natgillin/translations-raw huggingface dataset:
Člen 56, odstavek 3, točka (a)
Article 56, paragraph 3, point (a)
(a) utemeljitev, da so predložena poročila o preskusih in študijah potrebna za prvo registracijo ali spremembo registracije fitofarmacevtskega sredstva;
(a) justification that the test and study reports submitted are necessary for the first authorisation, or for the amendment of the authorisation of a plant protection product;
(a) utemeljitev, da so predložena poročila o preskusih in študijah potrebna za prvo registracijo , podaljšanje ali pregled ali spremembo registracije fitofarmacevtskega sredstva; ali zaradi spremenjene zakonodaje;
(a) justification that the test and study reports submitted are necessary for the first authorisation, renewal or review, or for the amendment of the authorisation of a plant protection product; or as a result of changes to legislation ;
V primerjavi s sedanjo situacijo je predlog Komisije pomemben korak naprej, saj si prizadeva za preživetje malih in srednje velikih podjetij v Evropi.
The Commission’s proposal is a very important step forward by comparison with the current situation, as it aims to ensure that small and medium-sized enterprises in Europe can stay in business.
Namen spremembe je pojasniti vsebino predloga.
The aim of the amendment is to clarify the text.
Glej obrazložitev pri členu 56(1).
See the justification to Article 56, paragraph 1.
Člen 56, odstavek 3 a (novo)
Article 56, paragraph 3 a (new)
Z odstopanjem od odstavka 1 se poročila o poskusih in študijah v primeru, da so bila uporabljena že za registracijo drugega proizvoda in se obdobje varstva podatkov še ni izteklo, zaščitijo za preostalo obdobje.
By way of derogation from paragraph 1, where tests and study reports have already been used to grant authorisation to another product and the period of protection has not yet expired, those reports shall be protected for the remaining period.
Omeniti je treba študije, za katere še vedno velja obdobje varstva podatkov.
Reference should be made to studies which continue to be under the period of protection.
Člen 57, odstavka 1 in 2
Article 57, paragraphs 1 and 2
Država članica poročevalka za vsako aktivno snov, varovalo in sinergist hrani seznam poročil o preskusih in študijah, potrebnih za prvo odobritev, spremembo pogojev za odobritev ali obnovitev odobritve , in ga da na voljo zainteresirani strani na njeno zahtevo .
For each active substance, safener and synergist, rapporteur Member States shall keep, and make available to any interested party upon request , a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval.
Država članica poročevalka za vsako aktivno snov, varovalo in sinergist posreduje Agenciji seznam poročil o preskusih in študijah, potrebnih za prvo odobritev, spremembo pogojev za odobritev ali obnovitev odobritve ter povzetek rezultatov preizkusov in poročil o študijah, da se določi učinkovitost snovi ter njena neškodljivost za ljudi, živali, rastline in okolje, Agencija pa ju da na voljo javnosti .
For each active substance, safener and synergist, rapporteur Member States shall forward to the Authority, who shall make available to the public , a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and a summary of the results of the tests and study reports to establish the efficacy of the substance and its harmlessness to humans, animals, plants and the environment.
Na zahtevo katere koli zainteresirane strani dajo države članice za vsako fitofarmacevtsko sredstvo, ki ga registrirajo, hranijo in dajo na voljo :
For each plant protection product which they authorise, Member States shall keep and make available to any interested party upon request :
Države članice za vsako fitofarmacevtsko sredstvo, ki ga registrirajo, posredujejo Agenciji, ki da javnosti na voljo :
For each plant protection product which they authorise, Member States shall forward to the Authority, who shall make available to the public :
(a) seznam poročil o preskusih in študijah, potrebnih za prvo registracijo, spremembo pogojev registracije ali podaljšanje registracije; in
(a) a list of the test and study reports necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and
(a) seznam poročil o preskusih in študijah, potrebnih za prvo registracijo, spremembo pogojev registracije ali podaljšanje registracije;
(a) a list of the test and study reports necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation;
(b) seznam poročil o preskusih in študijah, za katere velja varstvo v skladu s členom 56, in utemeljitve, predložene v skladu s tem členom.
(b) a list of test and study reports for which protection is claimed under Article 56 and any justifications submitted in accordance with that Article.
(b) seznam poročil o preskusih in študijah, za katere velja varstvo v skladu s členom 56, in utemeljitve, predložene v skladu s tem členom; in
(b) a list of test and study reports for which protection is claimed under Article 56 and any justifications submitted in accordance with that Article; and
(ba) povzetek rezultatov preizkusov in poročil o študijah, da se določi učinkovitost sredstva ter njegova neškodljivost za ljudi, živali, rastline in okolje.
(ba) a summary of the results of the tests and study reports to establish the efficacy of the product and its harmlessness to humans, animals, plants and the environment .
Zaradi lažje izmenjave podatkov je treba vzpostaviti osrednjo bazo podatkov, ki bi jo vodila Agencija in bi obsegala vse informacije o poskusih in študijah, ki so bili predhodno izvedeni za namene te uredbe.
In order to facilitate data sharing, it is necessary to establish one central database with all the information on tests and studies carried out previously for the purposes of this Regulation, managed by the Authority.
Člen 58, odstavek -1 (novo)
Article 58, paragraph - 1 (new)
Vse osebe, ki imajo namen pridobiti registracijo za fitofarmacevtsko sredstvo, pred izvajanjem preskusov ali študij pregledajo bazo podatkov iz členov 34a, 54 in 57.
Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the database referred to in Articles 34a, 54 and 57.
V povezavi s predlogi sprememb k uvodni izjavi 32 ter k členom 34a, 54(1), 57(1) in (2).
Linked to the amendments to Recital 32 and Articles 34a, 54(1), and 57(1) and (2).
Za zagotovitev najboljše izmenjave podatkov bi morali vlagatelji pregledati bazo podatkov Agencije in pridobiti vse informacije o poskusih in študijah, ki so bili predhodno izvedeni za namene te uredbe.
To ensure maximum data sharing, applicants should consult the Authority database in order to find all the necessary information on tests and studies carried out previously for the purposes of this Regulation.
Člen 58, odstavek 1, pododstavek 1
Article 58, paragraph 1, subparagraph 1
Katere koli osebe, ki želijo pridobiti registracijo za fitofarmacevtsko sredstvo, pred izvajanjem poskusov ali študij preverijo pri pristojnem organu države članice, v kateri želijo vložiti zahtevek, ali je bila v zadevni državi članici že odobrena registracija za fitofarmacevtsko sredstvo, ki vsebuje enako aktivno snov, varovalo ali enak sinergist.
Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, enquire of the competent authority of the Member State to which they intend to make an application whether an authorisation has already been granted in that Member State for a plant protection product containing the same active substance, safener or synergist.
Takšna poizvedba v skladu s členom 54 vključuje posvetovanje o razpoložljivih informacijah.
Such enquiry shall include consultation of the information available pursuant to Article 54.
Katere koli osebe, ki želijo pridobiti, podaljšati ali pregledati registracijo za fitofarmacevtsko sredstvo, pred izvajanjem preskusov ali študij obvestijo pristojni organ države članice, v kateri želijo vložiti zahtevek, da je bila v zadevni državi članici že odobrena registracija za fitofarmacevtsko sredstvo, ki vsebuje enako aktivno snov, varovalo ali enak sinergist , sklicujoč se na ustrezne informacije iz baze podatkov .
Any persons intending to seek , renew or review an authorisation for a plant protection product shall, before carrying out tests or studies, inform the competent authority of the Member State to which they intend to make an application that an authorisation has already been granted in that or another Member State for a plant protection product containing the same active substance, safener or synergist , referring to the relevant information in the database .
V povezavi s predlogi sprememb k členom 34a, 54(1), 57(1) in (2) ter 58(-1).
Linked to Amendments to Articles 34a, 54(1), 57(1) and (2) and 58(-1).
Varstvo podatkov je treba razširiti tudi na podatke za podaljšanje in pregled registracije, zato da se zaščitijo srednje velika podjetja in razvojni sektorji fitofarmacevtske industrije.
Data protection must also be extended to data for renewal and review of an authorisation to protect medium-sized companies and the research based sectors of the plant protection industry.
Člen 58, odstavek 2
Article 58, paragraph 2
Če ima pristojni organ države članice dokaz, da morebitni vlagatelj namerava vložiti zahtevek za registracijo, mu zagotovi ime in naslov imetnika ali imetnikov obstoječih zadevnih registracij ter hkrati sporoči imetnikom registracij ime in naslov vlagatelja.
The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.
Če ima pristojni organ države članice dokaz, da morebitni vlagatelj namerava vložiti zahtevek za registracijo , njeno podaljšanje ali pregled , mu zagotovi ime in naslov imetnika ali imetnikov obstoječih zadevnih registracij ter hkrati sporoči imetnikom registracij ime in naslov vlagatelja.
The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.
Glej obrazložitev k členu 58, odstavek 1, pododstavek 1.
See the justification to Article 58 paragraph 1 subparagraph 1.
Člen 58, odstavek 3
Article 58, paragraph 3
Morebitni vlagatelj registracije in imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o preskusih in študijah, varovanih v skladu s členom 56, ki jih zahteva vlagatelj za registracijo fitofarmacevtskega sredstva.
The prospective applicant for the authorisation and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 56 that are required by the applicant for authorisation of a plant protection product.
Morebitni vlagatelj registracije , njenega podaljšanja ali pregleda, in imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o poskusih in študijah, varovanih v skladu s členom 56, ki jih zahteva vlagatelj za registracijo fitofarmacevtskega sredstva , za njeno podaljšanje ali pregled .
The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 56 that are required by the applicant for the authorisation, or the renewal or review, of a plant protection product.
Namesto takšnega dogovora se lahko zadeva predloži razsodišču in sprejme njegova odločitev.
Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.
Da bi zagotovili, da bodo stroški razširjanja informacij izračunani pravično, pregledno in nediskriminacijsko, lahko Komisija na podlagi teh načel v skladu z regulativnim postopkom, navedenem v členu 76(3), sprejme smernice o delitvi stroškov.
In an endeavour to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way, the Commission may, in accordance with the regulatory procedure referred to in Article 76(3), adopt cost-sharing guidelines based on those principles.
Glej obrazložitev k členu 58, odstavek 1, pododstavek 1.
See the justification to Article 58 paragraph 1 subparagraph 1 .
Da bi zmanjšali nepotrebno podvajanje poskusov, je treba vzpostaviti mehanizme arbitraže in delitve stroškov, ki bodo vlagateljem in imetnikom registracij pomagali pri dogovarjanju.
In order to minimise unnecessary duplication of tests, it is necessary to put in place arbitration- and cost-sharing mechanisms that could help applicants and holders of authorisation to reach an agreement.
Te določbe so bile vključene tudi v direktivo REACH.
These provisions have also been introduced in the REACH Directive.
Kadar država članica meni, da bi lahko nastal monopol, morebitni vlagatelj in imetnik ali imetniki registracij fitofarmacevtskih sredstev, ki vsebujejo enako aktivno snov, varovalo ali enak sinergist, pa se ne morejo sporazumeti o izmenjavi poskusov in študij, ki vključujejo vretenčarje, morebitni vlagatelj o tem obvesti pristojni organ države članice.
Where the Member State considers that a monopoly might be created, and the prospective applicant and the holder or holders of the authorisations for plant protection products containing the same active substance, safener, or synergist cannot reach agreement on the sharing of any tests and studies involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State to that effect.
Kljub temu pa se morata obe strani dogovoriti o pristojnem sodišču za namene drugega pododstavka člena 59(3).
The two parties shall nevertheless agree which courts and tribunals have jurisdiction for the purposes of the second subparagraph of Article 59(3).
Nova uredba bi morala vsebovati posebne določbe, ki bi preprečevale nastanek monopolnih razmer na trgu fitofarmacevtskih sredstev
The new regulation should lay down special provisions to prevent monopolies being created on the market in plant protection products.
Preskusi in študije, ki vključujejo vretenčarje, se za namene te uredbe ne smejo izvajati ponovno.
Tests and studies involving vertebrate animals shall not be repeated for the purposes of this Regulation.
Oseba, ki namerava izvajati preskuse in študije, ki vključujejo vretenčarje, sprejme ukrepe, potrebne za potrditev, da se ti preskusi in študije še niso začeli ali so že bili izvedeni.
Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated.
Oseba, ki namerava izvajati preskuse in študije, ki vključujejo vretenčarje, sprejme ukrepe, potrebne za potrditev, da se ti preskusi in študije še niso začeli ali so že bili izvedeni, zlasti s pregledovanjem baze podatkov .
Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated , in particular by consulting the database .
Člen 59, odstavek 2
Article 59, paragraph 2
Morebitni vlagatelj in imetnik ali imetniki zadevnih registracij si prizadevajo za zagotovitev izmenjave poskusov in študij, ki vključujejo vretenčarje.
The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals.
Stroški izmenjave poročil o preskusih in študijah se določijo na pošten, pregleden in nediskriminatoren način.
The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way.
Morebitni vlagatelj krije stroške le za tiste informacije , ki jih mora predložiti za izpolnitev zahtev za registracijo.
The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.
Morebitni vlagatelj krije stroške, ki nastanejo v celotnem postopku za pridobitev tistih informacij, ki jih mora predložiti za izpolnitev zahtev za registracijo.
The prospective applicant is required to share in the costs that accrue during the full process of generating the information he is required to submit to meet the authorisation requirements.
Stroški pridobivanja informacij so večji kot čisti stroški študije.
The cost of generating data is greater than the net cost of the study.
Prihodnji vlagatelj zahtevka bi moral biti obvezan k udeležbi pri skupnih stroških pridobivanja podatkov, ki bi jih kasneje smel uporabiti za potrebe svoje registracije.
The prospective applicant should be obliged to participate in the full costs of the data he is then entitled to use for his own registration purposes.
Člen 59, odstavek 3 a (novo)
Article 59, paragraph 3 a (new)
Komisija v …* opravi oceno določb te uredbe, ki se nanašajo na varstvo podatkov za preskuse in študije na vretenčarjih.
Not later than ...*, the Commission shall carry out a review of the provisions in this Regulation concerning data protection for tests and studies involving vertebrate animals.
Oceno in vse predloge sprememb za omejitev varstva podatkov o poskusih na živalih predloži Evropskemu parlamentu in Svetu.
The Commission shall submit this assessment, and any proposed amendments for limiting the data protection with regard to animal experiments, to the European Parliament and the Council.
* sedmih letih po začetku veljavnosti te uredbe
* Seven years after the entry into force of this Regulation.
Po tem predlogu za rezultate iz preskusov na vretenčarjih lahko velja varstvo podatkov, vendar je treba take podatke deliti.
Under this proposal, the results from tests involving vertebrate animals enjoy data protection, but such data have to be shared.
Kompromis je v tem trenutku potreben iz praktičnih razlogov (sicer mnogih novih proizvodov ne bi mogli tržiti), vendar ga je treba v doglednem času ponovno oceniti.
This compromise is at present necessary for practical reasons (otherwise many new products will not be marketable) but should be evaluated in due course.
Tudi manj strog režim varovanja podatkov bo zmanjšal število poskusov na vretenčarjih.
A less strict data protection regime will still reduce the number of tests on vertebrate animals.
Člen 60, odstavek 1 a (novo)
Article 60, paragraph 1 a (new)
Vlagatelju je ponujena možnost, da poda svoje mnenje, preden pristojni organ o zaupnosti podatkov sprejme odločitev, ki bo zavezujoča za vse države članice, Agencijo in Komisijo.
An opportunity to comment shall be given to the applicant before the competent authority adopts a decision as to the confidentiality of the data, which shall be binding on all Member States, the Authority and the Commission.
Odločitev, o kateri mora biti prosilec obveščen, vsebuje ustrezno utemeljitev.
The decision, which must be notified to the applicant, shall contain an adequate justification.
Prosilec ima pravico takšno odločitev, preden se ta izvede, izpodbijati na sodišču, zato da bi sodišče ocene in odločitev pristojnega organa pregledalo in da se prepreči razkritje zadevnih podatkov.
The applicant shall have the right to challenge such decision in court before it is implemented, with a view to having the assessments and decision made by the competent authority reviewed by the court and to preventing disclosure of the data in question.
Razkritje občutljivih informacij lahko močno vpliva na poslovne interese.
The disclosure of sensitive information can considerably impact commercial interests.
Imetnik takšnih informacij mora zato imeti možnost, da o odločitvi za razkritje, preden se ta sprejme, poda mnenje in da po potrebi uporabi pravna sredstva.
Consequently, the owner of such information must be given an opportunity to comment on a disclosure decision before it is taken and seek legal redress if necessary.
Člen 60, odstavek 2, točka (c a) (novo)
Article 60, paragraph 2, point (c a) (new)
(ca) Imena in naslovi ustanov in oseb, ki sodelujejo pri poskusih na vretenčarjih.
(ca) n ames and addresses of institutions and persons involved in testing on vertebrate animals.
Osebni podatki ustanov in oseb bi morali veljati za zaupne, saj so pogosto tarča radikalnih skupin, ki se borijo za dobrobit živali.
Personal Data of institutions and persons should be regarded as confidential as they are often targeted by radical animal welfare groups.
Člen 60, odstavek 2 a (novo)
Article 60, paragraph 2 a (new)
Pri podatkih preskusov, vključno s poročili o študijah, ki jih je vlagatelj predložil v podporo sklepu o registraciji ali spremembi fitofarmacevtskega sredstva v skladu s to uredbo, si zainteresirane strani takšne podatke lahko ogledajo na posebnih lokacijah, ki jih določijo Komisija, Agencija ali države članice.
For test data, including study reports, which have been provided by an applicant to support a decision to authorise or amend a plant protection product under this Regulation, such data may be viewed by interested parties in specific locations identified by the Commission, the Authority or the Member States.
Takšni podatki se ne objavijo v obliki kopij ali na kateri koli drug način objave (vključno z objavo v elektronski obliki).
Such data shall not be made public through the provision of copies or through any other means of publication (including electronic publication).
Javnost je upravičeno zainteresirana za dostop do informacij, ki bi moral biti v tej uredbi zagotovljen v skladu z Aarhuško konvencijo.
The public has a legitimate interest in the access to information, which should be guaranteed under this Regulation in accordance with the Aarhus Convention.
Koncept informiranja javnosti pa bi moral preprečevati zlorabe in nelojalno konkurenco.
The concept of informing the general public should however prevent misuse and unfair competition.
Predlagani čitalniški koncept je primerna rešitev, saj zainteresiranim tretjim stranem omogoča dostop do zaupnih informacij, potencialnim konkurentom pa preprečuje zlorabo sistema za pridobitev občutljivih komercialnih podatkov.
The proposed reading room concept will strike the right balance as interested third parties have access to confidential information but potential competitors can not misuse the system to obtain sensitive commercial data.
Člen 62, odstavek 1, pododstavek 2
Article 62, paragraph 1, subparagraph 2
Ta uredba vključuje tudi standardna besedila za posebna tveganja in varnostne ukrepe, ki dopolnjujejo besedila iz Direktive 1999/45/ES.
That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC.
Zajema besedilo prilog IV in V k Direktivi 91/414/EGS z vsemi potrebnimi spremembami.
It shall incorporate the text of the Annexes IV and V to Directive 91/414/EEC with any necessary modifications.
Prenaša besedilo prilog IV in V k Direktivi 91/414/EGS z vsemi spremembami , potrebnimi zaradi spremembe direktive v uredbo .
It shall transfer the text of the Annexes IV and V to Directive 91/414/EEC with any modifications necessary due to the change from a directive to a regulation .
Sprejetje uredbe o označevanju fitofarmacevtskih sredstev v postopku svetovanja bi se moralo omejiti zgolj na prenos obstoječih zahtev.
The adoption of a regulation on the labelling of plant protection products in the advisory procedure should be limited to a mere transfer of existing requirements.