Exemption 37 of Statutory Instrument 2004/1031

There are times when non-commercial studies can benefit from a regulatory exemption. Regulation 37 in Statutory Instrument 2004/1031 is an exemption from the requirement to hold a manufacturing authorisation for investigational medicinal products (IMPs). The regulation specifically applies to “assembly” carried out in a hospital or health centre by a doctor, a pharmacist or a person acting under the supervision of a pharmacist.

The regulation, for example, allows an investigator conducting a randomised and placebo-controlled paediatric trial, designed to test a marketed liquid medication, to procure the active and placebo IMPs in bulk (either separately or from the same source). “Assembly” – i.e. re-packing, randomising and labeling (in compliance with Annex 13) – of the active and placebo IMPs can then be carried out by a hospital pharmacy as opposed to a contract manufacturer. The benefit in this case for the investigator is increased flexibility (e.g. for a dose escalation study) and saving on cost of manufacture.

There are restrictions that apply to this regulation. “Assembly” is tightly defined in the statutory instrument as:
(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;
(b) where the product (with or without other medicinal products of the same description) is already in a container, labelling the container before the product is sold or supplied, or used in a clinical trial, in that container.

Furthermore, the IMPs being assembled must be exclusively for use in that hospital or health centre or in any other hospital or health centre which is a trial site for the clinical trial in which the product is to be used.

The exemption also does not apply to Phase 1 units or contract packaging organisations as they do not meet the criteria of being a hospital or health centre. Investigators should also be aware that irrespective of the way in which this work is done (i.e. under an MIA-IMP or under the exemption) there is an expectation that GMP will be applied.

Despite the restrictions, the exemption is particularly attractive for many proposed non-commercial trials. Provided the regulatory conditions are met, this approach, together with diligent IMP planning and high quality placebo formulation and manufacturing options provided by MODEPHARMA, can save valuable time and IMP costs.

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About MODEPHARMA
MODEPHARMA is an independent advisory, sales and project management company, active in various areas of non-commercial clinical trial supplies. MODEPHARMA supports customers and manufacturing partners in all issues concerning pharmaceutical contract manufacturing and packaging of investigational medicinal products as well as a broad range of supporting services for clinical trials and studies. MODEPHARMA maintains a growing network of high-quality pharmaceutical contract manufacturing companies across the United Kingdom and European Union who bring with them extensive know-how. Through its extensive network MODEPHARMA is able to offer its customers the skills, expertise, strengths, capacity and capabilities of industry experts and offer tailor-made solutions for virtually all dosage forms.