Licensing medicines

Licensed medicinal products are placed on the market when they have been assessed by the Medicines and Healthcare products Regulatory Agency (MHRA) to meet the quality, safety and efficacy standards for their intended use and have been granted a Marketing Authorisation (MA) in the UK.

Two legal mechanisms exist which allow for medicines to be made without a MA. These are:

• by a Manufacturer who holds a Specials (MS) licence
• by a pharmacist operating under section 10 exemption of the Medicines Act 1968

For further information, see our articles Understanding unlicensed medicines and Using unlicensed medicines.

Manufacturer’s “Specials” Licence

The manufacturer or assembler of “Specials” must hold a “Specials” (MS) Licence granted by the MHRA. MS licence holders may be commercial organisations or part of the NHS. The manufacturing site and its operations are inspected by the MHRA, both for compliance with GMP and with the conditions of the licence. The MHRA’s notes for applicants and holders of a manufacturer licence provides further information.

Products

The manufacture is limited to preparation of specific product categories which are stated on the MS licence. A wide range of products may be manufactured under a MS licence including examples such as terminally sterilised, aseptically manufactured, or non-sterile products. All MS holders are listed on the MHRA’s Human and veterinary medicines: register of licensed manufacturing sites.

A medicine which has been manufactured under an MS licence is identifiable by the presence of the MS licence number on the label, for example ‘MS12345’. Medicines made under the MS licence may be sold to suitable external organisations without the need for Wholesale Dealer’s Licence (WDL), also termed a Wholesale Distribution Authorisation (WDA).

Additional guidance can be found in the MHRAs ‘Guidance for Specials manufacturers’.

Repacking and Overlabelling

NHS hospitals with an MS licence which covers primary or secondary packaging may re-pack or overlabel medicines.

Repacking and overlabelling may also be undertaken in NHS pharmacies under Section 10 exemption. However, there are limits to the number and sizes of batches which may be prepared each month. For further information please see our guidance on repackaging and overlabelling small batches of medicines in pharmacy departments.

Section 10 exemption

The law also allows a pharmacist to prepare and supply medicines in a registered pharmacy without the need for the product to be licensed. Section 10 exemption of the Medicines Act 1968 (as referenced in The Human Medicines Regulations 2012), exempts pharmacists from the licensing requirements of a Marketing Authorisation (MA) in the following circumstances:

1. The medicinal product is prepared or dispensed in a hospital or health centre by or under the supervision of a pharmacist and in accordance with an appropriate practitioner’s prescription.
2. Assembling a medicinal product in a hospital or health centre by or under the supervision of a pharmacist.
3. Preparing medicinal products in a hospital or health centre by or under the supervision of a pharmacist in anticipation of a prescription.

Aseptic preparation

In the NHS, aseptic preparation under Section 10 exemption is subject to additional requirements defined in the 2023 Assurance of aseptic preparation guidance.

All NHS pharmacy aseptic preparation services operating under Section 10 exemption must meet the five criteria below:

1. Preparation is carried out by or under the supervision of a pharmacist. It is critical that the person responsible for supervision has the necessary competence and technical expertise in GMP.
2. Preparation uses only closed systems with the exception that emergency eye drop preparation is allowed under defined circumstances.
3. Preparation uses only licensed sterile medicinal products or, when appropriate, a sterile medicinal product with sufficient evidence to provide assurance of pharmaceutical quality.
4. Finished products are allocated a shelf-life of no more than 8 days and the allocated shelf-life is supported by validated stability data and an objective risk assessment
5. Preparation is carried out in accordance with the NHS professional standards referred to in NHS England – Assurance of aseptic preparation of medicines.

Compliance

NHS sites in England performing aseptic preparation under the Section 10 exemption are subject to an external quality audit by Specialist Pharmacy Service Quality Assurance. The audit interval is risk-based up to a maximum of 2 years.

Compliance with current European Union Good Manufacturing Practice is required in line with Royal Pharmaceutical Society standards, documented in the current edition of Quality assurance of aseptic preparation services.

Extemporaneous preparation

Under Section 10 exemption a pharmacist may extemporaneously prepare a limited quantity of a custom-made medicine for a specific patient.

Extemporaneous preparation is associated with a number of potential risks such as formulation failure, poor dose uniformity, and calculation error. It is therefore essential that the activity is only undertaken by staff with suitable knowledge and experience.

Alternative options should be carefully considered as part of a patient specific clinical risk assessment before opting for extemporaneous preparation. The Extemporaneous medicines handbook provides useful additional guidance on the topic.