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EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA

If the applicant withdraws a marketing authorisation application before the Agency has issued its opinion, the applicant must explain its reasons to the Agency.

Once all commercially confidential information has been removed from the assessment report, the Agency shall make this information public and publish the report, if available.

Those applications which have been withdrawn or whose marketing authorisation has been extended are covered by this guidance, along with the publication of documents following the withdrawal of these applications.

In addition to the application withdrawals mentioned above, this guidance also discusses communications on variation application outcomes in cases where an extension of indication was included in the original scope of the variation application.

EMA recommends that applicants use the withdrawal template and may request an applicant to resend a letter where insufficient information is provided. Withdrawal letters will be published on the EMA website with all personal contact information (addresses, emails, phone numbers and signatures) blanked out.

In three months after receiving the withdrawal letter, the EMA will publish the last adopted CHMP assessment report for all withdrawn applications.

Click this LINK to know more about the change of scope of variations initially involving an extension of indication, etc.


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