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The framework comprises three Lots: Lot 1: Pharmaceutical Assessment Assessment of pharmaceutical and quality data, including Module 3 and the sections of Module 2 relevant to Quality within the Common Technical Document. Lot 2: Medical Assessment Assessment of clinical, statistical and clinical pharmacology data, including Module 5 and the sections of Module 2 relevant to Clinical within the Common Technical Document. Lot 3: Non-Clinical Assessment Assessment of non-clinical data, including Module 4 of the Common Technical Document. The framework provides MHRA with access to specialist providers across these three areas, with work to be commissioned in accordance with the framework arrangements
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