EUROPE: Update of GD on Renewals according to Art. 43

This new revision (Rev. 14) of SANCO/2010/13170 on renewals according to Article 43 replaces revision 13 dated July 2015.

The update is based on the first experience gained regarding: notifications, list of studies relied upon, lists of end-points, data matching and specification checks, Cat. 4 data processes.

It should be applied from 1st January 2017 onwards.

To download:

SANCO/2010/13170 rev. 14, 7 October 2016, Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009

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