Germany to consider batch of OTC switches

26 June 2018 - Deborah Wilkes

Germany is set to consider a batch of applications to switch medicines from prescription to non-prescription status.

The country's Expert Committee for Prescription will consider the switches at a meeting on 3 July 2018.

One application involves the antihistamine levocetirizine for oral use. Levocetirizine already has non-prescription status in a number of countries including Australia, Hungary, New Zealand, Poland and the US.

Other switches on the agenda include the muscle relaxant methocarbamol for oral use, and skincare preparations containing sodium bituminosulfonate and hydrocortisone acetate.

The committee will also discuss an application to extend the non-prescription availability of diclofenac for external use as a plaster.

According to recent surveys conducted for the German medicines manufacturers association, the BAH, both pharmacists and doctors would like to see more medicines switched from prescription to non-prescription status. Around 85% of pharmacists and 51% of doctors are in favour of more switches, especially of medicines for allergies and skin conditions.

Industry wants three years of market exclusivity

The BAH says the lack of market exclusivity for switch innovators is an obstacle for many switches, as competitors can enter the market under the same conditions. The industry association is calling for three years of market exclusivity for medicines switched from prescription to non-prescription status.

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