Telematic management of applications and documents issued by the GMPMED Office. New provisions start

The GMP Medicines Inspections and Authorizations Office, in confirming the prescriptions already disclosed with the communication of 13 July 2022, relating to the start of the second phase of telematic management of the applications and documents issued by the GMP Medicines Inspections and Authorizations Office, represents the preliminary nature of the information contained therein for the purposes of the admissibility of the applications.

Given the incomplete adherence to these parameters found in the submission of applications, it is therefore considered appropriate to reiterate the following:

    the pre-inspection documentation or in response to requests for additional documentation as well as corrective and preventive actions (CAPA), must only be sent in digital format by sending to the PEC box: protocol@pec.aifa.gov.it. To this end, it is emphasized that the limit of 40 MB overall remains mandatory, therefore it is necessary that the documentation in question be divided into folders of less than or equal to 40 MB. Also with reference to this type of documentation, it is recalled the need to strictly comply with the instructions contained in the press release dated 17 January 2022 regarding the size and format of the files. In particular, for documentation presented with a USB key - as it exceeds the maximum limit of 40 MB - it is required not to exceed 12 MB for each individual file. Documents with files larger than 12MB will not be taken into consideration;
    the instructions contained in the press release dated 17 January 2022 regarding the size and format of the files - with particular regard to the applications submitted with a USB key, as they exceed the maximum limit of 40 MB - must be fully respected, therefore the instances with larger than 12 MB will not be taken into consideration.

Starting from November 1, 2022, the requests that do not comply with the indications expressed in the communication of January 17, 2022 and that of July 13, 2022, will be deemed inadmissible and the GMP Medicines Inspection and Authorization Office will therefore proceed with the notification of non-admissibility due to non-compliance with the instructions in question.

For all matters not covered by this communication, please refer to the instructions in force from 17 January 2022, as well as to the additions made known by means of a communication dated 13 July 2022, accessible from the "related link box".

Source: AIFA

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