The Natural and Non-prescription Health Products Directorate (NNHPD) has posted an updated SL guidance document. Along with the updated guide the Quality Assurance Report (QAR) and Summary of Net Changes (SNC) forms have also been updated.
Important changes to note to the SL review process include:
- SL renewals will be refused for companies who have not conducted activities in the 12 months prior to filing their application (regardless of the renewal cycle), and who do not have records demonstrating their ability to comply with GMP.
- NNHPD has divided GMP evidence into three groups:
- Pre‐Cleared Evidence
- QAR
- Alternate GMP standards and/or accreditation bodies
- Each type of GMP evidence has an associated period of validity
- Service standards have been defined for each of the above GMP evidence categories. Depending on the type of GMP evidence provided SL new applications and renewals could take anywhere from 30 up to 90 days to be reviewed and approved.
Service standards will take effect April 1, 2016.