On 26th 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 ...