+121. Before decisions on material changes to products, processes or systems or on exceptional …

121. Before decisions on material changes to products, processes or systems or on exceptional …

Before decisions on material changes to products, processes or systems or on exceptional transactions are taken, the RMF should be involved in the evaluation of the impact of such changes on the issuer of ARTs and should report its findings directly to the management body before a decision is taken.

1. Overview

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Summary Regulation

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements
Source Requirement

3. Related Standards

Standards
Source Requirement
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