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.
- Ensure your company has informed ANVISA that TraceLink is acting as their report proxy and provided ANVISA with TraceLink's Brazil CNPJ number.
- Select [Company Name] Brazil Compliance Network from the drop-down in the header.
- Select the button in the header.
- Filter for the compliance report to manually submit.
- Select the View icon for the report.
- 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.
See the information that displays in the panel- Status – Indicates whether the SNCM successfully received the report.
This status reflects successful submission or failure only. It does not reflect the status response from the SNCM (e.g. Accepted, Partial, Warning).
This status reflects successful submission, failure, or the status response from the SNCM.
- Status Description – The description of the Status.
- Response Details – The complete details of the response from the SNCM, including the SNCM status response.
- Status – Indicates whether the SNCM successfully received the report.
- In the panel, save the Response Information for your records.
After the panel is closed, this information is retrievable only by contacting TraceLink Support.
- 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.