Chapter II, Section II, Article 10 · Commission Delegated Regulation (EU) 2026/255

Contents

Article 10Decision on the authorisation and related safeguards#

1.The application shall be considered complete when the Agency receives all the required information, as laid down in Articles 3 to 7.

2.When the Agency deems the application complete, it shall without undue delay notify the applicant.

3.When the application has been deemed complete, the Agency shall assess whether the applicant complies with the requirements set out in Articles 11 to 29 of this Regulation, Article 4a(3) to (5), and Article 9a(1) and (3) of Regulation (EU) No 1227/2011. If the applicant complies with those requirements, the authorisation shall be granted and otherwise the application shall be rejected. The decision to grant or reject the application shall be adopted within three months from the date of receipt of the notification referred to in paragraph 2.

4.If the Agency deems that it needs more time for adopting an authorisation decision, the Agency shall, prior to the expiry of the three-month period referred to in paragraph 3, inform the applicant of the additional time it needs to adopt the decision. Such additional time shall not exceed two months from the expiry of the three-month period. If the Agency does not adopt a decision within that additional time period, it shall be deemed to have granted the authorisation.

5.The Agency shall, within five working days from the adoption of the authorisation or rejection decision, notify that decision to the following parties:

(a)the applicant IIP or RRM;

(b)the national regulatory authority of the Member State in which the IIP or the RRM is established.

6.Where an applicant fails to communicate or to provide the required information for more than three months after the submission of the application or, where applicable, after a request for clarification from the Agency, the Agency may consider the application withdrawn. At least two weeks prior to the expiry of the three-month period, the Agency shall notify the applicant of their inactive status and remind them of the consequences deriving from it.

7.Any decision by the Agency in the context of an authorisation process shall be subject to procedural safeguards, including the legal remedies available pursuant to Articles 28 and 29 of Regulation (EU) 2019/942.