Notice of Intent to Amend the Prescription Drug List (PDL): Brimonidine

November 15, 2021
Our file number: 21-119262-176

The purpose of this Notice of Intent to Amend is to notify the revision of brimonidine or its salts on the Prescription Drug List (PDL), by adding a qualifier. Both the human and veterinary parts of the PDL are to be revised. Health Canada has conducted a scientific review of brimonidine tartrate against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations that led to this decision.

The current listing is:

The revised listing will be:

Consultation summary

The proposal for this amendment to the PDL was communicated through a Notice of Consultation. The Notice of Consultation was posted on the Health Canada website on September 1, 2021, followed by a 60-day comment period. No comments were received during the consultation period.

Based on the results of this consultation, the Minister of Health intends to go forward with the proposed revision of the listing of brimonidine or its salts, for human and veterinary use, with the above-noted qualifier. This decision will be effective six months from the date of this Notice.

Rationale

Brimonidine tartrate is a highly selective imidazoline alpha-2 adrenergic receptor agonist, a chemical class known to cause vasoconstriction (narrowing of blood vessels). Currently, drug products containing brimonidine or its salts as a medicinal ingredient require a prescription for human and veterinary use. Health Canada received a new drug submission for a brimonidine tartrate ophthalmic solution 0.025% (weight-volume, w/v), for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue, for adults 18 years and older.

Health Canada's review of the submission's safety, efficacy and quality evidence revealed that this new brimonidine tartrate ophthalmic product did not meet any of the criteria for listing on the PDL outlined in section C.01.040.3 of the Food and Drug Regulations. Clinical and consumer use studies confirmed that this product would be suitable for non-prescription use. It should be noted that when this PDL amendment proceeds, use of brimonidine tartrate products in children will continue to require a prescription.

A summary of how the submission does not meet any of the prescription criteria can be found in the consultation notice.

In conclusion, Health Canada's review revealed that none of the PDL criteria outlined in section C.01.040.3 of the Food and Drug Regulations apply to brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, used for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue for adults of 18 years and older.

Next steps

This PDL amendment will take effect on May 16, 2022 and communicated to stakeholders through the publication of a Notice of Amendment. No currently marketed product will be affected by this amendment.

Once the PDL is amended, sponsors seeking market authorizations for brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, for the indication included in the qualifier, can submit an application with safety and efficacy evidence to the Natural and Non-Prescription Health Products Directorate (NNHPD) for full assessment.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on this update to the Prescription Drug List, please contact:

Health Canada
Therapeutic Products Directorate
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca