The implementation of Health Canada’s Natural Health Product Regulations in 2004 left many applicants in the industry confused with submission requirements and frustrated with delays to market for their natural health products/dietary supplements in Canada. Approvals seemed to take forever. Reports surfaced of queue times of up to one year just to receive feedback on natural health product license applications; site license applications took several months for approval.
Turning the clock forward one decade, numerous and significant upgrades by the Natural Health Products Directorate (which has since been renamed the Natural and Non-Prescription Health Products Directorate) have appeared. These improvements have resulted in much speedier approval times which has in turn allowed natural health products and dietary supplement manufacturers to get their natural health products to market with minimal delay.
Here’s what’s changed for product license applications:
- Introduction of paperless product license applications.
- Use of an on-line secure system for submitting natural health product license applications.
- Introduction of attestation forms for natural health product license applications.
- Service standards which include a 10-day review for new Class I product license applications.
For natural health product site licenses, updates include:
- An abbreviated quality assurance report (QAR) with just twelve questions.
- Service standards for reviews which include a 30-day processing limit for site license applications using pre-cleared GMP evidence.
- On-line submission options for applicants, similar to the system used for product licenses.
While these upgrades are of course a welcome change for industry, they perhaps signify a shift in responsibility away from Health Canada in the direction of industry, requiring an even greater understanding of what is required for compliance with the Natural Health Product Regulations for natural health products and participating facilities.