20 January 2012

EMA: Submission Cover Letter summary table Template – Updated on 19th January 2011

The Regulatory Submission cover letter template has updated by European Medicines Agency. The following information has included in the template 

Submission in accordance to Art.8 of Pediatric Regulation (EC) No 1901/2006 of 12/12/2006 – If the  product is protected by a Supplementary protection Certificate (SPC) or a patent the Qualifies for a SPC? - tick (Yes) or tick (No)

Notes: If your product is protected by a Supplementary Protection Certificate (SPC) or a  patent   that qualifies for a SPC in accordance with Art.8 of Paediatric Regulation (EC) No 1901/2006 of12/12/2006 please tick YES, otherwise tick NO even if not applicable.

The following information has deleted form the template
Checksum field has deleted from the cover letter template.

To find more information and to download the updated cover letter please use the below mentioned weblink

Source: EMA Website

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