Following the end of the COVID-19 emergency in Italy, updates have been introduced to the submission of applications for variations or renewal of marketing authorisation through national, mutual recognition and decentralised procedures.

1. For variation or renewal applications that have been concluded or that are currently ongoing, as of 1 April 2022 (end of the COVID-19 emergency in Italy), marketing authorisation holders (MAH)/applicants will no longer be required to submit the documentation specified in AIFA Communication dated 1 April 2022.
MAHs/applicants shall be required to submit a formal declaration (“Self-Declaration affidavit of true copy”) certifying that the digitally sent document is a true copy of the original (either in paper or digital format). Such declaration shall also indicate that the original documentation is duly kept in such a way as to guarantee its integrity, security, fixity and exact correspondence, and that it is promptly and immediately available, should the Administration request that it is produced or sent. The above instructions do not apply to MAHs/applicants who have already sent the original documentation to AIFA.

The Self-Declaration affidavit shall be sent:

• for renewal applications, to the following certified e-mail (PEC) address: protocollo@pec.aifa.gov.it, by the applicant or its accredited attorney. The subject of the e-mail shall include: PPA_ Self-Declaration affidavit_ Italian case number_ name of the medicinal product_ European procedure number (where applicable).
  The Self-Declaration affidavit shall be digitally signed in compliance with Article 25(2) of Regulation (EU) No 910/2014 (eIDAS Regulation), or signed and submitted together with a copy of the signatory’s ID.
• For variation applications, the Self-Declaration affidavit shall be submitted as an integration to AIFA’s Variations portal, and digitally signed in compliance with Article 25(2) of Regulation (EU) No 910/2014 (eIDAS Regulation), or signed and submitted together with a copy of the signatory’s ID.

2. Applications for variations or renewal filed to the Post Authorisation Procedures Office (Ufficio PPA) after the publication of the present Notice, shall be submitted exclusively through AIFA’s Variations portal or Renewals portal, as applicable (https://servizionline.aifa.gov.it), in eCTD format. The relevant original documentation in paper format shall no longer be sent. 
With regard to applications submitted through national procedure or mutual recognition/decentralised procedure where IT acts as RMS, where the original documentation is required, the Self-Declaration affidavit referred to in point 1 shall be submitted instead.

The Self-Declaration affidavit shall be included in the folder named “additional data” of the eCTD dossier. It shall also be digitally signed in compliance with Article 25(2) of Regulation (EU) No 910/2014 (eIDAS Regulation), or signed and submitted together with a copy of the signatory’s ID.

For the purpose of completing and submitting the Self-Declaration affidavit, MAHs/applicants are invited to use the template provided in the “Related documents” section.

For the stamp duty payment, MAHs/applicants should refer to the relevant AIFA communications published on the institutional website (see “Related links”).

Finally, for sending any documentation relating to mutual recognition/decentralised procedures, the Common European Submission Portal (CESP) must be used.

Pending full integration between AIFA systems and CESP, all documentation shall also be submitted through the Variations portal or the Renewals portal, as applicable.

INFORMATION PURSUANT TO ARTICLE 13 OF REGULATION (EU) 2016/679 (GDPR) AND TO ARTICLE 48, PARAGRAPH 2, ITALIAN PRESIDENTIAL DECREE 445/2000

Data acquired through the Self-Declaration affidavit will be processed by AIFA - Data Controller, with registered offices in Rome, Via del Tritone 181 - for fulfilling legal or regulatory obligations and for pursuing the objectives connected with the administrative procedure for which they were collected, as well as for any administrative tasks resulting therefrom. The provision of the requested data is mandatory, since they are necessary for the proper conduct of the administrative procedure. For further information, please read the “Information pursuant to Article 13 of Regulation (EU) 2016/679” available on the AIFA institutional website at “Related links”. 

Published on: 07 April 2022