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Translation timelines
Centralised procedures: ARs / PSURs / PSUSAs



ANNUAL RENEWALS
(for conditional MAs)


With the renewal application, the approved product information documents are submitted with the documentation...


ANNUAL RE-ASSESSMENT


Annual re-assessment (MAs that were issued under exceptional circumstances)...



LINGUISTIC REVIEW OF PSURs AND PSUSAs
(centralised and decentralised authorised medicinal products)


The assessment procedure takes a total of 134 days. On day 61 the PRAC assessment report is issued...