Anvisa releases drug traceability model

Anvisa (national health surveillance agency) sent for public consultation proposal establishing the National Drug Control System. The resolution is published in today's Edition (3/4) of Diário Oficial da União.
The National Drug Control System (SNCM) establishes the mechanisms and procedures that will ensure the tracking of medicines. The system proposes the start control on production and accompany the medicine until the prescription products.
Anvisa has defined that the technology to be adopted for the SNCM is the code Datamatrix, a two-dimensional barcode (image to the side). This is the capture mechanism, electronic storage and transmission of data necessary for tracing medicines in Brazil.
The proposal forwarded to public consultation for 30 days determines that the responsibility for the quality, safety and efficacy of medicinal products must be shared between all actors involved in the chain of production, distribution and consumption of these products.
Companies holding registration at Anvisa-manufacturer or importer-will be responsible for generating and disposal in each package of medicine a number called a unique identifier of Medicine (IUM), which is formed by the record number of medicine at Anvisa, containing 13 digits, as well as the serial number, the expiration date and lot number.
The serial number is a species of RG for medicines, corresponding to each unit of the product to be marketed in the Brazilian territory. The serial is represented in a two-dimensional barcode and inscribed legibly on the packaging.
Secondary packagings of all medicines and hospital packages shall bear the identification mechanisms established by Anvisa.
For industry, the period of adaptation to the new rules is 180 days and for the retail trade, of 360 days.
The traceability of medicines was established by law in 2009. In 2011, after pressure from the pharmaceutical industry, the Anvisa suspended the previous proposal, which provided for the use of the seal of the Mint, that encareceria production costs. The current model was well received by the industry. "Only those who lose with this decision is evader, forger and thief of remedy. Let's make an effort so that the deadlines are met, "says Antonio Britto, Chief Executive of Interfarma (research-based pharmaceutical industry association).