Italian Medicines Agency (AIFA) has implemented a system for the automatic retrieval and processing of eCTDs submitted by pharmaceutical companies through the CESP platform.

In order to allow AIFA to correctly identify all eCTDs intended for Italy, pharmaceutical companies are required to include, within the specific folder for Italy (It) in the M1 module of the eCTD, a PDF file containing the 6-digit AIC national code of the medicinal/s product/s the eCTD of which is part of the CESP submission. If the 6-digit AIC national code is not known or issued, the string ‘N/A’ should be included.

Please note that the 6-digit AIC national code must be inside the PDF, without other information.

Furthermore, the file can be equally inserted in "Appendix 1.2" or in "Appendix 1.3" or in "additional-data"; the file must be placed in the COUNTRY SPECIFIC part (Italy) and it doesn’t have to be inserted in "working documents”.

These instructions are mandatory for all pharmaceutical companies uploading eCTDs to the CESP as of September 16, 2024, however, prompt implementation is strongly recommended in order to facilitate correct upload of sequences into the eCTD browser.

Any request of information related to technical issues should be addressed to the following email address: cesp.submission.ita@aifa.gov.it

Updated on: 09 August 2024