Substantial amendments

Substantial amendments to a previously approved clinical trial according to the old regulation can be submitted until January 31, 2025.

The sponsor must apply for a substantial amendment to the clinical trial protocol and submit other related information to IMA, according to Article 15 of Regulation no. 443/2004 on clinical trials of medicinal products in humans.

Substantial amendments should be sent electronically via CESP or with an e-mail to the address [email protected] with the cover letter attached.

The cover letter for the amendment must include the EudraCT number and sponsor's protocol number as well as clear explanation of the foreseen changes and the rationale behind them. A special form Notification of Amendment Form must be filled in and submitted together with other application documentation.

Fee for substantial amendments to the protocol or other information is according to the current IMA tariff

All relevant material needs to be in place before the amendment can be validated by IMA. Furthermore the application fee has to be paid, up on receipt of an invoice sent by IMA.

If the application fee has not been paid by the due date the application will be considered invalid.

Last updated: October 17, 2023
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