Article 5 Evaluation and decision on applications for ... authorisationF1F6

F3Subject to paragraph 2, by way of derogation from Article 30 of Regulation (EU) No 528/2012, the F4competent authority shall decide whether to grant or refuse authorisation of a same product in accordance with Article 19 of that Regulation within 60 days from the validation of the application in accordance with Article 3 of this Regulation, or, where applicable, from the subsequent date of adoption of the corresponding decision concerning the related reference product.

By way of derogation from Article 30 of Regulation No 528/2012, where an application for authorisation of a same product is validated in accordance with Article 3 before 1st November 2027, or, where applicable, the subsequent date of adoption of the corresponding decision concerning the related reference product is before 1st November 2027, the competent authority must decide whether to grant or refuse the authorisation in accordance with Article 19 of that Regulation before 31st December 2027.