In order to allow the prescription for active principle established by article 15, paragraph 11-bis, of the decree law 6 July 2012 n.95, converted with amendments by the law 7 August 2012 n. 135, the Italian Medicines Agency makes available to all healthcare professionals the tables containing the list of class A medicines, dispensed by the National Health Service, ordered respectively by active principle and for commercial name. The Medicines Agency itself announces it on its website, specifying how these tables constitute a technical tool and include both medicines present in the Aifa Transparency List updated on 04/15/2013 and medicines covered by patent protection, and the medicines of which it is patent protection has expired but for which substitutability is not envisaged. Unlike transparency lists, underline! to Aifa, the tables containing the indication of the grouping by active principle they do not set maximum redemption prices. Here is the text of paragraph 11-bis
"11-bis. The doctor who treats a patient, for the first time, for a chronic pathology, or for a new episode of a non-chronic pathology, for the treatment of which more equivalent medicines are available, indicates in the prescription of the National Health Service the denomination of active principle contained in the drug or the name of a specific medicinal product based on it active principle accompanied by the name of the latter. The indication of the specific medicinal product is binding for the pharmacist if the non-substitutability clause referred to in article 11, paragraph 12 of the decree-law of 24 January 2012, n. 1, converted, with amendments, by law 24 March 2012, n. 27. The indication is ! binding for the pharmacist even when the drug indicated has a price equal to the reimbursement price, without prejudice to the customer's different request.
11-ter. In adopting any decisions based on the therapeutic equivalence between medicinal products containing different active ingredients, the regions comply with the justified and documented assessments expressed by the Italian Medicines Agency."
April 18, 2013 - DoctorNews
