ilag 5 Oversigt over grundgebyrer og tillægsgebyrer for behandling af ansøgninger om godkendelse af plantebeskyttelsesmidler Overview of basic fees and additional fees for processing of s for approval of plant protection products. Godkendelse af aktivstoffer, jf. 47, stk. 2. ehandling af en anmeldelse efter plantebeskyttelsesmiddelforordningen eller kommissionsforordning (EU) Nr. 1141/2010 af et aktivstof til vurdering med henblik på optagelse på listen over godkendte aktivstoffer til plantebeskyttelsesmiddelforordningen.. pproval of active, cf. 47, 2. Processing of a notification according to Plant Protection Regulation or ommission Regulation (EU) No. 1141/2010 of an active for evaluation with a view to inclusion on the list of approved active s for Plant Protection Regulation. Processing of for equivalence assessment of active s ehandling af ansøgning om ækvivalensvurdering af aktivstoffer Maks. 1.900.000 150.000. Godkendelse af kemiske uthorisation of chemical Plant Protection Products Type of of pr. Tillægsgebyrer dditional fees of Product (new or renewal) Produktansøgninger (nye eller fornyelser) 9202. DK is the examining member state (ZRMS) (new active in DK, me-too or renewal of ) DK som ZMRS foretager vurdering (nyt as DK, me-too, fornyelse af tidligere godkendelser) 9203. Other examining member state than DK. DK (MS) (new active in DK, me-too or renewal of a) DK som MS foretager vurdering på baggrund af andet lands RR (nyt as DK, me-too, fornyelse af tidligere godkendelser) 9204. DK is the examining member state (RMS) for an nter Zonal assessment (new as in DK, me-too or renewal of ) Evaluation for all zones (i.e. use in greenhouses, post harvest treatment, treatment of empty rooms or containers used for storing plants or plant products, and for seed treatment) DK foretager vurdering (RMS) for hele EU (nyt as i DK, me-too og fornyelse af tidligere godkendelser). Evaluering for alle zoner (til brug i væksthuse, behandling af afgrøder efter høst, behandling af tomme lagerrum eller til bejdsning 9205. DK is the examining member state (ZRMS) for a Plant Protection Product containing a low risk as (new as in Dk, me-too or renewal of ). DK foretager vurdering (ZRMS) for produkter med lav risiko aktivstof (nyt as i Dk, me-too, fornyelse af tidligere godkendelser) 9206. DK - MS assessment on the basis of another country s RR- Plant protection product containing a low risk as. DK foretager vurdering (ZMS) på baggrund af andet lands RR for lav risiko aktivstof 9240. DK is the examining member state (RMS) for an nter Zonal assessment for a Plant Protection roduct containing a low risk as (new as in Dk, me-too or renewal of ). Evaluation for all zones (i.e. use in greenhouses, post harvest treatment, treatment of empty rooms or containers used for storing plants or plant products, and for seed treatment) DK foretager vurdering (RMS) for produkter med lav risiko aktivstof for hele EU (nyt as i Dk, me-too og fornyelse af tidligere godkendelser). Evaluering for alle zoner (til brug i væksthuse, behandling af afgrøder efter høst, behandling af tomme lagerrum eller til bejdsning). 253.700 40.600 47.700 79.200 10.900 30.500 8.630 9.640 166.700 34.500 28.000 43.600 10.900 15.200 7.110 5.080 275.500 40.600 47.700 75.100 10.900 30.500 8.630 9.640 145.300 20.300 47.700 35.500 10.900 30.500 4.060 9.640 83.400 17.300 24.400 29.400 10.900 15.200 4.060 5.080 165.600 20.300 47.700 35.500 10.900 30.500 4.100 9.600 1
. Godkendelse af kemiske uthorisation of chemical Plant Protection Products Type of of pr. Tillægsgebyrer dditional fees of Product (new or renewal) Produktansøgninger (nye eller fornyelser) 9207. Provisional (based on a DR) Provisorisk godkendelse (Kræver at 232.000 17.300 47.700 116.000 10.900 30.500 4.060 5.080 der er en DR) 9208. 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 of empty rooms or containers used for storing plants or plant products, and for seed treatment) Gensidig anerkendelse (N-zone, EU - Reg. 1107) nsøgning på baggrund af en 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. 90.600 16.200 12.200 43.600 10.900 9209. Mutual recognition (Other zone - Reg. 1107) The reference member state belongs to a different zone than the northern zone or have evaluated for all zones (i.e. use in greenhouses, post harvest treatment, treatment of empty rooms or containers used for storing plants or plant products, and for seed treatment) 101.500 21.800 12.200 43.600 10.900 Gensidig anerkendelse (nden zone - Reg. 1107) nsøgning på baggrund af en godkendelse givet i et land udenfor Nordzonen (f.eks. nabolande) eller for EU-lande til produkter til væksthuse, behandling af afgrøder efter høst, til tomme lagerrum eller bejdsning. 9210. Mutual recognition (Dir. 91/414) The has been granted in accordance with directive 91/414/EE. The reference member state belongs to the northern zone or have evaluated for all zones (i.e. use in greenhouses, post harvest treatment, treatment of empty rooms or containers used for storing 101.500 21.800 12.200 43.600 10.900 plants or plant products, and for seed treatment) Gensidig anerkendelse (Dir. 91/414) nsøgning på baggrund af en 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 9241. Mutual recognition for which national addenda are submitted. Gensidig anerkendelse hvor der skal udarbejdes national addenda. 166.700 34.500 28.000 43.600 10.900 15.200 7.110 5.080 9211. Mutual recognition for a product containing a low risk active The reference member state belongs to the northern zone or the evaluation voversall zones Gensidig anerkendelse for et produkt med et lav risiko aktivstof og 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 61.100 16.200 12.200 36.500 10.900 2
. Godkendelse af kemiske uthorisation of chemical Plant Protection Products Type of of pr. Tillægsgebyrer dditional fees of of product 9212. of use or conditions for a use that is not covered by the previous evaluation (a new assessment for health and Uniform Principles needs to be DK is the examining member state (ZRMS or national - new use) Ændret anvendelse eller udvidet anvendelse, som kræver ny sundheds- og miljøvurdering Danmark foretager vurderingen (ZRMS eller nationalt - ny anvendelse) 9213. of use or conditions for a use that is not covered by the previous evaluation (a new assessment for health and Uniform Principles needs to be Other examining member state (MS - new use) Ændret anvendelse eller udvidet anvendelse som kræver ny sundheds- og miljøvurdering DK foretager vurdering på baggrund af andet lands RR (MS - ny anvendelse) 9214. of use or conditions for use that is covered by the previous evaluation (a new evaluation on health and uniform principles does not need to be DK is the examining member state (ZRMS, national) Ændret anvendelse eller udvidet anvendelse. Danmark foretager vurdering for ændret anvendelse der ligger inden for tidligere vurdering for miljø og sundhed (ZRMS eller national - ændret anvendelse) 130.500 22.800 32.500 79.200 79.700 16.700 16.200 43.600 25.400 22.800 32.500 79.200 9215. of use or conditions for use that is covered by the previous evaluation (a new evaluation on health and uniform principles does not need to be. DK is concerned member state (MS) Ændret anvendelse eller udvidetnvendelse. DK foretager vurdering ud fra andet lands RR for ændret anvendelse der ligger indenfor tidligere vurdering for miljø og sundhed (MS ) 9242. ssesment of Substitution per active Subtitution aktivstof 9216. of use or conditions for use that is not covered by the previous evaluation (a new principles needs to be Low-risk plant protection product, Dk performs the assessment (ZRMS, national - low risk) Ændret anvendelse - alternativer / low risk DK foretager en ny vurdering (ZRMS, national - lav risiko - ny anvendelse) 21.700 16.700 16.200 43.600 34.500 10.500 17.900 92.300 19.300 32.500 35.500 3
. Godkendelse af kemiske uthorisation of chemical Plant Protection Products Type of of pr. Tillægsgebyrer dditional fees of 9217. of use or conditions for use that is not covered by the previous evaluation (a new principles needs to be Low-risk plant protection product. Dk is concerned member state (MS - low risk - new use) Ændret anvendelse - alternativer / low risk DK foretager en ny vurdering (MS - lav risiko - ny anvendelse) 9218. of use or conditions for use that is covered by the previous evaluation (a new principles does not need to be Low-risk plant protection product (ZRMS, national - low risk - new use) Ændret anvendelse. Danmark foretager vurdering lav risiko produkter for ændret anvendelse der ligger inden for tidligere vurdering for miljø og sundhedalternativer (ZRMS, national - lav risiko - ny anvendelse) 9219. of use or conditions for a use that is covered by the previous evaluation (a new principles does not need to be Low-risk plant protection product (MS) Ændret anvendelse. Danmark foretager vurdering lav risiko produkter ud fra andet lands RR for ændret anvendelse der ligger inden for tidligere vurdering for miljø og sundhed (MS) 54.700 16.700 16.200 29.400 25.400 19.300 32.500 35.500 21.700 16.700 16.200 29.400 of product 9221. hange of product composition. DK performs assessment (ZRMS or national) ormuleringsændring 57.300 8.120 10.900 DK foretager vurdering (ZRMS eller national) 9222. hange of product composition (MS - composition change) ormuleringsændring DK foretager vurdering på baggrund af andet lands vurdering (MS ) 38.400 4.060 10.900 4
. Godkendelse af biologiske plantebeskyttelsesmidler (produkter, der indeholder mikroorganismer) uthorisation of biological Plant Protection Products (products containing micro-organisms) Type of of residues and of efficacy, pr. Tillægsgebyrer dditional ees of Product (new or renewal) Produktansøgninger (nye eller fornyelser) of product (se note 4) 9223. DK assessment of Plant protection product containing microorganisms ( Zonal RMS, new as in Dk, me-too or renewal of) DK foretager Zone vurdering for micrkorganismer (ZRMS, nyt as i Dk, me-too, fornyelse af tidligere godkendelser) 9224. DK MS for plant protection product containing micro-organisms DK foretager vurdering på baggrund af andet lands RR for mikroorganismer (MS) 9225. Mutual recognition for a plant protection product containing microorganisms Gensidig anerkendelse for et produkt med mikroorganismer nsøgning på baggrund af en 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 9226. Dk assessment of amendment of use or conditions for use and change of product composition that is not covered by the previous evaluation (a new evaluation according to the uniform principles needs to be for a ppp with microorganisms (ZRMS ao) Dk foretager vurdering af ændret anvendelse og formuleringsændringer for mikroorganismer (ZRMS mm) 9227. Other MS asssessment of amendment of use or conditions for use and change of product compositionthat is not covered by the previous evaluation (a new evaluation according to the uniform principles needs to be for micro-organisms (MS) Ændret anvendelse og formuleringsændringer DK foretager vurdering pba andet lands RR for mikroorganismer (MS) 9228. Dk assessment of amendment of use or conditions for use and change of product composition that is covered by the previous evaluation (a new evaluation according to the uniform principles does not need to be micro-organisms (ZRMS ao.) Ændret anvendelse og formuleringsændringer DK vurderer i hht. tidligere godkendelse for mikroorganismer (ZRMS) 9229. Other MS asssessment of amendment of use or conditions for use and change of product composition that is covered by the previous evaluation (a new principles does not need to be micro-organisms (MS) Ændret anvendelse og formuleringsændringer DK vurderer pba andet lands RR og i hht. tidligere godkendelse for mikroorganismer (MS ) 47.800 26.900 47.700 35.800 5.080 5.580 9.640 34.100 20.300 24.400 5.080 4.060 5.080 39.900 17.300 12.200 33.300 19.300 32.500 21.000 16.700 16.200 12.500 19.300 32.500 11.800 16.700 16.200 5
V. ndre gebyrer for (kemiske og biologiske) Other types of fees for Plant ptrotection products (chemical and biological) Type og of residues and of efficacy, pr. Tillægsgebyrer dditional fees of of product (se note 4) Derogation Dispensationer Parallel trade permit Parallel Extension of for minor uses Mindre anvendelse Simple administrative updates dministrative simple opdateringer 9230. Minor change that requires technical assessment (fx minor composition change or reclassification) Mindre ændring med faglig vurdering (fx. mindre formuleringsændringer og omklassificeringer). 9231. dministrative amendments (e.g. change of product name, approval holder, revocation of approval) dministrative ændringer (fx Produktnavneændring, ændring af godkendelsesindehaver, afmeldelse) 9232. Label approval Etiketbehandling Vurdering og godkendelse af etiketter når det ikke er en del af en ansøgning om godkendelse 9233. Emergency situation which cannot be contained by any other reasonable means Dispensation dispensationsansøgning 9234. Emergency situation which can not be contained by any other reasonable means based on previous assessments Dispensation dispensationsansøgning på baggrund af tidligere vurderinger 9235. Research and development purposes, experiment or test program orsøgsmæssig afprøvning National godkendelse af forsøgsmæssig afprøvning 9236. Parallel import The plant protection product is authorised in another member state and is identical in composition to a plant protection product already authorised in DK Parallel import Produktet er godkendt i et andet land og identisk til et produkt der er godkendt i Danmark 9237. Kopi dentical product authorised in Denmark for the same use dentiske produkter dentisk produkt er godkendt i Danmark til samme anvendelse 9238. Minor use of a minor use (crop group) for similar products (Label approval not included) Mindre anvendelse (M) en anvendelse (afgrødegruppe) for sammenlignelige produkter (Etiketbehandling ikke inkluderet) 9239. Simple administrative updates (handling of minor administrative changes eg. change of product name, approval holder, revocation of approval) dministrative simple opdateringer (f.eks. overførsel af mindre anvendelser ifm. navneændring, adresseændring, afmeldelse) 10.100 2.540 10.900 4.700 5.800 3.500 30.300 20.300 4.000 10.900 1 Vurdering 20.300 2 Ekstrapolering 11.800 4.000 5.100 10.200 18.100 3.500 10.100 2.540 5.800 1.200 1 Vurdering 10.150 2 Ekstrapolering 5.900 2.000 6
dditional fees Opkrævning af tillægsgebyrer ee : dditional fee for assessment of residue levels/ of active s in plant protection products. pplicable for plant protection products used on edible crops or fodder. ee per active Gebyr : Tillægsgebyr for vurdering af restkoncentrationer i fødevarer og foderudført af ødevarestyrelsen/dtu.gebyret opkræves for vurdering af reskoncentrationer () af aktivstoffet i plantebeskyttelsesmidler, der bruges på spiselige afgrøder og foder. Gebyr for hvert aktivstof Note 1: f VST finds out that they do not need to evaluate residues, or if the is rejected during validation, a fee of only DKK 3.200 will be charged. Note 1: Hvis VST konstaterer, at der ikke skal vurderes restkoncentrationer, eller hvis ansøgningen afvises ved valideringen, nedsættes gebyret til 3.200 kr. ee : dditional fee for assessment of efficacy, phytotoxicity and selectivity. pplicable for all s for product (GRO) Gebyr : Tillægsgebyr for vurdering af plantebeskyttelsesmidlets effektivitet, phytotoksisitet og selektivitet, udført af arhus Universitet, nstitut for groøkologi (GRO). ee : dditional fee for assessment of a new active /microorganism in Denmark or an active /microorganism that has to be renewed. pplicable for all plant protection products containing a new active or an active that has to be renewed. ee per active in the product. Gebyr : Tillægsgebyr for første vurdering af nyt aktivstof (eller ny mikroorganisme) eller første fornyelse af et aktivstof i Danmark. Gebyr for hvert aktivstof. Note 2: or of the first plant protection product with the concerned active, if not approved in Denmark, or first after re-evaluation of the active Note 2: Ved ansøgning om det første plantebeskyttelsesmiddel med det pågælgende aktivstof, hvis det ikke er godkendt i Danmark, eller ved første ansøgning efter at aktivstoffet er blevet revurderet i EU. ee : dditional fee for assessment of in plant protection products Gebyr : Tillægsgebyr for vurdering af i plantebeskyttelsesmidler Note 3: or s with alternative the fee is double Note 3: Ved ansøgninger om alternative fordobles gebyret Note 4: New approved change entails the approval of a new label. separate fee is charged for the approval of the new label (fee type no. 9232) Note 4: Hvis godkendelsen af en ændring bevirker, at der skal godkendes en ny etiket, opkræves særskilt gebyr for etiketgodkendelsen (gebyr nr. 9232). dditional fees for changes during assessment: Tillægsgebyrerne for ændringer under sagsbehandlingen opkræves således: dditional fee for MST amendment. pplicable when there is a need for a new assessment (e.g. addition of crop, change of dose or time for ) Gebyret for Miljøstyrelsens vurdering omfatter nye vurderinger, for eksempel ved ændring af afgrøde, ændring af dosis eller ændring af tidspunkt for udbringning. VST/DTU: dditional fee for assessment of residue levels/ of plant protection products. pplicable for plant protection products used on edible crops or fodder. Gebyret for ødevarestyrelsens vurdering omfatter ændringer der indebærer ny vurdering af restkoncentrationer i spiselige afgrøder og foder. GRO: dditional fee for assessment of efficacy, phytotoxicity and selectivity. pplicable for all s Gebyret til ahus Universitet, nstitut for groøkologi omfatter ændringer, der kræver fornyet vurdering af effektivitet, phytotoksisitet og selektivitet. 7