(12) The Minister shall only make regulations under this section to provide for the exception referred to in subsection (2)(m)(ii) if the Minister, after having had regard to the nature and purpose of the medicinal product concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the medicinal product to be sold or otherwise supplied by a person other than a person referred to in subsection (2)(m)(i).".