Explanatory note

This Order makes provision enabling pharmacists to authorise others, in particular pharmacy technicians, to perform tasks that would otherwise need to be performed by or under the supervision of pharmacists – and for pharmacy technicians to take primary responsibility for the preparation and assembly of medicinal products in hospital aseptic facilities.

The placing on the market of medicinal products for human use in the United Kingdom is regulated principally by the Human Medicines Regulations 2012, but there are additional requirements in the Medicines Act 1968 and a separate scheme for investigational medicinal products in the Medicines for Human Use (Clinical Trials) Regulations 2004.

At the end of the medicines supply chain, under section 10 of the Medicines Act 1968, pharmacists are entitled to carry out, or supervise the carrying out of, tasks of preparation, assembly and dispensing of medicinal products without a manufacturing licence, even if this means the product is altered in a way that means it is no longer supplied in accordance with the terms of its product licence, if it has one – provided that what is done is done in a registered pharmacy (most commonly a community pharmacy), a hospital, a health centre or a Scottish care home service. Article 4 of this Order amends the Medicines Act 1968 to allow a pharmacist instead to authorise a pharmacy technician either to carry out these tasks or, with the permission of the pharmacist, to supervise others to carry out these tasks. That authorisation can be given subject to conditions and can be expressed in either specific terms, relating to particular orders for medicinal products, or in general terms, potentially covering prescriptions issued after the authorisation is given. That authorisation can also relate to procuring the performance of these tasks, as well as to the actual performance of them. In giving such an authorisation, the pharmacist must have due regard to patient safety, and failure to do so will not invalidate the permission given but the pharmacist will be liable to disciplinary proceedings. These new arrangements will only apply in Great Britain for the time being because pharmacy technicians are not currently a regulated profession in Northern Ireland.

The Human Medicines Regulations 2012 separately regulate (that is, separately from the regulation of preparation, assembly and dispensing) the carrying out of the final sale or supply of medicinal products. Subject to exceptions (for example, ordinary hospital supply), if the transaction involves a prescription only or a pharmacy medicine, prior to the amendments made by this Order, the transaction has had to take place on registered pharmacy premises and has had to be carried out by or under the supervision of a pharmacist. Going forward, in Great Britain, article 7(1) to (3) enables pharmacists to authorise pharmacy technicians to carry out the transactions that take place at or from registered pharmacy premises, or supervise the carrying out of such transactions, subject to a similar framework to that put in place by the parallel changes to section 10 of the Medicines Act 1968 described above. A relevant amendment has also been made by regulation 7 of the Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758). This replaced the historic requirement that sales or supplies must take place “on” registered pharmacy premises with a requirement that they must take place “at or from” such premises.

Additionally, if a prescription only or pharmacy medicine has been dispensed and is ready for sale or supply at or from a registered pharmacy (a “checked and bagged medicine”), a pharmacist will be able to authorise any member of the pharmacy staff to undertake the final supply of that checked and bagged medicine in the pharmacist’s absence – or where the pharmacist is treated as being absent because they are unavailable or not in a position to intervene (for example, because they are providing clinical services to a patient). This will apply in Northern Ireland as well as Great Britain (article 7(4)).

As indicated above, final supply in the course of the business of a hospital is handled differently to final supply at or from a registered pharmacy. Article 5 of this Order also allows preparation, assembly and dispensing of a medicinal product in a hospital aseptic facility, prior to its final supply, to be done by or under the supervision of a pharmacy technician rather than a pharmacist – thereby enabling a pharmacy technician rather than a pharmacist to lead such a facility. Final supply will then proceed as before. In enabling this change, it is made clear that the medicines supplied to the hospital aseptic facility for preparation, assembly or dispensing must generally be lawfully on the market in the United Kingdom and must not be modified by the preparation, assembly or dispensing to such an extent that a “new” medicinal product is created by that process (there are exceptions for what are known as magistral or officinal formula products). Again, because pharmacy technicians are not a regulated profession in Northern Ireland, this hospital aseptic facility provision will not apply in Northern Ireland for the time being.

Under the separate scheme for the regulation of clinical trials, hospital and health centre pharmacies and dispensaries are able to assemble investigational medicinal products without the need for a manufacturing licence – and article 6 provides that the new arrangements for authorisation by pharmacists and supervision by pharmacy technicians will also apply, in a simplified way, to the assembly of investigational medicinal products.

For all of these new arrangements for authorisations, the relevant regulators will be able to set standards of conduct, ethics and performance relating to them and article 8 makes clear that these standards could include descriptions of the professional responsibilities that pharmacists are to have for documenting authorisations given orally and of the professional accountability that the pharmacists who give authorisations retain.

Consequential amendments are made to the Misuse of Drugs (Safe Custody) Regulations 1973 (article 9), the Misuse of Drugs Regulations 2001 (article 10), the Medicines for Human Use (Clinical Trials) Regulations 2004 (article 11) and the Human Medicines Regulations 2012 (article 12).

Commencement of the provisions of this Order is split into two categories. In the first category are the provisions of this Order which come into force 28 days after this Order is made. These are the introductory provisions (articles 1 to 3) and the provisions of this Order which relate to checked and bagged medicines (that is, article 7(4), which inserts regulation 220B into the Human Medicines Regulations 2012, and the other amendments and the transitional provisions which are associated with regulation 220B). In the second category are the rest of the provisions of this Order, which will be commenced separately by one or more Orders of the Privy Council (for which, see articles 1(3) and (4) and 3).

An impact assessment has been produced for this instrument and is available from the Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU. A copy of it is also published alongside this instrument on www.legislation.gov.uk.