Pharmacy owners and employers: FAQs

It’s a legal requirement that the owner of a pharmacy must appoint a Responsible Pharmacist, who is a registered pharmacist, to oversee the safe and effective running of the registered pharmacy when it’s operational. 

The responsibilities of this role include: 

• displaying a notice that gives the details of who the Responsible Pharmacist is
• making and keeping records
• pharmacy procedures
• the responsible pharmacist’s absence from the pharmacy

To find out more about the legal requirements that apply, you can read the legislation, refer to professional leadership organisations such as the Royal Pharmaceutical Society and the Association of Pharmacy Technicians UK, or pharmacy organisations such as the National Pharmacy Association. You can also seek your own legal advice.

The Department of Health and Social Care has guidance on the requirements for the role of the responsible pharmacist, and is in the process of reviewing the law in this area.  You can find out more on the Department’s website. 

 

Registration as a temporary and occasional service provider is no longer possible. To work as a pharmacist or pharmacy technician, pharmacy professionals must join our register or our temporary register.

All applicants and registrants must provide evidence that they have English language competency. You can find out more about this on our language requirements for pharmacists and pharmacy technicians page.

Our requirements concerning evidence of English language skills don’t replace the important role that you as an employer play in checking that the pharmacy professionals you wish to employ are competent and have the necessary knowledge of English to practise safely and effectively. You need to do this as part of your interview and selection processes.

 

Although the sale or supply of pharmacy medicines and prescription only medicines can only take place from a registered pharmacy, legislation gives an exemption from this requirement to hospital pharmacies.

Hospitals are exempt provided that the supply is made ‘in the course of the business of that hospital’ to its own in-patients or out-patients and in accordance with the directions of a prescriber.

Trusts or health boards may include several different hospitals on different sites, but all the hospitals within a trust or health board are viewed as being part of a single legal entity. The supply of medicines from one hospital to a patient in another hospital of the same trust or health board is a supply within the same legal entity. This means that it would be regarded as a supply in the course of the business of that hospital, and so the supplying hospital pharmacy wouldn’t be required to be registered with us.

A hospital pharmacy would need to be registered with us if they wished to supply pharmacy medicines or prescription only medicines to:

• patients in another hospital belonging to a separate Trust or Health Board
• private patients of a separate legal entity based within the same hospital 
• provide a community pharmacy service for members of staff and the public 

It depends on what medicines you’re going to sell. If you’re intending to sell only medicines that are on the General Sale List (GSL medicines) over the internet, you don’t meet our registration criteria and your premises are not eligible to register. This is because GSL medicines can be sold from other retail outlets, such as supermarkets and petrol stations, when the appropriate legal conditions are met.

If you intend to make sales or supplies of pharmacy medicines or prescription only medicines, then the premises from which you make these supplies from must be registered with us as a pharmacy.

If your service model consists solely of supplying medicines licensed for animal use only, then we can’t register your premises as a pharmacy.

However, if your pharmacy supplies P medicines or POMs against prescriptions written by veterinary practitioners for the treatment of animals under the ‘cascade’, then you are eligible and required to register your premises as a pharmacy.

The cascade means that if no suitable veterinary medicine is authorised in the UK, the veterinary surgeon responsible can use professional judgement.

The quantity of medicines or proportion of the business doesn’t matter. This is a change from our previous interpretation which was that the medicines would have to be human medicines for use by human patients.

You’ll only meet the registration criteria if the unlicensed medicine you manufacture is then supplied by you as a dispensed medicinal product, labelled for a specific patient against a prescription and supplied directly by you, or on your behalf, to the patient.

If this is not your service model, then you won’t be eligible for registration with us and would need to apply to the MHRA for a ‘specials manufacturing licence’. This licence would permit you to manufacture an unlicensed medicinal product and to supply a stock of it through wholesale supply to a registered pharmacy. In this service model, it’s the registered pharmacy’s role to label the product for a specific patient as a dispensed medicinal product and supply it to the patient.

‘Supply in circumstances corresponding to retail sale’ is defined in the Human Medicines Regulations 2012 as supply otherwise than by way of sale.

Case law (Pfizer Corp v Ministry of Health 1965) has established that the supply of a P medicine or POM against an NHS prescription is not a retail sale. Such a supply is regarded as being made in ‘circumstances corresponding to retail sale’.

Yes, you’ll need to register if you’re going to sell Pharmacy medicines or Prescription only Medicines. You’d need to make an application for registration and inform us of the expected duration of service provision from the temporary premises.

A central ‘hub’ pharmacy is required to be registered if it’s making supplies of P and POMs against prescriptions labelling the product for a specific patient as a dispensed medicinal product.