The Decree Law n. 248 of 31 December 2007 (Official Journal no. 302 of 31 December 2007) established that pharmaceutical companies holding marketing authorizations for medicines not subject to medical prescription (SOP and OTC) "are required to notify the Ministry of Health and AIFA of the maximum ex-factory price at which each medicine is offered for sale".
The disclosure obligation, which has the purpose of "allowing the competent authorities to continue to have the necessary elements of knowledge on the dynamics of the pharmaceutical market", constitutes an integration of the provisions of the Law of 27 December 2006 n. 296 (Finanziaria 2007) where it introduced, starting from 1 January 2008, the liberalization of the prices of SOP and OTC medicines by providing that they are no longer established by the manufacturing companies but by each owner of a pharmacy or business authorized to sell such medicines.
MAXIMUM EX FACTORY ASSIGNMENT PRICE NET OF VAT FOR SOP AND OTC EX ART. 9 Legislative Decree 248/2007
(Source Farmadati)
