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Pharmaceutical Services Negotiating Committee

Pharmacy Regulation


The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

These regulations come into effect on 1 April 2013, and replace the 2012 Regulations below.  These regulations reflect the new NHS architecture, in which the NHS Commissioning Board (NHSCB)  is responsible for maintaining pharmaceutical lists, and the Health and Wellbeing Boards (HWB) are responsible for developing and publishing the Pharmaceutical Needs Assessments, which are used in the determination of routine applications for new pharmacies.

The regulations are available here.

NHS (Pharmaceutical Services) Regulations 2012 (Note: revoked when the 2013 Regulations above come into force)

The National Health Service (Pharmaceutical Services) Regulations 2012 which come into effect on 1 September 2012 incorporate the market entry provisions, rural dispensing regulations, the Terms of Service under the community pharmacy contractual framework and Fitness to Practise provisions for pharmacy contractors.  Note: these regulations revoke the 2005 regulations and the amendments to those regulations that appear below.

The authoritative source is the, and the following are links to the Statutory Instruments. Whenever it is necessary to identify what the law requires, the original statutory instrument must be used, then check for subsequent amendment in any amending regulations.

Click on the link below to view the National Health Service (Pharmaceutical Services) Regulations 2012 Number 1909 (the main regulations which come into effect on 1 September 2012):

Amendment Regulations (Note: the amendments below are all revoked when the 2013 Regulations come into force)

Click on the links below to view the amending regulations:

Came into effect during 2012 (Note: the amendments below are all revoked when the 2013 Regulations come into force)

These regulations remove the ‘calendar pack’ rule, and introduce a new requirement to supply in original packs, where the quantity prescribed is equivalent to a complete pack, where it is practicable to do so.

Came into effect during 2011

These regulations make changes to the clinical governance framework.

Came into effect during 2010

These amendment regulations introduce changes to the terms of service for pharmacies providing Appliances. For pharmacies that were included on the pharmaceutical list before 1 April 2010 there is a transitional period until the end of 2010, or until the pharmacy undertakes to provide either of the Appliance Advanced services, whichever occurs earlier. The two new Advanced services introduced: Appliance Use Review Service and Stoma Appliance Customisation Service are set out in Secretary of State Directions. See below.

These Amendment Regulations introduce the requirement for a PCT to prepare and publish a Pharmaceutical Needs Assessment.

In addition to PNAs, the amendments also cover the process for determining applications from dispensing doctors by removing references to reserved location status (which is relevant only to pharmacy applications).

There are further minor and consequential amendments, including updating the references to the FHSAA, as fitness to practise appeals are now dealt with by the ‘First-Tier Tribunal’; amendments to the extent of notification required for bodies corporate that appoint a new director or superintendent pharmacist; and removing the reference to the FP57 prescription charge forms associated with refunds, so that different forms or manner of claims can be amended as the Secretary of State determines.

Came into effect during 2009

The above amendment regulations introduce a number of changes. PSNC has produced a briefing for pharmacy contractors that seeks to explain the amendments. This briefing can be downloaded below. However, in all cases, the legislation is contained in the Statutory Instrument published on the Office of Public Sector Information, and that is the authoritative source of law.

Download PSNC briefing on the NHS (Miscellaneous Amendments Relating to Community Pharmaceutical Services and Optometrist Prescribing) Regulations 2009 Number 2205 (PDF Format)

Came into effect during 2008

Came into effect during 2007

Came into effect during 2006

Came into effect during 2005


Secretary of State Directions

Click on the link below to view the Secretary of State Directions, which provide the regulatory framework for the Advanced Services (Medicines Use Review and Prescription Intervention Service, the New Medicine Service, the Stoma Appliance Customisation service, and the Appliance Use Review service) and the Enhanced Services.

The Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2012 

Support on Regulatory Issues

Pharmacy contractors can obtain support on regulatory issues by contacting PSNC directly.


DOWNLOADS: Some documents are available in PDF format, you will require Adobe Acrobat Reader 5.0 or later for viewing which can be downloaded from the Adobe Website

DOWNLOADS: Some documents are available in ‘Microsoft Word’ format. If you do not have Microsoft Word, you can read these forms by downloading the free 'Word Viewer'. This program can be downloaded at the Microsoft website