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Italian Medicines Agency Agenzia Italiana del Farmaco

Price update of class- C medicines with prescription - Price update of class- C medicines with prescription

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Price update of class- C medicines with prescription

According to Law Decree No. 87 of 27 May 2005 in art. 1, paragraph 3, increases in prices of class-C products with prescription, pursuant to art. 8, paragraph 10, letter c), of Law No. 537 of 24 December 1993, are allowed only in the month of January of odd-numbered years

In order to standardise the price increase procedure for year 2021, it has been planned to implement a web application for communications from companies. In particular, the following provisions apply:

  • The company must notify the price change by 31 January 2021 at the latest;
  • The notification shall be made through the application at least 15 days prior to the effective date of the new price.
  • The company shall indicate the starting date of the new price (not prior to 1 January 2021) relating to each marketing authorisation, the public price in force, the new price including the change, and any notes. The percentage change will also be calculated by the system;
  • The notification of the price change shall be transmitted through the web application provided by the AIFA starting from 15 December; 
  • The receipt generated by the system (in pdf format) shall be attached by the user to the PEC for official communication of the increase to be made through the address hta.prezzi@pec.aifa.gov.it, including in Cc the email address prezziclassec@aifa.gov.it and indicating  in the subject line the following references “Price increase class-C with prescription – Company_code SIS_send n.XX”.

Starting from 7 December at 10.00, the Company will have to access the application, without the possibility to communicate increases in price, only to verify the correct presence of the MA of interest for the purposes of the subsequent notification of increase. In case of data anomalies, or absence of the MAs, the Company shall request the timely alignment within the Banca Dati Farmaco (BDF) through appropriate communication to the email address taskforce.bdf@aifa.gov.it, reporting in the subject line of the request “Price increase class C with prescription – request alignment BDF_medicines_MA”, indicating the MA code and the SIS code of the package and the associated MA holder for which the update of the database and any references to the Official Gazzette is requested. 

For problems of a purely technical nature and/or malfunctions detected on the web application, the Agency’s HelpDesk is available via the traditional channel (helpdesk@aifa.gov.it).

Notes:

In light of the CPI in the period January 2019 -November 2020 (CPI: Consumer price index) close to zero, we invite companies that want to increase the price of their medicinal products, classified in class C with prescription, to report supportive arguments in the dedicated section (Note field provided for each marketing authorisation). Companies that have already forwarded the price change notifcation to AIFA are required to send a new communication following the above-described procedure.

For information on profiling and registration  to the AIFA Services Portal please refer to the information provided by the Agency, available on AIFA's institutional website ("Accesso ai Sistemi Informatici di AIFA" accessible through the box "Related links") and/or to the video tutorial available on the Agency’s YouTube channel ("Portale dei servizi - Registrazione e richiesta profilo" accessible through the box "Related links").


Published on: 03 December 2020
Last updated on: 14 December 2020

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