1.5 Materials Not Subject to Preclearance

A) Learning Materials

Information materials that have been independently controlled and prepared, with industry involvement limited to purchase and/or sponsorship of the distribution (e.g. a textbook).

Collaterals such as reports that contain sections of accredited Healthcare Professional Meetings or Continuing Education (CE) events or activities organized independently of the sponsor of the materials and those materials are not focused on, or provide emphasis on, the sponsor’s product(s). This means these materials do not promote the sale of the sponsor’s product(s).

See Health Canada guideline: “The Distinction Between Advertising and Other Activities,” regarding the section: “Continuing medical education, scientific/medical exhibits and conferences” that states: “reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience

  1. Please note that these items are not required for PAAB preclearance review, however, they may fall under the definition of “advertising” in the Food & Drugs Act and Regulations. See the Health Canada Policy “The Distinction Between Advertising and Other Activities” on the Health Canada website. See definition of advertising.
  1. Materials that are created by the academic organizers of accredited Continuing Education events or activities may be distributed at the event or to the registrants of that meeting at a later date. 
  1. If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsor’s products are emphasized; the complete document must be submitted to PAAB for preclearance. The respective roles of the authors and the sponsoring pharmaceutical company must be stated clearly on the title page.
  1. Sponsorship statements must not include any listing of product(s) in order to fall within this section. This means if products are listed in information materials and statements it will trigger preclearance requirement.

B) Person-to-Person Correspondence

This applies to a single letter carrying a personal response or message and does not apply to multiple personal letters initiated by the company.

C) Government Agency Correspondence

This refers to requirements over which PAAB has no jurisdiction such as, but not limited to, drug recalls or warning notices.

D) Contextual use of a Healthcare Product Name

Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages.

The following is permitted:

i. Company price lists containing no therapeutic claims, price comparisons or claims of company or product merit, status or issues.

ii. A message comprised only of the words “now on provincial formulary” (or equivalent) in a manner which is not linked to a therapeutic message in any way and does not include a coverage criteria or code.

iii. A message of “available at company X”.

iv. A message of “Congratulations to company X on their 30th anniversary – sponsored by Company X makers of product Y”.

v. Images of packaging materials are acceptable if no therapeutic claims are visible.

E) Corporate Messages that do not Contain Product Information or Product Lists

F) Patient Information direct from and consistent with the Product Monograph or when the information is solicited by the patient directly from the manufacturer.