Posts Tagged ‘Compassionate Use’

Named Patient and Compassionate Use

Thursday, February 4th, 2010

In Ireland the legal term is “exempt medicinal product” whilst it is referred to as  “specials” in the UK. The definition of “exempt medicinal product” means a medicinal product to which paragraph 2 of Schedule 1 to the Medicinal Product (Control of Placing on the Market) Regs2007, or any equivalent legislation in any other EEA State, applies. This is to say that Paragraph 2 of Schedule 1 specifies that Regulation 6 “shall not apply to the sale/supply of medicinal product in response to a bona fide unsolicited order, formulated in accordance with the specifications of practitioner for use by his individual patients, in order to fulfil special needs of those patients, but such sale/supply is subject to conditions in Para 3” (i.e. that the licensing requirements can be waived in this instance.)   

References:

• S.I. 539/07 Medicinal Products (Control of Manufacture) Regulations 2007: http://www.dohc.ie/legislation/statutory_instruments/pdf/si20070539.pdf?direct=1

• S.I. 540/07 Medicinal Products (Control of Placing on the Market) Regulations 2007: http://www.dohc.ie/legislation/statutory_instruments/pdf/si20070540.pdf?direct=1