SNCM and ANVISA
The National Health Surveillance Agency (ANVISA) is responsible for implementing, coordinating, and defining the categories of drugs subject to the National Medication Control System (SNCM) in Brazil.
SERIALIZATION AND TRACEABILITY IN BRAZIL
SNCM aims at tracking drugs throughout the entire production chain, from manufacturing through to consumption. Currently more than 40 countries work on laws and regulations that guarantee safety in the supply of pharmaceutical products around the world.
- Greater safety for patients and professionals.
- Control of production and logistics within compliance standards.
- Inhibits counterfeiting and the commercialization of smuggled medicines.
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T3 and serialisation management
Identifying product ownership and custody requires a storage of records that can be shared for regulatory verification.
Compliance in Reverse Logistics
Reverse Logistics is the collection and return of solid residual waste to the commercial sector for reuse or adequate final disposal.
In Brazil, the law requiring full traceability of the pharmaceutical manufacturer's supply chain, with a digital system connected to SNCM, comes into force in 2016.
Final Implementation deadline
Completion of the pilot stage
Good practices for distribution, storage and transport of medicines are set out. The need to regulate the implementation phase of the SNCM is established.
The pilot stage for the construction of the final regulations involving serialization and traceability of medicines begins. Deadlines are set for the future evaluation and final regulation of the SNCM.
Regulation of the SNCM
Regulates SNCM with new disciplines applicable to drugs and members of the medical drug movement chain. Involves definitions, data capture technology, identification of SNCM members, labelling and storage standards, and event instance reporting.
Medicinal Drug Tracking
Amends the 2009 law establishing the tracking of the production and consumption of medicines through technologies for the capture, storage and electronic transmission of data. In 2016 SNCM implementation milestone deadlines are set. A centralised database is envisaged.
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