The Self-Declaration affidavit shall be included in the folder named “additional data” of the eCTD dossier. 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 relevant original documentation in paper format shall no longer be sent. 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.Ģ. 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 (), in eCTD format. 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. 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). for renewal applications, to the following certified e-mail (PEC) address: by the applicant or its accredited attorney.The Self-Declaration affidavit shall be sent: The above instructions do not apply to MAHs/applicants who have already sent the original documentation to AIFA. 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. 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). The new rule applies to those who have come from, or stayed in Belgium, France, the Netherlands, the UK, Northern Ireland, the Czech Republic and Spain in the previous 14 days.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.ġ. 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. Those arriving into the country need to demonstrate that they have taken a test and received a negative result during the previous 72 hours, or they will have to take a test within 48 hours of arrival. It is advisable that people check the restrictions that apply to them as Italy has expanded its list of high-risk countries from which travelers must get tested for COVID-19. It also lets them know if must self-isolate or prove they recently tested negative for COVID-19. It also asks them if they are an EU citizen or from a Schengen country, and whether they are legally resident in Italy? Based on the responses, it lets them know if they can enter the country without restrictions or only under particular circumstances, such as proven work reasons, absolute urgency, health reasons and study. The questionnaire asks potential visitors to select the state or territory from which they will enter Italy, then select all the states or territories they have been in or have passed through in the 14 days prior to departure.
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