(1)A general medical services contract must contain provision requiring the contractor or contractors to comply with any directions given by the Welsh Ministers for the purposes of this section as to the drugs, medicines or other substances which may or may not be ordered for patients in the provision of medical services under the contract.
(2)A direction under this section must, subject to subsection (3), be given by regulations.
(3)A direction under this section may be given by an instrument in writing where it gives effect to a request made in writing to the Welsh Ministers by a person who is a holder of a Community marketing authorization or United Kingdom marketing authorisation in respect of the drug, medicine or other substance to which the request relates.
(4)“Community marketing authorization” and “United Kingdom marketing authorisation” have the meaning given by regulation 1 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144).