EMA’s Frias Defends EU Centralized Switch Procedure Despite Only Delivering Four Reclassifications In 10 Years
Despite delivering only four switches in 10 years, the European Union’s centralized switch procedure was defended by the EMA's Zaide Frias at AESGP's March regulatory conference. Frias pointed to the recent success of HRA Pharma's EllaOne, to the role of pharmacists in driving switches and to the possibility of an OTC Expert Forum as ways forward for the procedure.
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Longer Exclusivity Periods For EU Centralized Rx-To-OTC Switches? Commission Says No
One way to revitalize interest in the EU's centralized switch procedure would be to introduce longer data exclusivity periods or market exclusivity for successful applicants, concluded an AESGP expert switch panel presenting at the association's 59th Annual Meeting in Paris, France. However, a European Commission representative told another panel that this was not under consideration as part of the EU pharmaceutical legislation revision.
Recordati Launches Fortacin OTC In Germany Following EU-Wide Switch
Men in Germany can now purchase premature ejaculation treatment Fortacin without a prescription as a result of the EU-wide switch of the drug earlier this year.
Fortacin Wins Commission Approval As Fifth EU-Wide Rx-To-OTC Switch
European Commission approval of Fortacin as OTC premature ejaculation treatment makes it only the fifth drug switched EU-wide through the centralized procedure.