2024-11-12 15:33:03
We reported in August on intended amendments to the Human Medicines Regulations 2012, involving exemptions for naloxone from the usual requirements when Prescription Only Medicines are supplied.
The exemptions will come into force on 2 December 2024 through the Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024. An extract from the Explanatory Note to these Regulations is pasted below.
“Prior to these Regulations, limited provision had previously been made to allow people working for drug treatment services to benefit, when supplying naloxone hydrochloride, from an exemption from the ordinary restrictions in the 2012 Regulations on the supply of prescription only medicines. That exemption allowed people working for drug treatment services to supply naloxone hydrochloride without being authorised prescribers. New exemptions introduced by these Regulations also allow people working for the police, prison services, probation services and youth justice services – as well as a list of registered health care professionals – to supply the broader range of naloxone products, provided those individuals have undergone appropriate training. A new exemption is also created for the medical services of His Majesty’s forces. A further new exemption is created for a new type of entity,referred to as local naloxone providers, whose workers will also benefit from the new exemptions. These local naloxone providers will be part of networks, run on behalf of central government and the devolved administrations by entities that agree to act as naloxone supply network co-ordinators. The local naloxone arrangements that are to govern the local supply are required to cover a list of issues that includes appropriate training, the storage and handling of naloxone products and record keeping. Specific provision has also been made for the transfer of information to specified national bodies. Provision has also been made to allow specified national bodies to set national standards for training in the storage and supply of naloxone products nationally.”