Manually submit compliance reports to the SNCM

After generating compliance reports in TraceLink, Owners can submit reports manually or automatically to the National Drug Control System (SNCM) to ensure compliance with Brazil regulations.

By default, reports are submitted automatically to the SNCM. If a report fails submission to the SNCM (e.g. if the SNCM is not available), Owners can submit the reports manually.

Brazil Compliance authenticates to the SNCM using TraceLink's ICP-Brazil digital certificate. Your company does not need to manage its own SNCM credentials in TraceLink.

  1. Ensure your company has informed ANVISA that TraceLink is acting as their report proxy and provided ANVISA with TraceLink's Brazil CNPJ number.
  2. Select [Company Name] Brazil Compliance Network from the Network drop-down in the header.
  3. Select the Go button in the header.
  4. Filter for the compliance report to manually submit.
  5. Select the View icon for the report.
  6. In the Report Submission section, select the Submit to SNCM icon for the Report File to manually submit.

    TraceLink submits the file to the SNCM, and a panel opens with information about the SNCM response.

  7. In the panel, save the Response Information for your records.

    After the panel is closed, this information is retrievable only by contacting TraceLink Support.

  8. Repeat step 4 until every Report File is submitted.

    If multiple Report Files display, each file must be submitted individually for the SNCM to receive the full report. For large reports, TraceLink generates multiple report files to accommodate the SNCM file size limit.