MHRA reclassifies 'Gina 10 mg' from POM to over-the-counter

Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines and Healthcare products Regulatory Agency (MHRA).

The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period for at least one year.

The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public consultation.

The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.

Pharmacists are trained healthcare professionals. They will have access to training materials and a checklist that will enable them to advise women on whether these low dose vaginal tablets are appropriate and safe for them to use and to give the information they need, so they can make informed choices. Other vaginal tablets that also contain estradiol, including Vagifem 10 microgram vaginal tablets, will still be available on prescription.

Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: “This is a landmark reclassification for the millions of women in the UK who are going through the menopause and experience severe symptoms that negatively impact their everyday life. Women will be able to safely obtain a local vaginal HRT product without a prescription, which increases women’s access to treatment and gives them greater control over their choices while relieving pressure on frontline GP services.

“In reaching this decision, we have seen positive support from a wide range of people, including many women aged 50 years and above who could benefit from this decision. We would like to thank everyone who submitted their view in our public consultation.

“We will continue to improve women’s access to medicines for menopausal care when it is safe to do so, and to place their views at the centre of our regulatory decisions.”