OTC Products in Canada

Posted November 1, 2016

By: Joanna Chudyk, M.SC., REGULATORY AFFAIRS SPECIALIST, email

Over-the-counter products, also sometimes called OTC products or OTC drugs, are non-prescription medications or products that consumers commonly find on the shelves of their local pharmacy.

OTC products in Canada are regulated by the Natural and Non-Prescription Directorate (NNHPD), a regulatory arm of Health Canada. OTC products are subject to pre-market approval before they can be sold legally in the Canadian market. Registration and approval is a notoriously complicated and time-consuming process. But don’t worry, Dell Tech can help you with OTC regulations.

In this article, we’ll review the basics of over-the-counter products in Canada, including product registration and site licensing. And of course we’ll let you know how Dell Tech can support you in registering OTC products in Canada.

What OTC products require registration?

The following products are classified as over-the-counter drugs by Health Canada. Depending on the formula’s active ingredients, the product will require either a valid Drug Identification Number (DIN) or Natural Product Number (NPN) for natural health products:

Sunscreen
Acne therapy products
Antiseptic skin cleansers
Anti-dandruff products
Athletes foot treatments
Cough medicines
Medicated skincare products
Diaper rash products
Throat lozenges
Herbal supplements
Multi-Vitamin and Mineral Products
Hand Sanitizers

The Canadian over-the-counter product registration process is time-consuming and complex. Registrants must have formulations reviewed against the Natural Health Products Ingredients Database (NHPID) and once approved, product labels will need to be reviewed against the Product License. Any registrant selling or conducting distribution for an over-the-counter product in Canada must hold a drug establishment license or a site license.

The importance of product registration for OTC products in Canada

Over the counter, non prescription drugs are regulated by Health Canada to address product safety and to reduce health risks to consumers.

When a product label contains a DIN, consumers can be confident that it meets the requirements for safety, quality and effectiveness set out by Health Canada.

Non prescription drugs must follow the product’s terms of authorized health, marketing and advertising claims.

If you manufacture or provide distribution for over the counter products in Canada, you are responsible for ensuring the product has approved market authorization. You may also have requirements for a site license. Failure to adhere to the regulations can result in product recall, Health Canada inspection and fines.

How can Dell Tech Laboratories support you with OTC product registration?

Dell Tech’s team of Canadian regulatory consultants has successfully registered thousands of over the counter, non prescription drugs over the last 30+ years. We offer confidential, professional advice to help your company bring compliant OTC products to market in Canada.

Our OTC services include:

Formula assessment
Product label development, annotation and review
Access to scientific and regulatory evidence to support your application
Accurate, efficient and worry-free product registration assembly
Ongoing with liaison with NNHPD during the review period, right through to registration

Dell Tech’s other areas of expertise with Health Canada include food regulation, medical device regulation, cosmetics and personal care products. Visit our Regulatory Affairs service page to learn more.