A general medical services contract shall contain provision requiring the contractor or contractors to comply with any directions given by the Department for the purposes of this Article 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.

A direction under this Article shall, subject to paragraph (3), be given by regulations.

A direction under this Article may be given by an instrument in writing where it gives effect to a request made in writing to the Department by a person who is a holder of a F2EU marketing authorisation or United Kingdom marketing authorisation in respect of the drug, medicine or other substance to which the request relates.

A direction under this Article given by an instrument in writing may be varied or revoked by a further direction under this Article (whether given by an instrument in writing or by regulations).

In this Article “ F3EU marketing authorisation” and “United Kingdom marketing authorisation” have the meanings given by F4regulation 8(1) of the Human Medicines Regulations 2012.