Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Pre-positioning of COVID-19 drugs

A promising COVID-19 drug may be imported into Canada before it receives a Canadian market authorization. This early importation and placement in Canadian facilities is referred to as “pre-positioning.” It facilitates the immediate distribution of the drug upon authorization, making it available to Canadians as early as possible.

This mechanism may be used to import a promising COVID-19 drug into Canada if the Chief Public Health Officer (CPHO) of the Public Health Agency of Canada has notified the Minister identifying the COVID-19 drug that is to be pre-positioned.

To be eligible to import a COVID-19 drug for pre-positioning, several conditions are required:

• The Government of Canada has entered into a contract for its procurement.
• An authorization for the drug has not been issued.
• The manufacturer has filed a submission for the drug’s authorization.
• The importer of the drug to be pre-positioned has a valid Canadian drug establishment licence.
• The CPHO has provided the Minister with information required under C.08.009.03.
• The DEL holding importer has provided the Minister with information required under C.08.009.03(2), including
• Evidence demonstrating the foreign building(s) for which the COVID-19 drug is fabricated, packaged, labelled or tested meets the applicable requirements of the provisions of Divisions 2 to 4 of Part C of the Regulations.

Importation and distribution of a pre-positioned drug

Following the review of the information provided by the CPHO and importer, the Minister of Health issues a letter to the CPHO indicating whether the requirements of pre-positioning have been met. To facilitate importation of the pre-positioned drug into Canada, a copy of this letter should accompany the product across the border.

The person importing a COVID-19 drug for pre-positioning must have a drug establishment licence (DEL), but does not require the activity of importation to be licensed on the DEL. However, the DEL holder responsible for importing the pre-positioned COVID-19 drug will be subject to certain sections in Part C, Divisions 2 to 4 of the Regulations concerning storage, distribution, quality control and rapid recall.

A pre-positioned COVID-19 drug cannot be distributed for use until it is authorized in Canada. It can, however, be moved to an alternate storage facility, as long as the Minister has been notified by the CPHO of the civic address of that facility.

Once the drug receives market authorization in Canada, all DEL requirements apply to subsequent importation and distribution.

Pre-positioned COVID-19 drugs that do not receive market authorization under the Regulations must be destroyed or returned to the manufacturer.

For guidance on meeting the regulatory requirements for record keeping, storage and distribution of pre-positioned COVID-19 drugs, consult the:

• Good manufacturing practices guide for drug products (GUI-0001)

Evidence requirements to support the GMP compliance is included in the following guidance document:

• How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

For more information about good manufacturing practices and COVID-19, visit Good manufacturing practices and COVID-19.

Transition of pre-positioned drugs from the ISAD IO to the Regulations

After ISAD IO expires, COVID-19 drugs that met the requirements under sections 27 to 30 of the ISAD IO are deemed to have been pre-positioned under the Regulations.

Any information provided under sections 27 to 30 of the ISAD IO before it expires but has not been deemed to have met all requirements to pre-position will continue to be reviewed under the Regulations.