These Regulations principally make amendments to the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 (“the 2009 Regulations”).

Regulation 3 adds new definitions to regulation 2 of the 2009 Regulations.

Regulation 4 makes amendments to regulation 5 of the 2009 Regulations to reflect changes to the application process, including the introduction of a pre-application and joint consultation stage and a new process for applications relating to a controlled locality.

Regulation 5 inserts regulation 5A which sets out provision on the new pre-application and joint consultation stage.

Regulation 6 amends regulation 15 of the 2009 Regulations, adding a controlled locality to the list of particulars that a Health Board must publish and make available at its offices for inspection.

Regulation 7 makes an amendment to Schedule 2 to the 2009 Regulations by replacing Form A(1) (application for inclusion in the pharmaceutical list to provide pharmaceutical services) with the form set out in the Schedule to these Regulations.

Regulation 8 makes amendments to Schedule 3 of the 2009 Regulations reflecting changes to the application procedure including: the introduction of a requirement to notify a community representative of an application; making provision on controlled localities and arrangements for their review by a Health Board; updating rules on assistance at an application hearing; and requiring the Pharmacy Practices Committee to submit more detailed information with the determination of an application. In addition, the Pharmacy Practices Committee and National Appeal Panel must make determinations within a 3 month period.

Regulation 9 makes amendments to Part I of Schedule 4 of the 2009 Regulations concerning the Pharmacy Practices Committee and introduces a right for the Pharmacy Practices Committee to appoint an independent legal assessor to assist them.

Regulations 11 and 13 make corresponding amendments to the provision in The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 and The National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004 that permits medical practitioners to provide dispensing services. The amendments provide that such dispensing practitioners must receive support from a pharmacist independent practitioner where the Health Board considers it appropriate to improve patient health outcomes.

Regulation 14 makes transitional and saving provision.

A Business Regulatory Impact Assessment has been prepared and placed in the Scottish Parliament Information Centre. Copies can be obtained from the Scottish Government Pharmacies and Medicines Division, St Andrew’s House, Regent Road, Edinburgh, EH1 3DG.