Over-the-Counter (OTC) Products in Canada
By: Joe McCarthy, Lab Service Manager/Senior Regulatory Affairs Specialist, email
Are you selling or distributing an Over-the-Counter (OTC) product in Canada? Product registration with Health Canada’s Natural and Non-Prescription Directorate (NNHPD) is a complicated and time-consuming process.
Dell Tech makes DIN/NPN registrations easy.
The Dell Tech team of Scientific Regulatory Consultants has successfully registered thousands of OTC products for hundreds of clients in Canada over the last 30 years.
The Canadian over-the-counter product registration process is time-consuming and complex. Registrants must have labels reviewed against the various monographs and formulations reviewed against the Natural Health Products Ingredients Database (NHPID). Any registrant selling or distributing an over-the-counter product in Canada must hold a drug establishment license or a site license.
Dell Tech’s team of Scientific Regulatory Consultants have worked with Canadian and International companies for over 30 years, ensuring efficient and worry-free product registrations. Our flexible and confidential consulting services support every stage of the Drug Identification Number (DIN)/ Natural Product Number (NPN) registration process. We start by reviewing product formulations and labels, and then completing and submit all the necessary paperwork. Dell Tech Consultants will follow your product right through to registration.
The following products are classified as over-the-counter drugs by Health Canada and will fall into either DIN or NPN depending on the active ingredients:
- Acne therapy products
- Antiseptic skin cleansers
- Anti-dandruff products
- Athletes foot treatments,
- Medicated skincare products
- Diaper rash products
- Throat lozenges
Joe McCarthy, Senior Regulatory Affairs Specialist
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.