How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Requesting a foreign onsite inspection
On this page
- When to submit a request for a foreign onsite inspection
- How to submit a request for a foreign onsite inspection
- Health Canada assessment
This section describes:
- when and how an importer can request for a foreign onsite inspection to support the addition, amendment or a renewal of a foreign building
- the assessment of the request
- the decision the importer can expect
When to submit a request for a foreign onsite inspection
If there is no supporting GMP evidence and the foreign building is not eligible for a NERBY extension request, you may submit a request for Health Canada to conduct an inspection of the foreign building.
For more information on supporting GMP evidence, refer to:
An onsite evaluation (OSE) conducted by Health Canada's Biologic and Radiopharmaceutical Drugs Directorate is different from an onsite inspection described in this section.
If a DEL application for the foreign building is in queue at the same time you requested an onsite inspection of that same foreign building, we may ask you to withdraw your DEL application.
How to submit a request for a foreign onsite inspection
Email your application to foreign.site-etranger@hc-sc.gc.ca. Include the following:
- cover letter
- FRM-0213
Once we receive your application, we will send you an acknowledgment by email within 1 month. We will assess the information provided in the cover letter and FRM-0213 and may ask for clarification.
If recent GMP evidence becomes available while a request for an onsite inspection is pending, you should withdraw your request for an onsite inspection and submit the new GMP evidence to us. Include the DEL application number in your email requesting withdrawal of the onsite inspection request to foreign.site-etranger@hc-sc.gc.ca.
For instructions on how to submit the evidence, refer to Submitting an amendment to the FB annex.
Health Canada assessment
During our assessment, we consider the:
- nature of the product
- for example, medical necessity, real or imminent drug supply shortage of a medically necessary drug as determined by Health Canada
- foreign building's compliance history
- plans by other trusted regulatory authorities to inspect or have recently inspected the foreign building
- licensable activities conducted by the foreign building
- categories of drugs and dosage forms fabricated by the foreign building
- activities, categories and dosage forms requested in FRM-0213
To help us with the assessment, include this information in your cover letter or in the Good manufacturing practices - Request for inspection of a foreign site form (FRM-0213). We usually complete an assessment within 2 to 3 months of acknowledging receipt, but this can be delayed if we do not receive responses to our requests for clarification quickly.
Our assessment of your request for inspection will result in 1 of 2 outcomes:
- Decision to accept the inspection request:
- an inspection may be conducted
- an email will be sent accepting the inspection request
- Decision to reject the inspection request:
- an inspection will not be conducted at this time
- an email will be sent declining the request and giving a reason for the decision
A Health Canada decision to accept a request for an onsite inspection does not contain a timeframe in which the inspection will be conducted. We take a risk-based approach when planning and scheduling inspections. It's the responsibility of the importer to work with their foreign buildings to obtain relevant evidence from within the last 3 years (or a validity period acceptable by Health Canada) on GMP compliance.
Note: In certain cases, we may inspect a foreign building remotely. When deciding whether a remote inspection is appropriate, we consider the:
- feasibility of an onsite inspection
- feasibility of a remote inspection
- is the foreign building capable of hosting a remote inspection
- type of inspection required
- critical nature of the products fabricated by the foreign building
- type of activities conducted by the foreign building
- foreign building's compliance history
You will be notified of the inspection outcome if an inspection is conducted. For more information on outcomes of inspections conducted by Health Canada, refer to Health Canada assessment outcomes.