Dear All,
I am writing to request clarification regarding the application of Articles 33 and 35 of the European regulations related to the marketing of medicinal products authorised for a paediatric indication.
Specifically, we would like to confirm the obligations for a medicinal product that is currently authorised and marketed in Italy for an adult indication, and for which an extension of the indication to the paediatric population (new dosage form specific for this population) has recently been granted, following the completion of an agreed paediatric investigation plan (PIP).
According to the information on EMA website, the MAH is required to place the product, including the paediatric indication, on the market in the Member States where the paediatric indication has been authorised within two years of the paediatric indication authorisation. In this regard, we would appreciate clarification on the following points:
- Does the two-year obligation apply even if the product is already available on the market for other indications (e.g., for adults for different strength/presentation)?
- Is the two-year deadline calculated from the date of authorisation for the paediatric indication in the specific Member State or from EMA EC decision?
Thank you in advance for your attention and support.
Kind regards,
Giulia
