Food and Drug Regulations

C.01.014.9 (1) Subject to subsection (5), if a shortage of a drug exists or is likely to occur, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall post the following information in English and French on the designated website:

• (a) the manufacturer’s name and contact information;

• (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 when the shortage began or is anticipated to begin;

• (k) the anticipated date when the manufacturer will be able to meet the demand for the drug, if they can anticipate that date; and

• (l) the actual or anticipated reason for the shortage.

(2) The manufacturer 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 make that determination; 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 the manufacturer changes, they shall update that information on the designated 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 manufacturer is able to meet the demand for the drug, they shall post information on the designated website to that effect.

(5) This section does not apply in respect of a shortage of a drug that results from a decision by the manufacturer to discontinue its sale.