Food and Drug Regulations
C.01.014.9 (1) If a shortage of a drug exists or is likely to occur, the authorization holder for the drug shall post the following information in English and French on a website that is operated by a party for that purpose with whom Her Majesty in right of Canada has entered into a contract to make that information available to the public:
(a) the authorization holder’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 under subsection C.01.014.2(1), if applicable;
(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 when the shortage began or is anticipated to begin;
(k) the anticipated date when the authorization holder will be able to meet the demand for the drug, if the authorization holder can anticipate that date; and
(l) the actual or anticipated reason for the shortage.
(2) The authorization holder shall post the information
(a) if they anticipate that a shortage will begin in more than six months, at least six months before the day on which they anticipate it to begin;
(b) if they anticipate that a shortage will begin in six months or less, within five days after the day on which they anticipate it; or
(c) if they did not anticipate the shortage, within five days after the day on which they become aware of it.
(3) If any of the information that was posted by an authorization holder 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.
(4) Within two days after the day on which the authorization holder is able to meet the demand for the drug, they shall post information on the website to that effect.
- SOR/2016-139, s. 5
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