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Pharmaceutical Services Negotiating Committee

Market Entry Regulations

Please note: Existing pharmacy contractors (i.e. persons already on a pharmaceutical list) who have queries on the Market Entry system, can seek support from their Local Pharmaceutical Committee (LPC). Persons who are not already pharmacy contractors should seek their own legal advice, since PSNC and LPCs are unable to offer support. The following are links to the relevant regulations and guidance.

The 2013 market entry provisions

From 1 April 2013, pharmaceutical lists are maintained by the NHS Commissioning Board (NHSCB).  Applications for new, additional or relocated premises must be made to the NHSCB.  Routine applications for a new pharmacy will be assessed against the Pharmaceutical Needs Assessment for the area, prepared either by the Primary Care Trust, or the Health and Wellbeing Board (HWB).  PNAs prepared by PCTs will continue to be valid until the HWB has published its own.  The HWBs have until 1 April 2015 to publish a PNA.

Apart from introducing provisions to reflect the structural reforms of the NHS, the market entry provisions are almost identical to the 2012 Regulations below.

The regulations are available here.

The  2012 market entry regulations (came into effect on 1 September 2012, but are revoked from 1 April 2013).

The NHS (Pharmaceutical Services) Regulations 2012 which set out the arrangements for pharmaceutical lists, and the applications that may be made are available here.

The Department of Health has issued guidance on the new regulations, which is available here.

Application forms have been published by NHS Primary Care Commissioning, and these can be found here. Note: the use of these or any other forms is not mandatory – Schedule 2 of the regulations (see link above) sets out what information must be provided in an application.

Under these revised market entry arrangements, routine applications are assessed against Pharmaceutical Needs Assessments.  These were first published by PCTs by 1 February 2011, and as part of the reforms introduced by the Health and Social Care Act 2012, the responsibility for PNAs pass to Local Authorities' Health and Wellbeing Boards from 1 April 2013.  Until guidance has been issued to Health and Wellbeing Boards, the Guidance to PCTs on preparing PNAs is available here.

Existing pharmacy contractors who have questions about the interim arrangements for applications made prior to 1 September 2012 should check the FAQs below, and if there are further questions, please contact the PSNC Information Team and / or seek legal advice.

FAQs on the market entry changes

1. My 100 hour pharmacy application has been granted prior to the announcement of the 2012 regulations. Do the changes prevent me from opening or do I still have up to 9 months to open?

If a full application (i.e. not a preliminary consent) has been granted under the 2005 Regulations, then the 2012 Regulations do not affect the granting of the application. The pharmacy will have six months in which to open, which may be extended by the PCT for up to a further 3 months.

2. Do the 2012 regulations affect my preliminary consent?

The transitional arrangements are set out in schedule 7 of the 2012 Regulations.  The Department of Health is publishing information for PCTs about the Regulations which may assist with the interpretation, but for an authoritative explanation of how the regulations may affect any individual preliminary consent, an applicant should consider taking legal advice.

3. Is there a summary of the types of application that will continue to be dealt with under the 2005 and those that will be void?

The Department of Health has published information for PCTs on the transitional arrangements. This includes a table setting out applications and other matters affected by the 2012 regulations. The information is available here. There has also been an addendum, which is available here.

4. The regulations state that distance-selling pharmacies are to provide essential services "without face to face contact" between the contractor or their staff and the patient.  Can a distance-selling pharmacy use a delivery driver to collect prescriptions and deliver medicine to patients?

The prohibition on face to face contact has been in place since 2005 and continues under the regulations which came into effect on 1st September 2012. The prohibition on face to face contact only covers the provision of essential NHS pharmaceutical services, at the pharmacy premises. This means that a delivery driver employed by the contractor could (a) collect a prescription from the GP surgery; and (b) deliver the dispensed items to the patient at their home.

Extended Advisory Group on the NHS (Pharmaceutical Services) Regulations

Regulations requiring PCTs to develop and publish pharmaceutical needs assessments (PNAs) came into force in May 2010. From 1 April 2013, the responsibility for the development and updating of PNAs will transfer to local authority Health and Wellbeing Boards. To help with this transfer, the Department of Health has extended the work of the Advisory Group who helped develop the 2012 regulations in order to develop them to fit the new NHS architecture. For those interested in finding details of the minutes of their meetings, and any associated papers, please visit the Department of Health’s website.

Fees for applications for inclusion on the pharmaceutical list

Applications for inclusion in the pharmaceutical list must be accompanied by the relevant fee.  The fees are set out in Directions issued by the Secretary of State.

Secretary of State Directions of Fees for applications

Archive for applications to be continued under the 2005 regulations

Some applications made before 1 September 2012 will be processed under the 2005 regulations. The guidance for those applications is available here.

DH guidance to PCTs on Control of Entry (2005 regulations)



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