This paper describes the publication of information on the withdrawals of marketing authorisation applications for human medicinal products and withdrawals of applications for variations/extensions to marketing authorisation. This paper should be read in conjunction with EMA’s general guide to information published on human medicines.
The legal basis for the publication of information on the withdrawal of applications for marketing authorisation for human medicinal products is Article 11 of Regulation (EC) No 726/2004, which states that:
If an applicant withdraws an application for a marketing authorisation submitted to the Agency before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the Agency. The Agency shall make this information publicly accessible and shall publish the assessment report, if available, after deletion of all information of a commercially confidential nature…
