Further to Health Canada’s amendments to the Food and Drug Regulations (FDR) to make the provisions under the one-year Interim Order respecting drug shortages (safeguarding the drug supply) permanent, the regulations (spanning sections C.01.014.13 to C.01.014.14) come into force on November 27, 2021. The provisions, carried over from the interim order, prohibit a drug establishment licence (DEL) holder from distributing drugs intended for the Canadian market for consumption or use outside Canada if the DEL holder had reasonable grounds to believe the distribution would cause or exacerbate a drug shortage.
On November 10, 2021, Health Canada published the Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145) to help DEL holders interpret the regulations in sections C.01.014.13 to C.01.014.14 of the FDR. This guidance, which does not apply to natural health products, over-the-counter drugs and drugs for veterinary use, outlines the responsibilities of DEL holders and Health Canada. One such responsibility of DEL holders is to evaluate the potential impact on the Canadian drug supply if the distribution of the drug intended for the Canadian market is made available for consumption or use in another country. The guidance also provides a non-exhaustive list of examples of factors to consider in an assessment of drug shortage risks, including considerations such as:
- Listing of the drug as a Tier 3 drug shortage, as deemed by a Tier Assignment Committee on a case-by-case basis;
- Reporting of actual or anticipated drug shortages or discontinuations of the drug on the mandatory drug shortage reporting webpage;
- Anticipating demand changes for the drug;
- Availability of the drug in other markets; and
- Ability to meet Canadian customers’ requirements.
In addition to assessing the potential of a drug shortage risk, DEL holders are responsible for maintaining detailed documentation of this analysis, with a clear rationale for the conclusions about shortage concerns and maintain records of source information (e.g. publicly available information, organization’s business intelligence). DEL holders are required to maintain the documentation until one year after the latest expiration date of the distributed drugs.
As per section C.01.014.12 of the FDR, market authorization holders (MAHs) and DEL holders may be required to provide information on an actual or anticipated drug shortage to Health Canada in the format and within the timeframe determined by Health Canada. The process for providing this information is described in Health Canada’s Guide on the requirements for providing information related to drug shortages (GUI-0146), also published on November 10, 2021 and should be read in conjunction with the Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145). Notably, the guidance describes the criteria that must be met in order for Health Canada to require MAHs and DEL holders to provide information on an actual or anticipated drug shortage.
Following the coming into force of the amended FDR on November 27, 2021, DEL holders will be required to comply with the new regulations immediately. In order to hold DEL holders accountable for their business decisions and to ensure the stability of the Canadian drug supply, Health Canada may undertake compliance and enforcement activities, as described in the Compliance and enforcement policy for health products (POL-0001).
Author: Lydia To
References:
- Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145). https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/guide-distributing-canadian-market-consumption-outside-canada.html
- Guide on the requirements for providing information related to drug shortages (GUI-0146). https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/guide-requirements-providing-information-shortages.html
- Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply). https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/interim-order-drug-shortages-protecting-supply.html
- Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages): SOR/2021-199. https://www.gazette.gc.ca/rp-pr/p2/2021/2021-09-01/html/sor-dors199-eng.html
- Compliance and enforcement policy for health products (POL-0001). https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html
- Drug Shortages Canada. https://www.drugshortagescanada.ca