If you are looking for aifa submission portal, simply check out our links below :
1. Welcome to the Italian Medicines Agency | AIFA Agenzia …
http://www.agenziafarmaco.gov.it/en
AIFA Agenzia Italiana del Farmaco logo … give a general overview of the tasks and the organization of AIFA, the Italian competent authority for drugs. … How to submit a variation type I and type II · Submission of Applications where Italy acts as…
2. Mandatory use of CESP portal for delivery of mutual … – Aifa
http://www.agenziafarmaco.gov.it/en/content/mandatory-use-cesp-portal-delivery-mutual-recognition-and-decentralised-procedure-submission
27 Jun 2019 – Until a full integration of AIFA IT system with CESP portal is achieved, submissions should continue to be delivered also in accordance with usual…
3. FAQ | AIFA Agenzia Italiana del Farmaco
http://www.agenziafarmaco.gov.it/en/content/faq
What happens if the event organisers submit a new pre-authorisation request for the … sends the pre-authorisation request via impresainungiorno.gov.it portal.
4. GUIDANCE ON SUBMISSION OF MARKETING … – Aifa
https://aifa.gov.it/documents/20142/0/CESP_EN_07.05.2019.pdf/eb16b795-721e-b305-c936-33f3e9af0541
7 May 2019 – Please be informed that AIFA adheres to the eSubmission Roadmap … With regard to the use of the Common European Submission Portal…
5. REGULATORY AFFAIRS – MANDATORY USE OF COMMON …
25 Jul 2019 – … the use of the Common European Submission Portal (CESP) has become mandatory also for AIFA. This system is applicable only to mutual…
6. CESP portal
https://cespportal.hma.eu/
Allow submission of an application once to reach all required Agencies; Reduce the burden for both Industry and Regulators of submitting/handling applications…
7. Contacts – CESP
https://cespportal.hma.eu/Public/Contacts
… according to the communication published on the AIFA portal … need to be submitted as e-dossier via CESP (Common European Submission Portal) or…
8. Summary of the Italian Medicines Agency’s (AIFA) press …
https://www.osborneclarke.com/insights/summary-italian-medicines-agencys-aifa-press-releases-measures-covid-19-emergency-17-march-2020/
18 Mar 2020 – AIFA gave instructions on how to submit applications (i) for the … the Transparency List on its portal is temporarily suspended until 3 April, 2020.
9. National dossier requirements in the European … – DGRA
https://www.dgra.de/media/pdf/studium/masterthesis/master_frantescu_a.pdf
Different modalities for dossier submission (CESP, national portals or paper/CD … AIFA. Agenzia Italiana del Farmaco- Italian Medicines Agency. ANSM.
10. Official Italian Agency for AIFA submissions (Prerichiesta AIFA …
https://www.escardio.org/Congresses-&-Events/EuroHeartCare/Registration/italian-agency
Official Agency for AIFA submissions (Prerichiesta AIFA). According to Italian legislation, any Marketing Authorisation Holder or pharmaceutical company…
11. Italy: New Platform for the “National Observatory on Clinical …
1 Sep 2014 – Guidance on how to use OsSC is available from the AIFA Portal of … the applicant must submit to AIFA the modules for the initial registration…
12. How to submit type I and type II variation during the … – Aifa
http://www.agenziafarmaco.com/en/content/how-submit-type-i-and-type-ii-variation-during-transitional-period-due-change-aifa-system-ma
1 Feb 2013 – AIFA is working on a new web-portal which will be in line next February 2013. Thus, during the transitional period, variations should be…
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