Blog Brazil SNCM

The National Drug Control System (Sistema Nacional de Controle de Medicamentos, SNCM) is the technological environment provided by Anvisa for exchanging data with members of the pharmaceutical supply chain. Reporting begins with activation of the drugs by the registration holder. Movements of the drugs are then reported by distributors and finally by the dispensers who complete the process. This reporting is done through what are known as “event instances.” Event instances are made up of information about a packaging unit or a transport package that describes the context in which an operation occurred. 

Blog Brazil SNCM

HOW WILL REPORTING TO THE SNCM (ANVISA) BE DONE?

Reporting to Anvisa will be done through the Client System of each supply chain member, by means of web services. The data will be passed on through XSD standard XML files, and Internet access will be required for reporting. In order to perform the event reporting, the supply chain member will need to:

  1. Create an XML message containing the event instances with the other elements required for the operation;
  2. Access the “evtIn” web service and report the event instance; and
  3. Check the response of the “evtIn” web service for success, rejection or warning messages.
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What events are available in the SNCM?

ACTIVATION – Activation of the product’s unique ID (IUM) must be done by the registration holder for a drug that is about to be introduced into the pharmaceutical supply chain. Only registration holders can “activate” drugs.

DISPATCH – Dispatch is the operation of shipping one or more traceable commercial packages to another member of the pharmaceutical supply chain. In order to perform a dispatch operation, you must always first declare that you are in possession of the drug.

RECEIPT – Receipt is the operation of receiving one or more traceable commercial packages from another member of the pharmaceutical supply chain. At the Receipt stage, the supply chain member can report the IUM(s) individually, the transport package identifier (IET), or a mixture of individual IUMs and IETs.

COMPLETION – The final operation in the movement of a commercial pharmaceutical package is considered to be a “completion” event; the event instance could be any one of several options.

REPLACEMENT – The reporting of a new version of an event instance to the SNCM. The first event instance is designated “replaced” and the second is designated “replacement”. This might happen when, for example, the list of IUMs dispatched needs to be amended after verifying that particular packages were not loaded onto the transportation vehicle. You only have authorization to replace an event instance that you reported in the first place. And you can only replace an event instance with another of the same type.

REVOCATION – A previously-reported event instance that has to be disregarded. A supply chain member can only revoke events they have reported, and must do so within 30 days following the original report.

Major steps in implementing drug traceability

ONCE A DRUG IS READY FOR ACTIVATION, IS THERE A TIME LIMIT FOR DOING SO?

Yes, there is a time limit of 3 days to report the activation of drugs. Once a drug is a finished product and ready for physical transportation, the registration holder must report its activation. In the case of imported drugs, this must happen following customs clearance.

SEE ALSO:

Source: Anvisa, MONITORAMETO – GUIA Nº 01/2020 – Versão 1.0, de 07 de outubro de 2020
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