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What Is An Asmf? |
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Answer» Active SUBSTANCE master file is a submission which is made to EMA, MHRA or any other DRUG Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance. In simple words, “It is a submission made to EUROPEAN Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical INGREDIENT (API)”. Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance. In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”. |
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