EUROPE: 27 March 2021, new rules for confidentiality claims for dossiers

The Transparency Regulation (EU) 2019/1381 entered into force on 27 March 2021.

From this date, new rules apply as regards the confidentiality of dossiers.

The applicants who want to request for certain information to be kept confidential pursuant to article 63 of Regulation (EC) 1107/2009 amended by Regulation (EU) 2019/1381 should submit with their applications the form « Request for certain information to be kept confidential » available in Annex 10 of the guidance document SANCO/13169/2010 Rev. 11 on zonal assessment, mutual recognition, withdrawal and amendment of authorisations.

By default, only the information regarding the identity of authors of vertebrate studies are considered as confidential. For all the other data for which confidentiality is claimed, the applicants must justify their request in the form. The applicants should demonstrate that the disclosure of such information potentially harms their interests to a significant degree.

See also our previous article:

EUROPE: Update of guidance document on zonal evaluation, mutual recognition, withdrawal and amendment of authorisations

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