EMA Reviewing Two Centralised Switch Applications

13 Mar 2020

Teva's Ratiopharm and Italy's Recordati have submitted applications to switch drugs from prescription-to-OTC status through EMA's centralised procedure. Given only four products have been switched centrally to date, a double reclassification would be unprecedented.

Two centralized prescription-to-OTC switch applications are currently under review by the European Medicines Agency for an premature ejaculation treatment and a product to relieve the symptoms of allergic rhinitis. Approvals would see the drugs available OTC throughout the whole of the European Union.

First, Italy’s Recordati Industria Chimica & Farmaceutica SPA – through its Irish subsidiary – is seeking to change the...