TABLE 1. Plant protection s: Chemical Category Product (new or renewal) Produktansøgni nger (nye eller forny) Type type 1. DK is the examining member state (E.g. Zonal RMS, new as in Dk, me-too or renewal approval) DK foretager (Fx. ZRMS, nyt as i Dk, me-too, fornyelse af tidligere 2. Other examining member state than DK (CMS, new a in Dk, me-too or renewal approval) DK foretager på baggrund af andet lands RR (CMS, nyt as i Dk, me-too, fornyelse af tidligere 3. DK is the examining member state for an Inter Zonal assessment(izrms, new as in Dk, me-too or renewal approval) Evaluation for all zones (i.e. use in greenhouses, post harvest treatment, treatment empty rooms or containers used for storing plants or plant s, and for seed treatment) DK foretager for hele EU (Inter Zonal RMS, nyt a i Dk, me-too og fornyelse af tidligere. Evaluering for alle zoner (til brug i væksthuse, behandling af afgrøder efter høst, behandling af tomme lagerrum eller til bejdsning). 4. DK is the examining member state for a Plant Protection Product containing a low risk as (E.g. Zonal RMS, new as in Dk, me-too or renewal approval). DK foretager for produkter med lav risiko aktivst (Fx. ZRMS, nyt as i Dk, me-too, fornyelse af tidligere 5. DK CMS - Plant protection containing a low risk as. DK foretager på baggrund af andet lands RR for lav risiko aktivst (ZCMS ) 6. Provisional (based on a DAR) Provisorisk godkendelse (Kræver at der er en DAR) 7. Mutual recognition (N-zone, EU - Reg. 1107) The reference member state belongs to the northern zone or have evaluated for all zones (i.e. use in greenhouses, post harvest treatment, treatment empty rooms or containers used for storing plants or plant s, and for seed treatment) Gensidig anerkendelse (N-zone, EU - Reg. 1107) godkendelse givet i et andet land i samme zone eller for EU-lande til produkter til væksthuse, behandling af afgrøder efter høst, til tomme lagerrum eller bejdsning. Additional fees residues efficacy *, pr. as as kr. 188.000,00 kr. 40.000,00 kr. 47.000,00 kr. 78.000,00 kr. 39.000,00 kr. 63.000,00 kr. 30.000,00 kr. 8.500,00 kr. 9.500,00 kr. 104.000,00 kr. 34.000,00 kr. 24.000,00 kr. 43.000,00 kr. 63.000,00 kr. 15.000,00 kr. 7.000,00 kr. 5.000,00 kr. 214.000,00 kr. 40.000,00 kr. 47.000,00 kr. 74.000,00 kr. 39.000,00 kr. 63.000,00 kr. 30.000,00 kr. 8.500,00 kr. 9.500,00 kr. 144.000,00 kr. 20.000,00 kr. 47.000,00 kr. 35.000,00 kr. 38.000,00 kr. 30.000,00 kr. 4.000,00 kr. 9.500,00 kr. 83.000,00 kr. 17.000,00 kr. 24.000,00 kr. 29.000,00 kr. 15.000,00 kr. 4.000,00 kr. 5.000,00 kr. 167.000,00 kr. 17.000,00 kr. 47.000,00 kr. 114.000,00 kr. 30.000,00 kr. 4.000,00 kr. 5.000,00 kr. 74.000,00 kr. 16.000,00 kr. 12.000,00 kr. 43.000,00 kr. 63.000,00 1
TABLE 1. Plant protection s: Chemical Category Product (new or renewal) Produktansøgni nger (nye eller forny) Amendment Type type 8. Mutual recognition (Other zone -Reg. 1107) The reference member state belongs to a different zone than the northern zone Gensidig anerkendelse (Anden zone - Reg. 1107) godkendelse givet i et land udenfor Nordzonen (f.eks. nabolande) 9. Mutual recognition (Dir. 91/414) The has been granted in accordance with directive 91/414/EEC Gensidig anerkendelse (Dir. 91/414) godkendelse givet i et andet land i samme zone eller for EUlande til produkter til væksthuse, behandling af afgrøder efter høst, til tomme lagerrum eller bejdsning for substitution 10. Mutual recognition for a containing a low risk substance The reference member state belongs to the northern zone or have evaluated for all zones Gensidig anerkendelse for et produkt med et lav risiko aktivstng på baggrund af en godkendelse givet i et andet land i samme zone eller for EUlande til produkter til væksthuse, behandling af afgrøder efter høst, til tomme lagerrum eller bejdsning 11. Amendment use or conditions for a use that is not evaluation (a new assessment for health and environment according to the Uniform Principles needs to be DK is the examining member state (Zonal-RMS, national new use) Ændret anvendelse eller udvidet anvendelse, som kræver ny sundheds- og miljø Danmark foretager en (ZRMS eller nationalt - ny 12. Amendment use or conditions for a use that is not evaluation (a new assessment for healt and environment according to the Uniform Principles needs to be Other examining member state (CMS- new use) Ændret anvendelse eller udvidet anvendelse som kræver ny sundheds- og miljø DK foretager på baggrund af andet lands RR (CMS- ny Additional fees residues efficacy *, pr. as as kr. 87.000,00 kr. 21.500,00 kr. 12.000,00 kr. 43.000,00 kr. 63.000,00 kr. 89.000,00 kr. 21.500,00 kr. 12.000,00 kr. 43.000,00 kr. 63.000,00 kr. 61.000,00 kr. 16.000,00 kr. 12.000,00 kr. 36.000,00 kr. 117.000,00 kr. 22.500,00 kr. 32.000,00 kr. 66.000,00 kr. 16.500,00 kr. 16.000,00 2
TABLE 1. Plant protection s: Chemical Category Amendment Type type 13. Amendment use or conditions for use that is on health and environment DK is the examining member state (ZRMS, national) Ændret anvendelse (udvidet Danmark foretager for ændret anvendelse der ligger inden for tidligere for miljø og sundhed (ZRMS, national - ændret 14. Amendment use or conditions for use that is on health and environment DK is concerned member state (CMS) Ændret anvendelse (udv. DK foretager ud fra andet lands RR for ændret anvendelse der ligger indenfor tidligere for miljø og sundhed (CMS ) 15. Amendment use or conditions for use that is not principles needs to be, Dk performs the assessment (ZRMS, national - low risk) Ændret anvendelse - alternativer / low risk DK foretager en ny (ZRMS, national - lav risiko - ny 16. Amendment use or conditions for use that is not principles needs to be. Dk is concerned member state (CMS - low risk - new use) Ændret anvendelse - alternativer / low risk DK foretager en ny (CMS - lav risiko - ny 17. Amendment use or conditions for use that is (ZRMS, national - low risk - new use) Ændret anvendelse. Danmark foretager lav risiko produkter for ændret anvendelse der ligger inden for tidligere for miljø og sundhedalternativer (ZRMS, national - lav risiko - ny Additional fees residues efficacy kr. 31.000,00 kr. 22.500,00 kr. 32.000,00 kr. 28.000,00 kr. 16.500,00 kr. 16.000,00 kr. 92.000,00 kr. 19.000,00 kr. 32.000,00 kr. 54.000,00 kr. 16.500,00 kr. 16.000,00 kr. 31.000,00 kr. 19.000,00 kr. 32.000,00 *, pr. as as 3
TABLE 1. Plant protection s: Chemical Category Amendment Type type 18. Amendment use or conditions for a use that is (CMS) Ændret anvendelse. Danmark foretager lav risiko produkter ud fra andet lands RR for ændret anvendelse der ligger inden for tidligere for miljø og sundhed (CMS) 19. New source or change in manufacturing process and/or manufacturing location substance ( ) Ny aktivstkilde som kræver (Ækvivalens ) 20. Change composition, Dk performs assessment (ZRMS or national) Formuleringsændring DK foretager (ZRMS eller national) 21. Change composition (CMS - composition change) Formuleringsændring DK foretager på baggrund af andet lands (CMS ) Additional fees residues efficacy kr. 28.000,00 kr. 16.500,00 kr. 16.000,00 kr. 52.000,00 kr. 37.000,00 kr. 8.000,00 kr. 26.000,00 kr. 4.000,00 *, pr. as as 4
TABLE 2. Plant protection s: Biological (containing micro-organisms) Additional fees Category Product (new or renewal) Produktansøgninger (nye eller forny) Amendment Type type 22. DK assessment Plant protection containing micro-organisms (E.g. Zonal RMS, new as in Dk, me-too or renewal approval) DK foretager Zone for microorganismer (Fx. ZRMS, nyt as i Dk, me-too, fornyelse af tidligere 23. DK CMS for plant protection containing micro-organisms DK foretager på baggrund af andet lands RR for microorganismer (CMS) 24. Mutual recognition for a plant protection containing micro-organisms Gensidig anerkendelse for et produkt med microorganismer godkendelse givet i et andet land i samme zone eller for EU-lande til produkter til væksthuse, behandling af afgrøder efter høst, til tomme lagerrum eller bejdsning, samt iht. 91/414 25. Dk assessment amendment use or conditions for use and change composition that is not principles needs to be for a ppp with micro-organisms (ZRMS ao) Dk af ændret anvendelse og formuleringsændringer (ZRMS mm) 26. Other MS asssessment amendment use or conditions for use and change compositionthat is not covered by the previous evaluation (a new evaluation principles needs to be for micro-organisms (CMS) Ændret anvendelse og formuleringsændringer DK foretager ny pba andet lands RR (CMS) 27. Dk assessment amendment use or conditions for use and change composition that is principles does not need to be micro-organisms (ZRMS ao.) Ændret anvendelse og formuleringsændringer DK vurderer i hht. tidligere godkendelse (ZRMS) 28. Other MS asssessment amendment use or conditions for use and change composition that is covered by the previous evaluation (a new evaluation micro-organisms (CMS) Ændret anvendelse og formuleringsændringer DK vurderer pba andet lands RR og i hht. tidligere godkendelse (CMS ) residues efficacy Assesment pr. substance evaluation., pr. as Ny kilde, kr. 35.000,00 kr. 26.500,00 kr. 47.000,00 kr. 53.000,00 kr. 15.000,00 kr. 5.000,00 kr. 5.500,00 kr. 9.500,00 kr. 25.000,00 kr. 20.000,00 kr. 24.000,00 kr. 15.000,00 kr. 5.000,00 kr. 4.000,00 kr. 5.000,00 kr. 23.000,00 kr. 17.000,00 kr. 12.000,00 kr. 25.000,00 kr. 19.000,00 kr. 32.000,00 kr. 16.000,00 kr. 16.500,00 kr. 16.000,00 kr. 13.000,00 kr. 19.000,00 kr. 32.000,00 kr. 12.000,00 kr. 16.500,00 kr. 16.000,00 5
TABLE 3. Plant protection s: Chemical and Biological Additional fees Category Type type residues efficacy Assesment pr. substance evaluation., pr. as Ny kilde, Amendment Derogation Dispensationer Parallel trade permit Parallel Extension for minor uses Mindre anvendelse 29. Minor change that requires technical assessment (minor composition change or reclassification) Mindre ændring med faglig (fx. mindre formuleringsændringer og omklassificeringer). 30 Administrative amendments (e.g. change name, approval holder, revocation approval) Administrative ændringer (fx navneændring, ændring af godkendelsesindehaver, afmeldelse) 31. Label approval Etiketbehandling Vurdering og godkendelse af etiketter når det ikke er en del af en ansøgning om godkendelse 32. Emergency situation which cannot be contained by any other reasonable means Dispensation dispensationsansøgning 33. Research and development purposes, experiment or test program Forsøgsmæssig afprøvning National godkendelse af forsøgsmæssig afprøvning 34. Parallel import The plant protection is authorised in another member state and is identical in composition to a plant protection already authorised in Denmark Parallel import Produktet er godkendt i et andet land og identisk til et produkt der er godkendt i Danmark 35. Kopi Identical approved in Denmark for the same use Identiske produkter Identisk produkt er godkendt i Danmark til samme anvendelse 36. Minor use a minor use (crop group) for similar s Mindre anvendelse en anvendelse (afgrødegruppe) for sammenligenlige produkter (Etiketbehandling ikke inkluderet) kr. 8.000,00 kr. 5.000,00 kr. 5.000,00 kr. 2.500,00 kr. 30.000,00 kr. 20.000,00 kr. 2.500,00 kr. 7.500,00 kr. 15.000,00 kr. 2.500,00 kr. 10.000,00 kr. 6.000,00 kr. 20.000,00 kr. 2.500,00 A B Additional fee for assessment residue levels/mrl substances in plant protection s. Applicable for plant protection s used on edible crops or fodder. Fee per substance Additional fee for assessment efficacy, phytotoxicity and selectivity. Applicable for all s for C D E Additional fee for assessment an new substance/microorganism in Denmark (not provisional) or an substance/microorganism that has to be renewed. Applicable for all plant protection s containing a new substance or an substance that has to be renewed. Fee per substance in the. Additional fee for assessment substance (different source, manufacturing process and/or manufacturing location than the one that was assessed in connection to the approval the substance). Additional fee for comparative assessment for a containing an substance that is candidate for substitution. Additional fee for amendment. Applicable when there is a need for a new assessment principles (e.g. addition crop, change dose or time for ). FVST/DTU: Additional fee for assessment residue levels/mrl plant protection s. Applicable for plant protection s used on edible crops or fodder. DCA: Additional fee for assessment efficacy, phytotoxicity and selectivity. Applicable for all s. 6