notice classification of non-medicated eyewashes 2 pages in english and french . canada is proposing that all non-medicated eyewashes licensed as medical devices be regulated as natural health products nhps under the natural health products regulations nhpr of the food and drugs act. the goal of this transition is to increase consistency and predictability for both consumers and manufacturers of non-medicated eyewashes. the department of health the department has made this proposal because non-medicated eyewashes meet the definition of drug in section 2 of the food and drugs act given they are a mixture of substances used in the treatment of an abnormal state. when intended for human use they meet the definition of nhp because their medicinal ingredient purified water is a natural substance as per schedule 1 to the nhpr. more information on the factors that influence the classification of a therapeutic product as either a drug or device can be found in the guidance document factors influencing the classification of a product at the device-drug interface. manufacturers of non-medicated eyewashes marketed as medical devices will be given an opportunity to make representation to the department on the proposed classification of their products from a medical device to a nhp. the departments therapeutic products directorate tpd will make a final product classification determination within 30 days of receiving any submissions from manufacturers explaining why their product should remain a medical device. under the nhp regulatory framework all nhps must have a product licence identified by a natural product number npn . implicated manufacturers of non-medicated eyewashes will have their files transferred to natural health products directorate nhpd without additional filing requirements for issuance of the npn. canadian sites that manufacture package label or import nhps also must obtain site licences as per the nhpr. implicated manufacturers packagers labellers and importers of non-medicated eyewashes will be given detailed information and support on how to complete the site licensing application process. during the transition the department is proposing to allow non-medicated eyewashes to remain on market until a npn and site licence is issued by the nhpd. once a npn is issued for the product the department will expect new labelling to be made available to consumers by the sooner of the next label run or 12 months from the date the npn was issued