Dell Tech helps companies register Natural Health Products (NHPs) with Health Canada. We provide support with product classification, formula and label review, NPN submissions, and site licensing to ensure your NHPs meet all regulatory requirements for safe and compliant sale in Canada.
We provide complete regulatory support from concept through to sale. Our experts help companies choose the correct regulatory pathway, prepare and submit all required documents, and respond to NNHPD requests.
We support both initial Site License applications and renewals. Our team ensures your SOPs, GMP documentation, and quality systems meet Health Canada’s expectations.
We review and develop compliant product label text in accordance with Natural Health Product Regulations and the Food and Drugs Act. Although Health Canada does not pre-approve NHP labels, all content must be accurate, non-misleading, and consistent with the approved Product License. Dell Tech ensures that your label meets formatting, language, claim, and ingredient listing requirements to avoid enforcement actions or delays at the retail level.
Health Canada requires every NHP to meet stringent guidelines related to formulation, safety, efficacy, and manufacturing. Companies must submit detailed documentation proving that the product meets the NNHPD’s requirements, and manufacturers must be able to demonstrate Good Manufacturing Practices (GMP). Products cannot be legally sold or imported until the required licenses are issued.
Every manufacturer, packager, labeler, and importer of NHPs in Canada must hold a valid Site License. This license confirms compliance with Canadian GMP standards, including SOPs, quality management systems, sanitation procedures, and storage protocols.
Site Licenses are valid for one to three years and must be renewed annually for the first three years, every two years for the next two cycles and then every three years after that, for as long as the site license is active.. Dell Tech can assist with the initial application process, as well as license renewals and audit preparation.
Canada’s NHP regulations play a key role in keeping food and drug products safe for Canadian consumers. All Natural Health Products must hold a Product License. The license process involves a review of the formula and the product claims to ensure the ingredients present are safe and efficacious when used as intended. Additionally, NHP regulations require that any sites that manufacture, package, label or import these products must hold a site license, which ensures the products meet safety and quality requirements.
Dell Tech is available to provide expert regulatory guidance at any stage of the product life cycle, including formula reviews, product registrations, labelling, site license registration and more. We also tailor our services based on our clients’ needs, whether it be providing answers to any regulatory questions that come up during review or compiling the entire registration package on their behalf. Our consultants are diligent in keeping their knowledge of NHP regulations up to date and ensure clients are aware of any upcoming changes that will affect their product.
Our team starts all projects with an in-depth review of your product’s complete formula to determine the product classification. There are 3 classes of submission under the NHP regulations, each with its own ingredient requirements – Class I, Class II, and Class III. Class I and II applications rely on pre-cleared monograph evidence for efficacy and safety. Class III applications can require a full review of safety, efficacy and quality data that supports the ingredients and claims listed on the application. The final step once classification is finalized is to file the complete product application, answer any questions that come up through the assessment process, and wait for Health Canada approval. Once approval is received our work is not complete – we are available to assist with compliant labeling, and any product changes that may occur or post-license information request notices.
Yes, our consultants’ comprehensive knowledge of the package and labelling requirements in Canada are a valuable asset when assisting clients in creating a compliant NHP label. Although the label is not reviewed by Health Canada during the registration process, it is still crucial that the label complies with the Food and Drugs Acts and Natural Health Product regulations. Not only do labels need to be compliant, but any marketing material and websites must also be consistent with the Product License.
Sellers, manufacturers, packagers, labelers, importers and distributors are responsible for ensuring the activities they conduct are in compliance with Canada’s Food and Drugs Acts as well as Natural Health Product regulations. Health Canada periodically audits licensed sites and product license holders to ensure they are operating in compliance with the NHPR . Failure to comply with the requirements outlined in the Product or Site License can result in repercussions that vary based on the severity of the offence; consequences range from a fine or warning to a full product recall. Companies can lose their licenses if the non-compliance issue continues and is not rectified.
Yes. Labels, IFUs, and packaging must be available in both English and French. Dell Tech reviews and formats documentation to ensure compliance with language requirements under Canadian law.
Our regulatory consultants are ready to help. Whether you need a full-service solution or support with a specific step in the process, Dell Tech will ensure your product reaches the Canadian market with confidence and compliance.
