+Artikolu 25 Kunfidenzjalità
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Artikolu 25 Kunfidenzjalità
Artikolu 25 Kunfidenzjalità 1. In-notifikatur jista' jissottometti talba lill-Awtorità kompetenti biex ċerti partijiet tal-informazzjoni sottomessa skont din id-Direttiva jiġu ttrattati bħala kunfidenzjali, akkumpanjati minn ġustifikazzjoni verifikabbli, b'konformità mal-paragrafi 3 u 6. 2. L-awtorità kompetenti għandha tivvaluta t-talba għall-kunfidenzjalità sottomessa min-notifikatur. 3. Fuq talba ta' notifikatur, l-awtorità kompetenti tista' tagħti trattament kunfidenzjali biss fir-rigward tal-punti ta' informazzjoni li ġejjin, wara ġustifikazzjoni verifikabbli, fejn in-notifikatur juri li d-divulgazzjoni ta' tali informazzjoni potenzjalment tagħmel ħsara fi grad sinifikanti lill-interessi tiegħu:
(a)
l-informazzjoni msemmija fil-punti (a), (b) u (c) tal-Artikolu 39(2) tar-Regolament (KE) Nru 178/2002;
(b)
informazzjoni dwar is-sekwenza tad-DNA, ħlief għal sekwenzi użati għall-fini ta' detezzjoni, ta' identifikazzjoni u ta' kwantifikazzjoni tal-avveniment ta' trasformazzjoni; u
(c)
ix-xejriet ta' tnissil u l-istrateġiji.
4. L-awtorità kompetenti, wara konsultazzjoni man-notifikatur, għandha tiddeċiedi liema informazzjoni trid tiġi trattata bħala kunfidenzjali u għandha tinforma lin-notifikatur bid-deċiżjoni tagħha. 5. L-Istati Membri, il-Kummissjoni u l-Kumitat(i) Xjentifiku(/ċi) rilevanti għandhom jieħdu l-miżuri neċessarji sabiex jiżguraw li l-informazzjoni kunfidenzjali notifikata jew skambjata skont din id-Direttiva ma ssirx pubblika. 6. Id-dispożizzjonijiet rilevanti tal-Artikoli 39e u 41 tar-Regolament (KE) Nru 178/2002 għandhom japplikaw ukoll mutatis mutandis. 7. Minkejja l-paragrafi 3, 5, u 6 ta' dan l-Artikolu:
(a)
fejn azzjoni urġenti hi essenzjali għall-protezzjoni tas-saħħa tal-bniedem, tas-saħħa tal-annimali jew tal-ambjent, bħal f'sitwazzjonijiet ta' emerġenza, l-awtorità kompetenti tista' tiddivulga l-informazzjoni msemmija fil-paragrafu 3; u
(b)
informazzjoni li tagħmel parti mill-konklużjonijiet tal-outputs xjentifiċi forniti mill- Kumitat(i) Xjentifiku(/ċi) rilevanti jew il-konklużjonijiet tar-rapport ta' valutazzjoni u li huma relatati ma' effetti prevedibbli fuq is-saħħa tal-bniedem, is-saħħa tal-annimali jew l-ambjent għandha madankollu ssir pubblika. F'dak il-każ, għandu japplika l-Artikolu 39c tar-Regolament (KE) Nru 178/2002.
8. F'każ ta' rtirar tan-notifika min-notifikatur, l-Istati Membri, il-Kummissjoni u l-Kumitat(i) Xjentifiku(/ċi) rilevanti għandhom jirrispettaw il-kunfidenzjalità kif mogħtija mill-awtorità kompetenti skont dan l-Artikolu. Meta l-irtirar tan-notifika jseħħ qabel ma l-awtorità kompetenti tkun iddeċidiet dwar it-talba rilevanti għall-kunfidenzjalità, l-Istati Membri, il-Kummissjoni u l-Kumitati Xjentifiċi rilevanti ma għandhomx jippubblikaw l-informazzjoni li għaliha tkun intalbet il-kunfidenzjalità.
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1. Ħarsa ġenerali
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Regolamentazzjoni |
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Article 25 1.
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The notifier may submit a request to the competent authority to treat certain parts of the information submitted under this Directive as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.
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Article 25 2.
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The competent authority shall assess the confidentiality request submitted by the notifier.
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Article 25 3.
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Upon request of a notifier, the competent authority may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the notifier to potentially harm its interests to a significant degree:
(a)
items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;
(b)
DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and
(c)
breeding patterns and strategies.
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Article 25 4.
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The competent authority shall, after consultation with the notifier, decide which information is to be treated as confidential and shall inform the notifier of its decision.
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Article 25 5.
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Member States, the Commission and the relevant Scientific Committee(s) shall take the necessary measures to ensure that confidential information notified or exchanged under this Directive is not made public.
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Article 25 6.
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The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.
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Article 25 7.
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Notwithstanding paragraphs 3, 5 and 6 of this Article:
(a)
where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and
(b)
information which forms part of the conclusions of the scientific outputs delivered by the relevant Scientific Committee(s) or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.
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Article 25 8.
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In the event of a withdrawal of the notification by the notifier, Member States, the Commission and the relevant Scientific Committee(s) shall respect the confidentiality as granted by the competent authority in accordance with this Article. Where the withdrawal of the notification takes place before the competent authority has decided on the relevant confidentiality request, Member States, the Commission and the relevant Scientific Committee(s) shall not make public the information for which confidentiality has been requested.
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1.1 Referenzi
1.2 Rekwiżiti identifikati
1.3 Standards relatati
2. Rekwiżiti identifikati
3. Standards relatati
- Builddate: 27.03.2021 00:00:00 -Doknr: CELEX:32001L0018
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