Paediatric Cough and Cold Products Attestation of Compliance

Contact: BGIVD Enquiries

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Paediatric Cough and Cold Products Attestation of Compliance

Product Name:

Drug Identification Number:

For this Post-authorization Division 1 Change (PDC), the revisions should be limited to the options listed in the table below. For any other changes, including revisions to the medicinal ingredients, a DINA submission should be submitted.

Options	Check (X)
1. The authorized cough and cold product is revised to remove indications for children under 12 years of age. No other changes are being made. (Proceed to signature line.)
2. The authorized cough and cold product will be retaining a paediatric indication in keeping with the labelling standard. (Complete sections below).

The following items must be completed for Option 2 only:

1. By Fall 2009, the labelling of marketed paediatric cough and cold products will be revised to comply with the Nonprescription Oral Paediatric Cough and Cold Labelling Standard¹.
   
   
2. The submitted label is an accurate representation of the label to be marketed and complies with the Nonprescription Oral Paediatric Cough and Cold Labelling Standard, as identified below (please check the appropriate boxes):
   

Subjects	Specifications as per the relevant sections of the Labelling Standard	Check(X)
1. Medicinal Ingredients	Each of the medicinal ingredients in the product is listed in Table 1, Section 2.
2. Pharmaceutical Forms	The product dosage form is listed under the "Acceptable dosage forms" (see Section 3).
3. Indication(s)	a) The product indication is listed under the "Acceptable Indications" (see Section 4.1). b) The brand name does not imply use in an unacceptable age group.2
4. Dosage Directions	a) Single and daily; and b) age group (see Section 5.1).
5. For Liquid Formulations	The single dose IS contained and labelled in a standard unit (see Section 5.1).
6. Directions For Use For Liquid Formulations	The following statement IS included with the directions for use: "Use only the measuring device provided." (see Section 5.2).
7. Warnings	As per Section 6.
8. Child Resistant Container	A child resistant container has been used (see Section 7.1).
9. Non-medicinal Ingredients	If listed, must be all inclusive.

Note: Sponsors should provide the documentation outlined in the Notice: To Market Authorization Holders: Health Canada's Decision on re-labelling of Certain Paediatric (0 to under 12 years) Nonprescription Cough and Cold Products in Canada, with this Attestation form. Health Canada reserves the right to request other changes where appropriate.

I hereby certify that the product will be in compliance with the Food and Drugs Act and Regulations:

Signature of the responsible officer of the Company certifying the accuracy of this document:

Signature Date
NameTitle
Company

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[1] Adult cough and cold products which include paediatric dosing ranges should also be revised to be in compliance with the Nonprescription Oral Paediatric Cough and Cold Labelling Standard.

[2] Changes to the brand name to remove any implication for use in an unacceptable age group will be accepted under this Post-authorization Division 1 Change stream (e.g. removing "infant" from the brand name). NO other brand name changes will be accepted under this stream.