Internet Pharmacy / Distance Selling (NHS)
How to Set Up a Distance Selling Pharmacy
Rushport has helped more clients secure permission to open distance selling pharmacies than any other advisor. In fact, we have secured more NHS permissions for distance selling pharmacies than every other consultant, advisor and law firm in the UK added together. If you are wondering how to set up a Distance Selling Pharmacy in the United Kingdom or how to make a distance selling pharmacy application, then please contact us, we can help.
Defining your pharmacy
Pharmacists often use the terms “private pharmacy”, “NHS pharmacy” and “distance selling pharmacy”. Some pharmacists contact us to say that their pharmacy will be online so they “don’t need physical premises”, which is wrong. Before starting out on the path of opening any of these it is important to make sure that you know what you really mean.
All pharmacies in England are regulated by the General Pharmaceutical Council (“GPhC”). By registering your premises with the GPhC and filling out the registration of new premises forms and passing your GPhC inspection you have a pharmacy that most people would refer to as a “private pharmacy” even though there is nothing particularly private about it. That private pharmacy can operate from normal retail premises. It could even operate purely online as a distance selling pharmacy but it still needs GPhC-registered premises to operate from.
Then you have to ask if you want to provide NHS services from your pharmacy. If you do then you need to make an application to the NHS for permission to be on the relevant NHS “pharmaceutical list”. This guide is about the NHS distance selling pharmacy application process. It details what we can do to help you secure permission from the NHS to provide NHS services.
Complying with NHS Regulations
The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 contain an exemption that allows pharmacists to open an NHS pharmacy without having to show that the need for that pharmacy was identified within the PNA, or having to satisfy NHS England that the pharmacy would satisfy the test under Regulation 18 for unforeseen benefits.
This exemption is contained within Regulation 25 and is known as a “Distance Selling” or “Internet Pharmacy” contract. Even though this type of application is exempt from the more stringent regulatory tests, the NHS is refusing many of these applications. Or Primary Care Appeals (formerly known as the NHS Litigation Authority) are refusing them at appeal. The ICB or NHS Resolution will only grant the application if they are satisfied that the pharmacy procedures in place at the proposed pharmacy premises are likely to secure the uninterrupted provision of essential services to persons anywhere in England without face-to-face contact.
In addition to this applicants must also satisfy the ICB that regulation 31 does not apply before their application will be granted. We receive lots of enquiries about how to set up an internet pharmacy. We hope that this page, along with our information pack (available on request) will answer most of your questions.
How much does an application cost?
There are occasions when the NHS will grant applications without the applicant providing a full suite of standard operating procedures (SOPs). However, many applicants are now having to provide full SOPs at some stage in the application process. We provide advice at all stages of the application process but we prefer to be involved at the very beginning to make sure we can help you present applications in the strongest way possible.
An application costs £750 to submit so it is far better to get it right the first time than waste an application fee. We are often contacted by applicants who receive extensive letters of objection following their application. In most of these cases, the applicant has simply taken SOPs that were used in normal retail pharmacies and tried to change them to meet the requirements of Regulation 25. Alternatively, they have bought a set of cheap SOPs from a company which do not cover the requirements. Unfortunately, this approach rarely works, as not only do SOPs need to be changed but a significant amount of additional information is required in order to meet the requirements of the Regulations.
How we can help you through the process
Rushport has developed a full suite of SOPs for distance selling pharmacy applications. We can tailor these SOPs to meet the individual operating requirements that each pharmacy company has. We are aware of companies that try to sell SOPs online and can only advise applicants to be very careful about what they purchase as cheap does not mean good. SOPs are also just one part of the application process; they can be vital, or not required at all. It is important not to separate the SOPs from the rest of the application as all parts of the process link together in a successful application.
Since 2016 we have handled over 50% of all distance selling applications that have gone to appeal and our success rate is 100% where applicants instructed us from the beginning of the process
We receive a lot of enquiries from pharmacists who are considering setting up Distance Selling pharmacies and they regularly ask the same questions, so we have updated this page to provide some answers to the most frequently asked questions. We hope this information is helpful – our competitors seem to think it is as they often copy our work with minimal changes and put it on their own websites.
How to Set Up a Distance-Selling Pharmacy
1. What type of premises do I need?
It is possible for an application to be approved at any type of premises. Some pharmacists think that the GPhC won’t accept retail premises, or that premises must be a certain distance from an existing pharmacy – this isn’t true. The important thing is that Essential Services can be delivered without face-to-face contact with patients. We have had clients make successful applications for retail premises, units on the first floor above retail premises, warehouses and even their own homes.
You must specify your premises in the application form. Therefore, you should decide on premises at an early stage.
2. Will I need Planning Permission?
Some types of premises will come with suitable planning permission, e.g. retail units. For others, you will need to check with a landlord to find out what type of planning permission the proposed premises operates under and also check with the local council to ensure that the existing planning permission allows you to operate a Distance Selling pharmacy. You may need to submit a planning application, or request a Certificate of Lawful Development. The landlord is also likely to want to know what type of business will be operating from their premises, so you should ensure you get their permission to allow the premises to operate as a distance selling pharmacy.
The way that the pharmacy operates and the type of building chosen will impact the planning requirements. There are different “use classes” for different properties. Most people are familiar with A1 (known as ‘retail’) consent. However, from 1 September 2020, there has been a change in use classes. This includes three new use classes covering shops, financial and professional services, restaurants and cafes, offices, learning and community uses. This change should make it easier for premises to be deemed as suitable for use as a distance selling pharmacy.
It is also possible to receive permission to operate a pharmacy from a residential address and there is a precedent that one of our clients obtained for allowing an internet pharmacy to operate from a house. It is worth noting that the council did insist on security grilles on the windows of the house. This might not be very appealing to you or your neighbours if your local council takes a similar approach! In addition, the GPhC will want to see that any pharmacy at a residential address is separate and secure with its own access. Therefore, an outbuilding such as a converted garage or other suitable structure is the best option. This is because the GPhC are likely to refuse a room within a residential property.
Planning permission falls outside the Pharmacy Regulations, so the NHS should not make too many enquiries into this area of the proposal, but some Area Teams still take a keen interest in this.
3. Does the GPhC have different standards for distance selling premises?
The GPhC is primarily concerned with protecting the health, safety and wellbeing of the user of pharmaceutical services. The standards that they ask contractors to adhere to are not intended to stifle innovation. They instead help encourage high standards. The GPhC will not be looking at whether the NHS should have approved the application or not. They also (probably) won’t mention planning permission. However, they will want to satisfy themselves that the pharmacy fit-out and operation is of an acceptable standard before they will allow it to open and register the premises. There are new guidelines for Distance Selling pharmacy operators and we can incorporate parts of the guidance into SOPs. Any new contractor will need to understand the GPhC guidance as it applies to distance selling pharmacies and ensure that they can demonstrate compliance with the guidance.
For understandable reasons, the GPhC is very cautious about approving pharmacy premises at a residential dwelling. It is advisable to have a completely separate annexe or garage conversion if you are considering this approach.
Remember – you can’t dispense an NHS or private prescription until you have registered the premises with the GPhC.
We are happy to help and guide you through the GPhC registration process. This is something that all new pharmacies have to go through. Our services in this area range from providing templates for you to work from all the way to setting up premises and hosting GPhC inspections.
4. Do I need a website?
Until recently, the answer to this question was “no”. Technically there was no website requirement. However, from 1 April 2021 all NHS distance selling pharmacies must have a website. In addition, the website needs to have particular types of information on it. There are quite a few companies that provide pharmacy websites. Some of these companies provide websites for a large number of pharmacy contractors. However, despite the fact that they all claim to be compliant with the various regulations and guidance, we have found that they are not.
To fill this gap we have worked with leading pharmacy website provider pharmacymentor.com. This helps us to enable them to provide a website that meets the requirements of the Regulations and also the SOPs that we provide. There is no other pharmacy website provider that provides this service, so we recommend speaking to the Pharmacy Mentor team to discuss this further – click here for more information.
IN SUMMARY – How to set up a distance-selling pharmacy
Looking at the questions above, it should become clear that there are a number of different considerations and these include;
- Identifying the right premises.
- Checking with the landlord that they will allow the premises to be used as a pharmacy.
- Checking with the council to see if a planning application is required for the premises to be used in the manner that you want to.
- Making sure your application is completed properly.
- Making sure you have robust SOPs in place.
- Considering the GPhC requirements for opening in the premises you have chosen.
- Thinking about your website – we can help you with that too!
Are you considering making an application for a distance selling pharmacy contract? Or have you received an application and want to know how to set up a Distance Selling Pharmacy? Contact us or book a consultation. We will be able to advise you on how to set up a distance selling pharmacy to suit your needs.Contact us to book