We are currently setting up a trial whereby the preparation, packaging, labelling and distribution of the IMPs are managed by a commercial clinical trial supply company under their MIA(IMP). In addition, the commercial clinical trial supply company will be dispensing/supplying IMPs (by post) directly to patients' home. The question is what are the specific requirements, if any, for the commercial organisation to undertake dispensing/ supplying IMP directly to subjects? More specifically, does this commercial organisation need to be a registered pharmacy?
My understanding is that within the Clinical Trials Regulation, there is no requirement, nor any references, to the dispensing/ supplying of IMPs to participants. In this respect, my interpretation was that there was no legislative requirement underpinning this activity. It was (and still is) unclear to me whether clinical trials activity is within the scope of other UK regulations such as the Medicines Act and therefore I have seeked advice from the MHRA and their response was as follow: " It is not defined in the Clinical Trial Regulations that you require a site (i.e GP surgery) or other commercial organisations to be a registered pharmacy in order to dispense IMP to subjects. However, you may want to check with GPC relating to any additional requirements for commercial organisations dispensing IMP directly to subjects."
Indeed, I will contact the GPC for further advice but I was wondering whether anyone has any comments/ experience on a similar matter. I remember a similar post was previously posted on this forum but I wan't sure whether we got anywhere with it.
Paediatric Research Pharmacist
L&SE Medicines for Children Research Network