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MHRA consultation reclassifying two medicines containing desogestrel from prescription only (POM) to pharmacy (P)

Published: 08 Jul 2021 in Policy statements

The Medicines & Healthcare products Regulatory Agency (MHRA) opened a call for evidence about the potential reclassification of Lovima and Hana – oral contraceptives used for the prevention of pregnancy in women of childbearing age. Lovima and Hana tablets contain desogestrel and are a progestrogen-only oral contraceptive, sometimes known as the mini-pill.

A key difference between Hana and Lovima is that Lovima contains soya bean oil and therefore should not be taken by peanut or soya allergy.

The Commission on Human Medicines advised that Lovima and Hana be made available from pharmacies as a Pharmacy (P) medicine, the first time an application has been made for an oral contraceptive, and called for a public consultation on the matter.

In our submission, we highlighted that this medication meets the usual MHRA specifications for Pharmacy medicines. However, we also considered in our recommendation a wider social and healthcare context – identifying several areas of concern and noted the need for reassurance before making a formal recommendation.

As a result of the consultation, Lovima and Hana have now been approved for the pharmacy (P) legal status.

Read our submission on Lovima.

Read our submission on Hana.