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Market Entry

Pharmaceutical lists are maintained by NHS England and all market entry applications must continue to be made to the NHS England Regional Local Team. PCSE is responsible for validating and processing market entry applications on behalf of NHS England.

 

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6 easy steps for Market Entry applications

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Step One – Completing an application form

Application forms for Market Entry and Fitness to Practise Applications can be downloaded here.

Alternatively, visit the NHS England website if you wish to download forms to:

  • Notify or apply for changes to opening hours
  • Notify of premises closures
  • Or, submit serious difficulty application forms for patients

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Step Two – Submitting an application form plus fees

Once you have completed your form, applications should be sent, by post or email, to PCSE with any relevant application fee made payable to NHS Commissioning Board.

Legal guidance about the fees can be found here.

Further information about the cost of different applications can be found here.

Email: PCSE.marketentry@nhs.net


Post: Primary Care Support England, PO Box 350, Darlington, DL1 9QN

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Step Three – Receipt and acknowledgement of application

Our Market Entry team will acknowledge receipt of your application by email. We will check your form has been completed properly and the correct fee is attached (where applicable) and will contact you if any information is missing.

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Step Four – Referral to NHSE

We will then refer your Application to NHSE for their initial decisions regarding Deferral, acceptable Best Estimates and to approve any Interested Parties to be notified of the Application.

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Step Five – Notification of Interested Parties (where applicable)

Where required we will notify Interested Parties of your application and allow 45 days for representations to be made. We will then circulate any representations for a further 14 days for comments. We then forward the application and accompanying information to NHSE to make a decision on the application.

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Step Six – NHS England decision

Once NHS England informs us of the decision we will communicate that to the applicant by email or letter and any Interested Parties confirming any right of appeal and how to make an appeal.

The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, require NHS England to endeavour to determine an application as soon as is practicable, and unless consideration is deferred or there is good cause for the delay:

  • Notifiable applications must be determined within four months
  • Non-notifiable applications must be determined within 30 days.

Notifiable applications are those offering:

To meet current or future needs that are included in the relevant pharmaceutical needs assessment (PNA), to secure current or future needs that are included in the relevant PNA, and unforeseen benefits.

They also include relocations that do not result in significant change, distance selling premises, combined changes of ownership and relocations that do not result in significant change, and consolidation applications.

The four month or 30-day clock starts on receipt of the application.  It stops if missing information and/or documentation is requested and only restarts once that has been provided, or where an applicant successfully requests a review of the requirement to provide missing information and/or documentation.  The clock will also stop where NHS England decides to defer the application, for example on fitness grounds or where it decides to undertake a controlled locality determination in connection with the application.

NHS England may take longer to determine an application where there is a delay in third parties providing information, for example referees fail to respond to a request for a reference.

Our people

Find out more about the work of our Market Entry team with A day in the life of…

Nick Speight, Market Entry Officer

I’ve worked at PCSE since it was first established back in 2015.  I started in the Customer Support Centre taking calls, before moving to the Market Entry team in April 2016.

Prior to working at PCSE, I worked for NHS primary care services in Huddersfield, where I specialised in supplies and medical records.  I was there for 15 years, so think I’ve got a good grounding in primary care support.

There isn’t a typical day and that’s what I like.  We have many applications from pharmacies going through the process at any one time, which are all at different stages that’s why the team has to be multi-skilled so that we can all work across different stages of the application process.

We’ve recently reorganised the team so that we’re aligned with the four NHS England regions.  I’m working with the Midlands region.  It’s good to be building relationships with our colleagues at NHS England so that we can ensure the application process works smoothly for pharmacies from start to finish.

Every application is unique so the challenge is around understanding the different aspects of each one and working out the best way to approach it.  Everything we do has to be in line with the regulations in the Pharmacy Manual, which is a hefty document, so our knowledge needs to be wide-ranging.

I like it because it’s varied and is important to our customers. Sometimes we get direct feedback from those pharmacists who we’ve supported, and it’s good to know we’re helping them establish their business.

The Pharmacy Manual because that is the central resource that guides our work. It’s our Bible.