CMD(h) posts updated requirements for electronic submissions and paper documentation for Variations and Renewals within MRP or National procedures

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has posted another updated version of the "Requirements on Electronic submissions (eCTD or NeeS) and paper documentation requirements for Variations and Renewals within MRP and/or National procedures".

The updated requirements (Rev6, December 2010) include the following major changes:

• Hungary does now accept electronic-only submissions for Variations and Renewals. Some additional signed paper documents according to national requirements must be provided in addition.
• For Spain, the requirement to provide the Application form in national language has been removed from the table entries and the footnotes
• Requirements for electronic-only submissions of Variations and Renewals in Portugal have now been included in the table (Note: this information was missing in the last update (Rev4) posted in November last year - see our related News article)
• The requirements for "Other national variations" have been removed from all tables.

The updated requirements are available for download from the CMD(h) website (see link at the bottom of this article).

[Source: CMD(h) website]

Related News:

 CMD(h) released updated requirements for electronic submissions and paper documentation for Variations and Renewals within MRP or National procedures - 29.11.2010 14:54

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