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NeeS AU module 1 and regional information

Specification and guidance for use, V2.0

18 October 2017

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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.

Further guidance

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.

Further guidance

Module 1.2.1 Application forms in CTD Module 1.


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