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