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Will a negative end in the performance evaluation course of action have an impact about the maturity degree (ML) from the NRAs, and As a result on prequalified solutions?
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What criteria must be fulfilled for any regulatory authority to become qualified with the WLA evaluation procedure?
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In the situation of products types – for example vaccines and medicines which include multisource (generics) and new medicines (new chemical entities), biotherapeutics and equivalent biotherapeutic products – all regulatory functions will probably be assessed, as they form an inter-related framework for ensuring the correct regulatory oversight of products and solutions about their lifecycle.
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