Update on Canadian product licenses

Update on Canadian product licenses

NHPD has a present backlog of about 2,000 files to be completed as soon as possible, probably in another three to four months.

A total of 60,000 natural products have now been licensed by the Natural Health Products Directorate (NHPD) of Health Canada.

You may still have some applications with valid Exemption Numbers (EN) attached to them. There are 434 such files. These are now the highest priority for the NHP to complete promptly. They have indicated that these will be done by the end of February.

Going forward, the NHPD has a present backlog of about 2,000 files that are going to be completed as soon as possible, probably in another three to four months.

Once all of these files are out of the way, the NHPD expects to be able to complete 75 percent of new files within 30 days. These new applications are considered to be Class 1, which are fairly straightforward. They consist of formulas with only ingredients and claims that have pre-cleared information (i.e. monographs, labeling standards, etc.)

Applications that are a little more complicated ideally will take up to 60 days.

For very complicated products with new or novel ingredients or claims, as they require a lot of assessment, they could take up to180 days for a regulatory decision.

According to the Government of Canada, it takes 10 years to completely establish new regulations. The Natural Product Regulations are in their ninth year. By Sept. 1, 2014, all natural product and compliance regulations will come into full force.

 

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