For every CTA, please provide information about previous submissions / filings (submission number) appropriate to the Investigational Medicinal Product in the cover letter.

If a scientific advice meeting with the competent authorities of the EU member states or a scientific advice at the EMEA has been conducted, it is requested that the minutes of these consultations should be attached to the CTA.

Please indicate changes within the IB or the IMPD regarding preclinical data and give a brief statement, if, based on new preclinical data, the benefit-risk assessment has been changed.

If an IMP will be used in humans for the first time, please discuss in the cover letter whether the IMP has the potential to cause severe adverse reactions (i.e. new class of substances, new mode of action, impact on the immune system).