One of the largest barriers to growth as a pharmaceutical manufacturer or distributor is the differences in how products may be classified in different jurisdictions and the effect this has on getting your product to market. Until you know if your product is considered a Drug, Natural Health Product (NHP) or Cosmetic, you cannot begin the process of bringing your product to Canada.
We specialize in meeting Health Canada’s requirements and importing regulated products into Canada. We can help you to obtain your own licensing, or import your products under our licences.
Working as your Canadian-based partner, we leverage our industry knowledge and expertise to decrease your time-to-market and distribute your product across North America and Internationally.
Before selling your product several critical steps are required. First you must have a Drug Identification Number for each product, an Establishment License for your business importing and ensuring everyone along your supply chain complies with GMP standards. Additionally all applicable precursor Class A and B, controlled substance, and narcotic license applications must be submitted.
If your product is a biologic we will work to develop your lot release program, which minimizes delays while complying with Health Canada's BGTD requirements.
Q&C’s can significantly simplify this process, by importing your products under our own licences. This removes the need for you to establish a Canadian presence streamlining distribution.
Before importing an API into Canada, several critical steps are required. You must have an Establishment License authorizing you to import the API with Health Canada. You must also ensure everyone involved throughout your entire supply chain meets or exceeds the GMP standards. This includes having appropriate Quality Agreements in place between parties, such as the raw material suppliers to the API fabricator. This is where many people make their mistakes.
By importing under Q&C’s licences, you bypass the need to establish a Canadian presence helping you get your product to market much faster.
Natural Health Products are more common then most people think. Vitamins, probiotics and anti-acne products are all common examples.
To distribute these products the product needs a Natural Product Number and a Site License for importing We've been helping business with their Natural Product Number applications since before the guidelines were officially posted. Let's start yours now.
In order to import and/or sell a medical device in Canada you need to have the proper registrations from Health Canada for your device(s) and for your importers. Health Canada has four classes of medical devices and the class of your device depends on what it is used for. Approval of your license to sell and/or import your device can range from 15-180 days depending on the type of device and the application required. The more complicated the device the longer the review and approval time.
Q&C has an existing MDEL and can import on your behalf to simplify the application process and the maintenance of your registration(s). To add you to our existing MDEL is a straightforward application – contact us now to begin the process of importing your medical device.