Notice: Updates to the Guidance Document: Fees for the Review of Drug Submissions and Applications

November 6, 2015
Our file number: 15-111707-967

On July 2, 2014, Health Canada published in the Canada Gazette, Part II, the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use). These amendments aim to improve the safe use of drugs by making labels and packaging easier to read and understand. The regulatory amendments came into force on June 13, 2015 for prescription products and products administered or obtained through a health professional for human use.

Accordingly, the Guidance Document: Fees for the Review of Drug Submissions and Applications has been updated. The Document Change Log has been revised to reflect the changes and other minor revisions.

This guidance document becomes effective from the date of posting on the Health Canada website.

Questions or concerns related to this guidance document should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9

Facsimile: 613-941-1812
E-mail: policy_bureau_enquiries@hc-sc.gc.ca