Natural and Non-Prescription Health Products Directorate

The Natural Health Product Directorate (NHPD) is the regulatory body responsible for issuing product licenses for all NHPs. All products regulated as natural health products must be registered, labelled, and sold in accordance with the NHP regulations.

Q&R can prepare NHP submissions including:

Formulations are typically single ingredient and have well known dosages and clinical indications.

Formulations are typically more illustrative of contemporary NHP’s on the market.

Formulations contain botanical ingredients. These formulations are well described in traditional herbal literature.

All homeopathic medicines are to have a license before being sold in Canada. License holders are issued a product number that must appear on the label of their product preceded by DIN-HM.

Q&R Canada, Canada Compliance, Product regulatory, Health Canada, drug establishment licences, Health Canada

For NHP Submissions, the NHPD is involved in the process of reviewing and approving the finished product specifications. Q&R will prepare a report stating the final product specifications, including the identity, purity, potency and quantity of the medicinal ingredients. Our team will also review your labels to advise you on compliance with the NHP Regulations.

Q&R can accelerate preparation of your submissions utilizing the electronic submission system which provides quicker turn around for the submission number and subsequent NPN number. This system also reduces the possibility of the issuance of an IRN (Information Request Notice) or PDN (Processing Deficiency Notice) letters due to embedded rules while checking for specific regulatory requirements.

Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits.