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poročilo o oceni tveganja za okolje
1 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
poročilo o oceni tveganja za okolje (ERA), pripravljeno na podlagi podatkov, opredeljenih v prilogah III in IV Direktive 2001/18/ES in v skladu s Prilogo II Direktive 2001/18/ES,
an environment risk assessment (ERA) report prepared on basis of the information specified in Annexes III and IV of Directive 2001/18/EC and in accordance with Annex II of Directive 2001/18/EC;
2 Končna redakcija
CELEX: 32004L0028
Če se država članica v roku iz člena 32(4) ne more strinjati s poročilom o oceni, povzetkom glavnih značilnosti, označevanjem in navodilom za uporabo zaradi potencialnega resnega tveganja za zdravje ljudi ali živali ali za okolje, predloži referenčni državi članici, drugim državam članicam in predlagatelju podrobno navedbo razlogov.
If a Member State cannot, within the period allowed in Article 32(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant.
3 Pravna redakcija
finance
CELEX: 32003L0063
- poročilo o oceni tveganja za okolje (ERA), pripravljeno na podlagi podatkov, opredeljenih v Prilogah III in IV Direktive 2001/18/ES in v skladu s Prilogo II Direktive 2001/18/ES;
- an environment risk assessment (ERA) report prepared on basis of the information specified in Annexes III and IV of Directive 2001/18/EC and in accordance with Annex II of Directive 2001/18/EC;
4 Pravna redakcija
DRUGO
Ko pristojni organ ali Komisija po členih 15(1), 17(4), 20(3) ali 23 ugovarja v zvezi s tveganji GSO za zdravje ljudi ali okolje ter vztraja pri tem ali kadar poročilo o oceni iz člena 14 kaže, da GSO ne bi smel biti dan v promet, se Komisija na lastno pobudo ali na zahtevo države članice o ugovoru posvetuje z ustreznim(i) znanstvenim(i) odborom(i).
In cases where an objection as regards the risks of GMOs to human health or to the environment is raised by a competent authority or the Commission and maintained in accordance with Article 15(1), 17(4), 20(3) or 23, or where the assessment report referred to in Article 14 indicates that the GMO should not be placed on the market, the relevant Scientific Committee(s) shall be consulted by the Commission, on its own initiative or at the request of a Member State, on the objection.
5 Pravna redakcija
DRUGO
V roku 90 dni po prejemu poročila o oceni zdravila mora zadevna država članica ali priznati odločitev prve države članice ter sprejeti povzetek glavnih značilnosti zdravila, ki ga je ta država odobrila, ali pa mora, če meni, da obstaja razlog za domnevo, da bi dovoljenje za promet z zdravilom za uporabo v veterinarski medicini lahko predstavljalo tveganje za zdravje ljudi ali živali ali okolja, uvesti postopke, kot jih določata člena 33 in 38.
Within 90 days of receipt of the assessment report, the Member State concerned shall either recognise the decision of the first Member State and the summary of the product characteristics as approved by it or, if it considers that there are grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health or the environment, it shall apply the procedures set out in Articles 33 to 38.
6 Prevajalska redakcija
izobraževanje
CELEX: 32004L0028
Če se država članica v roku iz člena 32(4) ne more strinjati s poročilom o oceni, povzetkom glavnih značilnosti, označevanjem in navodilom za uporabo zaradi potencialnega resnega tveganja za zdravje ljudi ali živali ali za okolje, predloži referenčni državi članici, drugim državam članicam in predlagatelju podrobno navedbo razlogov.
If a Member State cannot, within the period allowed in Article 32(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant.
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poročilo o oceni tveganja za okolje