Template for Notice to Hospitals - Health Product

Revised Date: 2012-07-27

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

Notice to Hospitals - Health Canada Endorsed Important Safety Information on [Health Product]

[Sponsor logo]

[Date (mm/dd/yyyy)]

[Version Number]

[Salutation]

[Insert the following text: Please distribute to relevant Departments [Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Dentistry, Intensive Care and/or other Departments as required], and other involved professional staff and post this notice in your institution.]

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 reaction 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-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases 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. ...