Notice: Classification of Medicated Vapour Products

December 8, 2015

Health Canada determines whether a product is to be regulated under the Food and Drugs Act (FDA) as a drug (i.e. pharmaceutical, biologic, or natural health product) or as a (medical) device. Detailed information on the classification of therapeutic products is available in Health Canada's Guidance Document: Factors Influencing the Classification of Products at the Device-Drug Interface.

Purpose

The purpose of this Notice is to communicate to industry and health care professionals that medicated vapour products containing ingredients such as eucalyptus, menthol and/or camphor are classified and regulated as drugs under the FDA. It outlines the principles and considerations applied in determining whether or not these products are over-the-counter (OTC) drugs or natural health products (NHPs). It is also to assist Health Canada in the implementation of its mandate and objectives in a manner that is fair, consistent and effective.

This notice does not indicate a determination on the classification of a particular product but rather communicates Health Canada's general approach to classifying medicated vapour products that qualify as drugs and medical devices. Individuals looking to market medicated vapour products have the opportunity to make representation to Health Canada on the classification of their products if required/desired. Health Canada will make determinations on classification of individual products only after hearing such representations.

Rationale for the Classification of Medicated Vapour Products as Drugs

This category of products is intended to provide relief from symptoms of colds, coughs, congestion, etc., via inhalation. Medicated vapour products with intended purposes such as "provides soothing vapours", "nasal decongestant", and "used in aromatherapy to help relieve colds/cough" are considered to be drugs (OTCs and NHPs) subject to the FDA and thus require market authorization prior to sale in Canada. Depending on its ingredients, these products can either be regulated as a drug under the Food and Drug Regulations and require a Drug Identification Number (DIN), or as a NHP under the Natural Health Products Regulations and require a Natural Product Number (NPN). Individuals seeking to market medicated vapour products will have to determine under which of these two sets of regulations the ingredients contained in their products fall.

Medicated vapour products may be available as topical rubs, patches, plug-ins (inserts or pre-filled) and solutions for use in vapourizers or humidifiers. As such, the delivery system component of these products (when applicable) may be considered to be a medical device under the Medical Devices Regulations (e.g. personal vapourizers).

When medicated vapour products are sold pre-filled, they are considered to be combination products. To reduce the regulatory burden on sponsors of drug/medical device combination products, and in accordance with the Drug/Medical Device Combination Products Policy, the entire product is regulated as either a drug or a medical device depending on the principal mechanism of action by which the claimed effect or purpose of the product is achieved.

Transition

To assist those medicated vapour products classified as NHPs to transition to the NHP regulatory framework, the Department has developed a Medicated Vapours monograph. To obtain market authorization, sponsors of medicated vapour products must submit their product information to Health Canada. The Health Product and Food Branch's risk-based compliance and enforcement approach will apply to these products while regulated parties bring their products into compliance with the appropriate regulations.

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Questions regarding Medicated Vapour Products can be sent to:

Submission Management Division
Natural and Non-prescription Health Products Directorate
Attn: Submission Administration Unit
250 Lanark Avenue AL 2002B
Ottawa, Ontario
K1A 0K9 (Canada Post delivery including Xpress Post)
K1Z 1G4 (Courier service excluding Xpress Post)

Questions regarding delivery devices that are not prefilled can be sent to:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Qualicum (Tower B)
2934 Baseline Road
Address Locator: 3403A
Ottawa, Ontario  K1A 0K9

Telephone: (613) 957-7285
Facsimile: (613) 957-6345
E-mail: device_licensing@hc-sc.gc.ca

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