# The Medicines (Exemption from Licences) (Clinical Trials) Order 1995, Paragraph 2


The active or inactive constituents, or the method of manufacture or assembly, of the medicinal product, where such change will affect the bio-availability or the shelf life of that medicinal product or both.

---
Source: https://www.legislation.gov.uk/uksi/1995/2808/schedule/3/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-exemption-from-licences-clinical-trials-order-1995/schedule-3/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.