Changes to the Foreign Site Expiry dates on Canadian Drug Establishment Licences

OVERVIEW

Effective July 21, 2016, Health Canada has changed the expiry date for foreign building GMP renewal evidence to a NERBY (New Evidence Required By) date.

WHO DOES THIS APPLY TO?

·       Those who import or are seeking to import drugs from a foreign site listed on the DEL Foreign Annex, including API release testing sites.

WHAT’S NEW

·       GMP renewal evidence must now be submitted on or before a NERBY date assigned by Health Canada.

·       Health Canada reviews the submitted GMP renewal evidence, which includes an inspection report. Based on their review, Health Canada calculates a new NERBY date of three to four years from the start date of inspection.

·       Previously GMP renewal evidence had to be submitted 250 calendar days before the expiry date, requiring DEL holders to calculate and track their foreign building expiry dates.

·       Health Canada will not assign a NERBY date for the following (i.e., they must continue to submit GMP evidence 250 calendar days before the expiry date):

o   DELs for API foreign buildings listed on API Annex

o   MRA foreign buildings.

KEY POINTS

·       The foreign building expiry date is now a "new evidence required by" (NERBY) date.

·       Health Canada determines the NERBY date using a risk-based approach that takes into account factors such as the drug category and/or a building’s compliance history.

·       If Health Canada receives the application along with complete and updated GMP renewal evidence by the NERBY date, the foreign building will continue to be considered GMP compliant and remain on the DEL Foreign Building Annex during the Health Canada review period.

·       If you do not submit your application package to Health Canada by the NERBY date, the foreign building may be removed from the DEL.

·       If Health Canada deems the renewal evidence unacceptable or incomplete at any time during the assessment process, the foreign building may be removed from the DEL. 

·       You can request an extension 90 or more calendar days prior to the NERBY date or expiry date listed on the DEL.

·       Extension requests must be specific to each foreign building, and must be accompanied by an application form (section 5 of FRM-0033 for each foreign building).

References:

1.     Quality & Compliance Services Inc. QuickNote on “Changes to DEL Application Process (NERBY Date) dated January 2017 http://www.qualitycompliance.ca/sites/default/files/QuickNotes/QuickNote_Changes%20to%20DEL%20Application%20Process%20(NERBY)%202017-01-11.pdf

2.     Health Canada DEL Bulletin No. 1 dated July 21, 2016.

3.     Health Canada Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) - http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0002-eng.php