In line with the Government’s strategy to replace animals in science, the Medicines and Healthcare products Regulatory Agency (MHRA) supports the use of non-animal approaches where they are fit for purpose and accepts that, where a biological product is not pharmacologically active in animals and no relevant animal model exists, studies in animals, including with surrogate molecules, should not be undertaken and first-in-human applications can be supported using non-animal data, such as in vitro methods and computer modelling, to inform expected human exposure and safety. Further information is available at the following link:

https://www.gov.uk/government/publications/replacing-animals-in-science-strategy/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methods

More broadly, alternative methods used to characterise safety must be demonstrated as fit for their intended purpose, and MHRA guidance, published in March 2026, sets out its current approach to medicines using non-animal methods, including how such approaches can support regulatory submissions and the adoption of validated alternatives as they become available. For potency testing and for adventitious agent testing, separate information for manufacturers on controls for batch release is on the MHRA website explaining how adoption of non-animal methods for these purposes is supported. Further information is available at the following two links:

https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methods

https://nibsc.org/about_us/our_use_of_animals.aspx

In line with the Government’s strategy to replace animals in science, the Medicines and Healthcare products Regulatory Agency (MHRA) supports the use of non-animal approaches where they are fit for purpose and accepts that, where a biological product is not pharmacologically active in animals and no relevant animal model exists, studies in animals, including with surrogate molecules, should not be undertaken and first-in-human applications can be supported using non-animal data, such as in vitro methods and computer modelling, to inform expected human exposure and safety. Further information is available at the following link:

https://www.gov.uk/government/publications/replacing-animals-in-science-strategy/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methods

More broadly, alternative methods used to characterise safety must be demonstrated as fit for their intended purpose, and MHRA guidance, published in March 2026, sets out its current approach to medicines using non-animal methods, including how such approaches can support regulatory submissions and the adoption of validated alternatives as they become available. For potency testing and for adventitious agent testing, separate information for manufacturers on controls for batch release is on the MHRA website explaining how adoption of non-animal methods for these purposes is supported. Further information is available at the following two links:

https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methods

https://nibsc.org/about_us/our_use_of_animals.aspx

The Home Office does not collect data on the fate of animals at the end of procedures. Under the Animals (Scientific Procedures) Act 1986, licensed establishments are responsible for keeping records which include the fate of the animals. Home Office Inspectors in the Animals in Science Regulation Unit may ask to look at these records at any time. The number of animals used in scientific procedures can be found here: www.gov.uk/government/collections/animals-in-science-statistics. This data is broken down by year and by species and type of procedure.

To protect human safety there are legal requirements to test the safety and potency of medicinal products and drug substances containing botulinum toxin. The testing of this medicinal product is required by the Medicines and Healthcare Products Regulatory Authority (MHRA).

In November 2025, the Government published Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, which includes an aim to apply only validated alternative methods in the pharmacopoeial potency testing of botulinum toxin by the end of 2027.

The Government is currently considering what steps may need to be taken in relation to the safety of the non-surgical cosmetics sector. The Government will set out its position at the earliest opportunity.

All National Health Service providers in North West London Integrated Care Board area, which includes the ‘west London’ area, use botulinum toxin treatments where appropriate and in line with clinical advice.

In 2021 the Government introduced the Botulinum Toxin and Cosmetic Fillers (Children) Act to prevent children aged under 18 years old in England from accessing botulinum toxin and filler treatments for cosmetic purposes. Additionally, as part of the Health and Care Act 2022, the Government introduced legislation to give the Secretary of State for Health and Social Care the power to introduce a licensing regime for non-surgical cosmetic procedures, including botulinum toxin injections for cosmetic purposes.

The licensing scheme will ensure that practitioners offering specified procedures are suitably knowledgeable, trained, and qualified, hold appropriate indemnity cover and operate from premises which meet the necessary standards of hygiene, infection control and cleanliness. Following engagement with stakeholders, on 2 September 2023 we launched the first public consultation on the scope of the licensing scheme. The consultation will run until 28 October 2023.

The Medicines and Healthcare products Regulatory Agency (MHRA) has powers to investigate and take action when breaches or suspected breaches of the Human Medicines Regulations 2012 are identified. The action taken is determined on a case-by-case basis and will reflect relevant factors and evidence. Offences under the Regulations are criminal and if appropriate, the MHRA will bring a prosecution through the criminal courts. Penalties range from a fine to a two-year prison sentence.

The MHRA works with external healthcare partners to ensure the safety of the public and the Border Force on the importation of illegal Botox substitutes. The MHRA will take action if any trends associated to the safety or efficacy of a healthcare product are identified. The information requested on police action is not held as this is a matter for the Home Office.

The Department has no current plans to monitor the use of illegal botox substitutes. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the United Kingdom and ensures that all such products licensed for use meet all applicable standards of safety, quality and efficacy. The MHRA monitors the safety of all medicines and remains vigilant for any emerging new evidence from Yellow Card Reports, scientific publications or information from patients and stakeholders in relation to any illegal use of medicines and takes regulatory action where necessary.

The Medicines and Healthcare products Regulatory Agency monitors the safety of all medicines, any emerging new evidence in relation to any illegal use of medicines and will take regulatory action where necessary. Botulax is a brand of botulinum toxin not licensed for use in the United Kingdom. Botulinum toxins are prescription-only medicines and must be prescribed by a registered healthcare professional or medical practitioner. The prescriber may delegate the administration of the medicine to a secondary practitioner who is not required to be a healthcare professional. However, the prescriber retains responsibility for ensuring the treatment is provided safely.

While there have been no specific discussions with the Welsh Government, we are committed to improving the safety of cosmetic procedures. Advice for those considering receiving botulinum toxin injections for cosmetic purposes is available at NHS.UK. This includes ensuring that the chosen practitioner has the skills to perform the procedure safely and recommends asking the practitioner for the name of the product, whether it is licensed and how and where it is made.

The Medicines and Healthcare products Regulatory Agency monitors the safety of all medicines, any emerging new evidence in relation to any illegal use of medicines and will take regulatory action where necessary. Botulax is a brand of botulinum toxin not licensed for use in the United Kingdom. Botulinum toxins are prescription-only medicines and must be prescribed by a registered healthcare professional or medical practitioner. The prescriber may delegate the administration of the medicine to a secondary practitioner who is not required to be a healthcare professional. However, the prescriber retains responsibility for ensuring the treatment is provided safely.

While there have been no specific discussions with the Welsh Government, we are committed to improving the safety of cosmetic procedures. Advice for those considering receiving botulinum toxin injections for cosmetic purposes is available at NHS.UK. This includes ensuring that the chosen practitioner has the skills to perform the procedure safely and recommends asking the practitioner for the name of the product, whether it is licensed and how and where it is made.

The Medicines and Healthcare products Regulatory Agency monitors the safety of all medicines, any emerging new evidence in relation to any illegal use of medicines and will take regulatory action where necessary. Botulax is a brand of botulinum toxin not licensed for use in the United Kingdom. Botulinum toxins are prescription-only medicines and must be prescribed by a registered healthcare professional or medical practitioner. The prescriber may delegate the administration of the medicine to a secondary practitioner who is not required to be a healthcare professional. However, the prescriber retains responsibility for ensuring the treatment is provided safely.

While there have been no specific discussions with the Welsh Government, we are committed to improving the safety of cosmetic procedures. Advice for those considering receiving botulinum toxin injections for cosmetic purposes is available at NHS.UK. This includes ensuring that the chosen practitioner has the skills to perform the procedure safely and recommends asking the practitioner for the name of the product, whether it is licensed and how and where it is made.

National statistics on the number of prosecutions and the sentences imposed under the ‘The Botulinum Toxin and Cosmetic Fillers (Children) Act 2021’ for the calendar year of 2021 are due for publication in May 2022.

Cosmetic testing on animals was banned in the United Kingdom in 1998 and household products have not been tested on animals in the UK since 2011, with such testing formally banned in 2015.

Botox (Botulinum toxin) is regulated as a medicine in the UK. Unlike many biological medicines, a validated cell-based release assay has been approved for botulinum toxin in the UK and does not require the use of animals in the testing of Botox. There is no plan to alter this policy currently.