Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 191/2

1 August2014

Dear Sirs,

Commercial Information Circular No. 706/2014

Canada : New Labelling Requirements for Drugs

The Regulations Amending the Food and Drugs Relations (Labelling, Packaging and Brand Names of Drugs for Human Use) were published on Canada Gazette (CG) on 2 July 2014.The new regulations will come into force by phases.  For prescription drugs, the new regulations will be implemented twelve months after registration of the regulations while all provisions related to non-prescription drugs will come into force three years after registration of the regulations.

DETAILS

2. In gist, the regulations consist of targeted amendments to further emphasize the importance of plain language labelling.With the objective of improving the safe and effective use of drugs, the regulations consist of five targeted amendments (and consequential amendments) including a general requirement for clear, understandable, plain language labels; and four pre-market requirements (i.e. contact information on labels to report problems, standard table format for non-prescription drug outer labels, submission of label and package mock-ups, and look-alike/sound-alike name assessments).  The regulations apply to human drugs, specifically non-prescription and prescription, pharmaceutical and biologic drugs.  Details of the regulations are available at http://www.canadagazette.gc.ca/rp-pr/p2/2014/2014-07-02/html/sor-dors158-eng.php.

ENQUIRIES

3.For enquiries concerning this circular, please contact Mr Lewis LAU at telephone number 2398 5405.

Yours faithfully,

(Miss Janice LAU)
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.