Offering longer periods of data exclusivity or additional periods of market exclusivity for European Union centralized Rx-to-OTC switches would help revitalize interest in the process, reclassification experts argued at the AESGP 59th Annual Meeting in Paris, France.
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.