Updates to Mutual Recognition Agreement between Canada and Switzerland

Drug Establishment Licensing Bulletin #187, January 31, 2025

On this page

• Recognition of extra-jurisdictional inspections
• Recognition of active pharmaceutical ingredients
• Recognition of stable medicinal products derived from human blood or human plasma
• Contact us

In 2000, the Mutual Recognition Agreement (MRA) between Canada and Switzerland on Medicinal Products: Drug Good Manufacturing Practices (GMP) Compliance Certification (Sectoral Annex on GMP) became operational. The MRA allows Canada and Switzerland to maintain its efficiency and effectiveness of compliance and enforcement efforts, through a mutual recognition of certification for GMP for pharmaceutical facilities located in their respective countries.

As of January 31, 2025, Canada and Switzerland agreed to expand the scope of the existing MRA.

Recognition of extra-jurisdictional inspections

A regulatory authority issues a certificate of GMP compliance (GMP certificate) attesting that a facility is complying with the GMP requirements.

Currently, the Canada-Switzerland MRA covers the exchange of a GMP certificate for products in finished dosage form for inspections conducted within Canada and Switzerland.

Effective January 31, 2025, Canada and Switzerland are mutually accepting GMP certificates for extra-jurisdictional inspections (i.e. GMP inspections conducted by Canada and Switzerland outside of our respective countries). Health Canada will accept all new or previously issued extra-jurisdictional GMP certificates if they are within:

• the validity period listed on the GMP certificate
• the operational scope of Medicinal Products: Drug Good Manufacturing Practices (GMP) Compliance Certification (Sectoral Annex on GMP)

If an extra-jurisdictional GMP certificate is available, importers only need to submit a drug establishment licence (DEL) application (FMR-0033) to add or amend the foreign building. GMP certificates will continue to be exchanged directly between Health Canada and Swissmedic. You do not need to submit GMP evidence to us for review.

Once the foreign building is determined to be compliant, it will be assigned a new evidence required by (NERBY) date and importers will need to submit a DEL application to renew the foreign building by the NERBY date. If no extra-jurisdictional GMP certificate is available to support the renewal of the foreign building, then you will need to submit evidence according to How to demonstrate foreign building compliance with drug good manufacturing practices(GUI-0080).

Note that the GMP requirements outlined in the Food and Drug Regulations must still be met. Health Canada's GMP requirements will still apply, including C.02.019 of the Food and Drug Regulations for finished product testing requirements. There are no GMP exemptions for imported finished dosage form products from extra-jurisdictional foreign buildings.

Recognition of active pharmaceutical ingredients

On November 8, 2013, regulatory amendments for mandatory GMP of active pharmaceutical ingredients (API) intended for use in human drugs came into force in Canada. The implementation of these regulatory amendments under the Food and Drug Regulations enabled Health Canada to include API under the operational scope of its existing MRAs.

As of January 31, 2025, Canada and Switzerland recognize each other's GMP compliance programme as equivalent for the GMP oversight of API. Health Canada will accept new and previous API GMP certificates issued by Swissmedic as evidence of GMP compliance if they are within the validity period listed on the GMP certificate.

Note that C.02.009 of the Food and Drug Regulations for raw materials testing requires the finished dosage form manufacturer to fully test starting raw material upon receipt or to perform periodic confirmatory testing when there is a certification programme in place as long as the requirements of C.02.010 are met. This requirement will continue to be applicable regardless of the origin of import.

Recognition of stable medicinal products derived from human blood or human plasma

As of January 31, 2025, Canada and Switzerland recognize each other's GMP compliance programme as equivalent for the GMP oversight of stable medicinal products (SMP) derived from human blood or human plasma. Health Canada will accept new and previous GMP certificates issued by Swissmedic as evidence of GMP compliance if they are within the validity period listed on the GMP certificate.

Contact us

If you have questions on the Canada-Switzerland MRA, email us at drug.international.affairs-affaires.internationales.drogue@hc-sc.gc.ca.

If you have questions on the GMP certificate process, email us at foreign.site-etranger@hc-sc.gc.ca.

Related link

• Mutual Recognition Agreement between Canada and Switzerland