On December 1, 2015 Health Canada’s Natural and Non-Prescription Health Products Directorate published a Notice to Stakeholders that formalized the long-anticipated updates to the Site Licensing (SL) process. The changes include a new QAR form, revised GMP and SL guidance documents, and new service standards, all of which have been implemented as of April 1, 2016.
We’ve often heard clients comment that they think they may need a site license but aren’t sure what that really means. This article is designed to help clarify this area of the Regulations.
First, let’s start by outlining the 4 different types of Site Licenses applicable to Canadian companies dealing with health products: manufacturers, packagers, labellers, and importers. As a unique option to foreign sites, a foreign site reference number (note: NOT a license!) can be obtained by applying to Health Canada directly, otherwise facilities located outside of Canada are required to annex their facilities to a Canadian importer’s SL.
The Natural Health Product Regulations defines a manufacturer as “a person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient.” In other words, a manufacturer is considered a facility that produces an intermediate (blend or capsule/tablet) or finished products (packaged and labeled), with the exception of compounding.
What you may not know is that raw material manufacturers do not require a Site License. The distinction here is that the facility is not producing the final consumable product; therefore it does notrequire a site license. However, it is important to note that raw material producers are required to be GMP compliant, even though the facility is not formally licensed by Health Canada.
Facilities that package and label finished natural health products require a site license to conduct these activities, which should always go hand-in-hand (i.e., you shouldn’t have unlabeled bottles with product inside in stock). If your facility receives finished product (for example, in capsule format, or liquid format that requires no further blending) and you are responsible for placing that product in its immediate container (the container that is in direct contact with the NHP), then you would require a site license for packaging. Once packaged, the container requires a label and so a labeling license is required. Often, manufacturing, packaging and labeling are done at one facility, and so that facility would need a license for all 3 activities.
When manufacturing, packaging and/or labeling of the finished natural health product is done outside of Canada, then the site licensing process becomes a little more in-depth, since we are now also dealing with an importer and possibly a distributor(s) plus the foreign manufacturer/packager/labelers.
As defined by the NHP Regulations, an importer “means a person who imports a natural health product into Canada for the purpose of sale” whereas a distributor “means a person who sells a natural health product to another person for the purpose of further sale by that other person”. The key to this distinction is that the importer is responsible for receiving the product into Canada (i.e., receiving the product direct from the foreign exporter), whereas the distributor merely distributes product to direct sellers (such as retail stores).
Often, importing and distributing are handled by the same company, and so in this case, you would need a SL as an importer.A distributor who simply purchases inventory from other vendors within Canada, and who sells to resellers within Canada, does not require a site licence; however, they are still expected to follow GMP standards, which can be the subject of an audit.
Sometimes it is confusing as to whether or not a retail store requires a site licence. If the retailer is importing any nhp’s from outside Canada – and the product does not get imported by an intermediary with a site licence – then in fact the retailer requires a site licence for importing. It is not common, however, for retailers to have their own importer site licence, because the costs often outweigh the benefits for small businesses.
An importer’s site license is only available to Canadian companies, and requires that foreign facilities be linked to the importer via an “annex” to the importer’s site license. In essence, the Canadian site will be responsible for the product once in Canada, but before Health Canada will permit that product into the country, they need to ensure that that product is safe and of high standard. If you are importing products from more than one foreign facility, each facility will need to be linked to your importer’s site licence to ensure that your finished product passes customs and border patrol inspections seamlessly. To sum up, all natural health products sold in Canada must be manufactured under GMP standards; for imported products, it is the importer who is responsible for attesting to these standards, and the manufacturer simply supports the importer with documentation. Facilities not on Canadian soil are not eligible for a site licence of any kind.
The importing license is not complicated, but does require a high level of coordination and communication amongst all parties, since an importer’s license cannot be achieved in isolation. In other words, the Canadian company must have an active foreign site(s) to import from before licensing can be achieved.
The last type of registration to address is the one only available to foreign sites: the Foreign Site Reference Number (FSRN). The process is slightly different than if the site was an annex to an Importer’s SL, but the quality & GMP requirements are the same. The benefit to pursuing this type of registration is that the foreign site can deal directly with Health Canada concerning their unique facility and processes. A FSRN can streamline the process for both the foreign site and importer, especially if that foreign site contract manufacturers for more than 1 Canadian company. For example, a US manufacturer could achieve an FSRN for their US facilities, and if they decide to export their products to more than one Canadian importer-distributor, the FSRN is achieved at the beginning, and then provided to each importer. This is a cleaner process than providing GMP documentation to each importer separately.
Finally, I’d like to highlight the other end of the spectrum: who is exempt from having a Site License. I addressed a few scenarios above, but here is a complete summarized list as noted in the Site Licensing Guidance Document, Version 3.0
- A pharmacist, aboriginal healer, traditional Chinese medicine practitioner, or health care practitioner, who, at the request of a patient, compounds a NHP for the purpose of sale solely to that individual.
- Distributors that do not import NHPs into Canada.
- Persons (business or individual) performing the activities of growing, harvesting, cleaning, sorting, and/or importing raw material but do not produce a product that is ready for use or consumption by the consumer.
- Persons (businesses or individuals) that invoke section 37 of the Food and Drugs Act, to manufacture NHPs for the sole purpose of exporting outside of Canada (in other words, companies that make nhp’s but for export only)
- Persons (businesses or individuals) that manufacture, package, label, or import NHP’s solely for the purpose of a clinical trial
- Testing labs do not require a site licence.
If you think that you need a Site License, our team of Quality Assurance experts can help navigate and support you through the licensing process. Contact us to learn more about our site licensing services.