We often receive calls related to site licensed warehousing and importation from clients who had no idea their products required this service and now find that their product is being held at customs until they can comply or worse their product is rejected and has to be shipped back or destroyed. What a catastrophe!
All natural health products are regulated by Health Canada; these regulations set out the requirements, rights and responsibilities of the licensee and the Natural and Non-prescription Health Products Directorate (NNHPD) in regards to site licensing. The purpose is:
- To ensure that the NNHPD is aware of all the sites at which businesses are manufacturing, packaging, labelling, importing, and/or storing Natural Health Products (NHPs) in Canada.
- To require persons to meet the regulatory requirements related to manufacturing, packaging, labelling, and/or importing NHPs for sale; and
- To require site licence holders to demonstrate that they comply with the Good Manufacturing Practices (GMP) outlined in Part 3 of the Regulations.[i]
So, what is a site license and who needs one?
A site license is issued by Health Canada to any manufacturer, packager, labeler or importer of natural health products to ensure that the regulations are being followed while conducting the activities on their license and ensuring that they follow goods manufacturing practices (GMP).
It’s important to note that Canadian importers are required to be licensed and the onus is on them to provide evidence that products coming from foreign sites meet Canadian Goods Manufacturing Practices (GMP). It is also the importers responsibility to ensure that the reports submitted to the NNHPD are complete and that all requirements of the regulations for foreign sites are being met.
There is so much information required just to have your natural health product imported into Canada, that for some companies it is just too complicated to proceed. We help clients navigate through these regulations every day, and we enjoy finding the right solution to allow them to enter a new market and grow their brands.
[i] http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php
