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Unlicensed ‘Specials Medicines

Understanding the role of unlicensed ‘special’ medicines.

What is a ‘special’ (unlicensed) medicine?

The Drug Tariff provides the following definition of a special[1]:

“Specials are unlicensed medicinal products manufactured in the UK for human use which have been specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned.”

In accordance with MHRA 2014 “The supply of unlicensed medicinal products (“specials”) -MHRA Guidance Note 14”[2]

‘Special Needs 2.2; ‘An unlicensed medicinal product may only be supplied in order to meet the special needs of an individual patient. An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient.’

‘Specials’ represent 1% of all prescriptions in the UK, but account for more than 75,000 formulations.[3] There are many reasons that a ‘special’ may be required by a patient. These could include allergies to ingredients or an inability to swallow solid oral dosage forms.[2]

The manufacture of specials

The term ‘special’ may include[3]:

  • Batch manufactured products – manufactured as part of a production run
  • Bespoke products – made as a single pack for a named patient to specific requirements.


Rosemont only produce batch manufactured specials, made to the same GMP (Good Manufacturing Practice) quality standards as our licensed products.

The manufacturer or assembler of ‘specials’ must hold a Manufacturer’s ‘Specials’ Licence granted by the Licensing Authority. The manufacturing/assembly site and its operations are inspected for compliance with GMP which requires that manufacture or assembly is carried out under the supervision of appropriately qualified staff, including a named quality controller and production manager who are acceptable to the Regulatory Authority.[2]

A holder of a Manufacturer’s “Specials” Licence may also be a registered pharmacy supplying unlicensed medicinal products prepared under the exemption provided by regulation 4 of The Human Medicines Regulations 2012.[2]

Certificate of analysis vs. certificate of conformity

A certificate of analysis should be available for any batch manufactured special and is evidence that critical parameters have been confirmed by retrospective physical, chemical or microbiological assay of a sample of the final product. This differs considerably from a certificate of conformity which is a signed statement by the manufacturer that they believe the product complies with the purchaser’s specification.[4]

To ensure the quality of the medicine, the Royal Pharmaceutical Society advises that a certificate of analysis or a certificate of conformity should be requested by pharmacists with every product.[5]

Rosemont issue a certificate of analysis with every batch of our specials. These are available to account holders via our website. To register for an account click here.

ROS000046-006 DOP August 2023