Re-packing of Non IMP

We are going to a run a trial which involves EU licences non IMP product. This is a double blind cross over study where we have two strengths of nonIMP and
placebo. The patient will receive strenght 1 on day 1 strenght 2 on day 2 and placebo on day 3. The researcher wants to recruit about 10 subjects and wants to
keep all the stock in their department.

Is it OK to encapsulate the IMP to keep researcher and subject blinded at Hospital site or it has to be re-pack or encapsulate on a different site which has MA.
On a pharmacy side is it OK to re-pack the tablet in a empty capsules(for double blind) and dispensed to patient by patient basis.

Many thanks in advance

did you ever get a reply to this and work out your answer?

There is a specific exemption from the need for a MIA(IMP), which is described in Section 37 of The Medicines for Human Use (Clinical Trials) Regulations 2004. It is colloquially known as the Section 37 exemption. It applies to hospitals or health centres engaged upon assembly only. Such an institution does not require a MIA(IMP) if the assembled IMP is to be used in a clinical trial within that hospital or health centre, or another hospital or health centre named as an investigator site within that same trial.

“assemble”, in relation to an investigational medicinal product, means—
(a) enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or used in a clinical
trial, or
(b) where the product (with or without other medicinal products of the same description) is already contained in the container in which it is to be sold or supplied, or used in a
clinical trial, labelling the container before the product is sold or supplied, or used in a clinical trial, in that container.

“container”, in relation to an investigational medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet or
other article in which the product is or is to be administered.

Your question implies that the product in question is a market authorised product used in a clinical trial. The blinding mechanism (by encapsulation) indicates that it is used as an IMP. According to the definition of the Clinical Trial Regulation, encapsulation is a manufacture and does not fall into the definition of assembly. Therefore the pharmacy cannot re-pack the tablet in empty capsules (encapsulation) unless the site has a MIA(IMP) licence.

Note - the moderator has provided an answer in this incidence because the enquirer has not received a response for more than a few weeks.