FantasticSearch

1. The Authority shall establish and manage a database of studies commissioned or carried out by business operators to support an application or notification in relation to which Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion.

2. For the purposes of paragraph 1, business operators shall, without delay, notify the Authority of the title and the scope of any study commissioned or carried out by them to support an application or a notification, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates.

3. For the purposes of paragraph 1, laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by business operators and carried out by such laboratories or other testing facilities to support an application or a notification, its starting and planned completion dates, as well as the name of the business operator who commissioned such a study.

This paragraph shall also apply, mutatis mutandis, to laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements with those third countries, including as referred to in Article 49.

4. An application or notification shall not be considered valid or admissible where it is supported by studies that have not been previously notified in accordance with paragraph 2 or 3, unless the applicant or notifier provides a valid justification for the non-notification of such studies. Where studies have not been previously notified in accordance with paragraph 2 or 3, and where a valid justification has not been provided, an application or notification may be re-submitted, provided that the applicant or notifier notifies to the Authority those studies, in particular their title and their scope, the laboratory or testing facility carrying them out as well as their starting and planned completion dates. The assessment of the validity or the admissibility of such re-submitted application or notification shall commence six months after the notification of the studies pursuant to the second subparagraph.

5. An application or notification shall not be considered valid or admissible, where studies that have previously been notified in accordance with paragraph 2 or 3 are not included in the application or notification, unless the applicant or notifier provides a valid justification for the non-inclusion of such studies. Where the studies which have previously been notified in accordance with paragraph 2 or 3 were not included in the application or notification, and where a valid justification has not been provided, an application or notification may be resubmitted, provided that the applicant or notifier submits all the studies that were notified in accordance with paragraph 2 or 3. The assessment of the validity or admissibility of such re-submitted application or notification shall commence six months after the submission of the studies pursuant to the second subparagraph.

6. Where the Authority detects, during its risk assessment, that studies notified in accordance with paragraph 2 or 3 are not included in the corresponding application or notification in full, and in the absence of a valid justification of the applicant or notifier to that effect, the applicable time limits within which the Authority is required to deliver its scientific output shall be suspended. That suspension shall end six months after the submission of all data of those studies.

7. The Authority shall make public the notified information only in cases where it received a corresponding application or notification and after the Authority has decided on the disclosure of the accompanying studies in accordance with Articles 38 to 39e.

8. The Authority shall lay down the practical arrangements for implementing the provisions of this Article, including arrangements for requesting and making public the valid justifications in the cases referred to in paragraphs 4, 5 and 6. Those arrangements shall be in accordance with this Regulation and other relevant Union law.