MHRA produced FAQs for Investigational Medicinal Product (IMP)

[MHRA Super Moderator]

10. When does the Regulation 37 (Exemption for hospitals and health centres) apply?

Regulation 36 requires IMPs to be manufactured, assembled or imported in accordance with a manufacturing authorisation (MIAIMP).

Under the Regulation 37 exemption, hospitals and health centres are allowed to perform assembly activities for IMPs, without the need to hold a MIAIMP licence.

Assembly is defined as:
a. Enclosing the IMP in a container which is labelled, before the IMP is supplied or used in a clinical trial
b. where the IMP is already contained in the container in which it is to be supplied or used in a clinical trial, labelling the container, before it is supplied or used in a clinical trial, in that container.

However, exemption is only applicable for hospitals or health centres performing the assembly and by hospitals or health centres actively involved as a clinical site for that trial (this exemption does not apply to commercial Phase I units).