Giulia Tagliafico 
European and Italian Patent and Trademark Attorney
LITAPAT
Rome, Italy

Simona Venturini 
IP documentation specialist
SVIPsearch
Meda, Italy

On 26^th January 2007 the paediatric extension (PE) of the supplementary protection certificate (SPC) came into force also in Italy, with the European Regulation on medicinal products for paediatric use (CE n.1901/2006). Such Regulation had three main objectives:

• to promote high quality research with children to inform on the quality, safety and efficacy of medicines that children (from birth to less than 18 years) will receive;
• to provide more information on the use of paediatric medicines;
• to allow the authorisation of medicines for diseases that affect children, with age-appropriate pharmaceutical forms and composition (formulation) (1).

The Regulation introduced the paediatric investigation plan (PIP), a specific development plan for new medicines to market for use in children, and a new type of marketing authorization, the PUMA - Paediatric Use Marketing Authorization.

According to this Regulation, “Where an application […] includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall b ...