First HRT product in the UK to be made available without a prescription

For the first time, women in the UK will be able to access hormone replacement therapy (HRT) in community pharmacies without a prescription, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed.

Following a safety review and public consultation, in which over 88% of 1,229 respondents were in favour of the move, Gina 10 microgram vaginal tablets (estradiol; Novo Nordisk) will now be available to buy as a P medicine by women aged 50 years and above who have not had a period for at least one year.

Gina is a local oestrogen therapy used primarily to treat vaginal atrophy caused by oestrogen deficiency in postmenopausal women. The condition can lead to symptoms including dryness, itching and painful intercourse. Gina helps to restore the integrity of the vaginal wall, relieving these symptoms.

A press release, published by the MHRA on 20 July 2022, said that low-dose vaginal estradiol had been widely used for the treatment of postmenopausal vaginal symptoms as a prescription medicine since 1991 and had a well-established safety profile. 

“The product will be supplied from a pharmacy when it is considered safe and suitable to do so, following consultation with a pharmacist,” the press release said.

Pharmacists 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 provide information so that women can make informed choices.

Other vaginal tablets that also contain estradiol, including Vagifem 10 microgram vaginal tablets (Novo Nordisk), will still be available on prescription.

Laura Squire, chief healthcare quality and access officer at the MHRA, described the reclassification as “a landmark”.

“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,” she said.

Health minister Maria Caulfield said making Gina available without a prescription was 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.

Referring to the Women’s Health Strategy, also published on 20 July 2022, Caulfield said that the government were “putting women’s health to the top of the agenda”.

“More widely we’re continuing to work with suppliers and manufacturers to secure sustainable short-term and long-term access to HRT and our UK-wide menopause taskforce will tackle taboos and issues surrounding menopause,” she added.

Claire Anderson, president of the Royal Pharmaceutical Society, strongly welcomed the announcement. “In our response to the consultation on the proposed reclassification earlier this year, we stressed that pharmacists are well placed to offer this support through an NHS pharmacy service. We’re therefore pleased that pharmacists’ expertise will now be used to support women’s health in this way,” she said.

“While this reclassification certainly is progress, we continue to call on governments across Great Britain to go further to tackle health inequalities experienced by women and for the recommendations in our position statement on women’s health to be implemented.”

• This article was corrected on 21 July 2022 to clarify that Gina is taken vaginally