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This steerage just isn't intended to outline registration and/or filing necessities or modify pharmacopoeial demands. This direction won't have an affect on the power on the responsible regulatory company to ascertain precise registration/filing necessities with regards to APIs throughout the context of marketing/producing authorizations or drug pr
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The https:// guarantees that you'll be connecting into the Formal website Which any info you offer is encrypted and transmitted securely.This section is relevant just for orphan medicines. Demanded info on information and course of action are existing in “European Commission guideline on areas of the applying of Report eight of Regulation (EC) No