Updates to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy to reflect Plain Language Labelling Regulations

Notice

August 26, 2015
Our file number: 15-109291-58

Updates to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy to reflect Plain Language Labelling Regulations

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 Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Guidance Document has been updated.

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

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: