Commission Implementing Regulation (EU) 2020/1740Show full title

Article 8 U.K. Admissibility of the application for renewal

1. The rapporteur Member State shall consider an application for renewal admissible, provided that all the following requirements are met:

(a) the application for renewal has been submitted within the period provided for in Article 5(1) and in accordance with the format and using the software provided for in Article 7;

(b) the application for renewal contains all the elements provided for in Article 6;

(c) the application for renewal contains all studies, in full, that have been previously notified in accordance with Article 32b of Regulation (EC) No 178/2002 and no additional ones apart from those contained in the approval dossier or subsequent renewal dossiers or conducted before the obligation under Article 32b of Regulation (EC) No 178/2002 applied, unless a valid justification is provided;

(d) the relevant fee has been paid.

2. The rapporteur Member State shall, within a period of one month from the date provided for in Article 5(1), inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the application for renewal and of its admissibility.

3. Where an application for renewal has been submitted in accordance with point (a) of paragraph 1, but one or more elements provided for in point (b) or (d) of paragraph 1 are missing, the rapporteur Member State shall, within a period of one month from the date of receipt of the application for renewal, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements via the central submission system referred to in Article 7. Upon expiry of that period, the rapporteur Member State shall, without delay, proceed in accordance with either paragraph 4 or paragraph 5.

4. Where the application for renewal does not comply with point (c) of paragraph 1, the rapporteur Member State shall, in coordination with the Authority, within a period of one month from date of receipt of the application for renewal, inform the applicant accordingly and set a period of 14 days for providing a valid justification for this non-compliance. Upon expiry of that period and where a valid justification has not been provided, the application for renewal shall be considered inadmissible and Article 32b(4) or Article 32b(5) of Regulation (EC) No 178/2002 shall apply. The assessment of the admissibility of a resubmitted application for renewal shall only commence after the expiry of the six-month period mentioned in Article 32b(4) or Article 32b(5) of Regulation (EC) No 178/2002 following the notification of the relevant studies and/or submission of studies as necessary and provided that that point in time is no later than three years before the expiry of the approval of the active substance. If that point in time is later than three years before the expiry of the approval of the active substance, the resubmitted application for renewal shall be considered inadmissible.

5. Where the application for renewal has not been submitted within the period referred to in point (a) of paragraph 1, or where at the end of the 14-day period set for the submission of the missing elements in accordance with paragraphs 3 and 4 the application for renewal still does not contain all the elements provided for in Article 6, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application for renewal is inadmissible and of the reasons for inadmissibility.