2nd Aug 2012, 10:56 AM
IMP dispensing from a premises which is not a registered Pharmacy
Please can you advise
Active drug/Placebo IMP tablets are being dispensed directly from the manufacturer (who holds an MIA(IMP) license), to the patients home.
The researcher prescribes the IMP, and orders from the manufacturer on IWRS (web based), or the research nurse orders upon receipt of the prescription. The prescription doesn't go to the manufacturer but remains in the medical notes.
The manufacturer is not registered as a Pharmacy premises, as would be required by the General Pharmaceutical Council, under the medicines act. We have received conflicting advice on whether this requirement applies. One view is that IMPs are governed by the UK (Medicines for Human Use) Clinical Trials Regulations and therefore this requirement doesn't apply because it is not a requirement of this legislation, another is that we can't discount other regulations.
Are IMPs "Medicinal products" as defined under the medicines act? If so, do the requirements of the Medicines Act apply when it comes to dispensing?.