EUROPE – COM: Technical Guidelines on Data Protection

These technical Guidelines are intended to help Member States and Applicants for practical application of the legal provisions of Articles 59 – 62 and 80 of Regulation (EC) No 1107/2009. This Commission Notice replaces SANCO/12576/2012– rev. 1.1, 01.02.2013. The use of these revised Guidelines is recommended for any applications for active substance and/or plant protection products submitted after 3 October 2019.

This document covers 2 main areas:

  • Section 1 – explaining the periods of protection applied to studies under different circumstances – the “why, when and how long”
  • Section 2 – clarification of the special procedures and provisions that apply to vertebrate data sharing

The following parts have been revised compared to the first version of the document dating from 1 February 2013:

  • Change to provisions for protection of confirmatory data.
  • Clarification of general requirements for applying protection via increased emphasis of paragraph 6.
  • Clarification of other points of the technical Guidelines which were raised by Member States, thanks to their gained experience and while developing other guidelines, such as the one on Article 43 of Regulation (EC) No 1107/2009.
  • Change of rules for the acceptance of duplicate studies.

 

To download: 

COMMISSION NOTICE Technical Guidelines on Data Protection according to Regulation (EC) No 1107/2009 (08.07.2019)

 

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