Gina 10 mcg tablets (estradiol hemihydrate) have been reclassified from a prescription-only medicine to a pharmacy medicine following a safety review, independent advice, and a public consultation

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The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it has reclassified Gina 10 mcg tablets (estradiol hemihydrate) from a prescription-only medicine (POM) to a pharmacy medicine (P). The change will come into effect in September 2022.

In a press release, the MHRA stressed the importance of this development for treatment of the menopause, as it is the first time that postmenopausal women will be able to access low-dose hormone-replacement therapy (HRT) without a prescription.

Gina is a low-dose intravaginal oestrogen used for the treatment of vaginal atrophy in postmenopausal women aged 50 years and above who have not had a period for at least 1 year.

The most common symptoms of vaginal atrophy are dryness, soreness, itching, burning, and painful intercourse. The condition can be diagnosed based on symptoms alone, without the need for any physical examination—a key reason cited in the proposal for its suitability to the pharmacy setting. 

In order to be reclassified from POM to P, a medicine must:

  • be unlikely to be a direct or indirect danger to human health when used without the supervision of a doctor, even if used correctly
  • be generally used correctly
  • not contain substances or preparations of substances where the activity of the product or its side effects require further investigation
  • not normally be prescribed by a doctor for parenteral administration.

Further details of the decision can be found in the proposal, originally created by the MHRA in February 2022 and updated on 20 July 2022 in line with the reclassification. The reclassification follows a safety review by the MHRA, independent advice from the Commission on Human Medicines, and a public consultation that received 1229 responses.

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 MP, UK Minister of State for Health, also 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.

‘We’re putting women’s health to the top of the agenda—our Women’s Health Strategy, published [on 20 July 2022], is testament to that. 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.’

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