Minor change to legal instructions for use (WG/WGGA)
A separate application form is available for making a minor change to the legal instructions for use (WG/WGGA).
For zonally (core) authorised products (under Regulation (EC) No. 1107/2009), this form must be used for changes that concern only Netherlands-specific requirements, and for which only the national addendum of the assessment must be amended. These applications shall be processed nationally. An example is the addition or removal of a Netherlands-specific restriction sentence. This form cannot be used for changes that require amendment of the core (zonal) component of the assessment. For such changes, form G-ZRMS must be used.
With nationally authorised products (under Directive 91/414/EC), this form should be used for minor changes to the legal instructions for use (WG/WGGA). As part of the transition to Regulation (EC) No. 1107/2009, these applications shall be processed nationally. Examples of minor changes are changes in a restriction sentence, changes in time of use or small changes in the frequency of use. The addition of an LDS (Low Dosage System) to a full-field treatment is also considered a minor change. This form cannot be used for major changes such as extended authorisations with a new crop, addition of field cultivation to protected cultivation (and vice versa), major changes in the formulation, increased dose or an extended authorisation with a completely different method of use. For such changes, form G-ZRMS must be used. Changes in legal instructions for use of a product authorisation will cause the versions number of a label to change. Read more about version management on label versions.