Article 16 Admissibility of applications for non-standard amendmentF5

Applications for approval of a F1non-standard amendment to a product specification are considered admissible if they are submitted in accordance with Article 105 of Regulation (EU) No 1308/2013 and with Article 3 and Article 9(2) of Implementing Regulation (EU) 2019/34 mutatis mutandis, and if they are duly completed.

An application for approval of a non-standard amendment to a product specification shall be considered to be duly completed where it is comprehensive and exhaustive and where it complies with the requirements set out in Article 2 and Article 9(1) of Implementing Regulation (EU) 2019/34.

The approval by the F2Secretary of State of an application for approval of a F3non-standard amendment to a product specification shall only cover the amendments submitted in the application itself.

If the application is considered inadmissible, the F4applicant or, in the case of a third country application, the applicant established in, or the competent authorities of, the third country, shall be informed of the reasons for the inadmissibility.