1. What are the procedures for registering with AIFA’s online services, registering an event organiser, and the main features of the ACC application?

You can consult the manuals and video tutorials that explain the procedures for registering with AIFA's online services, registering a provider or profit/non-profit secretariat, understanding the main features of the new application. 

These resources are available:

• On the homepage of the application, accessible via AIFA’s Online Services, under the “Online Help” section
• On AIFA’s official YouTube channel, which features video tutorials showcasing the key functions of the new application
• On the AIFA website page dedicated to "Authorisation of Conferences and Congresses"

The links are available in the related links. 

2. How do companies register with AIFA’s Systems?

Companies wishing to use AIFA’s online services may appoint a Company User Administrator (abbreviated as AUA). The AUA, preferably an internal employee, will gain access to the requested applications and can authorize other company staff to access various online services.
For more information, please refer to the registration procedure for company access. 

3. Can more than one representative be registered for a company?

Yes, multiple company representatives can be registered for the same company.

4. Can one representative act on behalf of multiple companies?

Yes, provided they have been officially designated by the AUA of each company.

5. Does registering a company representative require approval?

Yes, to access the services, the representative must refer to their company’s AUA.

6. How to obtain a digital signature?

For more information, you can consult the page 'Qualified Trust Services - AGID (Agency for Digital Italy), available under related links.

Supported Signature Methods in the New Conferences and Congresses Authorisation System:

• Local Signature: performed using a smartcard or USB token
• Remote Signature: uses a remote service for which the user is registered. The user validates the signing operation using their credentials and a PIN generated via OTP (from a physical token, app, or SMS)

Requirements:

An active internet connection is required for accessing and completing the signature process. Remote signature must be provided exclusively by Aruba. Local signature requires the signing device (USB token or card reader with inserted smartcard) to be activated before starting the process

7. Is Organiser registration required?

Yes, through the AIFA online services: “Authorisation of Conferences and Congresses New”.

8. Requirements for Organiser registration

Organisers intending to hold events (conferences, congresses, etc.) involving medicinal products must first register their organization via the “Authorisation of Conferences and Congresses” online services. The following must be attached: a chamber of commerce certificate (visura camerale) and a delegation letter, if the registration is performed by someone other than the legal representative
Non-profit Organisers (e.g., hospitals, universities) must attach a document certifying the legal status of the entity (e.g., articles of association or bylaws) if they do not have a chamber of commerce certificate.
Once registered, the legal representative (or their delegate) may enable/disable users Authorised to manage communications related to conferences and congresses on behalf of the organization.

9. What types of events require AIFA Authorisation?

• Residential Events (RES)
• Distance Learning Events (FAD)
• Blended Events (combining RES + FAD)

Once an event type is selected, it cannot be converted to another type.

10. Who enters the application ("Pratica")?

• Multi-sponsor event: the Organiser is responsible for entering the data.
• Mono-sponsor event: the sponsoring company is responsible for entering the data.

If an event initially registered as multi-sponsor ends up being sponsored by only one company (which will validate the request), no further action or communication from the Organiser is required.

11. What data must be entered in the application section?

You must fill in the form provided by the application with:

• Event title
• Total hours
• Province
• City
• Venue: for blended events (FAD+RES), only the in-person venue info should be provided; FAD details go in the attached "file unico")
• Scientific topic
• Speakers
• Event dates (for blended events, the start and end dates must cover both FAD and RES components)
• “File unico” upload

12. What must be included in the “file unico” attachment?

In compliance with art. 124 of Legislative Decree 219/06, the "file unico" must include:

• Scientific program
• Scientific rationale

The structure must clearly show the relationship between the topics and the medicines owned by the sponsoring company.

The file must contain:

• Final (not draft) detailed program with all sessions (ECM and non-ECM). Links to external websites are not allowed. Lists of participants and speaker tables must be entered in specific fields in the application, not in the “file unico”
• Workshops: please provide a detailed description of the topic covered and include the names of the tutors
• Oral presentations: please provide a detailed description of the topic and include the names of the speakers 
• Free communications: please provide a detailed description of the topic and include the names of the speakers 
• Keynote lectures: please provide the title and the names of the speakers 
• Roundtables: please provide the topic and the names of the speakers 
• Symposia: please provide the title, the rationale, the program and the names of the speakers
• Discussions: please provide the topic 
• Acronyms: must be spelled out in full
• Clinical cases: please provide a description and include the names of speakers/tutors
• Clinical studies: please provide a description and include the names of speakers/tutors
• Practical sessions: please describe the topic and include the names of speakers/tutors

13. Where is accreditation information entered?

During the application process, you must select the appropriate “accreditation” field.
Once set, this field cannot be changed or updated.

14. What confirms that the Organiser has submitted the application?

After submission, the system displays a progressive application number ("numero Pratica") and sends a notification to each involved company, assigning a Request Number.
Each pharmaceutical company must then validate its own Request.

15. Can Organisers add additional participating companies?

Yes. After submitting the application, Organisers can access the "details" section and add new participating companies within the regulatory deadline of 60 days, without contacting the Helpdesk.

16. Can Organisers make changes to the application before AIFA’s evaluation?

Yes, Organisers can autonomously update the following fields before AIFA’s evaluation:

• Event title
• Total hours
• Province
• City
• Venue
• Topic
• Speakers
• Dates (start date can usually only be postponed. Bringing it forward is allowed only if the 60-day notice required by Art. 124, Legislative Decree 219 is still met).

The following fields cannot be modified: Status, Region, FAD event indicator.

17. Submission procedure in the case of repeated editions of the same training event

If multiple editions of the same training event are scheduled, the company must submit a separate application for each edition, at least 60 days prior to the start date of each session.
These editions typically share the same scientific program, but have different speakers, venues, and dates.

18. Is it necessary to submit a Practice (Pratica) for Investigator Meetings?

For Investigator Meetings, a Practice does not need to be submitted to AIFA, as these are internal meetings reserved for investigators involved in clinical trials.
This differs from congresses in which information about investigational drugs is shared, as outlined in the “Notice regarding congresses, conferences, and meetings” pursuant to art. 124 of Legislative Decree 219/06, dated February 11, 2010.
In such cases, a formal authorisation request must be submitted to AIFA. This implies that the company already holds a marketing authorisation (AIC) for a medicinal product related to the congress topics, and that the investigational molecule’s future therapeutic application is relevant to the event program.

19. How should pharmaceutical groups submit their Practice?

If a pharmaceutical group intends to take part in the sponsorship of a congress event, the application must be submitted by each individual branch of the group that holds the authorisations required under Title III or Title IV, or that, on the basis of a specific agreement with the Marketing Authorisation Holder (MAH), is responsible for the actual commercialization of medicinal products and organizes or contributes to the organization—through funding or the provision of other benefits, including indirect ones—of a congress, conference, or meeting, in Italy or abroad, on topics in any case related to the use of medicinal products manufactured or marketed by the same company. (Paragraph 1, Article 124, Legislative Decree 219/06). Notifications must be submitted as provided for in Paragraph 2, Article 124, Legislative Decree 219/06 (multi-sponsor events).

20. Can an organiser submit a Practice for a single company?

No. The organiser may submit a Practice only for multi-sponsored events (Art. 124, paragraph 2).
For mono-sponsor events, the sponsoring company must independently submit its own Authorisation Request using the “Autorizzazione per Convegni e Congressi New” portal, available in AIFA’s Online Services (link available under related links).

21. When to submit a Practice under Emergency conditions

As specified in the manual, emergency submission is allowed only in extraordinary situations officially declared by AIFA (e.g., pandemic), accompanied by specific criteria. The request must be authorised by AIFA. Companies should not select the emergency option unless their case explicitly qualifies.

22. How does a company complete the Request (Richiesta)?

The company must complete its Request via the ACC system and validate it within the legal timeframe. The following fields are mandatory:

• Medicinal products
• Budgeted costs
• Payment details
• Attachments: stamp duty receipt and any co-promotion declarations

Attachments must be uploaded as a single PDF file (not a folder).

23. Can the Request be updated before AIFA's evaluation?

Yes, before the Request is taken into account, and no later than 15 days prior to the event, the following updates are allowed:

• Add/modify medicinal products
• Add medicinal product not in the AIFA database
• Budgeted costs
• Participants and related reimbursement/compensation sections
• Attachments

24. Congress events with co-promoted medicinal products 

As per Art. 119, paragraph 5, co-promotion is allowed under a formal agreement between the AIC holder and another company. 
When a pharmaceutical company holding a Marketing Authorisation (MA) or authorised to manufacture medicinal products decides to promote a medicinal product in co-promotion with another company during a congress event, the following guidelines must be observed:

Participation of both companies in the event: 

In the case that both co-promoter companies participate in the event, the medicinal product subject to the co-promotion must be listed among the sponsored medicinal products. Additionally, a specific declaration of participation must be attached, conforming to the following model:

"The co-promotion agreement was signed on ……………… between (company name of the co-promoter), SIS code ….., and (company name of the other co-promoter), SIS code ………….., for the joint promotion of the medicinal product (drug name), pursuant to paragraph 5, article 119 of Legislative Decree 219/2006. The company (company name) will participate in this event."

Non-participation of the co-promoter company without logo display:

If the co-promoter does not participate (i.e., no funding or logo exposure), it must send a formal statement (in .odt and .pdf format, signed on letterhead) stating non-involvement and absence of brand visibility. However, it is necessary to prepare a communication in .pdf format, on company letterhead and duly signed by the sector manager, to be sent via email (a .pdf template is available in the related links). This communication must declare the absence of any form of participation in the event sponsorship and the non-display of the company logo within the congress context. The declaration must be included in the documentation attached to the Request submitted by the co-promoter company sponsoring the event.

Non-participation with company logo display:

If the co-promoter does not attend but displays its logo, it must submit an authorisation request.

It is recommended that co-promotion arrangements be defined before submitting applications to avoid discrepancies during authorisation.

25. How should a medicinal product not listed in the AIFA medicinal products database be entered in the Request?

• Click on "medicinal products  not included in the list" and enter the following details: type of medicinal product (foreign, homeopathic, vaccine, allergen)
• Authorisation code (national AIC, centralized, homeopathics/allergens/vaccines marketed ope legis – specify the relevant legal reference)
• Therapeutic indications: provide the indications foreseen for the medicinal product

26. Is it allowed to use the brand name of the medicinal product in the program or during the event?

No. Given the purposes of scientific information as established by paragraph 3, article 124, Legislative Decree 219/06, it is considered that during the conduct of a congress event no reference should be made to the trade name of the medicinal product, but only and exclusively to the active ingredient(s) it contains. Therefore, it is not permitted to include the names of medicinal products in the content or titles of the sessions that make up the program. Promotional activities are limited to the spaces dedicated to each company (stands) collateral to the congress itself.

27. Stamp duty payment

The stamp duty must be paid according to the procedures described in the notice "Applications submitted electronically to AIFA: procedures for paying stamp duty," accessible via the related links. The payment receipt, along with the documentation referred to above, must be attached within the Request. Please note that the stamp duty and any co-promotion documentation must be included in a single PDF file (not in a folder).

28. Payment of the fee due pursuant to the Ministerial Decree of December 6, 2016, published in the Official Gazette – General Series No. 25 of January 31, 2017, and subsequent increases.

For each Request, identifiable by a Request ID, the pharmaceutical company is required to pay the applicable fee according to the deadlines indicated in Article 4, paragraph 1 of the Ministerial Decree of December 6, 2016. The payment of the fee is made through the online fee payment system (POL). The ACC system automatically calculates the amount due based on the detailed cost estimate or, depending on their location (Italy or abroad), as provided by paragraphs 5 and 6 of Article 124 of Legislative Decree 219/06. In the case of distance learning (FAD) events, the system automatically generates the fee based on the detailed cost estimate.
Please note that the fee payment must be made within sixty days prior to the submission of the Request, using the online fee payment system. If the Request is not submitted within sixty days after the payment, the amounts paid may be refunded. AIFA retains, as reimbursement for administrative costs incurred, a fee equal to 10% of the amount paid, up to a maximum of €500.00.
It is recommended to include the following information in the payment reference field:

POL XXXX/year – Request ID

For further details, please refer to the “service guide” section and the FAQs related to the "fee payment system" within the POL system.

29. Is it possible to reuse or request a refund for an Online Payment (POL) already associated with a specific Request ID?

Request not yet processed by the relevant AIFA Office:

Yes, it is possible to request either the reuse or the refund of the Online Payment (POL).
AIFA will retain a fee equal to 10% of the amount paid, up to a maximum of EUR 500, to cover administrative costs incurred for the activities carried out.

Procedure for reuse:

• Send an email to integraconvcong@aifa.gov.it (cc: supportoamministrativo-pol@aifa.gov.it), indicating the POL number to be reused and the Request ID.
• Once approved, proceed with a bank transfer to AIFA equal to 10% of the original fee (up to EUR 500), specifying the reason for payment as: “Reuse of POL no. XXXXX/year”.
• Create a new POL with the amount corresponding to the new variation request you intend to submit, and proceed to pay any difference between the fee of the new POL and the amount intended for reuse.
• It is important that this POL is added to the cart section and the "PAGOPA generate payment notices" button is clicked (the generated notices should then be discarded).
• Send an email to supportoamministrativo-pol@aifa.gov.it including: the number of the previous POL, the number of the new POL, proof of the bank transfer related to the above-mentioned 10% administrative fee.

Procedure for refund: 

The refund request form is available at the related link.

Request already evaluated or authorised by the relevant AIFA Office:

No, reuse or refund of the POL is not allowed.

30. How to register the payment in the ACC system

The POL code must be entered in the "payment code" field in the format "POL number/year" (e.g., 123/2024). It is recommended not to enter the CRO number or other references in this field.

Payment Registration: payments must be registered within the specified deadlines by using the "register payment" action. Deadlines and the final date for payment entry can be easily checked in the "due date" function within the ACC application. During registration, it is mandatory to enter the POL code as described above, the payment date, and select the box “I declare that the payment has been made.”

Request Management: the competent office can only take charge of the Request if the payment status is marked as "paid."

It is recommended to upload the payment receipts within the specified deadlines.

31. Is it possible to make changes to the application during the evaluation phase following a request for additional information from AIFA?

Yes, but only based on AIFA’s request.

• The organiser handles updates to the “Practice”
• The company handles updates to the “Request”

All changes must be completed within the deadlines shown in the "deadlines" section of the ACC system. If the updates are inadequate, AIFA will issue a new request. If deadlines are missed, the request will be formally denied.

After updates, the company must re-validate the Request.

32. Can organisers make changes after evaluation?

Yes, following the evaluation and/or approval of an event by AIFA, the only fields that can be modified are:

• Speakers: modification allowed up to the day of the event or the day the replacement takes place;
• Province: modification allowed up to one day before the event;
• City: modification allowed up to one day before the event;
• Venue: provided it is within the same region, modification allowed up to one day before the event;
• Event start date: modification allowed no later than two days before the scheduled date. The start date can generally only be postponed. Advancement is allowed if the 60-day requirement established by paragraph 1, Article 124, Legislative Decree 219 between the validation date and the new start date is met;
• Event end date: modification allowed no later than two days before the scheduled date. The end date can be either advanced or postponed.

NB: Such changes can be made independently by the organiser by directly modifying the Practice data, always respecting the deadlines indicated above and providing a reason. Updating the file unico is not allowed.

Cases not included among those indicated above will not be accepted.

33. Can the organiser delete a Practice?

No.

34. Can the company cancel or suspend its Request?

No. Companies may simply choose not to validate the Request if they no longer wish to sponsor the event.
If AIFA has already evaluated the Request, it cannot be cancelled. In this case, the company must submit a final expense report (consuntivo).
Actual expenses must be declared; if none were incurred, enter 0.01 (system does not allow zero).

35. What are the authorisation status codes?

• “Authorised”: indicates that the Request has been approved.
• “AIFA authorisation signed”: final confirmation.

After the legal deadline, the system will automatically deny the request. Status cannot be changed.

36. Are companies required to submit a final expense report?

Yes. The company must enter the detailed final cost report within 90 days from the event end date. Considering that the final reporting process may depend on third-party timelines, if the company is unable to comply within the deadline, the system allows the final cost report to be submitted within a maximum of 180 days.
Once the final report has been submitted, it can be cancelled within 24 hours. After this period, cancellation will no longer be permitted. Therefore, the company is strongly advised to enter the definitive data while carefully observing the reporting deadlines.
If the submitted final cost report corresponds to a fee different from that in the initial estimate, the company must request a modification of the POL associated with its Request by sending an email to integraconvcong@aifa.gov.it.

37. Privacy Policy and Personal Data Processing

Pursuant to Article 13 of the General Data Protection Regulation (GDPR) 2016/679, please note that the data provided will be used solely for the purpose of the requested procedure.

In accordance with Article 15 of the same Regulation, the data subject has the right to obtain confirmation as to whether or not personal data concerning them are being processed, and, where that is the case, to access such personal data and the information specified in the same article.

The Data Controller is the Italian Medicines Agency (AIFA), located at Via del Tritone 181, 00187 Rome – Email: presidenza@aifa.gov.it

The Data Protection Officer (DPO) is Lawyer Francesco Gradozzi, Via del Tritone 181, 00187, Rome – Email: responsabileprotezionedati@aifa.gov.it