FSRH statement: we welcome reclassification of Gina 10 microgram vaginal tablets

From September, postmenopausal women in the UK will be able to access a low-dose type of hormonal replacement therapy (HRT) in pharmacies without a prescription. The Medicines and healthcare Products Regulatory Agency (MHRA) has reclassified Gina 10 microgram vaginal tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine. We are pleased with the decision, which follows engagement with the regulator and a public consultation, when we called for the reclassification of this form of HRT.

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.

Dr Asha Kasliwal, President of the Faculty of Sexual and Reproductive Healthcare (FSRH), said:

“We welcome the MHRA’s decision to make Gina 10 microgram vaginal tablets available over the counter in pharmacies. We have consistently engaged with the regulator to advise on reclassification of this medicine as a step towards improving women’s access to menopause treatment.

“Given the significant barriers to health management faced by women going through the menopause, reclassification provides women the opportunity to access medicines more easily and to take control of their menopause.

“We would like to see the UK Government work closely with pharmacies to ensure that Gina is affordable for everyone, especially to those on low incomes, to avoid exacerbating existing inequalities in women’s healthcare..

“We are wary of the prevalence of out-of-date and misleading information in relation to both HRT and vaginal oestrogen treatment. Therefore, it is important to ensure that product information for Gina does not simply duplicate that of systemic HRT, given that many of the purported risks in systemic HRT do not apply. Moreover, since Gina only addresses one of the many symptoms of menopause, women should continue to seek help from their GP or menopause care professional to manage other symptoms.”

ENDS

For further information please contact Camila Azevedo, FSRH External Affairs Manager, at cazevedo@fsrh.org / 02037945309

Notes to editors

• The Government’s announcement can be found here
• Our response to the MHRA consultation can be found here

About FSRH
The Faculty of Sexual and Reproductive Healthcare (FSRH) is the leader in the field of sexual and reproductive healthcare (SRH), and we are the voice for 14,000 professionals working in this area. A multidisciplinary professional membership organisation, we set clinical guidance and standards, provide training and lifelong education, and champion safe and effective SRH across the life course for all.