Ansøgning om godkendelse af pesticider. Gælder fra 12. februar 2015

Transkript

1 Ansøgning om godkendelse af pesticider. Gælder fra 12. februar 2015 TABLE 1. Plant protection products: Chemical Category of Godkendelseskategori Type of Godkendelsestype Basic fee A B C D E Amendment I Amendment II Amendment III residues and MRL stof efficacy (DCA) Assesment pr. active substance* aktivstof *, pr. as Additional fees (see explanatory notes below) Tillægsgebyrer (se tekstforklaring nedenfor) equivalence of as Ny as kilde, ækvivalens vurdering Substitution stof (DCA) DK is the examining member state (E.g. Zonal RMS, new a s in Dk, metoo or renewal of approval) DK foretager vurdering (Fx. ZRMS, nyt as i Dk, me-too, fornyelse af tidligere godkendelser) Other examining member state than DK (CMS, new a s in Dk, me-too or renewal of approval) af andet lands RR (CMS, nyt as i Dk, me-too, fornyelse af tidligere godkendelser) DK is the examining member state for an Inter Zonal assessment (IZRMS, new a s in Dk, me-too or renewal of approval) Evaluation for all zones (i.e. use in greenhouses, post harvest treatment, treatment of empty rooms or cont-ainers used for storing plants or plant products, and for seed treatment) DK foretager vurderingfor hele EU (Inter Zonal RMS, nyt as i Dk, metoo 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) DK is the examining member state for a Plant Protection Product containing a low risk a s (E.g. Zonal RMS, new a s in Dk, me-too or renewal of approval). DK foretager vurdering for produkter med lavrisiko-aktivstof (Fx. ZRMS, nyt as i Dk, me-too, fornyelse af tidligere godkendelser) DK CMS - Plant protection product containing a low risk a s af andet lands RR for lavrisikoaktivstof (ZCMS ) Product authorisation (new or renewal) Produktansøgninger (nye eller fornyelser) Provisional authorisation (based on a DAR) Provisorisk godkendelse (På baggrund af DAR) 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) lagerrum eller bejdsning 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)

2 9210. Mutual recognition (Dir. 91/414) The authorisation has been granted in accordance with directive 91/414/EEC Gensidig anerkendelse (Dir. 91/414) lagerrum eller bejdsning for substitution Mutual recognition for a product containing a low risk active substance The reference member state belongs to the northern zone or has evaluated for all zones Gensidig anerkendelse for et produkt med et lav risiko aktivstofng på baggrund af en lagerrum eller bejdsning Amendment of use or conditions for a use that is not (a new assess-ment according to the Unif-orm Principles necessary for health and environment) DK is t he examining member state (Zonal-RMS, national new use) Ændret anvendelse eller udvidet anvendelse, som kræver ny sundheds- og miljøvurdering Danmark foretager vurderingen (ZRMS eller nationalt - ny Amendment of use or conditions for a use that is not (a new assess-ment according to the Unif-orm Principles necessary for health and environment) Other examining member state (CMS- new use) Ændret anvendelse eller udvidet anvendelse som kræver ny sundheds- og miljøvurdering af andet lands RR (CMS - ny Amendment of use or conditions for use that is covered by evaluation on health and environment according to the uniform principles does not need to be performed) DK is the examining member state (ZRMS, national) Ændret anvendelse (udvidet Danmark foretager vurdering for ændret anvendelse der ligger inden for tidligere vurdering for miljø og sundhed (ZRMS, national - ændret Amendment of use or conditions for use that is covered by evaluation on health and environment according to the uniform principles not necessary)dk is concerned member state (CMS) Ændret anvendelse (udvidet Danmark foretager vurdering ud fra andet lands RR for ændret anvendelse der ligger indenfor tidligere vurdering for miljø og sundhed (CMS )

3 9216. Amendment of use or conditions for use that is not (a new evaluation according to the uniform principles is necessary) Low-risk plant protection product, Dk performs the assessment (ZRMS, national - low risk) Amendment of Ændret anvendelse - alternativer / product authorisation low risk Ændringer i DK foretager en ny vurdering (ZRMS, produktgodkendelser national - lav risiko - ny Amendment of use or conditions for use that is not (a new evaluation according to the uniform principles is necessary) Low-risk plant protection product. Dk is concerned member state (CMS - low risk - new use) Ændret anvendelse - alternativer / low risk DK foretager en ny vurdering (CMS - lavrisiko - ny Amendment of use or conditions for use that is covered by principles not necessary) Low-risk plant protection product (ZRMS, national - low risk - new use) Ændret anvendelse. DK foretager vurdering lav risiko produkter for ændret anvendelse der ligger inden for tidligere vurdering for miljø og sundhedalternativer (ZRMS, national - lavrisiko - ny Amendment of use or conditions for a use that is covered by principles not necessary) Low risk plant protection product (CMS) Ændret anvendelse. DK foretager vurdering af lavrisikoprodukter ud fra andet lands RR for ændret anvendelse der ligger inden for tidligere vurdering for miljø og sundhed(cms) New source or change in manufacturing process and/or manufacturing location of active substance ( equivalence) Ny aktivstofkilde som kræver ækvivalensvurdering (Ækvivalensvurdering) Change of product composition, DK performs assessment (ZRMS or national) Formuleringsændring DK foretager vurdering (ZRMS eller national) Change of product composition (CMS - composition change) Formuleringsændring af andet lands vurdering (CMS )

4 TABLE 2. Plant protection products: Biological (containing micro-organisms) Additional fees Category of Godkendelses kategori Type of Godkendelsestype DK assessment of Plant protection product containing microorganisms (E.g. Zonal RMS, new as in Dk, me-too or renewal of approval) DK foretager Zonevurdering for mikroorganismer (Fx. ZRMS, nyt as i Dk, me-too, fornyelse af tidligere godken-delser) Basic fee A B C D E Amendment Amendment Amendment residues and MRL stof efficacy (DCA) Assesment pr. active substance evaluation aktivstof, pr. as equivalence Ny kilde, ækvivalens vurdering Substitution stof (DCA) Product authorisation (new or renewal) DK CMS for plant protection product containing micro-organisms af andet lands RR for microorganismer (CMS) Mutual recognition for a plant protection product containing microorganisms Gensidig anerkendelse for et produkt med mikroorga-nismer lagerrum eller bejdsning, samt iht. 91/ DK assessment of amendment of use or conditions for use and change of product composition that is not covered by principles must be performed) for a ppp with micro-organisms (ZRMS ao) DK-vurdering af ændret anvendelse og formuleringsændringer (ZRMS mm) Other MS asssessment of amendment of use or conditions for use and change of product compositionthat is not covered by principles must be performed) for micro-organisms (CMS) Ændret anvendelse og formuleringsændringer DK foretager ny vurdering på baggrund af andet lands RR (CMS) Amendment of product authorisation 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 must not be performed) microorganisms (ZRMS ao.) Ændret anvendelse og formuleringsændringer DK vurderer efter tidligere godkendelse (ZRMS) 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 must not be performed) micro-organisms (CMS) Ændret anvendelse og formuleringsændringer DK vurderer på baggrund af andet lands RR og efter tidligere godkendelse (CMS )

5 TABLE 3. Plant protection products: Chemical and Biological Additional fees A B C D E Amendment Amendment Amendment Category of Godkendelses kategori Type of Godkendelsestype Basic fee residues and MRL stof efficacy (DCA) Assesment pr. active substance evaluation aktiv stof, pr. as equivalence Ny kilde, ækvivalens vurdering Substitution stof (DCA) Minor change that requires technical assessment (minor composition change or reclassification) Mindre ændring med faglig vurdering (fx. mindre formuleringsændringer og omklassificeringer) Administrative amendments Amendment of (e.g. change of product name, product authorisation approval holder, revocation of Ændringer i approval) produktgodkendelser Administrative ændringer (fx navneændring, ændring af godkendelsesindehaver, afmeldelse) Label approval Etiketbehandling Vurdering og godkendelse af etiketter, når det ikke er en del af en ansøgning om godkendelse Derogation Dispensationer Emergency situation which cannot be contained by any other reasonable means Dispensation dispensationsansøgning Emergency situation which cannot be contained by any other reasonable means based on previous assessments Dispensation dispensationsansøgning på baggrund af tidligere vurderinger Parallel trade permit Parallel Research and development purposes, experiment or test program Forsøgsmæssig afprøvning National godkendelse af forsøgsmæssig afprøvning 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 Denmark Parallel import Produktet er godkendt i et andet land og identisk til et produkt der er godkendt i Danmark Kopi Identical product approved in Denmark for the same use Identiske produkter Identisk produkt er godkendt i Danmark til samme anvendelse Extension of authorisation for minor uses Mindre anvendelse Minor use a minor use (crop group) for similar products Mindre anvendelse en anvendelse (afgrødegruppe) for sammenligenlige produkter (Etiketbehandling ikke inkluderet) 9239.Simple administrative updates (e.g. handling of minor uses regarding change of product name, approval holder, revocation of Simple administrative approval) updates Administrative simple opdateringer Administrative simple (fx. overførsel af mindre opdateringer anvendelser i forbin-delse med navneændring og ændring af godkendelsesi-ndehaver, eller afmelding) 1.120

6 A Additional fee for assessment of residue levels/mrl of active substances in plant protection products. Applicable for plant protection products used on edible crops or fodder. Fee per active substance Tillægsgebyr for vurdering af restkoncentrationer i fødevarer og foder udført af Fødevarestyrlsen. Gebyr for hvert aktivstof B Additional fee for assessment of efficacy, phytotoxicity and selectivity. Applicable for all s for product authorisation (DCA) Tillægsgebyr for effektivitetsvurdering udført af Aarhus Universitet, Institut for Agroøkologi (DCA).A57 C Additional fee for assessment of an new active substance/microorganism in Denmark (not provisional) or an active substance/microorganism that has to be renewed. Applicable for all plant protection products containing a new active substance or an active substance that has to be renewed. Fee per active substance in the product. Tillægsgebyr for vurdering af aktivstof i et plantebeskyttelsesmiddel (gebyr for hvert aktivstof i midlet). D Additional fee for assessment of equivalence of active substance (different source, manufacturing process and/or manufacturing location than the one that was assessed in connection to the approval of the active substance). Tillægsgebyr for ækvivalensvurdering af aktivstof (for hvert aktivstof). E Additional fee for comparative assessment for a product containing an active substance that is candidate for substitution. Tillægsgebyr for substitution, vurdering af aktivstof (for hvert aktivstof)