Most countries of the world will normally ensure that a prescription medicine has a "marketing authorisation", or "product licence" issued by the local governing health agency before it can be actively sold or supplied. Usually the product moves from the manufacturer through the wholesale market to the pharmacist and ultimately to the patient following the prescription issued by a qualified doctor.

However there are exemptions to this rule that allow patients to receive an "unlicensed medicine" if the prescribing doctor considers that there is no licensed alternative for their particular condition/circumstance. Such medicines may be imported from another country where it may already be licensed. Or the medicine may have been manufactured for a particular purpose or patient need e.g. some eye drops, and in such a case these medicines will be referred to as a "Specials".

In the UK the process for this provision is governed by the MHRA (The Medicines and Healthcare Regulatory Agency), who are responsible for ensuring the safe supply of medicines to patients. The MHRA will provide licences to companies who demonstrate the capabilities and facilities to manage the provision of unlicensed medicines in accordance with their guidelines (GN14) and within exemptions of The Medicines for Human Use (Marketing Authorisations etc.) Regulations SI 1994/ 3144 Schedule1. EU Directives and The EMEA (European Agency for the Evaluation of Medicinal Products) ensure each country in Europe has a policy for such provision, though each specific policy will vary from country to country.

The process of unlicensed provision is often referred to as "Named Patient Supply" reflecting the need for the provision to be for specific patients with an unmet clinical need.

Named patient supply, or "specials" provision, may arise due to the following conditions:

• A special requirement for a medicine awaiting a license or marketing authorisation.
• A licensed medicine is available, but is not suitable for the patient.
• A previously prescribed product has been discontinued for safety or commercial reasons.
• Supply chain problems exist with the licensed product.
• The medicine is still undergoing clinical trials.
• The product is used to treat a rare disorder, known as an "orphan drug".

Clinigen posses the capabilities to effectively manage the provision of named patient supply across the world.