S.L. 549.60 чл. 15Renewal of consent.

(1) By way of derogation from regulations 12, 13 and 14, the procedure set out in sub-regulations (2) to (6) shall be applied to the renewal of consents granted under Part C.

(2) A person seeking to renew a consent granted by the competent authority under regulation 14 or a consent previously renewed under this regulation shall:

(a) submit a notification to the competent authority no later than nine months before the expiry of the consent that it is proposed to have renewed,

(b) a person who has submitted a notification under this regulation may continue to market the product concerned in accordance with the terms and conditions of the relevant consent until a final decision has been made on the notification.

(3) A notification in accordance with sub-regulation (2)(a) shall include:

(a) a copy of the consent granted by the competent authority to the product being placed on the market and of any renewed consent,

(b) a report on the monitoring carried out in accordance with regulation 17,

(c) any new information that has become available with regard to the risks of the product to human health or to the environment, and

(d) any proposals the notifier considers appropriate for the amendment of, or measures additional to, the conditions contained in the original consent granted by the competent authority, including conditions relating to future monitoring and time limitation of the consent.

(4) On receipt of a notification under sub-regulation (2), the competent authority shall:

(a) acknowledge to the notifier the date of such receipt in writing,

(b) examine it for compliance with sub-regulation (3),

(c) ask the notifier in writing for any further information which the competent authority considers necessary, stating its reasons for so doing,

(d) prepare, in accordance with Schedule VI, an assessment report which shall indicate:

(i) whether the genetically modified organism concerned should remain on the market and under which conditions (referred to as a "favourable assessment");

(ii) or the genetically modified organism concerned should not remain on the market (referred to as a "unfavourable assessment"),

(e) send a copy of the notification and of the assessment report to the Commission, and

(f) send a copy of the assessment report to the notifier.

(5) The provisions under regulation 13(5) concerning a demand or demands for the adjustment to the geographical scope of a written consent shall also apply for the renewal of consents.

(6) In the case of a favourable assessment, the competent authority shall:

(a) provide any further information to the Commission where such information is requested by the said Commission or by a competent authority of a Member State for the purposes of the Directive,

(b) consider any comments, concerns or reasoned objections to the product remaining on the market made by the Commission or by a competent authority of another Member State for the purposes of the Directive where such comments or objections are made within a period of sixty days beginning on the day on which the documents referred to in sub-regulation (4)(d) were forwarded to each such competent authority by the Commission, and

(c) participate in any discussions in relation to the assessment report initiated by the Commission on the grounds of reasoned objections made in accordance with paragraph (b) with a view to reaching an agreement within a period of seventy-five days, beginning on the day on which the documents referred to in sub-regulation (4)(d) were forwarded to each such competent authority by the Commission.

(7) The competent authority shall renew consent to market a product where it has concluded a favourable assessment of the proposal, and -

(a) no reasoned objection to the favourable assessment has been made by the Commission or by a competent authority of a Member State in accordance with sub-regulation (6)(b), or

(b) a reasoned objection to the favourable assessment has been made by the Commission or by a competent authority of a Member State in accordance with sub-regulation (6)(b) but the matters concerned have been resolved in accordance with the provisions of Article 17(7) and (8) of the Directive, or

(c) a reasoned objection to the favourable assessment has been made raised by the Commission or by a competent authority of a Member State in accordance with sub-regulation (6)(b) and the said Commission has adopted a favourable decision in accordance with the provisions of Article 18(1) of the Directive.

(8) When the competent authority renews a consent in accordance to sub-regulation (7), it shall transmit to the notifier the final decision in writing and shall inform the other Member States and the Commission thereof within thirty (30) days beginning on the day that the consent was renewed: Provided that where a demand, or demands, in accordance with sub-regulation (5) are communicated to the Commission after the date of the circulation of the assessment report, the timelines to issue the written renewal consent shall be extended by a single period of fifteen (15) days, regardless of the number of the demands presented. This provision shall be without prejudice to Regulation (EC) No 1829/ 2003 on genetically modified food and feed.

(9) The competent authority shall, where it has concluded an unfavourable assessment, or where the Commission has adopted an unfavourable decision in accordance with the provisions of Article 18(1) of the Directive, inform the notifier that renewal of the consent is refused and stating the reasons for the refusal.

(10) A renewal or a refusal of consent under this regulation shall be conveyed by the competent authority to the notifier in writing. In the case of a renewal of consent, its validity shall not exceed ten years and may be limited or extended as appropriate for specific reasons.