The HumanMedicines Regulations 2012 applies to therapeutic doses. In this legislationthere are some exemptions from the need for a manufacturing licence such as the'Section 10' exemption which can be invoked here. There is no such exemptionfor the manufacture of IMPs. So, the manufacture of even...
as these documents do not form part of the clinical trial authorisation application. However, your report and comments on these aspects have been reviewed and considered with regard to the need for any regulatory action.