CRED 8 Presentations

01/07/2024

Example: Data exclusivity (1/2)

• Coveram (amlodipin and perindopril) authorised via 10b:8 year data protection; • Application for second same Fixed Dose Combination (FDC) by another MAH with same active substances based on article 10b or 10a; • Data exclusivity for studies of first FDC. Literature submitted by applicant contains reference to studies in the dossier of a product for which the relevant data exclusivity period has not expired ; • Information may not be used because the underlying data fall under data exclusivity

The Organisation for Professionals in Regulatory Affairs

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Example: Data exclusivity (2/2)

• Article 10(5) of Directive 2001/83/EC: request for a non-cumulative period of one year data exclusivity for new indication • Not restricted to innovator products, also generic products can generate data in support of a new indication not previously granted for the RefMP • Essential that the following conditions are met: 1. The indication should be new, i.e. the indication must not be approved for the same active substance within the EU before; 2. Significant pre-clinical or clinical studies should be carried out in relation to the new indication; 3. The Applicant should include his own preclinical and/or clinical studies into the dossier. “Own” means that such investigations have been conducted or sponsored by the applicant.

The Organisation for Professionals in Regulatory Affairs

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