Consultation outcome

Hana 75 microgram film-coated tablets (Desogestrel): Public Consultation

From:
Medicines and Healthcare products Regulatory Agency
Published
12 February 2021
Last updated
8 July 2021 — See all updates
This consultation has concluded

Download the full outcome

Hana public assessment report

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Detail of outcome

The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to reclassify Hana (containing 75 microgram desogestrel (DSG) per tablet) from prescription only (POM) to Pharmacy (P) for the prevention of pregnancy in women of childbearing age. See the public assessment report above for more information.

Published on 8 June 2021

Feedback received

A public consultation on reclassifying two medicines containing desogestrel from prescription only (POM) to pharmacy (P)

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Detail of feedback received

Consultation document ARM 99, which summarises the proposals on the prescription only (POM) to pharmacy (P) reclassification of Lovima 75 microgram film coated tablets and Hana 75 microgram film coated tablets both containing desogestrel for the prevention of pregnancy in women of childbearing age, was posted on the GOV.UK website on 12 February. The deadline for comments was 5 March 2021.

Original consultation

Summary

A 3-week public consultation on a proposal to make Hana 75 microgram film-coated tablets (Desogestrel) available from pharmacies.

This consultation ran from
to

Consultation description

We want to know what you think

  • Hana 75 microgram film-coated tablets are an oral contraceptive used to prevent pregnancy in women of childbearing age
  • We propose to make it available in pharmacies
  • Medicines containing desogestrel will still be available on prescription from GPs and sexual health clinics.
  • Women will have choice in where they obtain supply of this medicine from, either on prescription or from pharmacies and may opt to switch between methods of supply
  • We consider that this product may be available as a Pharmacy (P) medicine
  • The Commission on Human Medicines has advised that this product can be available as a Pharmacy (P) medicine.
  • We want to know what you think about this change

Please tell us your views – please use the form below.

The deadline for comments is Friday 5 March 2021.

Other consultations

We are currently carrying out a public consultation on Lovima, another desogestrel contraceptive product

Documents

Hana public consultation document

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Annex 1: Response document for MHRA public consultation on the proposal to make Hana available from pharmacies

MS Word Document, 214 KB

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Annex 2: Hana leaflet

PDF, 126 KB, 2 pages

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Annex 3: Hana Label

PDF, 583 KB, 4 pages

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Annex 4: Hana SPC

PDF, 237 KB, 14 pages

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Annex 5: Hana checklist

PDF, 266 KB, 5 pages

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Data Protection and Privacy Information

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Published 12 February 2021
Last updated 8 July 2021 + show all updates

  1. Outcome of reclassification published

  2. First published.