To this end, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted, at least nine months before the marketing authorization ceases to be valid
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For the preparation of nuclear extracts, frozen liver pieces were homogenized in homogenization buffer (20 mM HEPES, 70 mM sucrose, 220 mM Mannitol, 2 mM EDTA, 0.5 mg/ml BSA, 0.1 mM PMSF, 1.0 mM DTT, pH 7.5)
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