OpenLegislation

Paragraph 12

Original text. Later amendments are not shown.

(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.