What is a special (unlicensed) medicine?
The Drug Tariff provides the following definition of a special1:
“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:
- 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 quality standards as our licensed products.
The manufacturer or assembler of 'specials' must hold a Manufacturer's 'Specials' License granted by the Licensing Authority.2 This licence guarantees that sourcing of ingredients, product development, packaging and labelling, as well as manufacturing and supply processes, are all to regulatory standards.4 The manufacturing/assembly site and its operations are inspected for compliance with Good Manufacturing Practice (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.5
To ensure the quality of the medicine, the RPSGB (Royal Pharmaceutical Society of Great Britain) advises that a certificate of analysis or a certificate of conformity should be requested by pharmacists with every product.5
1. NHS England & Wales Electronic Drug Tariff. April 2020. Available at: http://www.drugtariff.nhsbsa.nhs.uk/#/00782291-DD/DD00781688/Definitions (accessed 16th April 2020) | 2. MHRA Guidance Note 14 The supply of unlicensed medicinal products (“specials”) 2014. Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf (accessed 16th April 2020) | 3. https://www.apsm-uk.com/specials (accessed 6th April 2021) | 4. McCague, P, McElnay J & Donnelly R. What are your views on specials and extemporaneous medicines preparation? Pharmaceutical Journal. June 2012. Available at: https://www.pharmaceutical-journal.com/news-and-analysis/news/what-are-your-views-on-specials-and-extemporaneous-medicines-preparation/11102745.fullarticle?firstPass=false (accessed 16th April 2020) | 5. Dealing with specials. June 2010, Pharmacy Professional 27. Available at: https://pharmacies.nhsforthvalley.com/wp-content/uploads/sites/6/2017/02/Specials-Article.pdf (accessed 16th April 2020).