Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, whether he plans to bring forward legislation to make all dermal fillers prescription-only products.

Currently, the Medicines and Healthcare products Regulatory Agency only regulates dermal fillers that are placed on the United Kingdom market as medical devices, as defined in the Medical Devices Regulations 2002. The majority of these products are intended to be used in reconstructive surgery, and thus they are considered to be medical devices, although some manufacturers also indicate their products for aesthetic use as well.

Cosmetic dermal fillers placed on the market without any medical purpose being attributed to them by the manufacturer fall outside the scope of the Medical Devices Regulations, although in practice the majority of the products on the UK market are CE marked as medical devices.

Under new European Union legislation concerning medical devices, published earlier this year, all dermal fillers will be regulated as medical devices, irrespective of whether or not the manufacturer ascribes a medical purpose to the product.

Medical devices cannot be designated as “prescription only”, as this term only applies to medicinal products. The Government currently has no plans to introduce such a category for medical devices.