Despite Health Canada adopting a risk-based enforcement policy until at least March 31 in acknowledgment of the Product License Application (PLA) backlog, the recently passed January 1, 2010 deadline continues to be a source of debate within the industry.
With thousands of PLAs still waiting to be addressed or completed, immediate enforcement of the Natural Health Product Regulations (NHPR) would have a serious impact on the industry and its consumers. Industry stakeholders attending the NHPD workshops last fall were given the opportunity to express their concerns, and were reassured that the transition into an enforcement policy would be gradual. Health Canada has since released information sheets on this topic which acknowledge the backlog, announce their risk-based approach to enforcement, but confirm that yes the Natural Health Product Regulations are in effect.
The National Association of Pharmacy Regulatory Activities (NAPRA), the Ontario College of Pharmacists (OCP) and the Order of Pharmacists of Québec (OPQ) have sent position statements to pharmacists which state that: "Pharmacists should not sell a marketed health product without a Drug Identification Number (DIN), Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-HM)." Industry members are asking why these associations feel the need to go beyond Health Canada's enforcement policies
The Canadian Health Food Association (CHFA) is in communications with the involved parties and the Natural Health Products Directorate (NHPD), in an attempt to maintain uninterrupted consumer access to new and existing NHPs. Their Save Our Natural Health Products campaign, which was launched last October, encourages industry members and consumers to take action by writing to Members of Parliament.
What can you do to ensure the sale of your NHPs continues uninterrupted? Keep your retail customers and consumers informed, direct them to the above-linked information sheets provided by Health Canada, and most importantly be sure that all your products have submission numbers.
dicentra will be hosting a webinar on February 24th, 2010 which will explore the current challenges facing the industry in obtaining Natural Product Numbers and will provide potential solutions to overcome these challenges. For more information or to register, please visit www.dicentra.ca/training.html .