UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The HMRs state that a person may not sell or supply, or offer to sell or supply, an unauthor- ised medicinal product, or a medicinal product other than in accordance with the terms of an MA. However, there are exceptions whereby a product can be placed on the market without an MA. The main exception is often called “named- patient supply” and applies if the medicinal product is: • supplied in response to an unsolicited order; • manufactured and assembled in accordance with the specification of a person who is authorised to prescribe; and • for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient. Certain conditions set out in the HMRs must also be met. When named-patient supply of medicinal prod- ucts is offered to a co-ordinated patient group, this is referred to as “compassionate-use scheme” . However, the legislative provisions of named-patient supply continue to apply. The Early Access to Medicines Scheme is a vol- untary scheme that allows patients to access innovative unlicensed medicines earlier than the current MA procedures permit, but applies only to medicines that target life-threatening or seri- ously debilitating conditions for which there are no existing satisfactory treatments. In relation to medical devices, it is also a require- ment that all devices placed on the market must have a UKCA or EU CE mark. However, devices that are custom-made for individual patients do
not need a UKCA mark. Custom-made medical devices are defined as devices manufactured specifically in accordance with a duly quali- fied medical practitioner’s written prescription that gives specific design characteristics, under their responsibility, and is intended for the sole use of a particular patient. The manufacturer of a custom-made medical device must meet the requirements of the UK Medical Devices Regula- tions that relate to custom-made devices. The MHRA may also approve exceptional use of a non-compliant device on humanitarian grounds. These devices do not need a UKCA mark. A manufacturer can apply to the MHRA to supply a medical device that does not com- ply with the law to protect a patient’s health if there is no legitimate alternative available. The same provision may be made for custom-made devices that have not complied with the stand- ard conformity assessment procedure. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations MA holders must operate a pharmacovigilance system to monitor the safety of their product’s life cycle, and to detect any change to their risk- benefit balance for the medicinal product. They must: • have an appropriately qualified person (QP) responsible for pharmacovigilance located in the EEA (however, where this person does not reside and operate in the UK, there will be a need for a national contact person for pharmacovigilance who resides and operates in the UK); • maintain a pharmacovigilance master file; • operate, monitor and update a risk manage- ment system for the product;
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