Opening a pharmacy
Opening a pharmacy
|Pharmacy Regulations 2013|
PSNC is sometimes asked to advise on how to open a new pharmacy. As PSNC is the national representative body for NHS community pharmacies in England, and negotiates with NHS England the terms on which NHS pharmaceutical services are provided, its remit does not generally extend to providing advice to individuals on opening new pharmacies. Existing pharmacy contractors who wish to open additional premises or to oppose new applications should consult their Local Pharmaceutical Committee, since it will be consulted by the local NHS England Team, and may be able to provide support.
For existing contractors already on a pharmaceutical list, wanting to open additional premises, the following sources of guidance may be helpful.
There are two parts to the process, the first is to make an application to the local NHS England Team for inclusion in the pharmaceutical list – this is a process that can take four months (or more, in the event of appeals), and secondly the pharmacy premises must be registered with the General Pharmaceutical Council (which can take up to 3 months).
Click on a heading below for more information.
Application for inclusion in the pharmaceutical list
Before a registered pharmacy can dispense prescriptions issued under the National Health Service, it must be included in the pharmaceutical list relating to a Health and Wellbeing Board Area, maintained by NHS England (administered by the local team). The process for dealing with applications is set out in the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, which can be found in the Market Entry section, and application forms are available from NHS England.
Fitness to Practise
An application from a person (or body corporate) who is not already on the relevant pharmaceutical list must submit fitness to practise information with his application. This requires declarations about any adverse fitness to practise findings against the applicant (pharmacist or company and its directors / superintendent pharmacist) and also whether there are any on-going investigations.
The details that must be provided are set out in Schedule 2, paragraph 3 (individuals) and paragraph 4 (bodies corporate) of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. In April 2016, NHS England published the NHS Pharmacy Manual – which consolidated and updated previous policies and procedures which may be useful to applicants. If an applicant has already submitted fitness to practise information to NHS England, or to a ‘Home’ PCT then it is not necessary to submit this again, providing the information held by NHS England is complete and up to date and has been confirmed to be so by the applicant, or the applicant provides the missing information with the application.
Registering a pharmacy
A pharmacy can be registered only by a pharmacist, a partnership consisting entirely of pharmacists, or by a body corporate (usually a limited company). In the case of a body corporate, a superintendent pharmacist must be appointed, to take responsibility for the way in which the company carries out its professional pharmaceutical activities.
The registration of pharmacy premises is subject to legislative provisions in the Medicines Act 1968; the Human Medicines Regulations 2012; and the Pharmacy Order 2010. Further information can be obtained from the regulator – the General Pharmaceutical Council – see registration section.
Q. Can a superintendent pharmacist be superintendent pharmacist of more than one body corporate (limited company)?
A. No. Under the provisions for superintendent pharmacists in the Medicines Act 1968, a superintendent pharmacist is permitted to be superintendent pharmacist of one body corporate only. The nomination form available from the General Pharmaceutical Council includes a declaration to be made by the superintendent pharmacist, in paragraph 8.4, that the pharmacist is not a superintendent pharmacist of any other body corporate.
Q. Can CCGs set up a pharmacy themselves?
A. No. Under the NHS Act 2006, each CCG has the function of arranging for the provision of services (e.g. locally commissioned services). These services are provided by service providers and a “service provider” includes a person or body with whom the CCG has made arrangements for the provision of services. Therefore, CCGs are excluded from being a “service provider”.