Following the end of the COVID-19 emergency in Italy, updates have been introduced to the submission of new marketing authorisation (MA)/line extension applications through national, mutual recognition and decentralised procedures.

1. For MA/line extension 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 2020.
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 document 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.

2. Applications for a new MA/line extension filed to the Marketing Authorisation Office (Ufficio AIC) after the publication of this Notice and until 31 May 2022 shall be submitted through the Common European Submission Portal (CESP), in eCTD format. At the same time, the applicant shall be required to send a certified e-mail (PEC) with a copy of the CESP submission delivery notification and a copy of the cover letter. The certified e-mail shall be sent to the following address: protocollo@pec.aifa.gov.it, by the applicant or its accredited representative. In the subject of the e-mail, the following shall be included: (a) “AIC/” [without any punctuation and/or any other characters between the words]; (b) applicant name; (c) (provisional) name of the medicinal product, (d) European procedure number (where applicable); (e) CESP submission ID.
In addition, with regard to applications submitted through national procedure or mutual recognition/decentralised procedure where IT acts as RMS, the Self-Declaration affidavit referred to in point 1 shall be attached.

3. All new MA/line extension applications filed after the publication of this Notice shall be submitted, as of 1 June 2022, through the Common European Submission Portal (CESP) only, in eCTD format. In addition, with regard to applications submitted through national procedure or mutual recognition/decentralised procedure where IT acts as RMS, the Self-Declaration affidavit referred to in point 1 shall be attached.

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. The Affidavit shall be submitted as follows:
-  In the cases referred to in point 1, the Self-Declaration affidavit shall be sent to the following address: protocollo@pec.aifa.gov.it, by the applicant or its accredited representative. In the subject of the e-mail, the following shall be included: (a) “AIC/” [without any punctuation and/or any other characters between the words]; (b) MAH/applicant name; (c) provisional/final name of the medicinal product, (d) European procedure number (where applicable); (e) Italian case number; (f) CESP submission ID.

-  In the cases referred to in points 2 and 3, with regard to applications submitted through national procedure or mutual recognition/decentralised procedure where IT acts as RMS, 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. Then, it must be included in the folder named “additional data” of the eCTD dossier.

For the stamp duty payment, MAHs/applicants should refer to the relevant AIFA communications published on the institutional website.

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.

Published on: 31 March 2022