Regulatory position
In the NHS, there is an increasing need to utilise off-site aseptic preparation of ready–to-administer injectable products in clinical trials which may result in the need for supply across legal boundaries.
Reconstitution of an aseptic product is not considered as an assembly activity, and so does not require a Manufacturer’s Authorisation for Investigational Medicinal Products (MIA(IMP)). However, the act of labelling an IMP is considered to be assembly and needs either to be performed under an MIA(IMP) or under an exemption allowing pharmacist supervision of the activity.
Guidance to the NHS
This guidance document helps pharmacy aseptic and clinical trials leads to consider the legal and practical implications when transferring aseptically prepared Investigational Medicinal Products (IMPs) across legal boundaries.
It was produced by the NHS Quality Assurance Committee and National Pharmacy Clinical Trials Advisory Group with input provided by the MHRA Clinical Trial Unit, and GMP and GCP Inspectorates.
Attachments
Update history
- Improved accessibility. Formatting and minor amendments pending full review.
- Published