Cosmetics: Afamelanotide
The question
To ask the Secretary of State for Health and Social Care, who has responsibility for preventing the availability of products containing Melanotan II in England; and what steps he has taken to tackle the availability of these products.
Answered by Dr Zubir Ahmed
The Medicines and Healthcare products Regulatory Agency (MHRA) is required to determine whether products are medicines on a case-by-case basis taking into account the definition of a medicine in The Human Medicines Regulations 2012, relevant case law, and any other evidence.
Melanotan II injections and pens are considered medicinal products due to their similarity to an authorised medicinal product and potential application to other medical conditions.
However, tan-enhancing nasal products which are clearly marketed for self-tanning purposes and which do not have a medical purpose do not fall under medicines regulations and are not within the MHRA’s remit.
Medicinal products must hold a relevant Marketing Authorisation to be legally sold and supplied in the United Kingdom. This also guarantees that the medicines have been tested for conformity with strict standards of quality, safety, and efficacy.
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