Article 6a Evaluation and decision on applications under the simplified procedureF1

F2Subject to paragraph 1A, by way of derogation from Article 26(3) and (4) of Regulation (EU) No 528/2012, the F3competent authority shall decide whether to grant or refuse authorisation of a same product in accordance with Article 25 of that Regulation within 60 days from the acceptance of the application in accordance with Article 4a(2) 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 26(3) and (4) of Regulation No 528/2012, where an application for authorisation of a same product is accepted in accordance with Article 4a(2) 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 25 of that Regulation before 31st December 2027.

The evaluation shall include a check that the information indicated in Article 2 has been submitted and that the proposed differences between the same product and the related reference product concern merely information which can be the subject of an administrative change in accordance with Implementing Regulation (EU) No 354/2013.

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