Health Canada’s approach to foreign building name and addresses listed on the drug establishment licence
Drug Establishment Licensing Bulletin 166, June 6, 2024
On this page
- Background
- What is changing and why
- What DEL holders should do
- What to do when the foreign building name or address changes
- Contact us
Background
An importer's drug establishment licence (DEL) must indicate the foreign building name and address from which Health Canada authorizes importation. This is set out in Division 1A of the Food and Drug Regulations (regulations). It applies to foreign buildings listed on the Foreign Building Annex or the Active Pharmaceutical Ingredient (API) Foreign Building Annex (Table A) of the DEL, depending on the activities conducted.
To add or amend a foreign building that's listed on the Foreign Building Annex of the DEL, you must:
- use the drug establishment licence application form (FRM-0033) to submit you application
- submit evidence demonstrating you are in compliance with good manufacturing practice (GMP)
Drug establishment licence application form (FRM-0033)
The type of evidence required is outlined in the following guidance document:
Evidence can include either:
- a site master file (SMF) or
- an equivalent document, such as a quality manual (QM) or site reference file (SRF)
Or you must indicate in the cover letter and in FRM-0033 that a certificate of compliance (CoC) from the relevant regulatory partner is available.
The foreign building name and address listed in the site master file (SMF) (or equivalent) or on the CoC should correspond to what's listed on the DEL application. Doing so ensures the application will be reviewed in a timely fashion.
What is changing and why
Moving forward, the name and address of the foreign building on DELs will match the information provided in the most recent CoC or SMF (or equivalent). We will only contact applicants if necessary.
We are making this change to:
- improve foreign building naming consistency and
- reduce the number of deficiency notices issued
In the past, there have been discrepancies with the foreign building name and address in section 5 of the application form or in the Table A form.
We will be updating FRM-0033 and GUI-0080 as well as the following guidance to reflect this approach:
What DEL holders should do
Effective June 6, 2024, when submitting a DEL application or an amendment application:
- make sure the foreign building name and address listed in section 5 of FRM-0033 or in the Table A form match the most recent CoC or SMF (or equivalent)
- explain any discrepancies in the cover letter
Note: If you have any issues with character limitations when completing your DEL application, email us at del.questions-leppp@hc-sc.gc.ca.
What to do when the foreign building name or address changes
You must submit a DEL amendment application to amend the name and address of a foreign building listed on your DEL. This is in accordance with C.01A.006(2)(d)(ii) of the regulations.
For foreign buildings that are not located in a country with whom we have a mutual recognition agreement (MRA) or those that are located in a MRA country but for which a CoC is not available, submit:
- a DEL application listing the foreign building name and address as it appears on the SMF (or equivalent)
- the SMF (or equivalent) to support the change
For foreign buildings located in a MRA country for which a CoC is available:
- submit an application listing the foreign building name and address as it is listed on the CoC or
- include an explanatory note in the cover letter accompanying the DEL application if a revised CoC listing the new name or address has not been issued
- we will confirm the name and address with the applicable MRA regulatory authority before we update the DEL
For more information on MRAs, consult the page on mutual recognition agreements.
Contact us
If you have any questions, contact the Drug Establishment Licensing Unit at del.questions-leppp@hc-sc.gc.ca.
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