Mutual Recognition Agreement between Canada and Switzerland

Date of last update: January 31, 2025

Contact information: Mutual Recognition Agreement (MRA)

Text of the Agreement

The text of the Agreement can be found at the Global Affairs Canada website. In the relevant document, refer to the section entitled "Sectoral Annex on Medicinal Products / Drug Good Manufacturing Practices (GMP) Compliance Certification".

Text of the Agreement on Mutual Recognition in Relation to Conformity Assessment between Canada and Switzerland

On this page

• Key dates
• Scope - Product coverage
• Regulatory authorities involved
• Status summary - Update

Key dates

• October 1998
  Ratification of the Agreement
• December 1998
  Start of the confidence building exercise
• June 1^st, 2000
  Start of operational phase
• January 1^st, 2002
  Organizational changes - creation of Swissmedic
• November 2005 and May 2019
  Successful re-evaluation of Swissmedic
• January 31^st, 2025

  Recognition of GMP extra-jurisdictional inspection outcomes

  Inclusion of active pharmaceutical ingredient and stable medicinal products derived from human blood or human plasma in the operational scope

  Agreement on the information sharing and reliance processes related to Health Canada's on-site evaluation and Swissmedic's pre-approval inspection

Operational phase

Once a regulatory authority's GMP compliance programme is found equivalent based on the Mutual Recognition Agreement (MRA) evaluation process, the regulatory authority is considered to be in the operational phase of the MRA, meaning the exchange of certificates of compliance and the information on the two-way alert system is shared between the regulatory authority and Canada.

Canadian companies exporting drugs/medicinal products to Switzerland that fall within the scope of the MRA and that are manufactured within Canada may benefit from specified GMP exemptions provided by the MRA.

Canadian companies importing drugs/medicinal products that fall within the scope of the MRA and that are manufactured within Switzerland may benefit from specified GMP exemptions provided by the MRA as listed in the Canadian good manufacturing practices guide for drug products (GUI-0001).

Scope - Product coverage

Human and veterinary medicinal/drug products

Products covered, as written in the Agreement:

• Human pharmaceuticals including prescription and non-prescription drugs, and medicinal gases
• Human biologicals including vaccines, stable medicinal products derived from human blood or human plasma, biotherapeutics, and immunologicals
• Human radiopharmaceuticals
• Veterinary pharmaceuticals including prescription and non-prescription drugs, and pre-mixes for the preparation of veterinary medicated feeds
• Vitamins, minerals, herbal remedies and homeopathic medicinal products
• Active pharmaceutical ingredients

Clarifications:

• Products intended for use in clinical trials or investigational medicinal products; manufactured by the manufacturers holding a manufacturing authorisation or establishment licence.
• Human biologicals
  • The MRA covers GMP evidence for manufacturing sites of human biologicals. It does not address the Canadian requirements for lot-to-lot release of these products as set out under Section C.04.015 of the Food and Drug Regulations.
• Vitamins, minerals and herbal remedies, homeopathic medicinal products (known in Canada as natural health products) manufactured by manufacturers holding a manufacturing authorisation or establishment licence, in the case of Canada.
• As of January 31, 2025, prior to planning and conducting a product-specific on-site evaluation (OSE) in Switzerland related to the review decision for a submission under consideration by Health Canada, or a pre-approval inspection (PAI) by Swissmedic to confirm GMP compliance for a facility in Canada, Health Canada and Swissmedic will inform the other Party of the possible scope of the OSE or PAI and will request available information about the facility (including inspections reports). Any decision to carry out an OSE or a PAI should only be made after an assessment of all information. If at the conclusion of the assessment, a Party considers an OSE or a PAI necessary, it will propose to the other Party to conduct one on its behalf. Where there is still a need to proceed with either an OSE or a PAI in the other Party's jurisdiction, each Party can conduct its own OSE or PAI, and the other Party will be invited to participate.

Natural health products (NHPs)

Products regulated in Canada as natural health products (NHPs) will be captured by this MRA, when they are manufactured to a GMP standard equal to those for pharmaceutical drugs. While not limited to the following, these will primarily include specific commercial products of herbal medicines, probiotics and vitamin/minerals.

The Swiss's Therapeutic Products Act provides definitions of medicinal products including herbal medicinal products. As such, manufactures of these products require a manufacturing authorization and need to comply with pharmaceutical GMP.

Health Canada considers GMP requirements of Switzerland, as being equivalent to the GMP requirements outlined in the natural health products regulations. Therefore, Health Canada accepts valid GMP certificates issued by the regulatory authority within the Switzerland - Canada MRA, as evidence of compliance to NHP GMPs. In addition, all products that are manufactured at these sites are considered to be acceptable and do not require further confirmatory finished product testing in Canada.

Upon request of a Canadian exporter, or a regulatory authority under the MRA, Health Canada will issue a certificate of GMP compliance (GMP certificate) for facilities manufacturing, packaging/labelling, importing, distributing and/or testing NHPs in addition to drugs, which will clearly indicate which NHPs are held to a drug GMP standard (including premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control department, packaging material testing, finished product testing, records, samples and stability).

Should a facility manufacture, package/label, import, distribute and/or test NHPs only, Health Canada will perform a drug GMP inspection (of the sections stated above) and issue a GMP certificate in support of the activities, listing all of the products to be exported to a MRA country. A Canadian drug establishment license will not be issued in these cases, as it is not required by Canadian law.

Definite exclusions:

• blood and blood components
• veterinary biologics

Regulatory authorities involved

List of Switzerland regulatory authorities

Status summary - Update

Recognition of GMP extra-jurisdictional inspection outcomes (as of January 31, 2025)

Background

In 2000, the MRA between Canada and Switzerland on Medicinal Products: Drug 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 good manufacturing practices for pharmaceutical facilities located in their respective territories.

As of January 31, 2025, Health Canada and Swissmedic agreed to expand the existing approach of recognizing GMP inspection results to include inspections that are conducted in countries outside of the respective parties' jurisdictions (i.e. extra-jurisdictional inspections) for products included in the indicative list of products of the Sectoral Annex on GMP.

Operationalization of stable medicinal products derived from human blood or human plasma, and active pharmaceutical ingredients (as of January 31, 2025)

As of January 31, 2025, Health Canada and Swissmedic recognized each other's GMP compliance programme as equivalent for the GMP oversight of stable medicinal products derived from human blood or human plasma (SMP) and API. Therefore, it was agreed to include SMP and API in the operational scope of the Sectoral Annex on GMP.

Benefits

Stakeholders will benefit from the exchange of certificates of GMP compliance between Canada and Switzerland for extra-jurisdictional inspections, SMP and API. This will contribute to reducing the regulatory burden for the importers to obtain information to demonstrate compliance to GMP for their foreign buildings.

No GMP exemptions

The GMP requirements outlined in the Food and Drug Regulations (FDR) must continue to be met. As such, Health Canada's GMP requirements (GUI-0001) continue to be applicable.

Extra-jurisdictional inspections

Compliance with section C.02.019 of the FDR for finished product testing requirements applies. Therefore, there are no GMP exemptions for imported products from these foreign buildings.

API

Section C.02.009 of the FDR for raw materials testing requires the finished dosage form (FDF) 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 requirements of C.02.010 are met. This requirement will continue to be applicable regardless of the origin of import.