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NeeS AU module 1 and regional information
Specification and guidance for use, V2.0
Module specific information
Please note: V1.0 of the specification is acceptable until 30 June 2018. This version (V2.0) becomes effective on 1 January 2018.
Module 1.0.3 Responses to requests for information
You must provide any additional information or data relating to the submitted dossier (for example, s. 31 responses, and new safety data), in the CTD format and meet the requirements specified in CTD Module 1.
Follow the NeeS folder and file structure and lodge as a new sequence.
Module 1.0.3 Responses to requests for information in CTD Module 1.
If you submit responses to more than one question a single file, use bookmarks within the PDF file to clearly identify each response.
Module 1.2.1: Application form
Always provide the application form as a PDF file within the NeeS format structure.
Module 1.2.1 Application forms in CTD Module 1.