political wrangling and pushback from industry over the implementation proposals in 11,903 and implementing regulation RDC 54/2013, the first attempt was abandoned and replaced with a new version – Law 13,410 and implementing regulation RDC 157/2017 – in December 2016 and May 2017, respectively.

The SNCM requires the addition of 2D barcodes to individual medicine packs that, as a minimum, will include a unique randomised serial number, national registration number, lot number and expiry date. Towards the end of last year ANVISA published a draft implementation guide for the SNCM, including specifications and technical criteria intended to help stakeholders in the Brazilian supply chain develop and integrate their own systems.

Scanning the code will allow the packs to be tracked through the supply chain, with each supply chain member required to capture transaction data and communicate it to a central government repository.

The pilot is expected to take up to a year, with an eight-month review period, which will be followed by a three-year implementation window before the requirements become mandatory. ANVISA confirmed recently that there may be opportunities to tweak the requirements depending on how the pilot programme develops, and it intends to publish around the end of this year.

The drugs involved in the pilot are Aché’s muscle relaxant Tandrilax, Bayer’s hormone replacement therapy Climene, Boehringer’s high blood pressure drug Micardis, Janssen-Cilag’s Levaquin antibiotic and Libbs’ cancer drug Faulblastina.