Submission and validation of applications for national authorisation
Article 3
1. Where the related reference product has been authorised by national authorisation or is the subject of an application for such an authorisation, applications for authorisation of a same product shall be submitted in accordance with Article 29(1) of Regulation (EU) No 528/2012 to the competent authority that has granted or is requested to grant the national authorisation of the related reference product. 2. By way of derogation from paragraphs 2 and 4 of Article 29 of Regulation (EU) No 528/2012, the competent authority shall validate the application within 30 days of accepting it, provided that the information indicated in Article 2 has been submitted. The validation shall include a check 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.