We are headquartered in Burlington, Ontario CANADA.
You are required to obtain a Natural Product Number (NPN), have a bilingual label and use a Health Canada licensed importer to sell your dietary supplement in Canada.
Can Quality Smart Solutions provide an effective alternative to hiring full-time personnel to handle my regulatory and quality assurance functions?
Yes, and we are able to provide considerable value during various stages of a company’s growth, whether your company is a startup or a multi-national corporation. Our consultants are often a more cost effective solution than full time employees, especially in the early stages of a company’s growth where cashflow is crucial. Sourcing, on-boarding, and training new personnel is costly, time consuming, and not always the most efficient use of your resources when starting up or reorganizing. Keeping your costs under control is a key driver to business success, survival, and longevity. You can eliminate risk, and quickly address your quality and regulatory concerns by taking advantage of our cost efficient and high value solutions. Should you experience untimely or unforeseen departures of key personnel at any stage, we have the resources to quickly help you cover key quality and regulatory functions while providing the expertise and stability you will need on an interim basis. Additionally, our consultants are routinely used by large and established organizations to fill gaps in knowledge or provide bandwidth support. We bring fresh and up to date perspective and expertise to regulatory and business issues that may not be seen “within the four walls” of a company. Consider the value we can add to your organization when evaluating your quality, regulatory and personnel needs.
An NPN is the abbreviation used for Natural Product Numbers issued for Natural Health Products in Canada. An NPN is a requirement to legally sell a dietary supplement in Canada. Natural Health Products are defined as vitamins and minerals; herbal remedies; homeopathic medicines; traditional medicines such as traditional Chinese medicines; probiotics; and other products like amino acids and essential fatty acids.
A submission number is issued when the product license application is submitted It is an acknowledgement that the application has been received. At submission acknowledgement stage the NHPD has conducted an administrative review of the application and the submission number is issued. The submission number will be referenced in all NHPD communications with the client until license issuance. Note that you cannot sell a Natural Health Product with a submission number.
An FDA structure-function claim notification should be submitted to the FDA either in writing or electronically through the FDA online portal no later than 30 days after commencement of sale of the dietary supplement in the United States. This notification informs the FDA of your product information and the structure-function claims you plan to make. This is not an approval. Prior to submitting an FDA notification we advise our clients to seek our advice on all product claims made on packaging to ensure that they are substantiated and are within the structure-function claim scope that is allowed for dietary supplements.
How quickly will I get receive an acknowledgement letter and submission number when my product license application has been submitted?
A submission acknowledgement letter is typically issued in 5 to 10 business days but this may take longer depending on Health Canada’s workload at the time the product license application was received.
All of the medicinal ingredients and their respective quantities in your Natural Health Product must be disclosed. This would be disclosed on your product license application, on Health Canada’s website, the Licensed Natural Health Products Database (LNHPD) and on your label. However, the quantity of your non-medicinal (inactive) ingredients are not required to be disclosed on your packaging.
English and French are both Canada’s official languages. As such, all labels must be bilingual when sold in Canada. There are few exceptions to this rule (eg. selling regionally within 50 km of its manufacturing site). In Quebec, enforcement of non-compliant (ie. French language missing or in the improper format) packaging can result in stop-sale, fines and/or recall.
If I worked previously with another consultant and would like Quality Smart Solutions to take over the work, how easy is to transfer the files and project?
This is a very simple process. For NPN, DIN or Medical Device handling from another consultant to Quality Smart Solutions a new Designated Party Authorization Form is completed. We will fill this out for you to sign and that’s it! The transition is that simple.
Do you prepare Nutrition Facts tables (Canada) and panels (USA) that are compliant with the new regulations?
For both our Canada Food label compliance solution and USA Food label compliance Solution the nutrition facts panels are future proofed meaning they comply with the new regulations that will come into force (USA) in January 1, 2020 and January 1, 2021 depending on the size of the company and in Canada, the transition date is December 15, 2021.