DEL Bulletin No. 190, Regulatory Requirements Prior to Distributing Canadian Drugs Outside Canada was published on Mai 20, 2025, reminding stakeholders of their obligations under the Food and Drug Regulations with regards to the export of certain drug products.
We are sharing this as a courtesy notice as the types of products we represent at Cosmetics Alliance are out of scope under these regulations.
As a reminder, the products included and excluded are as follows:
Inclusions
Sections C.01.014.8, C.10.004 and C.01.014.13 to C.01.014.14 of the FDR apply to distribution by a DEL holder of the following drugs intended for the Canadian market for human consumption or use outside Canada:
- drugs that may be sold without a prescription, but are administered only under a practitioner’s supervision
- drugs on the Prescription Drug List
- drugs listed in Schedules C and D of the Food and Drugs Act
- drugs listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances Act
Exclusions
Natural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of these provisions.
Sections C.01.014.8, C.10.004 and C.01.014.13 to C.01.014.14 of the FDR do not apply to:
- sales made by a person who is not required to hold a DEL (for example, pharmacies selling drugs at the retail level)
- exports of drugs that are imported for the sole purpose of export (transhipment)
- exports of drugs that are manufactured in Canada for the sole purpose of export
