Paediatric-Use Marketing Authorisation (PUMA) Medicine By Proveca

In 2007, European Paediatric Regulation came into force to improve the health of children by increasing research, development and authorisation of medicines based on specific paediatric experience. The Paediatric Regulation introduced the Paediatric-Use Marketing Authorisation (PUMA), a dedicated marketing authorisation for medicines developed exclusively for use in the paediatric population. As part of the pathway to PUMA, a Paediatric Investigation Plan (PIP) must first be agreed by the European Medicine Paediatric Committee.

The PUMA was introduced by the Paediatric Regulatory committee for medicines that are:

  • already authorised;
  • no longer covered by a supplementary protection certificate (SPC) or a patent that qualifies as a SPC;
  • to be exclusively developed for use in children.

Proveca Ltd specialises in identifying, developing and facilitating the licensing of off-patent medicines for children where priority healthcare needs exist.

Proveca collaborated with the Paediatric Regulatory Committee to obtain a PUMA in 2016.

To date only six paediatric medications have been approved by PUMA, two of which the co-founders at Proveca have been responsible for launching.

Updated March 2023