Irish Medicines Formulary (IMF)

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What is an Exempt Medicine (or ULM, Unlicensed Medicine)?

Medicines placed on the Irish market must be authorised by the HPRA or, in the case of centrally authorised products, by the European Commission. However, European regulations do provide for an exemption to this rule – this is via Article 5 of Directive 2001/83/EC. In this case, unauthorised medicines may be supplied where a registered doctor or dentist has prescribed the product for an individual patient under his or her direct responsibility.  This is in order to fulfil the special needs of those patients.

Exempt Medicines are sometimes loosely referred to in Ireland as ULMs or Unlicensed Medicines. However, although unlicensed in Ireland they are indeed licensed in their country of origin be it in the EU or a non-EU country.

Exempt Medicines Included in IMF...

Example, Colchicine

Colchicine has been used for many years for the treatment of acute attacks of gout. It is an Exempt Medicine and is GMS reimbursed.

Derived from the Cochicum plant family and commonly known as Autumn Crocus, Meadow Saffron or Naked Lady, the exact mechanism of action of colchicine is not fully known.

Colchicine is indicated for the treatment of acute gout and prophylaxis of gout attacks during initiation of allopurinol and uricosurics.

It should be used with caution in the elderly. In moderate renal impairment the dose should be reduced, or the dosing interval extended. It should be used with caution in mild to moderate hepatic impairment. Colchicine is contraindicated in both severe renal impairment and severe hepatic impairment.

Colchicine is potentially toxic and has a narrow therapeutic window. Therefore, the recommended dose should not be exceeded. It may cause severe bone marrow depression. It is teratogenic and contraindicated for use during pregnancy, lactation or in women of childbearing potential who are not using adequate and effective contraception.

Common side effects include abdominal pain, nausea, vomiting and diarrhoea.

For more information of this type, see the most recent IMF 26 (September 2019) book.