1. Paediatric medicines

1.3. Incentives and rewards

Apply if:

- development is compliant with agreed PIP (compliance statement in MA);

- results of studies (positive or negative) are included in the Summary of product Characteristics (SmPC) + Package Leaflet (PL);

- product is authorised in all Member States (except for PUMA)

They entail:

  • for PUMA: 8 plus 2 years of data and market protection (compliance with agreed PIP necessary, irrespective of the MA procedure) and fee reduction for MA/post-authorisation activities
  • for new medicines (article 7) or authorised medicines on-patent (article 8): a six-months extension to the supplementary protection certificate (SPC)[1], i.e., a six-months patent extension*
    *no reward if the product, following an application under Article 8, obtained a one-year extension of the period of marketing protection for the new paediatric indication
  • for paediatric orphan medicines: an additional two-years market exclusivity, added to the ten-years awarded under the Orphan Regulation.
  • Scientific advice: prior to the submission of a PIP and during its implementation, free of charge for questions relating to the development of paediatric medicines as well as to the design and conduct of pharmacovigilance and risk management systems

Product-specific or class waiver or inconclusive studies in PIP do NOT trigger the reward.