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Q&A

publicEuropean Medicines Agency · European Union · Updated Jul 13, 2026

Post-authorisation safety studies (PASS): Update on Assessment Timelines and Submission Requirements

MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Q&A

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publicEuropean Medicines Agency · European Union · Updated Jul 3, 2026

Variations Requiring Assessment (Veterinary Medicines) - Q&A Update

MAHs are advised to incorporate the updated FAQs into their compliance workflows and ensure that their submissions adhere to the updated guidance.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Q&A

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