Food and Drug Regulations
C.01.014.10 (1) If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug decides to discontinue the sale of the drug, they shall post the following information in English and French on the website referred to in subsection C.01.014.9(1):
(a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them;
(b) the drug identification number assigned for the drug;
(c) the drug’s brand name and proper name or, if it does not have a proper name, its common name;
(d) the proper names of the drug’s medicinal ingredients or, if they do not have proper names, their common names;
(e) the drug’s therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for, the drug;
(f) the drug’s strength;
(g) the drug’s dosage form;
(h) the quantity of the drug contained in its package;
(i) the drug’s route of administration;
(j) the date on which the manufacturer will discontinue the sale of the drug; and
(k) the reason for the discontinuation of sale.
(2) The manufacturer shall post the information
(a) if they decide to discontinue the sale of the drug in more than six months, at least six months before the day on which they will discontinue its sale; and
(b) if they decide to discontinue the sale of the drug in six months or less, within five days after the day on which that decision is made.
(3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.
- SOR/2016-139, s. 5
- SOR/2017-259, s. 10
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