Rx-to-OTC-Switch: Consulting, Support, and Implementation
Diapharm advises and supports clients in the planning, strategic approach, and implementation of Rx-to-OTC switches. A change in sales classification offers pharmaceutical manufacturers the opportunity to introduce previously prescription-only medicines as over-the-counter (OTC) products. This strategic shift from Rx to OTC expands market positioning opportunities.
Regulatory authorities will only approve such a request to switch the sales classification if it can be demonstrated that the active ingredient meets the necessary safety requirements for OTC use.
Rx-to-OTC-Switch: Assistance with Complex Procedures
Diapharm guides clients through the strategic planning of an Rx-to-OTC switch, taking on project management and offering support throughout all phases, from application to implementation.
In preparation for declassification from prescription status, active ingredients, indications, and package sizes must be evaluated, with safety considerations in mind. Diapharm assesses existing documents in light of the requirements of the Switch Guideline, as well as medical, clinical assessments, and drug safety.
Based on this evaluation, the necessary arguments and documentation for a compelling switch application are developed—ranging from clinical assessments and literature reviews to pharmacovigilance, as well as the creation of expert reports and statements by Key Opinion Leaders.
Managing a switch project also includes the application for and execution of a Scientific Advice Meeting with the regulatory authority—either independently or as support for clients.
