Template for Dear Health Care Professional Letters - Health Product

Revised Date: 2012-07-27

Also available in French: Modèle d'avis aux professionnels de la santé - Produit de santé

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 adverse reaction]

[Paragraph 1 - Description of health risk]

• [Key message 1 - Describe the health risk]
• [Key message 2 - State what health professionals 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 adverse reactions reporting instructions. The following statement should be included:]

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

[Name and address of sponsor in Canada]

To correct your mailing address or fax number, contact [name of sponsor]

You can report any suspected adverse reactions 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. ...