Understanding Regulatory Frameworks for Injectables

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Professor Steve Davies and Dr Anish Kotecha explore what aesthetic practitioners need to know about the aesthetic products they are injecting

The rapid expansion of the aesthetics specialty in the UK has seen an influx of a variety of aesthetic products from non-UK/European Union (EU) sources.1 Yet, the provenance of all these products is not readily clear. Estimates suggest that over 160 dermal filler brands are currently available in the UK market.1 Despite not claiming a medical purpose, these products are potentially injurious to the patient if they do not meet relevant regulatory standards.
The growing number of injectable brands with a lack of regulatory requirements makes it challenging for the aesthetic practitioner to be confident regarding compliance and safety. The issue is highlighted by the recent report of more than 400 ‘non-compliant’ dermal fillers being seized in a raid by the Medicines and Healthcare products Regulatory Agency (MHRA).2
The onus is on the practitioner to ensure the products they use are licensed, approved and intended for use in the UK.2 In a Freedom of Information request, the MHRA reported approximately 200-400…

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