Product Licensing (Canada DIN; USA OTC/Homeopathic)
Canada Pharmaceutical Submissions (DIN)
Canada has an intricate and detailed process for approving the sale of pharmaceutical (drug) products into the Canadian market, and pre-market approval is required. All drug submissions will undergo a rigorous review by Health Canada’s Therapeutic Products Directorate (TPD) or, in limited cases, by the Natural and Non-Prescription Health Products Directorate (NNHPD). Once the product undergoes a successful review, a Drug Identification Number (DIN) is assigned to the product, denoting its approval.
Products such as prescription and over-the- counter (OTC) drugs, ethical drugs, hard surface disinfectants, sunscreens, skin disinfectants, antiseptics, and ophthalmic products are likely to fall in this category.
Our experienced team members can advise on the application requirements for your specific product and prepare DIN applications to Health Canada, including the assembly of evidence packages for health claim substantiation, safety, and efficacy.
USA Pharmaceutical Submissions (OTC; Homeopathic)
In the USA, over-the-counter (OTC) drugs, also known as non-prescription drugs, are products that have been evaluated to be safe and appropriate for consumption without the supervision of a health care professional. Products such as sunscreens, topical analgesics, and homeopathic drugs often fall in this category. All OTC drugs in the United States are required to apply for and obtain a unique 3-segment National Drug Code (NDC) identifier prior to placing the product on the market.
Foreign manufacturers who produce OTC products for import into the USA are required to register with the FDA and also identify a United States agent (responsible party in the USA) and importer at the time of registration. All products are required to be manufactured according to good manufacturing practice (GMP) regulations in an approved facility, and must be labelled according to the OTC drug labeling regulations.
There are two regulatory pathways for OTC drugs in the United States – development under the OTC monograph process or through the New Drug Application (NDA) process. Products that do not meet the conditions of an OTC drug monograph must seek approval through the NDA process. At this time, NHP Consulting is only assisting with OTC drug submissions, and not NDA submissions.
Similar to OTC drugs, there are 2 types of homeopathic drugs in the United States, both of which are regulated by the Food and Drug Administration (FDA): prescription and over the counter (OTC). At this time, NHP Consulting is only assisting with OTC homeopathic drug submissions, and not prescription homeopathic drug submissions.
NHP Consulting has an in-depth understanding of these regulations and can determine the appropriate drug classification for your product, then register and list any OTC product with the FDA on your behalf.