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December 18, 2008
Our file number: 08-131053-434
To Market Authorization Holders: Health Canada's Decision on Labelling of Certain Paediatric (0 to under 12 years) Nonprescription Cough and Cold Products in Canada
This Notice provides information on Health Canada's decision related to the labelling of certain nonprescription cough and cold products that are regulated pursuant to Division 1 of the Food and Drug Regulations (FDR).
The medicinal/active ingredients included in the scope of this Notice are found in orally administered nonprescription cough and cold products and belong to the following therapeutic categories:
Nonprescription cough and cold products that are administered by routes other than oral are outside the scope of this Notice.
Aside from the ingredients, ephedrine and pseudoephedrine, which are now classified as natural health products, medicinal products or ingredients that are subject solely to the relevant sections of the Natural Health Products (NHP) Regulations are not affected by this decision.
By Fall 2009, the labelling of marketed orally administered paediatric nonprescription cough and cold products belonging to the therapeutic categories listed above are to include a statement to the effect of: "Do not use in children under 6 years of age." In addition, these products are also to have: (1) Enhanced labelling; (2) Child resistant packaging; and (3) The inclusion of dosing devices for all liquid formulations.
This decision for enhanced labelling and packaging is reflected in the draft Nonprescription Cough and Cold Labelling Standard. This labelling standard also identifies additional aspects that are being published for consultation, such as the permitted ingredients, doses, indications for use, font size, directions for use and ingredient-specific warning statements that will be required to appear on the product labels.
By Fall, 2009, the outer and inner labels for all the products will be required to carry advisory information and directions for use such as:
All of the following warnings may appear on an insert or inner panels if it can be demonstrated that space is limited on the packaging. Note that the packaging must carry clear instructions to access the insert or inner panels:
Market authorization holders are strongly encouraged to effect any necessary labelling changes as soon as possible. Health Canada will continue to monitor these products. By the Fall of 2009, Health Canada will be prepared to take appropriate regulatory measures, if circumstances warrant, to deal with any products that remain on the market without appropriate labelling. As of that date, orally administered nonprescription cough and cold products containing the ingredients listed above with dosing information only for children under 6 years (e.g. label has dosing for children under 6 years) are to be removed from the Canadian market.
In the interim, it is recognized that there will be products on the market that will not have the new enhanced labelling and packaging. Therefore, the appropriate use of these products will be communicated through a public advisory and an outreach/education strategy (see below).
Current market authorization holders for orally administered paediatric nonprescription cough and cold products belonging to the therapeutic categories listed above are to notify Health Canada's Submission Information and Policy Division (SIPD) within the Therapeutic Products Directorate as soon as they have met the new labelling and packaging requirements for their products by submitting a Post-authorization Division 1 Change for assessment that includes the following:
1. A signed and dated covering letter on company letterhead that includes a:
2. A copy of all current and proposed revised labelling with highlighted changes; and
3. The completed and signed documents:
To facilitate the assessment process, Health Canada encourages sponsors to also submit the information requested in electronic format.
Guidance related to how to provide electronic data to Health Canada is included in the following notice: Release of Health Canada's Revision to "1.6 Electronic Review Document" in draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.
The contact information for SIPD is:
Telephone: (613) 946-6431
Fax: (613) 941-0825
Only those changes outlined in this Notice will be eligible for the Post-authorization Division 1 Change process. Post-authorization Division 1 Changes which are compliant with the recommendations in the Paediatric Cough and Cold Attestation Form and which are received within 30 days after the posting of the final labelling standard will receive a priority review status. Any other changes should be submitted via a DIN application.
In collaboration with the relevant authorities within the health portfolio and professional health care societies, an education/outreach program has been created that:
As of today's date, manufacturers seeking authorization for the sale of cough and cold products in children, will be required to submit data from a pharmacokinetic study designed to provide additional dosing information for children's use, and efficacy data from paediatric protocols.
Information related to the Canadian clinical trial application process is available from the clinical trials manual, which also includes the contact information for submitting these applications to the Therapeutic Products Directorate for review.
Should you have any questions regarding the content of the Notice, please contact:
Bureau of Gastroenterology, Infection and Viral Diseases
Therapeutic Products Directorate
Health Products and Food Branch
Finance Building Address Locator 0202D1
101 Tunney's Pasture Driveway
Ottawa, Ontario K1A 0K9
Fax: (613) 941-1183