Neither pentoxifylline nor clasteon are authorised as medicines in Ireland.
Irish legislation requires that medicines are authorised before being placed on the market in Ireland. However, the legislation permits registered healthcare practitioners with prescribing rights to prescribe unauthorised medicines for use by their patients under their direct personal responsibility (Medicinal Products (Control of Placing on the Market) Regulations, SI No 540/2007, as amended, Schedule 1).
The Medicinal Products (Prescription and Control of Supply) Regulations, as amended provides for the system of control of supply of medicinal products to patients and identify those products which may only be supplied on medical prescription. In recognition of Ireland's position as part of the E.U. Internal Market, the term "supply" is defined in the broader context, so that the controls apply equally to supplies made to persons in the State and to persons who may at the time be in another Member State of the European Union
The original 2003 regulations were amended in 2020 by the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2020 (S.I. No. 614 of 2020). The effect of this was to;
- amend the definition of “prescription”, following the departure of the United Kingdom from the European Union, to enable the recognition of prescriptions written by registered medical practitioners, registered dentists and registered nurse prescribers, including midwife prescribers, in the United Kingdom for dispensing in the State, as long as such prescriptions have not been issued by means of information society services or for the purpose of enabling the supply of a medicinal product by mail order; and
- enable a prescription issued in the State to be recognised in the United Kingdom.