Site License Renewals – Natural Health Products
Health Canada’s requirement for Good Manufacturing Practices (GMP) is often a daunting prospect for those wishing to import or manufacture natural health products for sale in Canada. The GMP application process in Canada involves an initial submission to gain approval followed by an early verification by Health Canada of the applicant’s ability to maintain GMP compliance after the first year of operations.
In order to manufacture or import natural health products beyond the initial licensing stage, site license holders must submit a site license renewal package to the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada. Renewal applications should be submitted no less than 30 days before the site license expiry date. For most groups the renewal package is comprised primarily of completed records. The records will reflect the GMP activities that have occurred during the previous 12-month period (which is the first operational year since receiving a site license). License holders must provide one set of records for each facility listed on the site license, regardless of whether the facility is located in Canada or outside of Canada.
In earlier years the NNHPD allowed applicants to enter “no activity” for a particular facility if the site was not ready to participate by the time site license renewal came around, and this was permitted without any risk of having that facility removed from the site license. However the site license assessment unit of NNHPD will no longer allow dormant sites to be retained on a site license and therefore facilities, if not operational at the time of renewal, will be removed from the site license. An additional application will be required at a later date in order to have that site reinstated on the site license.
Formulating plans to sell natural health products in Canada should take this new condition into account when making final decisions regarding supply chain sites and their eligibility in the application process. Including and then removing sites and filing applications at a later time results in additional time, effort and duplicate sets of paperwork. This can be especially challenging when dealing with larger supply chains. The ideal site license site strategy, and one that involves a smooth transition to post license GMP compliance requires evaluation of each facility’s state of readiness independently, rather than treating the entire group of sites as a whole.
If the updates required for GMP compliance (such as new or updated equipment, additional staff and training, new procedures) will not be undertaken within 6-9 months after a site license is received, it may be wise to hold off on adding that particular site until they are closer to beginning operations.
