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1. Applications for marketing authorisations shall be submitted to the competent authority where they concern the granting of marketing authorisations in accordance with any of the following procedures:

(a) the national procedure laid down in Articles 46 and 47;

(b) the decentralised procedure laid down in Articles 48 and 49;

(c) the mutual recognition procedure laid down in Articles 51 and 52;

(d) the subsequent recognition procedure laid down in Article 53.

2. Applications for marketing authorisations shall be submitted to the Agency where they concern the granting of marketing authorisations in accordance with the centralised marketing authorisation procedure laid down in Articles 42 to 45.

3. Applications referred to in paragraphs 1 and 2 shall be submitted electronically and the formats made available by the Agency shall be used.

4. The applicant shall be responsible for the accuracy of the information and documentation submitted with respect to its application.

5. Within 15 days of receipt of the application, the competent authority or the Agency, as applicable, shall notify the applicant as to whether all the information and documentation required in accordance with Article 8 have been submitted and whether the application is valid.

6. Where the competent authority or the Agency, as applicable, considers that the application is incomplete, it shall inform the applicant accordingly and shall set a time limit for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn.

7. If the applicant fails to provide a complete translation of the required documentation within a period of six months after having received the information referred to in Article 49(7), 52(8) or 53(2), the application shall be considered to have been withdrawn.