How Specials are regulated

Companies producing Specials must operate a clean manufacturing facility which has been licensed and regulated by The UK Medicines and Healthcare products Regulatory Agency - the same government organisation that regulates the manufacture and sale of all medicines in the UK. Companies must hold a 'Specials Manufacturer's Licence', which is issued by the MHRA under Section 5 of the Medicines Act, which is further explained in Guidance Note 14. This covers all aspects of manufacture and quality processes and companies are regularly inspected to ensure compliance with a comprehensive set of standards and requirements.

The link below leads to a pdf document of guidance 14 titled: The Supply of Unlicensed Relevant Medicinal Products for individual Patients:
http://www.mhra.gov.uk/home/groups/is-lic/documents/publication/con007547.pdf

Although wholesale companies can re-sell Specials, only a small number of companies in the UK hold a licence to manufacture. Most of these companies are members of the APSM, Association of Pharmaceutical Specials Manufacturers.

One of the key aspects of Specials manufacture is that we cannot promote the drugs and medicines we manufacture or give any unsolicited information about our Specials. However, following recent changes to legislation (August 2010) companies can publish price lists.

In addition, APSM members sign up to a code of conduct which sets best practice standards for staff training, pharmacy advice and help lines, clear patient information and product labelling to support compliance.

For more information regarding licence activity, please click on the link below. http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Manufacturersandwholesaledealerslicences/index.htm#2

The responsibility for patient safety for a Special rests with the prescribing clinician. So any side effects or adverse reactions are the responsibility of the doctor. However, prescribing doctors are very experienced and knowledgeable in the use of Specials for types of patients and illness so the risks to patients are minimal.

Many Specials manufacturers voluntarily subscribe to good practice such as adverse event reporting, via the MHRA's yellow card scheme. This is where manufacturers, healthcare professionals and the general public can report on any side effects that they encounter with use of medicines.

For more information about the Yellow Card Scheme, please follow the link below. http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/TheYellowCardScheme/index.htm