Notice - Product Monograph Template Revisions

February 17, 2010

Notice

Our file number: 10-100000-600

Product Monograph Template Revisions: a) New Boxed Message Insert for Overdose Management Information; b) New Address for Canada Vigilance Program

The following Product Monograph template revisions outlined under (a) and (b) of this Notice, are effective immediately.

(a) New Boxed Message Insert for Overdose Management Information

The September 4, 2007 Notice titled: Product Monograph - Overdose Management Information, outlined Health Canada’s intended approach to introducing improvements in overdose management information within the Product Monograph. As a result of stakeholder comments, as well as feedback provided during previous consultations on these issues, Health Canada is implementing the following:

• As Product Monographs are filed with new drug submissions or with submissions for changes to products already authorized, Health Canada is requesting the addition of a boxed message insert following the overdose narratives in Part I: ‘Prescribing Information’ and Part III: ‘Consumer Information’, for all Product Monographs (noting that Product Monographs for Schedule C products only contain an Overdose section in Part I).

  The boxed message for Part I will contain the following text and is now reflected in the Product Monograph templates posted to the Department Web site:

  For management of a suspected drug overdose, contact your regional Poison Control Centre.

  The boxed message for Part III: ‘Consumer Information’ provides instruction to contact a health care practitioner, hospital emergency department or regional poison control centre immediately, and is also reflected in the Product Monograph templates posted to the Department Web site.

• Note that sponsors are required under the Food and Drug Regulations to ensure drug product labelling is up to date and supports safe conditions of use. This includes overdose management information provided in the Product Monograph.

(b) New Address for Canada Vigilance Program

As an administrative update, all Product Monographs that are submitted to Health Canada and authorized with new drug submissions, or with submissions for changes to products already authorized, are to include the new Canada Vigilance Program address in the Part III: ‘Consumer Information’ section. This address replaces the former address for public reporting of suspected side effects to the Department’s Marketed Health Products Directorate and appears in the Product Monograph templates posted to the Department website as boxed text:

Reporting Suspected Side Effects

 

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 Canada Vigilance Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to:
    Canada Vigilance Program
    Health Canada
    Postal Locator 0701D
    Ottawa, Ontario
    K1A 0K9

  Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

Please note that the Product Monograph template for Schedule D products (Appendix I) will include, in addition to the Canada Vigilance Program address, the Public Health Agency coordinates for reporting suspected side effects for preventative vaccines. This template instructs sponsors to include the appropriate text box according to the biologic drug product.

Questions regarding this notice should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B
2^nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca