Regulation (EU) 2019/6 of the European Parliament and of the CouncilDangos y teitl llawn

Section 6 U.K. Review procedure

Article 54 U.K. Review procedure

1. If the competent authority in a Member State concerned raises, in accordance with Article 49(5), 52(6), 53(8) or 66(8) an objection as referred to in those Articles to, respectively, the assessment report or the updated assessment report, it shall provide without delay a detailed statement of the reasons for any such objection to the competent authority in the reference Member State, to the competent authorities in the Member States concerned and to the applicant or the marketing authorisation holder. The competent authority in the reference Member State shall refer the points of disagreement without delay to the coordination group.

2. The competent authority in the reference Member State shall take, within 90 days of receipt of the objection, any appropriate steps in order to seek an agreement as regards the objection raised.

3. The competent authority in the reference Member State shall provide the applicant or the marketing authorisation holder with the opportunity to provide, orally or in writing, their point of view as regards the objection raised.

4. Where an agreement among the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) is reached, the competent authority in the reference Member State shall close the procedure and inform the applicant or the marketing authorisation holder. The competent authorities in the Member States concerned shall grant or vary a marketing authorisation.

5. When the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) reach an agreement by consensus to refuse the marketing authorisation or to reject the variation, the competent authority in the reference Member State shall close the procedure and inform the applicant or the marketing authorisation holder thereof, duly justifying the refusal or the rejection. The competent authorities in the Member States concerned shall thereafter refuse the marketing authorisation or reject the variation.

6. If an agreement among the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) cannot be reached by consensus, the coordination group shall provide the Commission with the assessment report referred to in Articles 49(5), 52(6), 53(2) and 66(3), respectively, together with information on the points of disagreement at the latest within a period of 90 days from the date on which the objection referred to in paragraph 1 of this Article was raised.

7. Within 30 days of receipt of the report and information referred to in paragraph 6, the Commission shall prepare a draft decision to be taken in respect of the application. The Commission shall forward the draft decision to the competent authorities and to the applicant or the marketing authorisation holder.

8. The Commission may request clarifications from the competent authorities or the Agency. The time limit laid down in paragraph 7 shall be suspended until the clarifications have been provided.

9. For the purpose of the work-sharing procedure in respect of variations requiring assessment in accordance with Article 66, references in this Article to a competent authority in the reference Member State shall be understood as references to a competent authority agreed upon in accordance with Article 65(3), and references to Member States concerned as references to relevant Member States.

10. The Commission shall, by means of implementing acts, take a decision to grant, change, refuse or revoke a marketing authorisation or to reject a variation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).