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並前往https://www.ema.europa.eu/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf

Post Authorisation Guidance-Integrated Version

EMEA-H-19984/03 Rev. 96 ... Example: EMEA/H/C/xxxx/IG/002 ... and EN tracked Word, together with the variation application.

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