Presubmission guidance: questions and answers

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This section of the website contains questions that marketing-authorisation holders (MAHs) may have related to presubmission guidance for innovative medicines. It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs.

These pages are updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation. Revised topics are marked 'New' or 'Rev.' on publication.

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

All of the information previously available on the European Commission's website in chapter 7 of the notice to applicants (volume 2A) related to marketing-authorisation applications for centrally authorised medicines is now primarily available in these questions and answers. For details, see the table below:

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

Presubmission guidance: Topics

These questions and answers on presubmission guidance address these topics:

Questions 1-11


Questions 12-23


Questions 24-33

Questions 34-44


Questions 45-56


Questions 57-68


If your question is not answered here please contact the Agency in advance of your planned submission.

Presubmission meetings

The Agency emphasises the importance of presubmission meetings, around seven months prior to the anticipated date of submission of the application.

These are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the Agency.

These questions and answers and successful presubmission meetings should enable applicants to submit applications that conform with legal and regulatory requirements and can be validated speedily.

Presubmission meetings also enable applicants to establish contact with the Agency staff who will be involved with the application.

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