In 2004, Canada enacted new regulations for Natural Health Products, touting these rules as game changers to the rest of the world.
For the past six years, and with a self-imposed 2010 deadline, the government’s Natural Health Products Directorate has been trying to catch up on a backlog of unprocessed product applications. As of January of this year, not only was the failure obvious, but the National Association of Pharmacy Regulatory Authorities (NAPRA) issued a national position saying that pharmacies were to stop selling products without actual Natural Products Numbers (NPNs) or risk losing their licenses.
Specifically, the group was objecting to an interim practice where manufacturers would submit applications to the NPN process, and go to market, pending regulatory approval. This practice had been unofficially accepted in light of the backlog of applications which has existed since the passing of the regulations. With NAPRA’s actions, the unthinkable was happening and products were being removed from pharmacy shelves – and new government activity was warranted.
May 8th’s Canada Gazette (the place where proposed rules are published) describes the government’s proposed actions to handle the crisis. With approximately 10,000 unlicensed products on the market, some way to officially exempt backlogged products is needed. Under this proposed amendment, specifically the part about sales without an NPN, the government suggests exempting products that have been on file with Health Canada for more than 180 days.
While this proposed solution would cover backlog applications, it has another market impact as well. For the past few years, companies have been going to market as soon as they receive notice that Health Canada has their application on file. Under the new amendment, this practice would no longer be allowed until at least 180 days had passed. Instead, if a decision has not been made within 180 days of receiving the application (providing there is no safety issue), an exemption will be issued, and the product will then b e governed by the regulation for adverse event reporting and other surveillance activities. The exemption expires when the product is approved or rejected. The proposed amended regulation would expire after 30 months, giving the government another couple years to eliminate the backlog.