Dermal fillers and medicines containing botulinum toxin (e.g. Botox) are regulated under different regulatory frameworks. Dermal fillers are regulated as medical devices in the EU and therefore regulated by Regulation 2017/745 (Medical Device Regulation, MDR). Botulinum toxin (‘Botox’) products are prescription-only medicines, and their administration is regulated by the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended. The HPRA is the competent authority for both medicines and medical devices in Ireland.

Dermal fillers:

Dermal fillers are regulated under the MDR as Class III medical devices (i.e. the highest risk class). The MDR outlines the requirements and obligations which must be fulfilled by medical device manufacturers, importers and distributors to maintain the integrity of the supply chain for the EU market. The Commission Implementing Regulation (EU) 2022/2346 requires that dermal fillers’ instructions for use include statements that dermal fillers "are not to be used in persons who are less than 18 years old" and that they should only be administered by appropriately trained healthcare professionals.

The HPRA does not approve or license medical devices for sale in Ireland. The HPRA’s role in regulating medical devices is primarily in the post-market phase through market surveillance and vigilance activities. The HPRA may inspect economic operators within the supply chain to evaluate the compliance of medical devices supplied to the Irish market. However, the HPRA does not regulate clinical practice relating to the use of medical devices such as dermal fillers and does not regulate the facilities or circumstances under which medical devices are used or administered. As such, the HPRA does not have a role in regulating the administration of dermal fillers.

I am aware of concerns in relation to the safe administration of dermal fillers and in this regard the Government has committed in its Programme for Government 2025 to ensure the administration of dermal fillers is only undertaken by trained healthcare professionals. My Department is currently conducting research activities with respect to legislative and regulatory options regarding the administration of dermal fillers. This includes a review by the Health Research Board, commenced in 2025, the report of which is expected in the coming months. Once received, the Department will consider the most suitable option with respect to administration of dermal fillers. We plan to engage with stakeholders as part of the programme of work to progress this matter.

In the meantime, the HPRA has published a webpage providing practical advice for consumers on dermal fillers. For those considering dermal fillers, the HPRA recommends attending a qualified healthcare professional. Further information can be found on the Dermal Fillers Information page: www.hpra.ie/safety-information/how-we-monitor-safety/medical-devices/comsumer-advice/dermal-fillers---information-for-consumers-and-clinics.

Botulinum toxin (‘Botox’) products :

Botulinum toxin (‘Botox’) products are prescription-only medicines and as such, their administration is regulated. The regulations concern, among other aspects, the use of appropriately authorised products and the individuals who can source and administer the medicine.

The authorised indications and conditions for use for each product are specified in the marketing authorisations granted by the HPRA or European Medicines Agency, as appropriate. The relevant product information for each product is available from the HPRA website.

The HPRA monitors for the illegal supply and administration, both in the physical and digital sphere, of unauthorised products and of products supplied by people who are not authorised or qualified to do so. This activity includes the inspection of facilities, practitioners, and/or businesses suspected to be in breach of the above regulations. The HPRA has taken action in a number of cases, including, in some cases, prosecutions in the District Court in relation to illegal supply/advertising of botulinum toxin containing medicines. The HPRA continues to engage in enforcement of the Regulations.

I understand that the relevant regulators, i.e. the Medical Council, the Nursing and Midwifery Board of Ireland, the Dental Council, and the Health Products Regulatory Authority, have collaborated closely in the development of guidelines for regulated professionals with respect to the prescribing and administration of botulinum toxin products. Relevant guidance is available via the websites of the respective regulatory bodies.