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The European Medicines Agency cooperates with the Health Products and Food Branch of Health Canada, Canada’s medicines regulatory body, on regulatory issues and international medicine inspections.

The Agency and Health Canada exchange information on pre- and post-authorisation applications, including issues of major public-health interest, such as extensions of indications and important safety concerns that may have an impact on the use of a medicine.

The confidential information that the Agency can share with Health Canada includes:

  • all legislation and guidance documents available under the rules and regulations governing medicinal products in the European Union (EU);
  • post-authorisation pharmacovigilance data, particularly those of an urgent nature related to adverse drug reactions originating from within or outside the EU, as well as safety concerns arising from periodic safety update reports and post-authorisation obligations and commitments;
  • information contained in applications for scientific advice, orphan designation, marketing authorisation or post-authorisation activities of significant public-health interest, and applications for agreement of paediatric investigation plans;
  • good-clinical-practice (GCP) inspections for specific products and GCP inspection reports available to the Agency or the European Commission;
  • information-technology systems supporting regulatory processes.

The Agency, the European Commission and Health Canada signed a confidentiality arrangement in 2007, which was renewed in 2013 for a further period of five years, with tacit renewal for subsequent five-year periods.

The Agency and Health Canada have also signed a mutual recognition agreement to improve activities around good-manufacturing-practice-inspection information.

For an update on cooperation in 2014, see:

Renewal of confidentiality agreement

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Confidentiality agreement

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Mutual recognition agreement

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