Draft for consultation: Guide to reporting drug shortages and discontinuations (GUI-0120): Definitions
This page is for consultation purposes only and may change. Learn about the consultation and how to provide your feedback. The consultation closes on March 8, 2025.
- Allocation:
- The action or process by which the manufacturer manages the limited availability or distribution of its drug product to prevent or mitigate a shortage.
- Avoided drug shortage:
- When a market authorization holder determines that they are no longer anticipating a shortage is likely to occur in the near future.
- Discontinue:
- To permanently stop selling the drug in Canada (FDR, C.01.001).
- Discontinuation:
- When a market authorization holder permanently stops selling the drug permanently in Canada.
- Drug establishment licence (DEL):
- A licence issued to a person in Canada pursuant to Division 1A of the FDR to conduct licensable activities in a building that has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the FDR
- Drug identification number (DIN):
-
An 8-digit numerical code assigned by Health Canada to each drug product marketed under the FDR.
A DIN uniquely identifies the following product characteristics:
- manufacturer
- product name
- medicinal ingredient or medicinal ingredients
- strength of medicinal ingredient or medicinal ingredients
- pharmaceutical form
- route of administration
- Establishment licence:
- Refer to the definition for drug establishment licence.
- Incorporation by reference:
-
A term to describe a mechanism, which allows a document or list that is not in the text of the regulations, in whole or in part, to be made a part of the regulations.
Health Canada uses incorporation by reference to:
- achieve policy and regulatory objectives
- leverage existing documents
- maintain agile regulatory frameworks that can more quickly adapt to changes in science or technology, or in response to an emerging health or safety risk
- Manufacturer or distributor:
- A person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug. (FDR, A.01.010).
- Market authorization holder (MAH):
- Refer to manufacturer or distributor definition
- Person:
- An individual or an organization as defined in section 2 of the Criminal Code.
- Resolved drug shortage:
- When a market authorization holder is again able to meet the demand for the drug.
- Shortage:
- In respect of a drug, a situation in which 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 is unable to meet the demand for the drug in Canada. (FDR, C.01.014.8 (2))
- Shortage prevention and mitigation plans (SPMPs):
- Plans that aim to prevent the occurrence or mitigate the impact of drug shortages by identifying, assessing and taking measures to prevent or mitigate the shortage risks associated with a drug.
- Tier Assignment Committee (TAC):
- An ad hoc committee of federal, provincial and territorial governments, health care professionals and industry stakeholders that makes recommendations on the tier assignment of a drug shortage.
- Wholesaler:
-
A person who is not a distributor described in section C.01A.003 of the FDR and who sells any of the following drugs other than at the retail level:
- a drug in dosage form that's listed in Schedule C or D to the act, a drug that's a prescription drug or a controlled drug as defined in section G.01.001 of the FDR
- an active ingredient
- a narcotic as defined in the Narcotic Control Regulations or
- a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act