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Change product authorisation - major changes

Are you intending to apply for a major change in the product authorisation, such as:

  • amendment of uses
  • extension of uses
  • change in restriction sentences
  • change in the legal instructions for use – WG(GA)
  • major change in product composition
  • changes that require a limited evaluation; f.e. Post Harvest Interval (PHI)

These major changes require an amendment of the existing authorisation (PPPR 1107/2009, art 33) and will be processed following the zonal procedure. Non-significant changes are evaluated at the national level. Changes in a derived authorisation follow the process of 'derived authorisation'. 

Exception change that requires a limited evaluation

Some major changes may require a limited evaluation. Ctgb considers an evaluation limited when it takes less than fifty hours to evaluate and can be requested a maximum of once per year per product authorisation. If multiple changes are desired, they must be combined in a regular application for a major change. 
Applicants who intend to apply for a major change that requires a limited evaluation need to consult the Ctgb service desk prior to submitting the major change application. Via the service desk, Ctgb will determine the hours needed to evaluate the requested change. In case the requested change can be evaluated in less than 50 hours, the change can be applied for as major change with limited evaluation. (See separate category ZKWTG on the zonal application form.) In case the requested change required 50 hours or more to evaluate, an application for major change should be made (ZWTG in the zonal application form).
Note that the total hours for the application can exceed the 50 hours, because of additional information that needs to be evaluated after the first evaluation and/or responses to comments received from other member states during the peer review.

dRR for label extensions/amendments

dRR for label extensions/amendments should be restricted to only those parts relevant to the application, in case the existing authorisation has a RR (under 1107/2009). For authorisations without a RR (under 91/414/EC), it is up to the MS how the dRR should be drafted. The relevant parts are described in the table below:

dRR required for label extensions/amendments on authorisations with RR:

Part C – Confidential information

not necessary since this covered by the original authorisation

Part A – Risk Management

should be submitted, covering:

  • only summaries of the risk assessment for the extension
  • gap table including only the extended uses (new uses)
  • new (complete) label text
  • copy of authorisation document for the extension

Part B0 – General Information

Background information of the active substance and the PPP shall be included.
GAP for which authorisation is applied for should be included and the justification for the risk envelope approach shal be included.

Part B1, B2 – B4 Identity, physical and chemical properties, further information

Should be submitted, covering:

  • EU gap table including only the extended uses
  • if the application rate (dilution) of the new uses is outside the range of the existing uses, relevant technical properties (e.g. foaming, suspensibility) should be re-evaluated, where appropriate
  • no further details needed, make reference to original RR

Part B3 – Efficacy

Should be submitted, covering:

  • all aspects, either by a new data, or by a statement or data showing that the aspect is covered by the RR for the original authorisation
  • bridging studies, if necessary
  • summaries of studies submitted in connection to the new uses

Part B5 – Analytical Method

Should only be submitted in case:

  • new analytical methods may need to be provided concerning the new uses (additional exposure scenarios or different crop groups)      
  • no further details needed, make reference to original RR

Part B6 – Mammalian Toxicology

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation

Part B7 – Metabolism and Residues

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation
  • residue trials and MRLs for the new uses
  • bridging studies, if necessary
  • summaries of studies submitted in connection to the new uses

Part B8 – Environmental Fate

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation
  • summaries of studies submitted in connection to the new uses

Part B9 – Ecotoxicology

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation
  • bridging studies, if necessary
  • summaries of studies submitted in connection to the new uses

Part B10 – Groundwater metabolites

Should only be submitted in case:

  • new uses give rise to assessment of relevant metabolites