Health Canada’s Regulatory Operations and Regions Branch (RORB) announced their new Compliance Monitoring Program (CMP) for NHPs last week. The program is part of efforts stemming from a recent commitment in the Health Canada evaluation report to proactively assess compliance with NHP regulations.
The site visits will be done from February to March 2017 and the sites selected represent 3% of all site licence holders. The sites were randomly chosen through objective criteria that considered the relative impact of activities on the quality and safety of products. This method of selection results in an unbiased sample that represents various licensable activities such as manufacturing, packaging, labelling, and importing.
Companies will receive one week’s notice via email to expect a Health Canada inspector visit. The RORB says that the purpose of the visit is to collect information, not conduct an audit or inspection. The information gathered will help the RORB:
- Better understand how regulated parties are complying with NHP regulations
- Assess and promote compliance
- Better understand certain regulation elements that include personnel, quality assurance, and written procedures
- Identify topics that could benefit from compliance promotional activities.
The RORB will aggregate the results and findings in a summary report which is expected to be released this summer and available on their website.
If you have any questions, please feel free to contact Focal Point Research. We are industry leading Natural Health Products Regulatory Consultants that you can trust to help guide your company in the right direction.