13.— (1) When a branded interchangeable medicinal product is prescribed for a patient and the prescriber is satisfied that the medicinal product should, for clinical reasons, be exempted from substitution in accordance with Chapter 2, the prescriber shall write, legibly and by hand, “do not substitute” on the prescription beside the name of the medicinal product.

(2) The Minister may make regulations to require prescribers, or a class of prescribers, who issue prescriptions for patients to whom a relevant scheme applies, to state (whether on the prescription concerned or otherwise, as specified in the regulations), whenever such a prescriber prescribes a branded interchangeable medicinal product for such a patient and then makes the medicinal product subject to a clinical exemption, his or her clinical reasons for the clinical exemption.

(3) A prescriber to whom regulations made under subsection (2) apply shall comply with the regulations.

(4) Where a prescriber participates in a relevant scheme in his or her capacity as a prescriber, it shall, by virtue of this subsection, be deemed a condition (“relevant condition”) of that scheme that a prescriber to whom regulations made under subsection (2) apply shall comply with the regulations and, in any case where the prescriber does not so comply, the provisions of the scheme relating to a failure to comply with a condition of the scheme shall likewise apply to the failure to comply with the relevant condition.