# The Medicines (Exemption from Licences) (Clinical Trials) Order 1995, Paragraph 11


(a) A summary of pharmaceutical data in respect of the method of synthesis or preparation of each active constituent and, where appropriate, the results of physico-chemical tests to substantiate the structure of the compound, or
(b) where the active constituent is the subject of a monograph, the monograph name, if preferred.

---
Source: https://www.legislation.gov.uk/uksi/1995/2808/schedule/1/paragraph/11 (the official version)
Page: https://openlegislation.uk/medicines-exemption-from-licences-clinical-trials-order-1995/schedule-1/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.