As a permit holder for Natural Health Products (NHPs), it is your obligation to know about and be aware of all the prerequisites for Canada to Import NHPs.
This blog will feature and sum up the normal entanglements of an organization that produces NHPs beyond Canada and tries to import them into Canada. Working with a shipper like Quality Import Solutions (QIS) and an expert like Quality Smart Solutions (QSS) will assist with directing you and getting your products into Canada while being compliant with import regulations.
Not having an Importer of Record
For Natural Health Products that are built beyond Canada, you are expected to have and work with an Importer of Record. This party will act as a contact inside Canada for your NHPs. Health Canada requests will be sent to the Senior Official of the permit holder as well as the listed Importer of Record.
This requirement plans to guarantee there is a domestic contact individual for all marketed products that can answer and act promptly. On the off chance that you don’t have an Importer of record, set up or set apart on your label, your products might be held or rejected at the time of products being imported across the border. This can prompt further enforcement action.
Not obtaining approval for Sites
Health Canada has to ensure that all sites engaged with the licensable exercises (producing, labeling, packaging, warehousing, and importing NHPs) hold a Site License.
Domestic/Canadian sites will hold a Site License themselves. For every single foreign site, this will imply that they are attached/annexed to the site of an authorized licensed Importer. This authorizing system means to guarantee the treatment of NHPs before the sale is done as such inside a climate that is clean, all-around controlled, and sticks to Good Manufacturing Practices (GMPs).
On the off chance that your destinations are not endorsed your NPNs might be suspended until GMP proof for each site is given to, assessed, and supported by Health Canada. This can likewise prompt further authorization/enforcement activity.
Not monitoring Site License timelines
If it’s not too much trouble, realize that the posted Health Canada timelines for Site License applications and changes that are not at present being met by the regulator. It is hard to give an unmistakable course of events for endorsement since there are numerous factors, for example, Health Canada’s overabundance/line, the intricacy of sites/submissions, holes in testing or GMP documentation, answering Health Canada’s questions, and so on. We suggest building more than adequate extra time for your send-off plan to represent expected postponements in site authorizing and annexation.
In the event that you don’t expect and anticipate appropriate timing with Health Canada and start making manages deals with retailers preceding endorsement, it is conceivable these deadlines may not be met. We recommend at every possible opportunity, hanging tight for all approvals (labels, licenses, sites) to be set up preceding setting the cut-off times to stay away and provide potential conflict.
Not having testing results or labels that meet Health Canada Requirements
All NHPs should go through testing at the finished product stage and through a shelf life of realistic usability (dependability). This testing will show that your item meets Health Canada’s necessities for potency, purity and physical characteristics. The Quality Guide is an incredible reference tool that shows generally required testing. Product testing results or verification (proof) of future testing as a layout is expected at the time of site annexation.
All NHPs should have a compliant and bilingual label. The Labeling Checklist is one more incredible reference that shows components for an NHP label. The Importer of Record and permit holder address has to be available on your label for imported items. For all items we import, we propose a label review be done before they are printed.
In the event that you are not testing or labeling your products compliantly, you may not get a release decision for your product at the time of import. You may likewise confront a Health Canada review or a trade complaint, which can prompt further enforcement action.
Not realizing the above are legal requirements
Once more, as a NHP import permit holder, it is your obligation to know the regulatory requirements for Canada. The principal requirements for Natural Health Products are an NPN (Natural Product Number), a consistent bilingual label, and authorized annexed or licensed sites. Audit and knowledge of the guidelines (regulations) and related guidance direction are imperative to a successful outcome in the Canadian market.
How we can help?
Working with regulatory consultants such as Quality Smart Solutions and Quality Import Solutions will help bring your products into Canada in a safe and compliant manner. We hold an NHP Site Licensing which allows us to import products and annex foreign sites for our clients. Please reach out to our team of specialists for all your NHP regulatory needs!