What is a ‘Special’?
A special refers to a formulationwithout a product licensethat 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 alicensed liquid formulation is not available.
Patients with swallowing difficulties havespecialist clinical needsthat 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 aspecific individual patient, on the prescriber’s direct personal responsibility.
Specials do not have amarketing authorisation (MA)and consequently cannot legally be advertised. Similarly, specials cannot lawfully be manufactured and supplied if an equivalent product is available.
如果在英国制造,特殊manufacturer must hold aspecials licencewhich is issued by theMedicines and Healthcare Products Regulatory Agency (MHRA)and ensures a safe, quality assured product.