Ministero della Salute
AGENAS is looking for collaboration also at european level for the national hta program for medical devices.
The notice is aimed at centers at european, national and regional level.
The National Agency for Regional Health Care Services intends to establish the Register of public or private Collaborative Centers at european, national and regional level with an extensive HTA expertise available to collaborate within the National HTA Program of Medical Devices 2023-2025. Only those who fall into one of the following categories can submit an application for registration in the Register:
- regions, autonomous provinces, Health Bodies and Public Health Authorities/Health Care Organization with an endorsement from their region or autonomous province;
- national, regional and autonomous province public entities;
- entities subject to the supervision of the Ministry of Health or the Ministry of University and Research (MUR);
- public and private universities and other public and private bodies, in their articulations, that grant academic degrees recognized by the Ministry of University and Research (MUR), including their structures with didactic, functional or economic autonomy;
- public or private research institutes;
- public and private university hospitals;
- similar entities operating in other countries of the European Union.
The application for registration must be submitted to the AGENAS General Directorate according to the format attached to the notice, signed by the applicant's legal representative and sent by certified e-mail to the address agenas@pec.agenas.it , together with the documentation referred to in Article 3, specifying in the subject line: "Application for registration in the Register of PNHTA DM Collaborative Centers Register".
The deadline for submitting the application is set at 60 days from the publication of the notice.
Postponed deadline 12.00 pm 12/03/2024
For more information hta@agenas.it
If the institution/organization sending the application for registration to the National Register of Collaborating Centres of the National HTA Program for Medical Devices is an institution/organization operating in a European country other than Italy and does not have a Certified electronic mail (PEC) , you can use the following email address to send the requested documentation: protocollodocsuite@agenas.it
The agenas@pec.agenas.it address is in fact enabled to receive only emails coming from other certified electronic mail (PEC) addresses. It is not enabled to receive emails from non-certified email addresses (PEC).
Registration on the Collaborating Centers Register will enable AGENAS, when it becomes necessary, in connection with the activities of the National HTA Program for Medical Devices 2023-2025, to contract, through public procedures and in accordance with all current regulations regarding the contracting of paid services by the public administration, the production of HTA documents or specific HTA assessment activities. The financing of such HTA activities by the Collaborating Centres is achieved through the use of the specific economic resources provided respectively from Articles 28 and 24 of Legislative Decrees No. 138/2022 and No. 137/2022, which established the Fund for the Government of Medical Devices.
Notice of Registration in the CC Register (PDF)
Annex1 - Application for Registration in the CC Register (WORD)
Annex2 - Declaration of Interests (WORD)
FAQ EN (PDF)
FAQ EN – UPDATE February 27th 2024 (PDF)
The selection procedure for the establishment of the Register of Collaborating Centres of the National Medical Device HTA Programme 2023-2025 (PNHTA DM) has been completed.
Entry in the Register is valid for three years from the date of publication on the AGENAS website.
The table below shows the structures - with their evaluation dimensions - positively selected:
The Table (PDF)