AIFA has recently circulated on its website the communication about the price increase of Class C medicinal products subject to medical prescription.
As foreseen by Article 1, paragraph 3 of the Law Decree n. 87 dated May 27th, 2005 the prices of the medicinal products classified in C class subject to medical prescription, with reference to art. 8, par. 10, letter c), of the Law December 24th 1993 n. 537, can be increased only in January of every odd year.
Companies that wish to apply for a price increase are requested to comply with the following dispositions:
• The company must communicate the price variation within and no later than January 31st, 2019
• The communication has to be received at least 15 days before the effective date of the new price
• The company must indicate the effective date of the new price (not prior to January 1st, 2019), the MA number, the medicinal product description and its presentations, the public price in force, the new price including the variation, the indication of the percentage change and any other possible annotation
Regulatory Pharma Net team is available to support companies in the documentation preparation and submission.