Naloxone is a medicine that reverses an opioid overdose, for example an overdose of heroin, oxies, fentanyl, or nitazenes. If someone does not have any opioids in your system, it won’t affect them.  

The supply of naloxone is governed by the Human Medicines Regulations 2012 (HMR). According to these regulations, naloxone is classified as a ‘prescription-only medicine’ (POM).  

Because it’s a POM, there is red tape around how it can be lawfully administered, sold, and supplied, but there are now many exemptions to these rules that make it easier.  

What is the HMR?  

The HMR combined many rules that were in existence before 2012 concerning the administration, manufacturing, dealing, mixing, licensing, selling, and supply of human medicines.  

What are the regulations on administering naloxone? 

ANYONE can administer naloxone to save a life in an emergency: there are no legal barriers preventing you from doing this. You do not need to be a doctor or healthcare professional. Naloxone is safe and easy to administer.  

Which regulations tell us this?  

Regulation 214(2) of HMR states that a prescription only medicine (e.g., naloxone) cannot be administered except by an appropriate practitioner. However, Regulation 238 creates an exemption to this rule, stating that certain prescription-only medicines can be administered by anyone, provided it is an emergency. Those exempted medications are listed in Schedule 19 and includes Naloxone.  

 

What are the regulations on supplying naloxone?  

The rules on supplying naloxone have developed significantly since the HMR 2012 came into force, because of three amendments in 2015, 2019, and 2024 (see details below under ‘history’). 

The most recent of these amendments came in 2024, effective 2nd December 2024. This amendment expanded the number of people who could supply naloxone without a prescription and the purposes for which naloxone can be supplied.  

These amendments to the HMR now govern the supply of HMR, creating a new regulation 237A in the HMR.  

 

Who can supply naloxone without a prescription? 

Any of the below people can supply naloxone to someone without a prescription if they have been sufficiently trained in storing and supplying naloxone products: 

• Anyone employed or engaged in providing drug treatment services 
• Pharmacists, pharmacy technicians, nurses, midwives, paramedics 
• A “local naloxone provider” (see below for what that is) 
• Anyone employed or engaged in providing medical services for the armed forces 
• Police forces in England, Wales Scotland, Northern Ireland  
• Prison services 
• Probation services 
• Youth justice services 

Appropriate practitioners, like doctors or pharmacist prescribers, can still prescribe naloxone with a prescription or without a prescription if someone is their patient (Reg 223(1) of the Human Medicines Regulations). Pharmacists can also prescribe naloxone without a prescription if a prescriber has been unable to issue a prescription due to an emergency (Regulation 224). 

For what reasons or purposes can naloxone be supplied?  

Another development of the 2024 amendment is the expansion of reasons for which naloxone can be supplied (Reg 237A (9))  

It can be supplied:  

1. For the purpose of saving a life in an emergency 
2. As take-home naloxone to keep in case. This is supplied for a potential emergency involving an opioid overdose (whether it’s yourself or someone else), 
3. As portable naloxone to carry in case. This is also supplied for a potential emergency involving an opioid overdose (whether it’s yourself or someone else). 

What is a local naloxone provider? 

A local naloxone provider is a group or organisation that has a local naloxone arrangement agreement in place with a naloxone supply network coordinator. 

Any group of people could form a local naloxone provider, provided they (i) meet the training requirements on storing and supplying naloxone and (ii) have an agreement in place with a coordinator.  

A naloxone supply network coordinator, in turn, has agreements called ‘network creation agreements’ in place. The full details of this have yet to be announced though it seems likely that guidance on local naloxone providers should be coming from the Department for Health and Social Care or the United Kingdom Health Security Agency.  with the appropriate secretary of state (for England and Wales, likely the SoS for Health and Social Care).

What are the requirements to become a local naloxone provider? 

Once the naloxone supply network coordinators are in place then we anticipate the guidance for becoming a local naloxone provider will require: 

1. A valid agreement with a naloxone supply network coordinator. 

The agreement should be valid if it ensures appropriate training, records of who is working for or engaged by the local naloxone provider and their training, named individuals responsible for storage and record-keeping, and if the agreement follows any national rules regarding storage, records, and provision of information to the naloxone supply network coordinator. These requirements are listed in Reg 237A (6).   

2. The training undertaken by local naloxone providers must meet the requirements listed in Reg 237A (8).  

The training must successfully teach someone lawful administration and supply of naloxone, safe storage and handling of naloxone, and how and when to administer naloxone.  

3. The naloxone supply network coordinator with whom the local provider has an agreement must themself have a valid agreement with the appropriate national body.  

Their agreement must meet the requirements listed in Reg 237A (7). 

History of the HMR and naloxone supply 

Originally, naloxone could only be supplied according to the following rules, which severely hindered the supply of naloxone: 

It could be supplied under the prescription of an “appropriate practitioner,” a listed group of healthcare professionals, such as doctors and pharmacist independent prescribers (Reg 214). It could only be sold and supplied in a registered pharmacy (Reg 220). The HMR did allow for ‘patient group directions’ to be set up to mean a wider group of healthcare professionals can supply naloxone under the direction of a multi-disciplinary team (Schedule 16).  

Three key amendments to the HMR 2012 made naloxone easier to supply:  

• First, the Human Medicines (Amendment) (No. 3) Regulations 2015 (Reg 10), which meant injectable naloxone could be provided by drug treatment services without a prescription for “the purpose of saving life in an emergency”.  
• Second, the Human Medicine (Amendment) Regulations 2019 No. 62 (Reg 18), which meant nasal naloxone could be provided by drug treatment services without a prescription “for the purpose of saving a life in an emergency”.  
• Third, the Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 No. 000., which has reformed naloxone supply arrangements, building on and replacing the previous two amendments (which are no longer in the HMR). 

What still needs to happen

Before the 2024 amendment came into force, the Government ran a public consultation, in which Release argued that naloxone should be classified as a pharmacy medicine, not a prescription only medicine. Doing this would have quickly facilitated much wider access to naloxone, but the 2024 amendment maintains the classification of naloxone as a POM, though it did follow Release’s advice about widening who can supply naloxone lawfully. 

We will keep pushing for naloxone to be made as accessible as possible, so that people can use their drugs safely and access naloxone without facing barriers. Following the 2024 amendment, we will be advocating for supply network coordinators and local naloxone providers to be set up as fast as possible and to prioritise peer-to-peer naloxone supply networks.

We’ve produced a A4 leaflet with the key updates on naloxone guidance below for anyone to print or display in their treatment services or where people may be using drugs.