+Člen 17 Obnovitev odobritve
---+Article 17 1.
---+Article 17 2.
---+Article 17 3.
---+Article 17 4.
---+Article 17 5.
---+Article 17 6.
---+Article 17 7.
---+Article 17 8.
---+Article 17 9.

Člen 17 Obnovitev odobritve

Člen 17

Obnovitev odobritve

1.  Z odstopanjem od členov 13, 14 in 15 se postopek iz odstavkov 2 do 9 uporabi za obnovitev:

(a) 

odobritev, izdanih po delu C; in

(b) 

pred 17. oktobrom 2006 odobritev, izdanih po Direktivi 90/220/EGS za dajanje v promet GSO kot proizvodov ali v proizvodih pred 17. oktobrom 2002.

2.  Prijavitelj po tem členu najkasneje devet mesecev pred potekom veljavnosti odobritve za odobritve iz odstavka 1(a) in pred 17. oktobrom 2006 za odobritve iz odstavka 1(b) predloži pristojnemu organu, ki je prejel prvotno prijavo, prijavo, ki vsebuje:

(a) 

kopijo odobritve za dajanje v promet GSO;

(b) 

poročilo o rezultatih spremljanja, ki je bilo opravljeno po členu 20. V primeru odobritev iz odstavka 1(b) se to poročilo predloži, kjer je bilo spremljanje izvedeno;

(c) 

vse druge nove informacije, ki so na voljo v zvezi s tveganji proizvodov za zdravje ljudi in/ali okolje; in,

(d) 

kot je primerno, predlog za spremembo ali dopolnitev pogojev iz prvotne odobritve, med drugim pogojev glede prihodnjega spremljanja in časovne omejitve odobritve.

Pristojni organ potrdi datum prejema prijave in, če je prijava skladna s tem odstavkom, nemudoma posreduje kopijo prijave in svoje poročilo o oceni Komisiji, ki ju v 30 dneh od prejema posreduje pristojnim organom drugih držav članic. Prav tako pošlje svoje poročilo o oceni prijavitelju.

3.  Poročilo o oceni navaja, ali:

(a) 

GSO smejo ostati v prometu in pod kakšnimi pogoji; ali

(b) 

GSO ne smejo ostati v prometu.

4.  Drugi pristojni organi ali Komisija lahko zaprosijo za dodatne informacije, podajo pripombe ali predstavijo utemeljene ugovore v 60 dneh od datuma razpošiljanja poročila o oceni.

5.  Vse pripombe, utemeljene ugovore in odgovore se posreduje Komisiji, ki jih takoj razpošlje vsem pristojnim organom.

6.  V primeru odstavka 3(a) in ko v 60 dneh od razpošiljanja poročila o oceni ni utemeljenega ugovora države članice ali Komisije, pristojni organ, ki je pripravil poročilo o oceni, prijavitelju pošlje končno pisno odločitev ter o tem v 30 dneh obvesti druge države članice in Komisijo. Veljavnost odobritve praviloma ne sme presegati deset let in se lahko iz posebnih razlogov omeji ali podaljša, kot je primerno.

7.  Pristojni organi in Komisija lahko razpravljajo o vseh odprtih vprašanjih zaradi doseganja dogovora v 75 dneh od datuma razpošiljanja poročila o oceni.

8.  Če se odprta vprašanja razrešijo v 75-dnevnem obdobju, navedenem v odstavku 7, pristojni organ, ki je pripravil poročilo, prijavitelju pošlje svojo končno odločitev v pisni obliki in o tem v 30 dneh obvesti druge države članice in Komisijo. Veljavnost odobritve je lahko omejena, kot je primerno.

9.  Po prijavi za obnovitev odobritve v skladu z odstavkom 2 lahko prijavitelj še naprej daje GSO v promet pod pogoji iz navedene odobritve do končne odločitve o prijavi.

1. Pregled

,
Article 17 1.

By way of derogation from Articles 13, 14 and 15, the procedure set out in paragraphs 2 to 9 shall be applied to the renewal of:

(a) 

consents granted under part C; and

(b) 

before 17 October 2006 of consents granted under Directive 90/220/EEC for placing on the market of GMOs as or in products before 17 October 2002,
Article 17 2.

At the latest nine months before the expiry of the consent, for the consents referred to in paragraph 1(a), and before 17 October 2006, for the consents referred to in paragraph 1(b), the notifier under this Article shall submit a notification to the competent authority which received the original notification, which shall contain:

(a) 

a copy of the consent to the placing on the market of the GMOs;

(b) 

a report on the results of the monitoring which was carried out according to Article 20. In the case of consents referred to in paragraph 1(b), this report shall be submitted when the monitoring was carried out;

(c) 

any other new information which has become available with regard to the risks of the product to human health and/or the environment; and

(d) 

as appropriate, a proposal for amending or complementing the conditions of the original consent, inter alia the conditions concerning future monitoring and the time limitation of the consent.

The competent authority shall acknowledge the date of receipt of the notification and when the notification is in accordance with this paragraph it shall without delay forward a copy of the notification and its assessment report to the Commission, which shall, within 30 days of their receipt, forward them to the competent authorities of the other Member States. It shall also send its assessment report to the notifier.
Article 17 3.

The assessment report shall indicate whether:

(a) 

the GMO(s) should remain on the market and under which conditions; or

(b) 

the GMO(s) should not remain on the market.
Article 17 4.
The other competent authorities or the Commission may ask for further information, make comments, or present reasoned objections within a period of 60 days from the date of circulation of the assessment report.
Article 17 5.
All comments, reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.
Article 17 6.
In the case of paragraph 3(a) and in the absence of any reasoned objection from a Member State or the Commission within 60 days from the date of circulation of the assessment report, the competent authority which prepared the report shall transmit to the notifier the final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent should not, as a general rule, exceed ten years and may be limited or extended as appropriate for specific reasons.
Article 17 7.
The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.
Article 17 8.
If outstanding issues are resolved within the 75 day period referred to in paragraph 7, the competent authority which prepared the report shall transmit to the notifier its final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate.
Article 17 9.
Following a notification for the renewal of a consent in accordance with paragraph 2, the notifier may continue to place the GMOs on the market under the conditions specified in that consent until a final decision has been taken on the notification.

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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