82 - We are currently preparing our submission for a new product to Health Canada. In the meantime, the company is preparing it's financial report for the investors and they would like to include a section on the disease, it's implication on patients and a section on the molecule itself with results of it's phase III trials. Are there any restrictions, and/or do we have to submit the report to PAAB?

  • There are restrictions. From a regulatory perspective, you could do something as a "Press Release" following the category requirements in the Health Canada guideline "The Distinction Between Advertising and Other Activities" available on the HC web-site or found through a link to HC in the "Resources" section of the PAAB web-site.. If done properly and it is not promotional in nature, it would not be considered "advertising" subject to PAAB review. However, please note that if the activity does not meet all of the requirements for the advertising exemption, it would be considered "advertising" and subject to the provisions in the PAAB Code of Advertising Acceptance and possibly be in violation of the Food & Drugs Act.