Full, staggered or mixed applications

The sponsor is allowed to submit a full initial application (part I and part II at the same time), a staggered initial application (first part I followed by part II) or a mixed initial application.

For a staggered initial application the following rules apply:

  • A part II application cannot precede a part I application
  • A part II application can be submitted after assessment part I has been concluded
  • A part II application has to be submitted within two years after conclusion part I. If a part II application is not submitted within two years after conclusion part I, the application part I will be lapsed.
  • The part II application shall be accompanied by a statement from the sponsor in which he declares that he is not aware of any new substantial scientific information that would change the validity of any item submitted in the application on the aspects covered by Part I of the assessment report.

The following additional rule apply for mixed initial application in a multinational clinical trial:

  • The sponsor can submit a whole application (Part I and II) to some Member States concerned (on the basis of article 5 CTR) and at the same time an application limited to Part I only (on the basis of article 11 CTR) to other Member States concerned.

Important for mixed initial applications (full and staggered) in a multinational clinical trial:

  • The “slowest” MS drives the process: the sponsor can only submit a substantial modification or an additional MSC if all MSC which were part of the initial application have authorized the clinical trial. See also question 2.3 (additional MS) and 3.6 (substantial modification) of the CTR Q&A. The procedure for substantial modifications in mixed applications will be modified, see also question 3.6 (expected in the first release of CTIS after go live).

More information on the procedures and rules for the submission of a substantial modification or addition of a MS can be found on the page Modifications.