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The IPRP is pleased to share an updated Questions and Answers document on key aspects for reliance, that was revised by the IPRP Reliance Discussion Group to clarify the question on sameness of product. The document gives responses to frequently asked questions on points to consider for the implementation of reliance such as: what is reliance, why it is important for the regulatory oversight of medical products, the main principles and different existing models of reliance, the risk-based approach, identified barriers and enablers, etc. Reliance is one of the IPRP’s focus topics and is strongly supported by IPRP Members.
The document is now available for download.