Questions and answers on the authorization of conferences and congresses (Updated February 2021)

As part of the development of the new AIFA information system, Pharmaceutical companies willing to interact with AIFA need to appoint the "Company User Administrator", hereinafter referred to as "AUA" (Amministratore Utenze Aziendali) for short.

The identified person, preferably within the individual company, will access AIFA applications as required can enable other people to access the applications as contact person. For more information, refer to the and to the User Manual for Pharmaceutical Companies (V 7.0 22 June 2015).

No, only one contact person can be appointed for each company. The contact person must have a Smart Card with a digital signature certificate in order to validate the requests.

Yes, as long as s/he has been appointed by the 'AUA' of each company.

Yes, in order to access the service, it is essential to refer to your 'AUA'.

It is advisable for organizing bodies to timely send their pre-authorization requests to let Pharma companies finalize the validation procedure within the prescribed legislative deadlines (60 days from the start date of the event, pursuant to paragraph 1, art.124, Legislative Decree 219/06). As mere example, the pre-request can be sent 70 days before the start date.

The pre-request must be entered exclusively through the portal at the following address http://www.impresainungiorno.gov.it . To receive support and clarifications regarding registration to “Portale Impresa”, please refer to their helpdesk.

You can request assistance by filling the appropriate form at the following link: http://www.impresainungiorno.gov.it/impresa.gov/contattaci or by sending an email to assistenza.impresagov@impresainungiorno.gov.it .

Registration can only be completed by the organizing bodies meeting the requirements (please contact the Impresa.Gov helpdesk for more information). In case the registration can’t be completed, the organization can entrust another regularly registered body to send the pre-request through “Portale Impresa”.

The pre-request entry service on the AIFA Portal is anyway available ONLY FOR ORGANIZING BODIES WHO ARE NOT ABLE TO FINALIZE THE PROCEDURE THROUGH THE IMPRESAINUNGIORNO.GOV PORTAL.

In the particular case in which several affiliates of the same pharmaceutical group decide to promote the same event and no external Organization has been appointed, the ACC contact person of the Company will send a multi-sponsor application through AIFA Portal, listing all the participating affiliates which shall subsequently complete and validate their own procedure.

No, the organizing body can send only multi-sponsored applications, pursuant to paragraph 2, art. 124. Legislative Decree 219/06. In the event of a mono-sponsored event, the company shall send and complete the request individually, pursuant to paragraph 1, art. 124 of Legislative Decree 219/06, by accessing the "Authorization for Conferences and Congresses" portal through the link: www.aifa.gov.it - ​​"Online Services" - "Authorization for Conferences and Congresses"

No, the organizing body shall only fill in the appropriate form in the system. Then each Pharma company will complete its own application.

Upon entering the pre-authorization request, the system displays on screen a progressive number (PACC number) and an automatic email alert system sends a notice confirming the correct procedure to the organizing body and to each concerned Pharma Company. Those messages carry also the identification number for each request which each Company will update and validate.

No, the number of a single company's application will be different from the pre-request number (PACC number), since each pre-request, while referring to the same multi-sponsored conference / congress, will create several applications to be completed by each Pharma company.

Request ID is an identification code/number automatically assigned by the Conference and Congress Authorization System (ACC) to each application. It is not the ECM ID which is instead assigned by the ECM System when a provider submits an accreditation request for a training event. It should be noted that pharmaceutical companies, upon submitting an authorization request for conferences / congresses, are obliged to enter the ECM ID if the event is ECM accredited together with the annex including meeting agenda, scientific rationale and speakers’ qualifications.

Organizations can update their applications after their submission through www.impresainungiorno.gov.it.

Additionally, Pharma Companies willing to promote an event but not initially listed by the Organization may adopt the following procedure:

  • submit a mono-sponsored application for the event by accessing the ACC system by its credentials
  • Ask through helpdesk@aifa.gov.it for the migration of the mono-sponsored application to the pre-request of the event it intends to attend. In order to simplify and speed up the procedure, companies are invited to effectively justify the migration.

Organizations are recommended not to submit multiple applications for the same event: this may cause confusion since a Company won’t know which is the right application, may cause delays in authorization process and, in extreme cases, evaluation fee double payments, as well as the submission invalidation.

Please, take into account what stated in paragraph 2, Art. 124, of Legislative Decree 219/06:

“When more than one pharmaceutical company sponsor the same congress or meeting, the information mentioned above are to be jointly submitted by an Organization body. Communications not in compliance with these provisions shall be ineffective.”

However, if the Organization deems e new submission as necessary, the Organization will promptly notify the concerned Companies of which application ID has to be completed.

No, Organization bodies cannot use the suspension function through “Portale Impresa”. Suspension function may be used by pharmaceutical companies through their own ACC access.

No, each company listed among sponsors and willing to support the meeting has to update its own application and validate it (i.e., digitally sign it).

Applications may be independently updated by Pharmaceutical companies any time before evaluation by AIFA Office in charge.

No, validation (i.e., digital signature) may be performed after request insertion in order to update it and check the data being correct, as long as it takes place within the foreseen legal frame.

The authorization process for a multi-sponsor event follows the steps below:

  • Submission of the pre-request by the Organization body through the impresainungiorno.gov.it portal.
  • ACC automatic notice to both Organization body and Pharma Companies about pre-request submission.
  • Application completion and validation by each Pharma Company through ACC access.
  • Automatic assignment to the Region in charge (when the application meets the requirements of paragraph 5. Art. 124, of Legislative Decree No. 219/06)
  • Opinion by in-charge Region (when the application meets the requirements of paragraph 5. Art. 124, of Legislative Decree No. 219/06), AIFA Office assessment and AIFA authorization/rejection release.
  • E-mail notice about AIFA authorization/rejection release to Pharma Company contact person.

Pursuant to the art. 124 of Legislative Decree 219/06, the file unico to be attached to the application must contain the following information:

  • EVENT AUDIENCE (Article 119, paragraph 1, Legislative Decree 219/06) in terms of professional profiles and specialties.
  • EVENT SCIENTIFIC AGENDA
  • EVENT SCIENTIFIC RATIONALE
  • SPEAKERS’ PROFESSIONAL AND SCIENTIFIC QUALIFICATIONS: according to the provisions of paragraph 1 of the same article and taking into consideration the ACC attachment size limit (3 megabytes), qualifications are required as summary table format containing complete names, professional and scientific qualifications and current job place for each listed speaker. For our privacy policy, please refer to the specific underlying FAQ.

In order to simplify the assessment of meeting topics and their relation to the drugs proposed as relevant by the Company, the event agenda must comply with the following criteria:

  • FINAL AGENDA (the agenda must be submitted as final and not as a draft, listing every foreseen ECM accredited and non-accredited session. Links to websites are not allowed);
  • WORKSHOPS (topics and tutors’ names are needed);
  • ORAL COMMUNICATIONS (topics and speakers’ names are needed)
  • FREE COMMUNICATIONS (topics and speakers’ names are needed);
  • LECTIO MAGISTRALIS (title and speaker name are needed)
  • ROUND TABLE (topics and participants’ names are needed)
  • SYMPOSIA (title, rationale, agenda, speakers’ names and qualifications are needed);
  • DISCUSSIONS (topics are needed if they last more than 30 minutes);
  • ACRONYMS (acronyms must be reported also in full);
  • CLINICAL CASES (a brief description of each one is needed);
  • CLINICAL STUDIES (a brief description of each one is needed)
  • PRACTICAL SESSIONS (topics and tutors’ names are needed);

ABSTRACT (information from abstracts, in press articles and posters is not allowed).

When in charge AIFA Office sends a completion request email as result of a first negative opinion, the Pharma Company may update its application data and/or its attached file unico.

Please be aware that, in case of multi-sponsored events, when data in common to all related applications have to be updated/modified, the organization body will promptly send the required updated information to the concerned Pharma Companies who will add it to its own ACC application.

Data that Companies cannot modify by themselves due to ACC safety blocks (i.e., “related drugs” and/or “title” fields) can be updated by writing to AIFA Helpdesk (helpdesk@aifa.gov.it ), attaching the AIFA Office request email. Email subject will be: “CONGRESSES AND MEETINGS- ID XXXXX (PACC NUMBER or ACC APPLICATION ID)”

Pursuant to art. 1, paragraph 3 of AIFA’s Regulation, for the implementation of Articles 2 and 4 of the Law August 7th1990, no. 241 as amended, for access to administrative documents and for dematerialization, Companies are encouraged to submit the required information within the time specified in the AIFA request (15 days since notice date). Otherwise, the procedure is declared as closed. This conclusion is notified to the concerned pharma company.

Pharma company confirms its application update by replying to AIFA request email.

Changes of scientific contents in file unico and agendas already positively assessed/authorized by AIFA are not allowed (for example, change of event/speeches’ title or addition of new speeches). Changing even just one speech in agenda would nullify the entire assessment procedure: a new evaluation process would need to be started bringing work problems and failure to comply with the foreseen deadlines for authorization release, pursuant to Art. 124 of Legislative Decree 219/06.

Changes allowed to concerned pharma companies after AIFA POSITIVE assessment are:

A) Province, Municipality and venue of the event, as long as they are within the same Region, within 1 day before event start date.

B) Event date within 2 days before previous start date. Usually start date can only be postponed. An earlier start date is allowed when the time lapse between application validation date and new start date is still within the foreseen legal frame (60 days as per paragraph 1, Art. 124, Legislative Decree 219).

C) Speakers’ replacement/addition/cancellation within the day when the change takes place

D) Sessions/speeches’ cancellation due to agenda changes within 2 days before event start date. If this modification is linked to item c), please refer to that time frame

E) Event agenda extension/shortening (with no new speech addition) due to schedule changes within 2 days before event start date. If this modification is linked to item c), please refer to that time frame

Modification notice is sent not before 7 days since event start and within aforementioned time frames to protocollo@pec.aifa.gov.it.

Email subject will be the following exact wording: “ACC/XXXXX (PACC NUMBER or ACC ID NUMBER) Variazione” (for example ACC/357217 Variazione)

Email attached notice includes all information as per form to the following link “ACC FAQ modification notice”

This file will have a .pdf format.

IT IS STRONGLY SUGGESTED TO SEND JUST THE DULY WRITTEN FORM WITHOUT ANY UPDATED FILE UNICO WHICH WON’T BE TAKEN INTO CONSIDERATION.

The foreseen notices will not be added to ACC applications and the sender will not receive any receipt/acceptance confirmation by in charge AIFA Office. Notices will be randomly checked.

IT IS STRONGLY SUGGESTED TO TRANSMIT JUST CHANGES LISTED IN A) TO E) ITEMS AND FOLLOW THE PRECISE INSTRUCTIONS: DIFFERENT/WRONG TRANSMISSIONS WILL NOT BE CONSIDERED APPLIED/APPLICABLE TO ACC AUTORIZATION REQUESTS.

Other changes not listed above (for example, ECM accreditation code update, professional profile/specialty addition to event audience) are not to be notified.

Yes, through ACC "query" function, pharma companies can check their application status at any time and assessment details, if already assessed by AIFA.

An entered application (i.e. not validated yet) can be cancelled through the "cancel" function, while a validated application can be cancelled through the "cancel" or "suspension" functions. Please, be aware: once an application is cancelled and/or suspended, it is no longer visible to the Company.

At the moment, ACC application allows to manage only Events and Training Projects as ECM accredited submissions. However, other types of training activities included in ECM accreditation plan must be submitted as Accredited Events, by entering the ECM identification code in the mandatory field of the form.

If multiple editions of the same training event are planned, the pharmaceutical company is required to submit an authorization application for each edition, 60 days before event start date.

Different editions of the same event are generally characterized by different speakers, venues and dates and by the same scientific agenda whose content is identical.

EACCME credits cannot be added to Italian ECM program; therefore the EACCME accredited training activities will be submitted as no-ECM events attaching to the application the following: agenda, rationale, speakers’ professional and scientific qualifications. Form “note” field will specify EACCME accreditation code.

In the case of investigator meetings, the authorization request shall not be submitted to AIFA, taking into consideration those are study meetings restricted to Investigators involved in the specific clinical trial.

On the other hand, when a meeting agenda foresees e speech about molecules under trial in compliance with the "Information note" regarding conferences, congresses and meetings referred to in Art. 124 of Legislative Decree. 219/06 of 11 February 2010, the authorization request shall be submitted to AIFA. In this case, Pharma company already owns a MA for a drug linked to meeting topics and also the new molecule under study is relevant to meeting topics.

Pursuant to paragraph 5, Art. 119 of Legislative Decree 219/2006, advertisement to health professionals can be carried out jointly to drug MAH, but in any case, according to a specific agreement with the MAH, by another company. This agreement must be indicated in the “note” field of the form as: The co-promotion agreement was signed on .................. between (company name of the co-promoter company), SIS code ........., and (company name of co-promoter company) SIS code ………… for the joint promotion of the medicinal product (name of the medicinal product), pursuant to paragraph 5, Art. 119, Legislative Decree 219/06. The company (company name) will take part/will not take part to this event.

When a pharmaceutical company holding a MA or authorized to manufacture medicines decides to promote the medicinal product in co-promotion with another company during an event, the following indications shall be complied with:

  • if the co-promoter company does intend neither to fund the meeting nor to exhibit its company logo, it is not required to submit any application. The company has to notify this by e-mailing the linked form (form .odt and .pdf) duly filled in. The same filled form is attached to the co-promoter company application in ACC system.
  • if the co-promoter does not intend to fund the meeting but still intends to exhibit its company logo, it shall submit an authorization application to in charge AIFA office.

PLEASE NOTE: Co-promoter companies are advised to plan their co-promotion activities timely before their application submission, in order to avoid inconsistencies in the provided information and not to cause delays during the authorization phase.

Yes, it is possible because pursuant to paragraph 1 of art. 124, Legislative decree 219/06, every pharmaceutical company holding any autorization provided for by Title III (Article 6, paragraph 1. No medicine can be marketed in the national territory without an authorization from AIFA or a EU authorization pursuant to Regulation (EC) No. 726/2004 in conjunction with Regulation (EC) No. 1314/2007) or Title IV (Chapter I Authorizations for production and import), is required to submit regular application for authorization if willing to organize a meeting in Italy.

Since on the basis of the provisions of paragraph 3 of art. 119, Legislative Decree. 219/06, the advertising of a medicinal product to healthcare professionals must always: include the summary of the product characteristics authorized at the time the advertising campaign is held; specify drug supply classification and report sale price and account for if/how the drug is paid by Italian NHS, limited to medicines with centralized MA only and pending Italian MA, the advertising of the medicine to health professionals must be limited to the proprietary name only, specifying the substance INN or active ingredients’ names. MAH registered name may be added to that information followed, in case of co-promotion, by the name of the company actually marketing the product (paragraph 4, art. 119 Legislative Decree 219/06).

The medicine is entered as a "foreign medicine" and centralized authorization code is added to the “note” field.

Given the purposes of scientific information according to the provisions of paragraph 3, art. 124, Legislative Decree 219/06, during a meeting no mention shall be made to drug proprietary names but just to its active ingredient(s). Therefore, it is not allowed to print drug proprietary names in meetings’ agendas. Promotional activity is limited to dedicated company spaces (stands) to the scientific sessions’ venue side.

Pursuant to art. 13 of the General Data Protection Regulation (GDPR) 2016/679, we inform you that the data provided will be used only for the purposes of the requested procedure. Pursuant to art. 15 of the said Regulation, the subject has the right to obtain confirmation as to whether or not personal data concerning him/her are being processed and, if this is the case, to have access to personal data and any other information referred to in the same article. The Data Controller is the Italian Medicines Agency, located in Via del Tritone n. 181, 00187 Rome, as its legal representative pro tempore, the Director General.

For each authorization request, identified with an ID request, the pharmaceutical company is required to pay the applicable fee. The payment of the due fee is made through the online fee payment system (POL) at the following link: https://servizionline.aifa.gov.it/.  For additional details, please check the section “Service Guide” of the POL system. Fees are paid in the sixty days’ period prior to the submission of the application.

If the application is not submitted within 60 days following the payment, the amount paid may be refunded against the administrative penalty equal to 10% of the entire payment up to a maximum of 500,00 euros.

It is recommended to enter the following information on causal field:

-n. of POL in the correct format (POL XXXXX / year)

-n. of ID request

Please also fill out the self-certification of the aforementioned payments within the POL by recalling the POL from "POL management", then click on the "+" at the top left of the POL and enter the CRO/TRN and the payment date.

How to enter the POL code within the ACC application:

Application paragraph 5:

The POL code shall be entered in field 3 of the application (duration in hours) excluding the reference year (eg. POL code 123/2017, enter 123).

Application paragraph 6:

The POL code shall be entered in the appropriate POL field.35. Ability to reuse an online payment system (POL) previously associated with a specific identification request.

It will be possible to reuse an old Payment Online (POL), previously associated with a specific authorization request, if the same has never been processed by the competent Office and suspended directly by the pharmaceutical company. AIFA retains, by way of reinstatement of the administrative costs incurred for the activities carried out, a share equal to 10% of the amount paid, up to a maximum of € 500.00.

Furthermore, reuse will not be possible if this request is already authorized or processed (AIFA evaluation inserted) by the competent Office. In this case you will have to proceed with a new payment of the fee.

Please note that a POL must be linked to each authorization request, which can be identified with an ID request.

For the reimbursement procedures, please refer to the Decree of 6 December 2016 of the Ministry of Health - Update of applicable fees and determination of fees relating to services not yet tariffed.

Please find below the procedure for reuse:

  • send an email to integraconvcong@aifa.gov.it copying supportoamministrativo-pol@aifa.gov.it and ask for authorization to reuse the POL;
  • upon approval of POL reuse by the competent offices, make a new payment equal to 10% of the entire fee up to a maximum of € 500.00, to be paid to AIFA;
  • create a new POL;
  • send an email to supportoamministrativo-pol@aifa.gov.it indicating the POL number you wis to reuse and the new POL number created;
  • attach to the email the receipt of the bank payment relating to the aforementioned 10% fine.

Within 90 days from the end date of the Congress, it is requested to enter the final balance in the appropriate field of the request. In case the final balance corresponds to a different fee from the budget, please send an email to integraconvcong@aifa.gov.it and ask for the reformulation of the POL linked to the ID request.

Within 90 days from the end date of the Congress, it is requested to enter the final balance in the appropriate field of the request. In case the final balance corresponds to a different fee from the budget, please send an email to integraconvcong@aifa.gov.it and ask for the reformulation of the POL linked to the ID request.

If an entire Pharmaceutical Group intends to sponsor a meeting, the application shall be submitted by each branch holding an authorization according to title III or title IV or that markets the drugs due to an agreement with the MAH and willing to sponsor - through financing or provision of other benefits, also indirect, in Italy or abroad - a congress, a conference or a meeting on topics in any case related to the use of medicines produced or marketed by the same company (paragraph 1, Art. 124, Legislative decree 219/06).

Info - Autorizzazione Convegni e Congressi

For further clarifications and information related to the authorization procedure, please contact the "Conference and Congress Authorization" Division at the following address: integraconvcong@aifa.gov.it , specifying the following in the specifying the following in email subject: “QUERY: TOPIC XXXX (topic description)”