Consultation on the new Prescription Drug List

As part of the Jobs, Growth and Long-term Prosperity Act (Bill C-38), which received Royal Assent on June 29, 2012, the Government amended the Food and Drugs Act to give the Minister of Health the power to establish a list that sets out prescription drugs.

This proposed new list of prescription drugs, known as the Prescription Drug List, will replace the existing Schedule F to the Food and Drug Regulations. The regulatory process to add or remove a drug from Schedule F will be replaced by an administrative process where drugs can be added more easily and in less time.

To operationalize these recent changes to the Food and Drugs Act, amendments to the Food and Drug Regulations are required. To support the proposed regulatory amendment, a draft guidance document and draft of the new Prescription Drug List have also been developed. More information and links to all of these documents can be found below under How to Get Involved.

A question-and-answer document has also been created to further explain some of the proposed changes with the new Prescription Drug List and the administrative process for assigning prescription status.

A news release was published in April of 2012.

How to Get Involved

This consultation is open for comment until March 7, 2013. Please read through the information provided and select the appropriate link.

Draft Regulations

The Food and Drug Regulations require amendments to replace Schedule F with the administrative process of the Prescription Drug List. On December 22, 2012, Health Canada published in Canada Gazette, Part I a regulatory proposal to amend the Food and Drug Regulations.

To access and comment, please go to the  draft regulations.

Draft Guidance Document

The draft guidance document Determining Prescription Status for Human and Veterinary Drugs supports the regulatory proposal by explaining the broad principles and factors that Health Canada considers when deciding whether a drug would be best sold as a prescription drug or a non-prescription product.

To access and comment, please go to the draft guidance document.

Proposed Prescription Drug List

The proposed Prescription Drug List will list drugs and classes of drugs divided into a user-friendly format for human use and for veterinary use. The proposed list will not include ingredients listed in Controlled Drugs and Substances Act Schedules.

To access and comment, please go to proposed Prescription Drug List.

For More Information

To comment on the individual consultation elements, click on the above links.

For general questions and concerns, please contact:

policy_bureau_enquiries@hc-sc.gc.ca

Health Canada
Health Products and Food Branch, Therapeutic Products Directorate
Bureau of Policy, Science and International Programs
Address Locator 3102C5
Holland Cross, Tower B
1600 Scott St.
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623

Interested parties are encouraged to provide comments and suggestions by March 7, 2013.

Reporting to Canadians

The results of the consultation will be made available.