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.ģ. 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 the subject of the e-mail, the following shall be included: (a) “AIC/” (b) applicant name (c) (provisional) name of the medicinal product, (d) European procedure number (where applicable) (e) CESP submission ID. The certified e-mail shall be sent to the following address: by the applicant or its accredited representative. 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 above instructions do not apply to MAHs/applicants who have already sent the original documentation to AIFA.Ģ. Applications for a new MA/line extension filed to the Marketing Authorisation Office (Ufficio AIC) after the publication of this Notice and until shall be submitted through the Common European Submission Portal (CESP), in eCTD 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. 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). 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.ġ. 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.
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