Hormone replacement therapy is to be offered over the counter for the first time in the UK after the medicines watchdog gave the green light.
Millions of women go through the menopause every year, with the majority experiencing some symptoms that can be severe and have a negative impact on everyday life.
In a landmark move hailed as a “huge step forward” for women’s health, the first type of HRT to become available at pharmacies without a prescription will be Gina 10 microgram vaginal tablets (containing estradiol).
The Medicines and Healthcare products Regulatory Agency (MHRA) said the vaginal tablets would be available for post-menopausal women from September after a safety review.
The tablets are for women aged 50 and over who have not had a period for at least one year. They treat vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by a lack of oestrogen.
The reclassification of the treatment follows a review of several months that included input from the Royal College of Obstetricians and Gynaecologists, the Faculty of Sexual and Reproductive Healthcare, and the British Menopause Society.
Low-dose vaginal estradiol has been widely used since 1991 and is regarded as safe, the MHRA said. Pharmacists will be able to use training materials and a checklist to ensure the tablets are prescribed appropriately.
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.”
Maria Caulfield, the minister for women’s health, said: “Menopause affects hundreds of thousands of women every year, but for some its symptoms can be debilitating and for many they can be misunderstood or ignored.
“Making Gina available over the counter is a huge step forward in enabling women to access HRT as easily as possible, ensuring they can continue living their life as they navigate the menopause.”
The MHRA announcement comes hours after ministers vowed to tackle decades of “systemic” and “entrenched” gender health inequality in England with plans to introduce compulsory women’s health training for doctors, more cancer checks and “one-stop shop” hubs across the NHS.
A consultation that received almost 100,000 responses from women and informed the government’s first women’s health strategy found that the menopause was the single most cited health issue for women aged 40-59.
A key concern for years has been access to treatment, with women reporting that symptoms are not taken seriously or recognised as the menopause, and that there are difficulties in accessing HRT, with some GPs reluctant to prescribe it.
