Unlicensed medicines - UK

From Ganfyd

Always check relevant primary sources before assuming this classification is correct. For example it has been known for a manufacturer to surrender a license for purely commercial reasons. Please notify Ganfyd if information is not up to date. Licensing can relate to several licenses but by default means UK marketing authorisation here. Note that legally use of a drug outside its authorised indication is legally equivalent to unlicensed use in the UK. However you are advised (eg by GMC, MHRA) to use in preference to a completely unlicensed drug with equivalent evidence base, a drug with marketing authorisation, even if that indication is not within the drugs marketing authorisation. A drug authorised for an indication should be used in preference to a drug not authorised for that indication, but authorised for another indication. As of 2012 the appropriate authorities are reserving their detailed advice, as a legal challenge has recently been raised (without coming yet to court and never may) where a product with similar clinical effectiveness in a condition but unlicensed in that indication was being used by the NHS when a licensed product is available and recommended as an option by the NHS in treating that indication. Big money is involved in the outcome of this issue. It seems likely that a formal direction to doctors by a funding authority to use an unlicensed medication rather than a licensed one for that indication, if that licensed one is funded, is unsustainable in the EU following a European Court of Justice ruling against the Polish Government.

Legal situation

• Essentially the MHRA implements via UK legislation EU law (Article 6(1) of Directive 2001/83 ). This states:
  • No medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the authorities of that Member State or granted in accordance with Regulation (EC) No 726/2004.
    • Thus a licensed medication is one with marketing authorisation in that particular member state
  • Article 5(1) provides an exception to this requirement, for medicinal products supplied to fulfil special needs, provided they are supplied in response to an unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional, and for use by an individual patient under their direct responsibility.
    • This provides the definition of an unlicensed medication. This could be formulated specially or be a product with marketing authorisation used outside this authorisation.

Data on licensed drugs

There are several primary sources relevant to UK. The MHRA primary database is not comprehensively web searchable.

• Any drug with a current EPAR(European Public Assessment Report) for authorised medicinal products for human use has technically UK marketing authorisation but may not be marketed in the UK immediately or ever!
• Since October 2005 MHRA Public Assessment Reports are produced for each new drug with UK marketing authorisation. A fairly full list is at Alphabetical list of Public Assessment Reports but a proprietary name in the case of proprietary medicines takes precedence over the generic name or rINN !
• Any drug with a current SPC will have technically UK marketing authorisation but some current SPCs are not on this website.