Guidance on the Food and Drug Regulations for public health emergency drugs: Pre-positioning a public health emergency 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 confirming that 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 PHED is subject to certain sections in Part C, Divisions 2 to 4 of the regulations concerning:

• storage
• rapid recall
• distribution
• quality control

A pre-positioned PHED 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.

For guidance on meeting the regulatory requirements for record keeping, storage and distribution of pre-positioned PHED:

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

Evidence requirements to support GMP compliance:

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