Drug Establishment Licence (DEL) Consulting

Drug Establishment Licence (DEL) Application & Renewal Consulting Services

What is a Drug Establishment Licence?

Who Requires a Drug Establishment Licence?Drug Establishment Licence (DEL) application consultant

What is the DEL Application process?

Our DEL Application services

How Are Foreign Sites Regulated?

 

What is a Drug Establishment Licence?

  • A DEL is a licence issued to a person (company) in Canada to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations (FDR).

Who Requires a Drug Establishment Licence?

  • Fabricators (manufacturers), Packagers, Labellers, Testers (Quality Control & Stability labs), Importers, Distributors and Wholesalers of drugs that have a Drug Identification Number (DIN) assigned to that product.

What is the DEL Application Process?

  • An application must be submitted to the the Health Products and Food Branch Inspectorate (HPFBI).
  • Someone from the most local HPFBI office inspects the drug establishment to assess whether a person (company) is performing licensable activities in compliance with the requirements of Part C, Divisions 2 to 4 of the FDR pertaining to Good Manufacturing Practices (GMP).
  • A DEL will only be issued once the HPFBI has assessed the applicant as being in compliance with these requirements. Typically, there are Observations found. ICS then helps you create an action plan to address those Observations, and submit it to the HPFBI for review & approval.

Please refer to our QA Implementation & Training Services web page and our QA Auditing service page.

Our DEL Application Services

We can provide assistance with:

  • completing the application forms to ensure that the correct Activities, Categories, and Dosage Form Classes are selected;
  • calculations of the initial and annual fees, including requests for fee reductions or adjustments;
  • development of the (recommended) Site Reference File.

How Are Foreign Sites Regulated?

  • Foreign sites whose drugs are to be imported into Canada importers also fall under the scope of drug establishment licensing.
  • If it is an US manufacturer, often a copy of the FDA audit report has to be submitted to Health Canada, as there is only a Memorandum of Understanding (MoU) between the two countries.
  • However, if the manufacturer is located in the EU, Australia, or certain other countries, Health Canada has a Mutual Recognition Agreement (MRA) with their health authorities. Therefore, typically, this requires only requires a copy of the GMP certificate.
  • A foreign site will then be annexed to the Importer’s DEL.

Drug Establishment License application & renewal

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.


1 Comment

John Haldane

June 20, 2017at 4:35 pm

We currently handle anesthetics for the dental profession. We have a device license but not the drug license. What would our costs be to get the drug license? We strictly buy & sell the product, from Canadian suppliers.

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