Draft Guidance Document – Labelling of Pharmaceutical Drugs for Human Use
The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations, the Controlled Drugs and Substances Act, and its related Regulations including the Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations and the Benzodiazepines and Other Targeted Substances Regulations. Once finalised, adherence to this guidance is expected to support the safe and effective use of drugs by health care professionals, patients, and consumers.
How to Get Involved
This consultation is open for comment starting July 7, 2010 until October 5, 2010. Please select and read through the link below titled “consultation document”. Once read please submit your comments via email, fax or by mail to:
Policy_Bureau_Enquiries@hc-sc.gc.ca
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
Fax: (613) 941-1812
Interested parties are encouraged to provide comments and suggestions by October 5, 2010.
