CRED 8 Presentations

01/07/2024

Example: Stability data

• Generic application for tablets; • Insufficient stability are provided: Data should cover a minimum of 6 months duration at the time of submission • (EMA/CHMP/CVMP/QWP/441071/2011- Rev.2); • As stability data up to 1 month only is provided, the suitability of the specification, analytical procedures and packaging cannot be assessed and a re-test period plus storage restriction cannot be granted. NB: should be resolved before end of procedure! Commitment to provide the data after approval not acceptable

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Example: sterilisation method

• Generic application for solution for injection; • Major objection regarding the proposed sterilisation method; • A justification should be provided to demonstrate that the proposed sterilisation method is the most adequate method for this product; • It should be explained why other preferable sterilisation methods are not feasible or otherwise the company should change the sterilisationmethod before the end of procedure See CHMP Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container

The Organisation for Professionals in Regulatory Affairs

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