MHRA consults on making first HRT product available over the counter

The consultation follows advice from the Commission on Human Medicines that Gina, used in the treatment of vaginal atrophy, is safe to be made available as a pharmacy medicine.
pharmacy counter

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on making the first hormone replacement therapy (HRT) product available in pharmacies without a prescription.

Gina (estradiol; Novo Nordisk) 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.

Through the consultation, the MHRA is seeking views on making Gina available over the counter to women aged 50 years and above, who have not had a period for at least one year. It follows advice from the Commission on Human Medicines, which states that the product is safe to be made available as a pharmacy medicine.

According to the consultation document, vaginal atrophy is currently diagnosed based on symptoms alone and without the need, in most women, for any physical examination, making it suitable for a pharmacy setting.

The MHRA said on 2 February 2022 that, if the product was reclassified, pharmacists would have access to training materials and a checklist to enable them to identify women who can be supplied the medicine safely.

It also highlighted that medicines containing low-dose vaginal estradiol would still be available on prescription from GPs and that women would have a choice in terms of where they obtain the medicine; whether on prescription or from pharmacies.

Laura Squire, chief healthcare quality and access officer at the MHRA, said that each consultation response received would be “vital” in helping the organisation gain a better picture of whether this form of vaginal HRT should be available over the counter.

“The menopause can cause unpleasant symptoms and HRT-based medications form an important part of alleviating them. This is why it’s so important for us to hear what women think about this possible reclassification,” she said.

“We want to hear from as many people, healthcare professionals and women’s groups as possible.”

The consultation will run until 23 February 2022.

  • This article was amended on 3 February 2022 to correct the name of the hormone replacement therapy product Gina

Read more: Is hormone replacement therapy worth the risks?

Last updated
The Pharmaceutical Journal, PJ, February 2022, Vol 308, No 7958;308(7958)::DOI:10.1211/PJ.2022.1.126965

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