Manufacturing and quality
Stability and shelf life
At the check date, EMA lists Q1A(R2) as effective and consolidated Q1 as a Step 2b draft. Distinguish draft proposals from adopted product and market requirements.
Scope: Do not generalise one stability condition or shelf life to every product and market.
Prepare your evidence before a decision
Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.
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