Following the end of the COVID-19 emergency in Italy, updates have been introduced to the submission of changes pursuant to Articles 61(3) and 62 of Directive 2001/83/EC (Articles 78 and 79 of Italian Legislative Decree 219/2006, respectively).

1. For 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:

• to the following certified e-mail (PEC) address: protocollo@pec.aifa.gov.it, by the applicant or its accredited attorney. In the subject of the e-mail, the following shall be included: “PPA_Self-Declaration affidavit (use the same subject as the application for change sent via certified email).
  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.

2. As notified on 1 March 2022, applications for changes pursuant to Articles 61(3) and 62 of Directive 2001/83/EC (Articles 78 and 79 of Italian Legislative Decree 219/2006, respectively), intended for the Post Authorisation Procedures Office (Ufficio PPA) shall be submitted exclusively in electronic format to the PEC address: protocollo@pec.aifa.gov.it by the applicant or its accredited attorney.

In the subject of the e-mail, the “PPA” acronym shall be included, followed by the specific subject matter: 

• PPA _ name of the medicinal product_ marketing authorisation number (first 6 digits) _ MR/DC/N (indicate whether mutual recognition/decentralised/national procedure) _ notification pursuant to Art.61(3) of Directive 2001/83/EC (Art. 78 of Italian Leg. Decree 219/2006) _ European procedure number (where available).
• PPA _ name of the medicinal product_ marketing authorisation number (first 6 digits) _ MR/DC/N (indicate whether mutual recognition/decentralised/national procedure) _ notification pursuant to Art.62 of Directive 2001/83/EC (Art. 79 of Italian Leg. Decree 219/2006).

In case of herbal or biological medicinal products, please specify the kind of medicinal product in the e-mail.

In addition, the original documentation shall no longer be submitted also in paper format (where available), and the Self-Declaration affidavit in point 1 shall be submitted instead. The 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 the purpose of completing and submitting the Self-Declaration affidavit, MAHs/applicants are invited to use the template provided in the “Related documents” section.

Additional documentation

Any additional documentation requested or deemed necessary shall be sent exclusively via certified e-mail (PEC) by the applicant or its accredited attorney to the following address: protocollo@pec.aifa.gov.it. The subject of the e-mail shall include:  

• PPA _additional documentation_name of the medicinal product_ marketing authorisation number (first 6 digits) _ notification pursuant to Art.61(3) of Directive 2001/83/EC (Art. 78 of Italian Leg. Decree 219/2006) _ European procedure number (where available)_Italian case number (where available)
• PPA _additional documentation_name of the medicinal product_ marketing authorisation number (first 6 digits) _ notification pursuant to Art.62 of Directive 2001/83/EC (Art. 79 of Italian Leg. Decree 219/2006)_Italian case number (where available)

If the additional documentation is of technical nature, please copy in the e-mail the name of AIFA’s technical assessor who requested the additional documentation.

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: 07 April 2022