CRED NPM

05/11/2024

Data Package Studies to support Rx-to-OTC Switch Applications

• Efficacy / safety study  Usually not required unless proposed OTC indication, dose, posology etc. not covered by existing data • Actual use study - Provides information on whether consumers can use the product correctly, safely and effectively in OTC setting  May be requested e.g., in case of first in class switch • Package leaflet - user consultation with target patient groups - Provides information on whether - package leaflet provides necessary information to consumer for appropriate use of the product - information in package leaflet is understood by the consumer  Mandatory

The Organisation for Professionals in Regulatory Affairs

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Data Package - Data Exclusivity Eligibility for & Decision on Exclusivity (Dir. 2001/83/EC Art. 74a)

• Preclinical tests or clinical trials are significant, if they are - related to a new strength / posology - using a new route of administration, new pharmaceutical form - for a new indication, particularly when not previously approved for an OTC medicine or subpopulations • New safety/efficacy data (e.g., actual use studies) - to confirm safety/efficacy profile - likely to be eligible for exclusivity • Data exclusivity - One year stand alone period of protection - Applicant must apply for data exclusivity - Data exclusivity to be decided upon by each competent authority  in MRP & DCP ‘to use best endeavors’ to reach agreement

The Organisation for Professionals in Regulatory Affairs

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