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MHRA announces ‘landmark’ POM to P switch for Gina 10mcg tablets


MHRA announces ‘landmark’ POM to P switch for Gina 10mcg tablets

Gina 10mcg vaginal tablets will be available at pharmacies without a prescription following a “landmark” POM to P switch announced this morning (July 20) by the Medicines and Healthcare products Regulatory Agency.

The announcement came as the MHRA published its report on a consultation that launched in February on its proposal to reclassify the locally applied, estradiol-containing medicine, which is indicated for vaginal symptoms such as dryness and soreness in postmenopausal women aged 50 an over.

Responses came from pharmacists, patients, prescribers and a number of organisations, with over 88 per cent expressing support for the reclassification.

The announcement also follows a safety review by the MHRA and independent advice from the Commission on Human Medicines.

The MHRA said Gina 10mcg tablets will be supplied following a consultation with a pharmacist, if they consider that it is safe and suitable to do so.

The regulator added: “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.”

MHRA chief healthcare quality and access officer Dr Laura Squire said: “This is a landmark reclassification for the millions of women in the UK who are going through the menopause and experience 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 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.”

Health minister Maria Caulfield commented: “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.”

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