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Majeure wijzigingen

Majeure, grote, wijzigingen zijn:

  • wijziging van gebruik
  • uitbreiding van gebruik
  • wijziging van een restrictiezin
  • wijziging van het WG(GA)
  • grote wijziging van de samenstelling

Voorgaande wijzigingen vergen een aanpassing van de toelating. Hiervoor wordt de zonale procedure gevolgd. Niet-significante wijzigingen worden op nationaal niveau afgehandeld. Veranderingen in een afgeleide toelating worden via het proces afgeleide toelating afgehandeld.

In de centrale zone is overeengekomen dat de (draft) Registration Report (RR) voor uitbreidingen / wijzigingen moet worden beperkt tot alleen die onderdelen die relevant zijn voor de toepassing, zowel in het geval dat de bestaande toelating een RR (onder 1107/2009) heeft en voor toelating zonder een RR (onder 91/414 / EG). In de tabel staat dit per sectie van de RR aangegeven:

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

Registration manual

In de Registration manual (alleen Engelstalig) leest u meer hierover. Per aanvraagtype wordt daar in 4 onderdelen (Characteristics, Registration process, Instruction for submission en Documentation) het proces uit de doeken gedaan.