Standards

‘Specials’ are a category of unlicensed medicines that does not have either a centrally authorised Marketing Authorisation in the European Union, or a UK Marketing Authorisation and are manufactured, imported or distributed to meet the special clinical needs of an individual patient97.

A ‘Special’ may only be supplied when there is no available licensed medicine which fully meets the patient’s special clinical needs. Specials can be prescribed when it is judged by the prescriber and agreed with the patient or carer that, on the basis of available information, a ‘Special’ is the most appropriate option for the patient 58 61.

To manufacture ‘Specials’ in the UK, an MHRA Manufacturer’s ‘Specials’ Licence (MS) is required. This guarantees that the sourcing of ingredients, product development, packaging and labelling as well as the manufacturing and the ex-factory processes are all to regulatory standards. (The manufacturer’s MS number is printed on the medicine’s label.) Whilst the MS licence provides some confidence in the quality of the product it does not require a formal assessment of product safety or efficacy. Therefore, a ‘Special’ is still considered to be an unlicensed medicine.

‘Specials’ manufacturers routinely provide their own documentation regarding their quality assurance and manufacturing process. This is either in the form of a Certificate of Analysis or a Certificate of Conformity. All ‘batch manufactured’ ‘Specials’ should be accompanied by a Certificate of Analysis which should state that critical parameters have been confirmed by retrospective physical, chemical and microbiological assay of a sample of the final product.

Many ‘Specials’ are not ‘batch manufactured’ but made up individually on receipt of individual patient requests. In this instance a Certificate of Conformity should be provided. This is a signed statement by the manufacturer that they believe the product complies with the purchaser’s specification.

Certificate of Analysis97

  • A Certificate of Analysis is a batch-specific certificate of finished product testing. It should detail:
  • the tests performed
  • required results
  • actual results
  • the laboratory which issued
  • signature by an authorised person such as someone working in a quality discipline, such as, Quality Assurance or Quality Control

Certificate of Conformity97:

  • A Certificate of Conformity is a declaration of conformity only, which is not supported by end product batch testing. A Certificate of Conformity will only state that the medicine was made under the MS Licence, according to GMP. Without an agreed product specification a Certificate of Conformity is of limited value.
  • A Certifcate of Conformity should be signed by an authorised person such as someone working in a quality discipline, such as, Quality Assurance or Quality Control.

Click here to download an example Certificate of Analysis.

Hence, the term ‘Special’ can encompass:

  • Medicines manufactured by a ‘Specials’ manufacturer holding a MS in multiple quantities with end product analytical testing.
  • A special medicine produced by a ‘Specials’ manufacturer holding a MS as a bespoke medicine without end product analytical testing.

The term can also include:

  • Extemporaneously prepared medicines – unlicensed medicines made in a pharmacy under a pharmacist’s direct supervision.

(Note: An MS is not required for extemporaneous dispensing as this can be carried out in a registered pharmacy under Section 10 exemption of the Medicines Act. In this instance there is no guarantee of any quality assurance.)