Over-the-Counter Drug Compliance Solutions (OTC)

OTC drugs, prescription medications, radiopharmaceuticals, biologics, and gene therapies are all drug types. OTC pharmaceuticals, often known as non-prescription drugs, are health items available in the Canadian market that may be purchased without a medical prescription. Evidence of safety and efficacy must be supplied to Health Canada, whether it be pre-cleared information from OTC drug monographs, or clinical trials. 

OTC medications are regulated by Health Canada to guarantee their safety and to reduce health hazards to Canadians.

Over-The-Counter (OTC) Drugs in Canada

Over-the-counter (OTC), prescription medications, radiopharmaceuticals, biologics, and gene therapies are all drug types. OTC Pharmaceuticals, often known as non-prescription drugs, are health items available in the Canadian market that may be purchased without a medical prescription. Evidence of safety and efficacy must be supplied, whether it be pre-cleared information from OTC drug monographs or clinical trials undertaken on the innovative medication. OTC medications are regulated by Health Canada to guarantee their safety and to reduce health hazards to Canadians.

Why are our OTC Drug Compliance Solutions Important?

OTC drugs to be sold in Canada require a Drug Identification Number (DIN Number). This DIN Number on a product label indicates the drug has met all requirements for quality, safety, and efficacy. Canadian firms that are engaged in manufacturing, packaging, labeling, and importing non-prescription drugs must be licensed for these activities.

Monograph Categories

There are several monograph categories for Over-the-Counter (OTC) Drugs in Canada. These include Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).

Good Manufacturing Practices

Any company (domestic or international) that manufactures, distributes, or imports OTC pharmaceuticals must provide proof that they adhere to GMP.

Establishment License

A mandatory requirement to fabricate (manufacture), package, label, test, import, distribute, or wholesale a finished drug or bulk process intermediate drug.

Products we have successfully licensed!

Our team of experts have licensed several different types of products, including disinfectants, cough & cold medication, allergy medication, sunscreens, and more! Some of these services include; NHP, medical devices, dietary supplements, and veterinary health products (VHP).

Sports Nutrition
Sunscreens
Hand Sanitizers
Multi Vitamins
Super Green Health Products
Energy Boost Products
Gummies

Turnkey Solutions for OTC Drug Compliance in Canada

Our Canadian OTC Regulatory Experts are backed with extensive knowledge and years of experience. We offer OTC compliance consulting services for all types of companies to lessen the regulatory risk and assure a speedy way for the launch of your OTC drug. 

Health Canada Pre-Submission Meeting

Former Health Canada officers will guide you on how to submit a meeting request, prepare for discussion as well as attend meetings with you to offer support with Health Canada officials.

Drug Establishment License (DEL) Registration

Wondering how to get a Drug Establishment License? We offer complete support to register your facility for an Establishment License and ensure compliance with Good Manufacturing Practices (GMP). Contact us for more information.

Establishment License (EL) Registration

Wondering how to get an Establishment License? We offer complete support to register your facility for an Establishment License along with annexing foreign sites to Canadian import license holders.

Plain Language Labelling Compliance & French Translation

Worried about Plain Language Labelling (PLL) compliance and French Translation? Don't worry. We ensure your drug product label meets the applicable language requirements and follows the PLL format.

Frequently Asked Questions - OTC Drugs & DIN Numbers

OTC stands for “Over-The-Counter”. Non-prescription drugs, also called over-the-counter drugs, are health products that can be bought without a doctor’s prescription. Canada regulates these types of products to ensure they are safe for use and reduce health risks to the public.
Non-prescription OTC drugs require a valid Drug Identification Number (DIN) to be sold in Canada.

A Drug Identification Number (DIN Number) is a computer-generated eight-digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada. A DIN lets the user know that the product has undergone and passed a review of its formulation, labeling and instructions for use. A drug product sold in Canada without a DIN is not in compliance with Canadian law.

Through Health Canada’s Plain Language Labelling Initiative, there are new requirements for health product labelling and packaging, including a requirement for a Drug Facts Table (Facts Table) on the outer label of non-prescription drugs. The standardized format of the Drug Facts Table will help consumers find important product information quickly and easily.

The Cosmetic Ingredient Hotlist (Hotlist) is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances may be prohibited or restricted for use in cosmetics.

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