Natural Health Product Registrations
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One of DSA’s NHP Consultants will review your proposed labelling and formulation to determine if your product meets the definition of a natural health product. Some products which appear to be natural health products, are really classified as drugs or cosmetics, so it is important to have a trained regulatory professional review your labelling and formulation to ensure your product is properly classified. A DSA NHP Consultant can review your labels to advise you on compliance with the NHP Regulations, maximizing of claims, and ensuring that your labels meet your marketing authorization. With DSA’s NHP Regulatory Consulting services, we can advise you on whether or not changes to your approved labelling require notification to NHPD or amendment of your product licences. All products regulated as natural health products must be registered, labelled, and sold in accordance with the NHP regulations. DSA can prepare a full range of NHP submissions including:
All new products that meet the definition of an NHP must be registered with Health Canada. These products must be labelled in accordance with NHP labelling requirements and have an NPN (Natural Product Number) on its label in order to be sold in Canada. IMPORTANT: There are some transitional provisions which may help bring your product to market before it is approved for sale. If you are not aware of the transitional provisions, you should contact DSA Consultants to find out more. One of the advantages of using a full-service NHP consulting firm like DSA Consultants is that we offer the expertise of both Regulatory Consultants and Quality Consultants to lend their expertise to the NHP submission process. One of the key differences between NHP Submissions and OTC drug submissions, is that NHPD is involved in the process of reviewing and approving your finished product specifications. Failure to comply with NHPD requirements for finished product testing can result in costly delays with the submission approval timelines. And compliance with NHPD expectations for finished product specifications can result in costly delays in finished product testing; both with respect to the actual testing costs and the delays in waiting for lab results. This is why at DSA, we involve our Quality Consultants in the submission process to help justify testing reductions and mitigate NHPD questions or concerns before they are even raised. DSA does not operate an in-house test laboratory nor do we derive any revenue or commissions from testing labs. Therefore, we are always working in the best interests of our clients to obtain approval on reduced testing from NHPD. Don’t waste your time trying to navigate the requirements for NHPs. Instead, hire the EXPERTS at DSA Consultants who have a range of NHP consulting solutions to offer. A DSA NHP Consultant can expedite preparation of your submissions and help you secure a submission control number. If you haven’t yet started your NHP submissions, contact us now to find out to get the process started. If you have already filed your submissions, but aren’t sure they were completed to the expected standard, let us review your work so that we can make corrections to help avoid issuance of an IRN (Information Request Notice) or PDN (Processing Deficiency Notice) letters. Contact us today to find out how we can help you spearhead your NHP registration projects and obtain more information on services offered. To receive a copy of our white paper on marketing a therapeutic product in Canada, please click here. |
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