A) Do I need an Establishment Licence?

If you fabricate, package/label, import, distribute, or wholesale drug products in Canada, you need an Establishment Licence (EL).

To determine what type of licence you require, follow the Establishment Licence Requirements flowchart (PDF).

	B) Do I need to release product? How do I make this happen?

Drug fabricators, packagers/labellers, and importers need to release product.
Each individual shipment must go through a disposition (lot release) process
before it can be released for use.

	C) Am I an importer, distributor, or wholesaler?      Which regulations apply to me?

As outlined in the GMP Guidelines:

• Distributor is a person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them, sells a food or drug
• Fabricator is a person who prepares and preserves a drug for the purpose of sale
• Importer is a person who imports into Canada a drug for the purpose of sale
• Packager/labeller is a person who puts a drug in its immediate container or affixes the inner or outer label to the drug
• Wholesalers sell certain drugs, other than at retail sale, where the seller's name does not appear on the label of the drugs

For regulations that apply to you, see
GMP requirements for particular activities (PDF).

If you are involved in any of these activities, you need to put a quality system in place and ensure it is maintained.

	D) How can Quality & Compliance Services Inc. (Q&C®) help me?

We can help you establish or re-organize your Quality Control system to meet HPFBI requirements in three basic steps:

1) The GMP Gap Analysis™
2) The Quality Control System Setup™
3) The Quality Control Officer Method™

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1) The GMP Gap Analysis™  evaluates existing quality systems, identifying
priority activities needed for compliance with Health Canada; also fulfills HPFBI’s requirement for annual GMP self-inspection. We perform the audit and provide a detailed written report outlining corrective actions. This report is stand-alone —
you can use it yourself or we can work with you to implement the
recommended changes.

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2) The Quality Control System Setup™  builds GMP quality systems and documentation meeting Health Canada requirements. We can fast-track
implementation of your quality system or take a phased approach, depending
on your needs. We work with you to develop The Compliance Quality Plan™
to provide a road map to long-term compliance.

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3) The Quality Control Officer Method™  provides day-to-day quality activities required to supply drug products to the Canadian marketplace, and manages Health Canada audits and queries. We use this method to maintain your quality system.

Our services include:

• Guaranteed 24-hour turnaround for product disposition
• Full coverage (our staff can manage variations in volume, urgent dispositions, etc.)
• Handling correspondence with and hosting audits by Health Canada
• Regulatory Services as required:
  • Drug Identification Number (DIN) applications
  • Transitioning of drug products to Natural Health Products (NHPs) where applicable

To view the process that applies to your operations, click on the following unique Q&C® flow diagrams:

	The GMP Importing Solution™
	The GMP Distribution Solution™
	The GMP Wholesaling Solution™