# The Medicines (Exemption from Licences) (Clinical Trials) Order 1995, Paragraph 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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Source: https://www.legislation.gov.uk/uksi/1995/2808/schedule/1/paragraph/12 (the official version)
Page: https://openlegislation.uk/medicines-exemption-from-licences-clinical-trials-order-1995/schedule-1/paragraph-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.