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Unlicenced Medicinal Products

The “Guidelines governing the use of medicinal products for human use without a Marketing Authorisation” (DH circular 137/04) was issued in June 2004 and the Committee for Unlicensed Medicinal Products was set up. The Pharmaceutical Unit is responsible for the processing of individual requests for medicinal products by prescribers and for departmental use in public hospitals and private hospitals. 

In the year 2006, the committee revised and amended the DH Circular 137/2004 and issued the relevant DH Circular 270/06* in September 2006 (* updated October 2007). This circular explains the “Guidelines for the supply of medicinal products for human use through processes which are not covered by the Medicines Act, 2003 and its subsidiary legislation (unlicensed medicinal products)” and includes the following forms:
  • Form I: Request for the use of an unlicensed medicinal product on a named patient basis, for a specific patient (applies to both the Government Health Services and the private sector) 
  • Form II: Request for the use of an unlicensed medicinal product by a Hospital Department within the Government Health Services
  • Form III​: Request for the use of an unlicensed medicinal product by a Hospital / Clinic in the private practice
 
These request forms are submitted to the Pharmaceutical Unit for processing.