# Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/426d2947-02d6-4b5c-b2b2-62d2382aea1b
Type: Guidance
Published: September 1, 2022

> The Canada-United Kingdom Trade Continuity Agreement (CUK TCA) officially entered into force on April 1, 2021, establishing a streamlined regulatory framework for the pharmaceutical industry. A key component of this agreement is the Protocol on the mutual recognition of Good Manufacturing Practices (GMP) compliance and enforcement. This protocol allows Canada and the United Kingdom to accept certifications for pharmaceutical manufacturing facilities located in each other's territories, significantly enhancing the efficiency of safety oversight. By recognizing each other's inspection results and compliance programs, both nations reduce redundant administrative burdens while maintaining rigorous quality standards. Because this document describes a broad bilateral policy rather than a specific enforcement action, it does not identify individual company names, inspection dates, or specific violations. Instead, the focus is on the systemic coordination between regulatory bodies. The required actions involve the continuous mutual recognition of GMP standards and the ongoing exchange of data to ensure that all pharmaceutical products meet high-quality manufacturing requirements. This cooperative framework ensures that the safety and efficacy of medications are upheld across international borders through a unified approach to facility certification and regulatory enforcement.

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## Content

On April 1, 2021, the Canada - United Kingdom Trade Continuity Agreement ( CUK TCA ) entered into force. The CUK TCA Protocol on the mutual recognition of the compliance and enforcement programme regarding Good Manufacturing Practices ( GMP ) for pharmaceutical products (herein referred to as the Protocol for pharmaceuticals) allows Canada and the United Kingdom 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.

## Attachments

- [Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices ](/government/publications/canada-united-kingdom-trade-continuity-agreement-protocol-for-recognition-of-good-manufacturing-practices/canada-united-kingdom-trade-continuity-agreement-protocol-for-recognition-of-good-manufacturing-practices)