Guidance on the Food and Drug Regulations for public health emergency drugs: Pre-positioning
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Importation and distribution of a pre-positioned drug
After reviewing the information provided by the Chief Public Health Officer (CPHO) and importer, the Minister of Health issues a letter to the CPHO indicating if 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 importer of the pre-positioned public health emergency drug is subject to certain sections in Part C, Divisions 2 to 4 of the Food and Drug Regulations (regulations) concerning storage, distribution, quality control and rapid recall.
A pre-positioned public health emergency 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 of Health is 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 public health emergency 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 public health emergency drugs, consult the:
Evidence requirements to support the GMP compliance is included in the following guidance document: