The online consultation is now closed. The final guidance is available now. Comments and suggestions received from the consultation on the draft version of the guidance were reviewed and considered in the finalizsation of this document.
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.
This consultation is open for comment starting July 7, 2010 until November 7, 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:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Fax: (613) 941-1812
Consultation Document: To obtain a copy of the draft guidance document that was consulted upon, please contact the Bureau of Policy, Science and International Programs.
Interested parties are encouraged to provide comments and suggestions by November 7, 2010.
If you have any questions, contact us at Policy_Bureau_Enquiries@hc-sc.gc.ca