William Morkel, BSc
Senior Quality Assurance and Regulatory Affairs Specialist, Dicentra

From late September to mid October the NHPD will be holding information sessions in Montreal, Toronto, Vancouver, and Halifax to update industry on new proposed changes to the current regulations governing Site Licencing and Good Manufacturing Practices. The nation-wide tour will be followed by a live webinar on October 12.

The planned changes are captured in a Concept Paper that was made public on August 29. There are 28 suggested changes in all, but the ones most likely to have the biggest impact are as follows:

• Issuing Site Licences based on successful on-site audits (instead of the current paper-based Quality Assurance Report approach) for all domestic and foreign, manufacturers, packagers, and labellers.
• Holding Product Licence Holders more accountable for manufacturing, packaging, labelling, importing, and testing activities that they contract out, including responsibility for ensuring product stability.
• Requiring manufacturers and packagers to exercise greater control over raw materials
• Requiring that Product Licence holders provide the name and address of the manufacturer, packager, labeller, and importer of the product before a product licence is issued for the product.

While these changes are still at the concept stage, they do represent a significant overhaul of the existing regulations/guidelines. Dicentra encourages industry to participate in the upcoming information sessions and to provide their feedback. Implementation of the proposals will undoubtedly reinforce product quality assurance, but will also invariably increase the costs, in terms of both time and money, of compliance. In particular, on-site inspections of domestic and foreign sites will be undertaken by third party auditors approved by the NHPD, but it is the site licence holder who will have to arrange for, and foot the bill for, these inspections.

When the proposed changes will take effect has yet to be determined, but according to NHPD insiders it will not be for at least another two to three years. Still, industry should be proactive in planning and budgeting for the new requirements.

For further information on GMPs, Site Licencing and other regulatory issues please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com