The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced that 2 Acnecide products (Acnecide Face 5% w/w Gel & Acnecide Face Wash 5% w/w Gel) will be formally reclassified from pharmacy (P) to general sale list (GSL) medicines.
This change means people will be able to purchase these Acnecide products without a pharmacist’s advice. Making these products more widely available will allow people to treat mild acne affecting the face more easily.
The active ingredient of Acnecide Face Gel and Face Wash is benzoyl peroxide. Benzoyl peroxide has been used to treat acne since the 1960’s and works by killing bacteria that cause acne on the skins surface.
Widening public access to medicinal products when safe to do so, provides greater convenience and choice for the consumer. It also empowers individuals, allowing them to take control of their own health.
This decision was made following a robust assessment of the safety of the Acnecide products, consideration by the Commission on Human Medicines (CHM) and a public consultation earlier this year.
Jan MacDonald, MHRA’s Group Manager for Access and Information for Medicines and Standards (AIMS) in Vigilance and Risk Management of Medicines, said:
“The move to make Acnecide Face Gel and Acnecide Face Wash Gel more widely accessible will make it easier for people to treat mild acne on the face.
“Wider availability of medicinal products and improved patient access and choice remain high on the health agenda. The MHRA is committed to improving access to medicinal products for self-care where it is safe to do so.”
NOTES TO EDITOR
- The licence-holder for Acnecide Face 5% w/w Gel & Acnecide Face Wash 5% w/w Gel (Galderma (UK) Limited) applied to the MHRA to make this product available through general sales outlets.
- Responses to the public consultation are discussed in the Public Assessment Report (PAR) section 5; the responses to consultation are provided at the end of the PAR.
- In the UK, Acnecide 5% w/w Gel was approved as a pharmacy (P) medicine in 1992 and Acnecide Wash 5% w/w Gel as a pharmacy medicine in 2002.
- To be reclassified from P to GSL, it must be demonstrated that a medicine meets the GSL criterion. Acnecide Face 5% w/w Gel & Acnecide Face Wash 5% w/w Gel were assessed against the GSL criterion. Further information on the GSL criterion and assessment of suitability of Acnecide Face products for GSL legal status may be found in the Public Assessment Report (PAR) section 3.
- The MHRA is responsible for regulating all medicines and medical devices in the UK. Underpinning all our work lies robust and evidence-based assessments to ensure the safety, efficacy and quality of medicinal products. The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.