Notice to Manufacturers/Sponsors of Nonprescription Drug Products: Emerging Regulatory Requirement for Non-Medicinal Ingredient (NMI) Labelling

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: Policy Bureau Enquiries

July 25, 2011

Our file number: 11-110824-728

Notice

Please read the Frequently Asked Questions (FAQ) carefully and note exemption categories to NMI labelling requirement.

This notice informs drug manufacturers/sponsors of Health Canada's expectations concerning the implementation of a regulatory amendment on NMI labelling.

This amendment to the Food and Drug Regulations requires the listing of NMIs on the outer label of non-prescription drug products for human use, and will come into force on May 13, 2012. It does not apply to prescription drugs, non-prescription drugs only administered under the supervision of a health care practitioner, low-level disinfectants, or veterinary-use drugs. This requirement will affect:

1. drug products that are already market authorized; and,
2. new applications for market authorization.

This requirement is not applicable to Natural Health Products (NHPs).

In order to facilitate a smooth and timely implementation of this requirement, drug manufacturers/sponsors are requested to take an initial step towards assuring compliance by sending Health Canada an attestation letter to indicate the date that they have met or plan to meet the NMI Labelling regulatory requirement for their non-prescription drugs for human use that are currently on the Canadian market. No attestation is required for new applications due to standard review processes already in place.

Drug manufacturers/sponsors should reproduce the Non-Medicinal Ingredients Labelling Attestation Letter Template (appended) on their company letterhead, have it signed by the responsible office of the Company certifying the accuracy of the document, and return it as a part of their response to Health Canada's Submission and Information Policy Division (SIPD) Annual Notification mail-out.

Attestation letters can also be directed to:

Submission and Information Policy Division (SIPD)
Therapeutic Products Directorate
Health Canada
101 Tunney's Pasture Driveway
Address Locator: 0201A1
Ottawa, Ontario
K1A 0K9

Questions or comments regarding this Notice should quote "NMI Labelling" in the subject line and 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
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca