What is a ‘Special’?
A special refers to a formulation without a product license that has been formulated in accordance with a prescriber’s instructions for a specific patient. Specials are most commonly liquid formulations prepared for patients with swallowing difficulties, where a licensed liquid formulation is not available.
Patients with swallowing difficulties have specialist clinical needs that often cannot be met by licensed medicinal products. Consequently, the law allows for the manufacture and supply of specials – unlicensed medicinal products manufactured for use by a specific individual patient, on the prescriber’s direct personal responsibility.
Specials do not have a marketing authorisation (MA) and consequently cannot legally be advertised. Similarly, specials cannot lawfully be manufactured and supplied if an equivalent product is available.
If a special is manufactured in the UK, the manufacturer must hold a specials licence which is issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) and ensures a safe, quality assured product.