The NHP regulations separate the GMP activities into four main categories that require a Site License (SL):
Product Site Licenses
Any foreign sites performing these activities must be listed as approved foreign sites on a Canadian Company’s SL.
The application for a SL requires detailed information showing that both the Canadian site and any foreign sites are compliant with NHP GMPs. The site’s Standard Operating Procedures (SOPs) and associated documentation are assessed by the NHPD for NHP GMP compliance during the licensing review.
Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits.