Renewal of registrations of homeopathic medicines in Italy

A new law published in the Official Gazette confirms the new fees and the timetable for the renewal of registrations of homeopathic medicines in Italy.

The new fees are:

• 800 euro for mono preparations, regardless of the dilutions or pharmaceutical form
• 1200 euro for complexes, regardless of the number of components or pharmaceutical form.

The Competent Authority AIFA is committed to clarify the necessary documentation for renewals by 31 March 2015. The new deadline for submission of dossiers is 30 June 2017. AIFA is to conclude the assessment until 31 December 2018.

ECHAMP welcomes the new regulation, having expressed its concerns to AIFA, the Italian Health Ministry and the European Commission that AIFA’s original programme for renewals, announced in September 2014, was unrealistic. ECHAMP Italian members will be in touch with AIFA with respect to the new guidelines through Omeoimprese, the Italian association of manufacturers of homeopathic and anthroposophic medicinal products. To date, there are no documents on the AIFA website.