This guideline aims to classify the requirements for submitting a renewal of marketing authorization and to provide applicants with recommendations on the data that may impact the assessment of their drug products.
This document has been developed to assist applicants in the preparation and submission of drug applications for renewal of marketing authorization .
Renewal applications should be reviewed carefully in light of the following notes
Renewal applications renewal application: have to contain a consolidated version of the file, containing at least the documents listed below and presented in accordance with the appropriate headings and numbering of the eCTD format.
Applicants should be aware that deficient documentation can lead to the rejection of the application. In addition, submitting redundant or irrelevant information may delay approval procedures.
This guideline considers issues associated with the processing of renewals with the aim of giving procedural guidance to marketing authorization holders (MAHs) and applies to all types of human medicinal product registration pathways that are described in the Regulatory Framework for Drugs Approval.
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