Anvisa's resolution establishes new rules for manufacturers and importers. In three years, identification on packaging will be standardized

Published on December 11, Resolution 54 of the National Health Surveillance Agency (Anvisa) established new rules for drug tracking in Brazil. The standard presents mechanisms and procedures for identifying the trajectory of drugs from their production to their sale, using technology for the capture, storage and electronic transmission of data throughout the production chain.

For controlled drugs, the system will bring information from the producer to the buyer. The drug packaging will adopt the Unique Drug Identifier (IUM), a type of two-dimensional code similar to the QR Code that will allow the user to know if the product is original.

The formation, generation and implantation of the IUM in the packaging of all drugs sold and distributed in the country will be the responsibility of the companies that have registered with Anvisa. The resolution also establishes the adoption of the two-dimensional bar code (Datamatrix) as a technology for the capture, storage and electronic transmission of data necessary for tracking. According to Anvisa, this technology ensures support, automation and visibility to drug tracking, in addition to allowing integration between information systems.

The code must be formed by the drug registration number with Anvisa and contain 13 digits, in addition to the expiration date, batch number and serial number, which cannot be repeated in the units of other products manufactured by the registration holder. The same rules also apply to fractionated drug packaging and hospital packaging.

The resolution also determines that the data for each drug must be maintained and made available in Anvisa's systems for at least one year after the expiration date of the product. Registration companies, manufacturers or importers will have the responsibility to guarantee and ensure the maintenance of the quality, safety and efficacy of the products to the final consumer, in order to avoid health risks.

In three years, the system will be fully implemented. Anvisa has set a deadline of two years for each pharmaceutical company to submit a full traceability report for at least three batches. To monitor the application of the standard, the regulatory agency will form a technical committee to monitor the implementation of traceability.