Template for Public Communications - Health Product

Revised Date: 2012-07-27

Also available in French: Modèle de communication au public - Produit de santé

Public Communication - Health Canada Endorsed Important Safety Information on [Health Product]

[Sponsor logo]

[Date (mm/dd/yyyy)]

[Version Number]

[Salutation]

Subject: Association of [insert Brand Name (generic name)] with [insert specific side effect]

[Paragraph 1 - Description of health risk]

• [Key message 1 - Describe the health risk]
• [Key message 2 - State what people can do about the health risk]
• [Key message 3 - Provide any other important information]
• [Key message 4 - Optional]

[Paragraph(s) including additional detailed instructions on how to use the new safety or therapeutic effectiveness information]

[Paragraph(s) describing risk management measures]

[Paragraph including side effect reporting instructions. The following statement should be included:]

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious [specific side effect] or other serious or unexpected side effects in patients receiving [brand name] should be reported to [name of sponsor] or Health Canada.

[Name and address of sponsor in Canada]

You can report any suspected side effect associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

For other health product inquiries related to this communication, contact Health Canada at:

Lead Directorate

E-mail: (Generic e-mail address)

Telephone:

Fax:

<Closing>

Original signed by

<Name>

References:

1. ...
2. ...
3. ...