+Artikolu 15 Proċedura standard
---+Article 15 1.
---+Article 15 2.
---+Article 15 3.
---+Article 15 4.

Artikolu 15 Proċedura standard

Artikolu 15

Proċedura standard

1.  Fil-każijiet riferiti fl-Artikolu 14(3), awtorità kompetenti jew il-Kummissjoni tista' titlob għal iktar informazzjoni, tagħmel kummenti jew tippreżenta oġġezzjonijiet raġjunati għat-tpoġġija fis-suq ta' GMO(s) in kwistjoni fi żmien 60 ġurnata mid-data ta' ċirkolazzjoni tar-rapport ta' stima.

Kummenti jew oġġezzjonijiet raġjunati u tweġibiet għandhom jintbagħtu lill-Kummissjoni li għandha immedjatament tiċċirkolahom lill-awtoritajiet kompetenti kollha.

L-awtortajiet kompetenti u l-Kummissjoni jistgħu jiddiskutu kwistjonijiet li għadhom ma ġewx deċiżi bl-għan li jilħqu ftehim fi żmien 105 ġurnata mid-data ta' ċirkolazzjoni tar-rapport ta' stima.

Kwalunkwe perijodi ta' żmien li matulhom qed jistennew iktar informazzjoni minn għand in-notifikant ma jittieħdux in konsiderazzjoni biex tikkalkula il-perijodu finali ta' 45 ġurnata biex jilħqu ftehim. Għandhom jingħataw raġunijiet fi kwalunkwe talba għal aktar informazzjoni.

2.  Fil-każ riferit fl-Artikolu 14(3)(b), jekk l-awtorità kompetenti li preparat ir-rapport tiddeċiedi li GMO(s) m'għandhomx jitpoġġew fis-suq, in-notifika għandha tiġi mwarrba. Din id-Deċiżjoni għandha tagħti ir-raġunijiet.

3.  Jekk l-awtorità kompetenti li ppreparat ir-rapport tiddeċiedi li l-prodott jista' jitpoġġa fis-suq, fl-assenza ta' xi oġġezzjoni raġjunata minn Stat Membru jew mill-Kummissjoni fi żmien 60 ġurnata wara d-data ta' ċirkolazzjoni tar-rapport ta' stima riferit fl-Artikolu 14(3)(a) jew jekk kwistjonijiet li għadhom ma ġewx deċiżi huma riżolti fi żmien 105 ġurnata riferit fil-paragrafu 1, l-awtorità kompetenti li ppreparat ir-rapport għandha tagħti l-kunsens tagħha bil-miktub għat-tpoġġija fis-suq, tibgħata lin-notifikant, u tinforma lill-Istati Membri l-oħra u lill-Kummissjoni b'dan fi żmien 30 ġurnata.

4.  Il-kunsens għandu jingħata għal perijodu massimu ta' għaxar snin li jibda mill-ġurnata meta jinħareġ il-kunsens.

Għall-għanijiet għall-approvazzjoni ta' GMO jew derivattiv ta' dak il-GMO maħsub biss għal marketing ta' dik iż-żerriegħa. Varjeta tal-Pjanti skond id-dispożizzjonijiet rilevanti tal-Komunità, l-perijodu ta' l-ewwel kunsens jispiċċa l-aktar tard għaxar snin wara d-data ta' l-ewwel inklużjoni ta' l-ewwel varjetà tal-pjanti li fihom GMO fuq katalogu uffiċjali nazzjonali tal-varjetà tal-pjanti skond id-Direttiva tal-Kunsill 70/457/EEC ( 4 ) and 70/458/EEC ( 5 ).

Fil-każ ta' materjal riproduttiv tal-foresta l-perijodu ta' l-ewwel kunsens jispiċċa l-aktar tard għaxar snin wara d-data ta' l-ewwel inklużjoni tal-materjal bażiku li jinsab fil-GMO fuq persuna uffiċjali ta' materjal bażiku skond id-Direttiva tal-Kunsill 1999/105/EC ( 6 ).

1. Ħarsa ġenerali

,
Titlu Regolamentazzjoni
Article 15 1.
In the cases referred to in Article 14(3), a competent authority or the Commission may ask for further information, make comments or present reasoned objections to the placing on the market of the GMO(s) in question within a period of 60 days from the date of circulation of the assessment report.

Comments or reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 105 days from the date of circulation of the assessment report.

Any periods of time during which further information from the notifier is awaited shall not be taken into account for the purpose of calculating the final 45 day period for arriving at an agreement. Reasons shall be stated in any request for further information.

Article 15 2.
In the case referred to in Article 14(3)(b), if the competent authority which prepared the report decides that the GMO(s) should not be placed on the market, the notification shall be rejected. This decision shall state the reasons.
Article 15 3.
If the competent authority which prepared the report decides that the product may be placed on the market, in the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the assessment report referred to in Article 14(3)(a) or if outstanding issues are resolved within the 105 day period referred to in paragraph 1, the competent authority which prepared the report shall give consent in writing for placing on the market, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days.
Article 15 4.
The consent shall be given for a maximum period of ten years starting from the date on which the consent is issued.

For the purpose of approval of a GMO or a progeny of that GMO intended only for the marketing of their seeds under the relevant Community provisions, the period of the first consent shall end at the latest ten years after the date of the first inclusion of the first plant variety containing the GMO on an official national catalogue of plant varieties in accordance with Council Directives 70/457/EEC ( 4 ) and 70/458/EEC ( 5 ).

In the case of forest reproductive material, the period of the first consent shall end at the latest ten years after the date of the first inclusion of basic material containing the GMO on an official national register of basic material in accordance with Council Directive 1999/105/EC ( 6 ).

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors Rekwiżit

3. Standards relatati

Standards
Sors Rekwiżit
  • Builddate: 27.03.2021 00:00:00 -Doknr: CELEX:32001L0018
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