• Pharmacy Regulation
• Current Issues
• Opening Hours
• Disability Discrimination Act (DDA) 1995
• Fitness to Practise
• Control of Entry
• Responsible Pharmacist
• Rural Issues

• Sign up for
  email list
• Feedback to PSNC
• RSS Feeds
• Services
  database
• LPC and Regional
  Websites
• LPC members only

Control of Entry

The Control of Entry system, introduced in 1986 and reformed in 2005 is again subject to review. In the White Paper: Building on Strengths - Delivering the future, it was proposed that the current test would be replaced by one based on the Pharmaceutical Needs Assessments prepared locally by PCTs. The Health Bill 2009 introduces the legislative framework and subject to Parliamentary approval, will become the Health Act 2009 towards the end of the year.

The Minister announced in a Written Ministerial Statement on 18 June 2009, that an advisory group would be established to advise on the Regulations needed to implement those changes. That group has begun meeting, and its papers are available on the following website:
http://www.dh.gov.uk/en/Healthcare/Medicinespharmacyandindustry/index.htm

The 'Control of Entry' test has been a feature of the NHS (Pharmaceutical Services) Regulations since the late 1980s. Under this test, an application for inclusion in a pharmaceutical list will be granted only if it is necessary or desirable to grant the application in order to secure, in the neighbourhood in which the premises from which the applicant intends to provide the services are located, the adequate provision, by persons included in a pharmaceutical list, of the services, or some of the services, specified in the application.

There are four exemptions from this test:

1) New One Stop Primary Care Centres;

2) Large retail developments;

3) Pharmacies undertaking to provide pharmaceutical services for at least 100 hours per week;

4) Pharmacies providing pharmaceutical services wholly by mail order or internet.

Click on the link below to view the regulations in which the control of entry provisions and the exemptions are set out.

NHS (Pharmaceutical Services) Regulations 2005

The Department of Health has also issued a number of resources to guide pharmacy contractors and PCTs about the control of entry provisions (and includes a link to the updated list of approved retail areas for retail shopping areas greater than 15000 square metres). You can access this information by clicking the link below:

DH guidance, including updated list of approved 15000 sq m developments

Guidance on Control of Entry 

The Department of Health has issued guidance to Primary Care Trusts on the control of entry provisions. Click on the link below to access this guidance (last updated 17 September 2007)

DH guidance to PCTs on Control of Entry

For guidance on the Control of Entry Regulations, existing contractors should contact PSNC's Aylesbury Office. Persons who are not already on a pharmaceutical list should contact the relevant Primary Care Trust

 Application for Inclusion in a Pharmaceutical List

The Department of Health has produced a standard template application form, for use by applicants seeking to have their premises included in a pharmaceutical list. Please note, however, that the use of this form is not mandatory. Click on the link below to view the standard template.

Note: applicants should also read the guidance on control of entry (see above).

DH application form for inclusion in a pharmaceutical list (PDF Format)

DH application form for inclusion in a pharmaceutical list (MS Word Format)

Proposed Further Revision to the Control of Entry Provisions 

The Department of Health (DH) announced in July 2005 that they were consulting on primary legislation to reform and modernise pharmaceutical services in England.

The DH consultation document set out details of two proposed amendments to the NHS Act in relation to introducing charges for applications for entry to community pharmaceutical lists and introducing new criteria for determining pharmacy applications (in relation to the provision of, or access to, over-the-counter medicines and other related healthcare products).

The DH consultation ended on 20th September 2005, and appropriate provisions were included in the NHS Act 2006.

In April 2008, the Secretary of State issued Directions to Primary Care Trusts to charge appliicants for inclusion in the pharmaceutical lists. 

Secretary of State Directions of Fees for applications

The proposal to amend the Control of Entry test to allow consideration of the availability of 'ancillary services' (including the availability of over the counter medicines) was included in the NHS Act 2006, but so far, no regulations have been laid.

Further Advice 

Pharmacy Contractors (i.e. persons already on a pharmaceutical list) who have queries on the Control of Entry system, can contact Steve Lutener, at PSNC 01296 438421 for advice.

Note: Persons who are not already pharmacy contractors should seek their own legal advice, since PSNC is unable to offer support.