Any Canadian company manufacturing, packaging, labeling and/or importing product destined for the Canadian market must have a Site Licence issued by the Non-Prescription and Natural Health Products Directorate (NNHPD) of Health Canada.
In Canada, a “natural health product” is approximately equivalent to what the US calls a “dietary supplement” or which the EU a “food supplement”. Since 2004, the Natural Health Products Regulations have defined nhp’s and the standards under which they are manufactured. The NHP Regulations have inclusive criteria for defining an nhp, namely any of: a plant or plant material; alga; bacterium; fungus; non-human animal material; extract or isolate of the previous; essential vitamins; amino acids; essential fatty acids; minerals; probiotics; or any synthetic duplicate of the above. Certain types of products are excluded from the nhp definition, such as tobacco and radiopharmaceuticals.
The definition of an nhp is broader than most countries, in that it allows any administration route and almost all dosage forms – including topicals, homepathics, powders, tablets, ear drops, eye drops, dental products, etc. In short, if it’s natural and if it’s healthy for you, it’s probably an nhp.
Nhp’s are required to be manufactured, packaged, and labeled in a facility that meets Good Manufacturing Practice (GMP) standards to ensure that products are safe and of high quality. This includes facilities on non-Canadian soil, but if the facilities are in Canada they need to be licensed. In order to be granted a Site Licence, a facility must have Standard Operating Procedures (SOP’s) in place that detail the appropriate practices that will ensure safe manufacturing, handling and storage of product.
Facilities will demonstrate compliance to GMP’s by providing Health Canada copies of SOPs and records that demonstrate each procedure in practice. Some examples of appropriate standards and procedures will be in the form of Sanitation Plans, Quality and Operational Systems and Recall Reporting. In addition to the facility’s paperwork, a Quality Assurance Report (QAR) form must be completed which further details each facility procedure.
Once complete, the Site License package (QAR, SOP and records) is submitted for review by the Site Licensing Division of the NNHPD. At this time, there are no government fees associated with the review of the Site License package. On average the review process typically takes somewhere between 4-6 months, and approved facilities are listed publicly (downloadable) from the Health Canada website.
NHP Consulting assist in the development and implementation of a Quality System unique to your operation, to ensure successful licensing.