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12.—(a) Where a specification has been established for a constituent—
(i)a summary of pharmaceutical data in respect of the specification of each such constituent (whether active or not) or, where a constituent is the subject of a monograph, the monograph name, if preferred,
(ii)in the case of each constituent (whether active or not), a summary of pharmaceutical data in respect of the quality control procedures and methods to be applied to ensure compliance with the specification of that constituent;
(b)where a specification has not been established for a constituent, a batch characterisation for each batch of that constituent to be used in the clinical trial.
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