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Specifies whether the agent\'s characteristic have been modified from those approved in the marketing authorization in a way that could affect its quality. EXAMPLE(S): OTHER NAME(S): NOTE(S): Modification may include a change in pharmaceutical form (e.g. over-encapsulation, colour, dilution, re-tabletting for blinding etc.) or removal from the primary packaging and repacking (e.g. removal from a blister and putting in a bottle).
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