Authorisation renewals and implementation of full declaration

Authorisation renewals and separate variation applications falling under the revised TPLRO TPO4 (e.g. implementation of full declaration) can either be submitted as two separate eCTD sequences or as one eCTD sequence. The cover letter should specify which of the two options has been chosen. When submitting several applications in a single sequence, the application with the longest deadline drives the process in all instances. For logical reasons, the eCTD envelope is named after the process-steering application. The present case (authorisation renewal and full composition declaration in one sequence) is a Type II Variation.