Change product authorisation - major changes

Do you 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

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'.

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