All Canadian drug establishments must have a drug establishment licence (DEL) to fabricate, package/label, distribute, import, wholesale or test a drug. This is required under Part C, Division 1A …

A DEL is not required for distributing or wholesaling active pharmaceutical ingredients (APIs), including API for veterinary use set out on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients.

Dec 17, 2025 · Who Needs a DEL in Canada: Activities in Scope, Business Models, and Edge Cases. A Drug Establishment Licence (DEL) is Canada’s legal gateway for companies that make, test, import, …

A Drug Establishment Licence (DEL) is a document issued by Health Canada to an establishment in Canada to authorize that site to conduct drug related activities in compliance with Good …

A Health Canada Drug Establishment Licence (DEL) is required for Canadian and foreign sites that manufacture, package, label, test, import or distribute drugs for the Canadian market.

The DEL framework governs the licensing of businesses that manufacture, package, label, import, distribute, and wholesale drugs in Canada. This framework ensures that drugs available to …

Drug Establishment License is required by Health Canada for companies that: Fabricate drug products. Package drug products into cartons, containers, bottles, blister packs. Compliant labeling and …

A DEL (Drug Establishment License) governed by Part C, Division 1A of the Food and Drug Regulations—is a mandatory license for any business in Canada involved in fabricating, …

Apr 1, 2020 · This document provides guidance to drug companies on complying with Part C, Division 1A of the Food and Drug Regulations (FDR) regarding Drug Establishment Licensing (DEL) …

The Drug Establishment Licence (DEL) is the foundational regulatory requirement issued by Health Canada. It is mandatory for any establishment that performs specific activities related to human or …