natgillin/translations-raw huggingface dataset:
For an application for authorisation of a plant protection product containing an active substance not yet approved, the Member State examining the application shall start the evaluation as soon as it has received the draft assessment report referred to in Article 12(1).
Po predložitvi vloge za registracijo fitofarmacevtskega sredstva, ki vsebuje aktivno snov, ki še ni odobrena, država članica, ki preuči vlogo, začne oceno takoj po prejetju osnutka poročila o oceni iz člena 12(1).
In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8, the Member State shall decide on the application at the latest within six months of the active substance being approved.
Če zadeva vloga isto fitofarmacevtsko sredstvo in iste uporabe, kot jih vsebuje dokumentacija iz člena 8, država članica odloči o vlogi najpozneje v šestih mesecih od odobritve aktivne snovi.
The other Member States concerned shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(2) and (3).
Druge zadevne države članice najpozneje v 120 dneh od prejema poročila o oceni in kopije registracije, ki jo je izdala država članica, ki je preučila vlogo, odločijo o tej vlogi v skladu s členom 36(2) in (3).
Assessment of equivalence under point (b) of Article 29(1)
Ocena ekvivalence v skladu s členom 29(1)(b)
Where it is necessary to establish for an active substance, safener or synergist whether a different source or, for the same source a change of the manufacturing process and/or manufacturing location complies with point (b) of Article 29(1), this shall be assessed by the Member State which acted as rapporteur for the active substance, safener or synergist as referred to in Article 7(1) unless the Member State examining the application as referred to in Article 35 agrees to assess the equivalence.
Kadar je v zvezi z aktivno snovjo, varovalom ali sinergistom treba ugotoviti, ali je drug vir, ali pa, če je sprememba v postopku izdelave in/ali mesta izdelave za isti vir, v skladu s členom 29(1)(b), to presodi država članica, ki je bila poročevalka za aktivno snov, varovalo ali sinergist, kakor je navedeno v členu 7(1), razen če se država članica, ki preučuje vlogo, kakor je navedeno v členu 35, strinja, da bo ocenila ekvivalenco.
The applicant shall submit all necessary data to the Member State assessing equivalence.
Vlagatelj državi članici, ki ocenjuje ekvivalenco, predloži vse potrebne podatke.
After giving the applicant the opportunity to submit comments, which the applicant shall also communicate to the rapporteur Member State or the Member State examining the application as the case may be, the Member State assessing equivalence shall prepare a report on equivalence within 60 days from receiving the application and shall communicate the report to the Commission, the other Member States and the applicant.
Ko se vlagatelju omogoči, da predloži pripombe, ki jih poleg tega sporoči tudi državi članici poročevalki oziroma državi članici, ki preučuje vlogo, država članica, ki preučuje ekvivalenco, v 60-ih dneh od prejema vloge pripravi poročilo o ekvivalenci in ga pošlje Komisiji, drugim državam članicam in vlagatelju.
In the case of a positive conclusion on equivalence and where no objection to this conclusion has been raised, point (b) of Article 29(1) shall be considered to be complied with.
Če je sklep o ekvivalenci pozitiven in se nanj nihče ne pritoži, se šteje, da je zahteva iz člena 29(1)(b) izpolnjena.
However, where a Member State examining the application does not agree with the conclusion of the rapporteur Member State or vice versa, it shall inform the applicant, the other Member States and the Commission stating its reasons.
Če pa se država članica, ki preučuje vlogo o ekvivalenci, ne strinja s sklepom države članice poročevalke, ali obratno, o tem obvesti vlagatelja, druge države članice in Komisijo ter navede razloge.
The Member States concerned shall try to reach agreement on whether point (b) of Article 29(1) is complied with.
Zadevne države članice poskušajo doseči sporazum o tem, ali je zahteva iz člena 29(1)(b) izpolnjena.
They shall provide the applicant with an opportunity to submit comments.
Vlagatelju omogočijo, da predloži pripombe.
Where the Member States concerned do not reach agreement within 45 days, the Member State assessing equivalence shall submit the matter to the Commission.
Če zadevne države članice ne dosežejo sporazuma v 45 dneh, država članica, ki preučuje ekvivalenco, zadevo predloži Komisiji.
A decision on whether the conditions referred to in point (b) of Article 29(1) are complied with shall be adopted in accordance with the regulatory procedure referred to in Article 79(3).
Odločitev o tem, ali so zahteve iz člena 29(1)(b) izpolnjene, se sprejme v skladu z regulativnim postopkom iz člena 79(3).
The 45-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State or vice versa that it does not agree with the conclusion of the latter, in accordance with paragraph 3.
45-dnevno obdobje se začne na dan, ko država članica, ki preučuje vlogo za registracijo, sporoči državi članici poročevalki ali obratno, da se ne strinja z njenim sklepom, v skladu z odstavkom 3.
Before such a decision is adopted, the Commission may ask the Authority for an opinion, or for scientific or technical assistance which shall be provided within 3 months of the request.
Pred sprejetjem te odločitve lahko Komisija prosi Agencijo za mnenje ali znanstveno ali tehnično pomoč, ki se zagotovi v treh mesecih od prošnje.
Detailed rules and procedures for the implementation of paragraphs 1 to 4 may be established in accordance with the regulatory procedure referred to in Article 79(3), after consultation of the Authority.
Podrobna pravila in postopki za izvajanje odstavkov 1 do 4 se lahko po posvetovanju z Agencijo določijo v skladu z regulativnim postopkom iz člena 79(3).
Reporting and exchange of information on applications for authorisation
Poročanje in izmenjava informacij o vlogah za registracijo
Member States shall compile a file on each application.
Države članice pripravijo dokumentacijo za vsako vlogo.
Each file shall contain the following:
Vsaka dokumentacija vključuje:
a copy of the application;
kopijo vloge;
a report containing information on the evaluation of and decision on the plant protection product; the format of the report shall be established in accordance with the advisory procedure referred to in Article 79(2);
poročilo z informacijami o oceni fitofarmacevtskega sredstva in odločitvi v zvezi z njim; oblika poročila se določi v skladu s svetovalnim postopkom iz člena 79(2);
a record of the administrative decisions taken by the Member State concerning the application and of the documentation provided for in Article 33(3) and Article 34 together with a summary of the latter;
evidenco upravnih odločitev države članice v zvezi z vlogo in dokumentacijo iz členov 33(3) in 34, skupaj s povzetkom dokumentacije;
the approved label, where applicable.
kjer je primerno, odobreno etiketo.
On request, Member States shall, without delay, make available to the other Member States, the Commission and the Authority a file containing the documentation provided for in points (a) to (d) of paragraph 1.
Države članice na zahtevo nemudoma dajo na voljo drugim državam članicam, Komisiji in Agenciji dokumentacijo z dokumenti iz odstavka 1(a) do (d).
On request, applicants shall provide a copy of the documentation to be submitted with an application pursuant to Article 33(3) and Article 34 to Member States, the Commission and the Authority.
Vlagatelji na zahtevo zagotovijo kopijo dokumentacije, ki se predloži z vlogo v skladu s členoma 33(3) in 34 državam članicam, Komisiji in Agenciji.
Detailed rules for the implementation of paragraphs 2 and 3 may be established in accordance with the regulatory procedure referred to in Article 79(3).
Podrobna pravila za izvajanje odstavkov 2 in 3 se lahko določijo v skladu z regulativnim postopkom iz člena 79(3).
Mutual recognition of authorisations
Vzajemno priznavanje registracij
The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases:
Imetnik registracije, izdane v skladu s členom 29, lahko zaprosi za registracijo istega fitofarmacevtskega sredstva, enako uporabo in v okviru primerljivih kmetijskih praks v drugi državi članici v skladu s postopkom vzajemnega priznavanja iz tega pododdelka, če:
the authorisation was granted by a Member State (reference Member State) which belongs to the same zone;
je registracijo izdala država članica (referenčna država članica), ki spada v isto cono;
the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone;
je registracijo izdala država članica (referenčna država članica), ki spada v drugo cono, če se zaprošena registracija ne uporabi za potrebe vzajemnega priznavanja v drugi državi članici iz iste cone;
the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs.
je registracijo izdala država članica za uporabo v rastlinjakih, ali za tretiranje po spravilu, ali za tretiranje praznih prostorov ali shramb za skladiščenje rastlin ali rastlinskih proizvodov, ali za tretiranje semen, ne glede na cono, v katero spada referenčna država članica.
Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply, with the consent of the authorisation holder, for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.
Če fitofarmacevtsko sredstvo v državi članici ni registrirano, ker se v tej državi članici ni predložila vloga za registracijo, lahko uradni ali znanstveni organi, ki sodelujejo v kmetijskih dejavnostih, ali strokovne kmetijske organizacije ob soglasju imetnika registracije zaprosijo za registracijo istega fitofarmacevtskega sredstva, enako uporabo in v okviru enakih kmetijskih praks v tej državi članici v skladu s postopkom vzajemnega priznavanja iz odstavka 1.
In that case the applicant must demonstrate that the use of such a plant protection product is of general interest for the Member State of introduction.
V tem primeru mora vlagatelj dokazati, da je uporaba takega fitofarmacevtskega sredstva v splošnem interesu države članice vnosa.
Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest.
Če imetnik registracije zavrne soglasje, lahko pristojni organ zadevne države članice na podlagi javnega interesa vlogo kljub temu odobri.
The Member State to which an application under Article 40 is submitted shall, having examined the application and the accompanying documents referred to in Article 42(1), as appropriate with regard to the circumstances in its territory, authorise the plant protection product concerned under the same conditions as the Member State examining the application, except where Article 36(3) applies.
Država članica, ki ji je predložena vloga v skladu s členom 40, po preučitvi vloge in spremne dokumentacije iz člena 42(1), če je to glede na okoliščine na njenem ozemlju potrebno, registrira zadevno fitofarmacevtsko sredstvo pod enakimi pogoji kot država članica, ki je preučila vlogo, razen če se uporablja člen 36(3).
By way of derogation from paragraph 1, the Member State may authorise the plant protection product where:
Z odstopanjem od odstavka 1 lahko država članica registrira fitofarmacevtsko sredstvo, če:
an authorisation under point (b) of Article 40(1) was applied for;
je bil vložen zahtevek za registracijo v skladu s členom 40(1)(b);
it contains a candidate of substitution;
vsebuje snov, ki je kandidatka za zamenjavo;
Article 30 has been applied; or
se je uporabljal člen 30; ali
it contains a substance approved in accordance with Article 4(7).
vsebuje snov, odobreno v skladu s členom 4(7).
a copy of the authorisation granted by the reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application;
kopija registracije, ki jo je izdala referenčna država članica, ter prevod registracije v uradni jezik države članice, ki prejme vlogo;
a formal statement that the plant protection product is identical to that authorised by the reference Member State;
uradna izjava, da je fitofarmacevtsko sredstvo identično tistemu, ki ga je registrirala referenčna država članica;
a complete or summary dossier as required in Article 33(3) when requested by the Member State;
popolna dokumentacija ali povzetek, kakor je določeno v členu 33(3), ko to zahteva država članica;
an assessment report of the reference Member State containing information on the evaluation and decision on the plant protection product.
poročilo o oceni referenčne države članice s podatki o oceni fitofarmacevtskega sredstva in odločitvi v zvezi z njim.
The Member State to which an application under Article 40 is submitted shall decide on the application within 120 days.
Država članica, ki ji je vloga predložena v skladu s členom 40, se v 120 dneh odloči o vlogi.
Where requested by the Member State, the applicant shall submit the application in the national or official languages of that Member State or one of those languages.
Na zahtevo države članice vlagatelj predloži vlogo v nacionalnem ali uradnem jeziku te države članice ali v enem od teh jezikov.
Renewal, withdrawal and amendment
Podaljšanje, preklic in sprememba
Renewal of authorisation
Podaljšanje registracije
An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met.
Registracija se podaljša na podlagi vloge, ki jo predloži imetnik registracije, če so zahteve iz člena 29 še vedno izpolnjene.
Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information:
V treh mesecih od podaljšanja odobritve aktivne snovi, varovala ali sinergista v fitofarmacevtskem sredstvu vlagatelj predloži:
a copy of the authorisation of the plant protection product;
kopijo registracije fitofarmacevtskega sredstva;
any new information required as a result of amendments in data requirements or criteria;
kakršne koli nove informacije, ki so potrebne zaradi sprememb zahtev glede podatkov ali meril;
evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;
utemeljitev, da so novi predloženi podatki rezultat zahtev po podatkih ali meril, ki niso veljala, ko je bila izdana registracija za fitofarmacevtsko sredstvo ali da so potrebni za spremembo pogojev za odobritev;
any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein;
kakršne koli informacije, potrebne za dokaz, da fitofarmacevtsko sredstvo izpolnjuje zahteve iz uredbe o obnovitvi odobritve za aktivno snov, varovalo ali sinergist, ki je vsebovan v sredstvu;
a report on the monitoring information, where the authorisation was subject to monitoring.
poročilo o informacijah, pridobljenih z monitoringom, če je bila registracija predmet monitoringa.
Member States shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20.
Države članice preverijo skladnost vseh fitofarmacevtskih sredstev, ki vsebujejo zadevno aktivno snov, varovalo ali sinergist, z vsemi pogoji in omejitvami iz uredbe o obnovitvi odobritve v skladu s členom 20.
The Member State referred to in Article 35 within each zone shall coordinate the compliance check and assessment of the information submitted for all Member States within that zone.
Država članica iz člena 35 znotraj vsake cone usklajuje izvajanje preverjanj skladnosti in ocenjevanja informacij za vse države članice znotraj te cone.
Guidelines on the organisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2).
Navodila za organizacijo preverjanj skladnosti se lahko določijo v skladu s svetovalnim postopkom iz člena 79(2).
Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein.
Države članice se odločijo o podaljšanju registracije fitofarmacevtskih sredstev najpozneje dvanajst mesecev po obnovitvi odobritve aktivne snovi, varovala ali sinergista, ki ga sredstvo vsebuje.
Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.
Kadar se zaradi razlogov, na katere imetnik registracije ne more vplivati, ne sprejme odločitev o podaljšanju registracije, preden ta poteče, zadevna država članica podaljša registracijo za obdobje, potrebno za zaključitev preučitve in sprejetje odločitve o podaljšanju.
Withdrawal or amendment of an authorisation
Preklic ali sprememba registracije
Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.
Države članice lahko pregledajo registracijo kadar koli, če obstajajo dokazi, da zahteva iz člena 29 ni več izpolnjena.
A Member State shall review an authorisation where it concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved.
Država članica pregleda registracijo, kadar ugotovi, da cilji iz člena 4(1)(a)(iv) in (b)(i) ter člena 7(2) in (3) Direktive 2000/60/ES morda ne bodo doseženi.
Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information.
Če namerava država članica preklicati ali spremeniti registracijo, o tem obvesti imetnika registracije in mu da možnost, da predloži pripombe ali dodatne informacije.
The Member State shall withdraw or amend the authorisation, as appropriate, where:
Država članica prekliče ali spremeni registracijo, kot je primerno, če:
the requirements referred to in Article 29 are not or are no longer satisfied;
zahteve iz člena 29 niso ali niso več izpolnjene;
false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
so bile predložene napačne ali zavajajoče informacije o dejstvih, na podlagi katerih je bila registracija izdana;
a condition included in the authorisation has not been met;
pogoj iz registracije ni bil izpolnjen;
on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or
se na podlagi razvoja znanstvenega in tehničnega znanja lahko spremenijo uporabljeni odmerki in način njihove uporabe; ali
the authorisation holder fails to comply with the obligations resulting from this Regulation.
imetnik registracije ne izpolnjuje obveznosti iz te uredbe.
Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority.
Če država članica prekliče ali spremeni registracijo v skladu z odstavkom 3, o tem nemudoma obvesti imetnika registracije, druge države članice, Agencijo in Komisijo.
The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where the second, third or fourth subparagraphs of Article 36(3) have been applied.
Druge države članice, ki sodijo v isto cono, registracijo ustrezno spremenijo ali prekličejo, pri tem pa upoštevajo nacionalne pogoje in ukrepe za zmanjšanje tveganja, razen v primerih, kadar so bili uporabljeni drugi, tretji ali četrti pododstavek člena 36(3).
Article 46 shall apply where appropriate.
Člen 46 se uporablja po potrebi.
Withdrawal or amendment of an authorisation at the request of the authorisation holder
Preklic ali sprememba registracije na zahtevo imetnika registracije
An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request.
Registracija se lahko prekliče ali spremeni na zahtevo imetnika registracije, ki navede razloge za svojo zahtevo.
Amendments may only be granted where it is established that the requirements referred to in Article 29 continue to be met.
Spremembe se lahko odobrijo le, če je dokazano, da so zahteve iz člena 29 še vedno izpolnjene.
Grace period
Prehodno obdobje
Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.
Če država članica prekliče ali spremeni registracijo ali je ne podaljša, lahko odobri prehodno obdobje za odstranjevanje, shranjevanje, dajanje v promet in uporabo obstoječih zalog.
Where the reasons for withdrawal, amendment or non-renewal of the authorisation are not related to the protection of human and animal health or the environment, the grace period shall be limited and shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned.
Kadar razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije niso povezani z varovanjem zdravja ljudi in živali ali okolja, je prehodno obdobje omejeno in ni daljše od šestih mesecev za prodajo in distribucijo ter dodatno največ enega leta za odstranjevanje, shranjevanje in uporabo obstoječih zalog zadevnih fitofarmacevtskih sredstev.
Placing on the market of low-risk plant protection products
Dajanje v promet fitofarmacevtskih sredstev z majhnim tveganjem
Where all the active substances contained in a plant protection product are low-risk active substances as referred to in Article 22, that product shall be authorised as a low-risk plant protection product provided no specific risk mitigation measures are needed following a risk assessment.
Če so vse aktivne snovi v fitofarmacevtskem sredstvu aktivne snovi z majhnim tveganjem iz člena 22, se to sredstvo registrira kot fitofarmacevtsko sredstvo z majhnim tveganjem, če po opravljeni oceni tveganja niso potrebni posebni ukrepi za zmanjševanje tveganja.
This plant protection product shall also meet the following requirements:
To fitofarmacevtsko sredstvo izpolnjuje tudi naslednje zahteve:
the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II;
njegove aktivne snovi, varovala in sinergisti z majhnim tveganjem so bili odobreni v skladu s poglavjem II;