Updates to the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use

September 15, 2015
Our file number: 15-109734-699

Notice

On June 19, 2013, Health Canada published in Canada Gazette, Part II amendments to the Food and Drug Regulations. The Regulations Amending Certain Regulations concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations) provided for the repeal of Schedule F and incorporation by reference of a list of prescription drugs. This regulatory amendment came into effect on December 19, 2013.

In addition, on July 2, 2014, Health Canada published in Canada Gazette, Part II, other amendments to the Food and Drug Regulations. The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) introduced targeted amendments to emphasize the importance of plain language labelling. These regulatory amendments came into force on June 13, 2015 for prescription products and products which are administered or obtained through a health professional.

Accordingly, the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use has been updated. The Document Change Log has been revised to reflect the changes and other minor revisions.

Note that this guidance document does not reflect information included in the draft Good Label and Packages Practices Guide. It will be revised to reflect the final version of the Guide once it becomes available.

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

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