Health Canada
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Template for Public Communications - Health Product
Revised Date: 2010-05-28
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(DOC Version - 32 K)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 adverse reaction]
[Paragraph 1 - Description of health risk]
- [Key message 1]
- [Key message 2]
- [Key message 3]
[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 reaction (AR) 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]
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.
For other health product inquiries related to this communication, please contact
Health Canada at:
Lead Directorate
E-mail: (Generic e-mail address)
Telephone:
Fax:
<Closing>
Original signed by
<Name>
References:
1. ...
2. ...
3. ...
