Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref : EIC 191/4
2 June 2010
Dear Sirs,
Commercial Information Circular No. 249/2010
Canada : Regulations amending the Food and Drug Regulations (743 – Non-medicinal Ingredients)
The Canadian Department of Health (Health Canada) published a notice in the Canada Gazette Part II of 26 May 2010 to promulgate Regulations amending the Food and Drug Regulations (743 – Non-medicinal Ingredients). This regulatory amendment will require all non-medicinal ingredients (NMIs) to be listed on the outer labels of nonprescription drugs for human use. It will come into force on 13 May 2012. The Gazette notice is available at http://canadagazette.gc.ca/rp-pr/p2/2010/2010-05-26/html/sor-dors105-eng.html.
DETAILS
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In order to assist consumers without the counsel of practitioners to avoid the adverse reactions caused by NMIs, Health Canada has determined to require for mandatory NMI labelling on the outer labels of non-prescription drugs for human use. The NMI labelling requirement does not apply to prescription drugs, non-prescription drugs only administered under the supervision of a practitioner, low-level disinfectants, or drugs for veterinary use.
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This amendment mandates that all NMIs be listed in alphabetical order or in descending order of drug proportion; NMIs be preceded with clear wording that distinguishes them from medicinal ingredients; flavours, fragrances, and pharmaceutical inks be listed but not their sub-ingredients. If the outer label is too small, drug manufacturers must clearly and prominently affix NMI labelling to the product so that it is readily discernible to the purchaser or consumer under the customary conditions of purchase and use.
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Other details of the NMI labelling requirement are set out in the Gazette notice mentioned above.
ENQUIRIES
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For enquiries concerning this circular, please contact the undersigned at telephone number 2398 5682.
Yours faithfully,
(Miss Carmen CHAN)
for Director-General of Trade and Industry
| Note : | While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same. |