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Choosing a ‘Specials’ manufacturer

Understanding unlicensed ‘special’ medicines and considerations for choosing a manufacturer.

An ‘unlicensed medicine’ or ‘special’ is a term used to describe medicines which are used outside of the terms of their UK licence or that have no licence for use in the UK.[1]

An unlicensed medicinal product may only be supplied to meet the special clinical needs of an individual patient. An unlicensed product should not be supplied where an equivalent licensed product can meet the special needs of the patient.[2]

A manufacturer or assembler of ‘Specials’ must hold a Manufacturer’s ‘Specials’ Licence granted by the licensing authority (MHRA). The manufacturing or assembly site is inspected regularly for compliance with Good Manufacturing Practice (GMP), the Human Medicines Regulations 2012 and against the conditions of the licence.[2]

‘Specials’ manufacturers are unable to advertise or promote their unlicensed products however the manufacturers may advertise that they provide such a service.[2] Therefore it can be difficult for prescribers and pharmacists to gather information about ‘Special’ products.

When selecting a ‘Specials’ manufacturer, consider asking some of the following questions to ensure the reliability of the supplier:

  • Do they hold an appropriate Manufacturer’s ‘Specials’ licence?
  • What is the turn-around time from an order being received to delivery?
  • Does the product have a reasonable shelf life that will allow you to get it to the customer before it expires?
  • Does the company have a specialism?
  • Does the company provide certificates of analysis or only a certificate of conformity?
  • Does the company guarantee quality?
  • Does the company have a transparent pricing policy and provide a published list of ‘Specials’ prices?

‘Specials’ can be obtained from a range of sources and are not all manufactured in the same way. This means that the quality, bioavailability and consistency of ‘Specials’ can vary even where the same product is prescribed. [3]

Rosemont produce only batch manufactured ‘Specials’, made to the same GMP quality standards as our licensed products. Rosemont issue a certificate of analysis with every batch of our ‘Specials’, which website account holders, can download via our product pages.

For more information on unlicensed products or ‘Specials’ click here

ROS000046-001 DOP August 2023