Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes before April 1, 2021

Drug Establishment Licensing Bulletin 116, July 7 2021

Canada and the European Union (EU) officially recognized good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions on April 22, 2021. The scope of these extra-jurisdictional inspections was limited to those conducted on or after April 1, 2021.

This notice was published in DEL bulletin No. 111.

As of July 12, 2021, Canada and the EU now recognize extra-jurisdictional inspections conducted before April 1, 2021. The certificate of GMP compliance must be within the period of validity issued by the EU regulatory authority.

If the certificate is still valid, you may add, amend or renew the foreign building on your drug establishment licence. Use FRM-0033. Send this and your cover letter to Health Canada at hc.el.applications-le.sc@canada.ca.

We will obtain the certificate from the EU on your behalf.

For more information on this extra-jurisdictional initiative, please see the Mutual Recognition Agreement page. Or, you may contact us at hc.foreign.site-etranger.sc@canada.ca.