EU: Updated harmonized guidances for eCTD and NeeS released by TIGes

The EU Telematics Implementation Group - electronic submissions (TIGes) has released a new version 2.0 of the "TIGes Harmonised Guidance for eCTD Submissions in the EU" and a new version 3.0 of the corresponding Harmonised Guidance for NeeS (human medicinal products). 

Both guidance documents have been changed significantly. Corresponding changes have been detailed in the respective release Notes:

• TIGes Harmonised Guidance for eCTD Submissions in the EU, version 2.0, August 2011
• Release Notes for TIGes eCTD Guidance – Comparison of version 2.0 with 1.0
• TIGes Harmonised Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU, version 3.0, August 2011
• Release Notes for EU NeeS Guidance – Comparison of version 3.0 with 2.0

Are available from the EMA / TIGes eSubmission website.

[Source EMA / TIGes]

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