In the UK a medicine must have a marketing authorisation before it is sold or supplied. Usually the product moves from the manufacturer through the wholesale market to the pharmacist and ultimately the patient. However there are exceptions which fall into two general categories:

Named Patient Supply products are either distributed directly from the manufacturer to a doctor or dentist to administer to a particular ‘named patient’. Alternatively the manufacturer may release pre-launch products at stages II or III of clinical trial on a similar named patient basis''.

Specials as the name implies allows an exemption for products to be supplied to meet a special need on the request of a clinician for their patients under their direct responsibility.

Named patient supply, or ‘specials’, may arise due to the following conditions:

• A special requirement for a medicine awaiting a license or marketing authorisation. Oncology drugs often fall into this category
• A licensed medicine is available, but is not suitable for the patient.
• A previously prescribed product has been discontinued.
• Supply chain problems with a licensed product.
• The medicine is still undergoing clinical trials.
• The product is used to treat a rare disorder, known as an ‘orphan drug’.

Pharmaceutical products for use in humans are controlled by the Medicines and Healthcare Regulatory Agency (MHRA) in accordance with the Medicines Act 1968 (UK legislation), and relevant EU Directives. Essentially, this legislation requires such products to have a Marketing Authorisation (or product license) in order to allow the product to be supplied. This guarantees the quality, safety, and efficacy of medicinal products and places liability on the marketing authorisation holder for any adverse effects that may arise.

The legislation also allows an exemption for products to be supplied to meet a “special need” on the request of a clinician for their patients and under their direct responsibility. This exemption is under strictly limited conditions, in accordance with SI 1994 No. 3144 Schedule 1.

Although named patient dispensing is more prevalent in hospitals, there are occasions where dispensing a medicine is necessary in the community, either through a community pharmacy or dispensing doctor to ensure a seamless service is offered to patients. Clinigen Healthcare meets all your requirements as a specialist distributor.