These questions and answers provide an overview of the European Medicine Agency’s position on issues which are typically addressed in discussions or meetings with Marketing Authorisation Holders for generic and hybrid applications. They  are updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation.

New or revised questions are marked with "New" or "Rev" together with the respective date.

The pre-authorisation questions address the following topics, click on a question link to go to the page:

In case your question is not answered here please contact the Agency. The Agency emphasizes the importance of Pre-Submission Meetings with applicants. Pre-Submission Meetings (which should take place approximately six months prior to the anticipated date of submission of the application) are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the EMA. These questions and answers and successful Pre-Submission Meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-Submission Meetings will also enable applicants to establish contact with the EMA staff closely involved with the application as it proceeds.

Additional documents:

• The pre-submission request form
• Draft guidance on pre-submission meetings for initial marketing authorisation applications for human medicinal products in the centralised procedure
• It should be highlighted that 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".
• Marketing Authorisation Holders must in all cases comply with the requirements of Community Legislation. Provisions, which extend to Iceland, Liechtenstein and Norway by virtue of the EEA agreement, are outlined in the relevant sections of the text.