NHPs & OTC Drugs

Non-Prescription (OTC), Natural Health Products, Herbal medicines, Dietary Supplements

In Canada, natural health products (NHPs) are defined as vitamins, minerals, herbal products, homeopathic medicines, probiotics, herbal products, essential fatty acids, and amino acids that are used to treat or diagnose a medical ailment.  Non-prescription drugs, also called over-the-counter drugs (OTC), are health products that can be bought without a doctor’s prescription and sold directly to consumers.  In Canada non-prescription drug will require a drug identification number (DIN).

At AxSource Consulting, we assist companies with NHPs and OTC registration. We liaise directly with the Natural and Non-Prescription Health Products Directorate (NNHPD) on behalf of our clients to process product applications (Class I, II, III) and review and suggest the most expeditious route to licensing.We also provide support to CROs, laboratories, packagers, and labelers of natural health products.

Let us review your formulations & health claims and register your products (PLAs) & facilities (SLAs) in Canada.

In USA, in accordance with regulations governing Dietary Supplements, products are assessed for safety and accurate labeling prior to marketing.  While in Europe, the Committee on Herbal Medicinal Products (HMPC) considers herbal products.

To learn more about our NHP, herbal medicines and OTC services, visit our Regulatory Affairs Services page.