|
Paediatric Investigation Plans (PIPs) and Paediatric Use Marketing Authorisations(PUMAs)
The Paediatric Regulation entered into force on 26 January 2007 . As it is an EU Regulation, it is applicable in all Member States as of that date.
Depending on the type of medicinal product there is a staggered entry into force of obligations relating to the development of medicinal products for use in children, as outlined below:
a) For medicinal products not yet authorised by 26 July 2008
According to Article 7 of the regulation, a Marketing Authorisation Application has to include either the results of studies (conducted in compliance with a paediatric investigation plan (PIP)) or an EMEA decision on a waiver or on a deferred PIP. This is requested for the validation of new application for marketing authorisation and applies as of 26 July 2008 .
This includes fixed-combination products, but not generics, well-established use or informed consent applications.
b) For authorised products protected by a supplementary protection certificate (SPC), or by a patent eligible for a supplementary protection certificate
According to Article 8 of the regulation, there is an obligation to include either the results of studies (conducted in compliance with a paediatric investigation plan) or an EMEA decision on a waiver or on a deferred PIP in applications for variation or extension (of an existing marketing authorisation) concerning a new indication, pharmaceutical form or route of administration. Article 8 will apply as well to stand-alone applications for an authorised patented product in the framework of a Global Marketing Authorisation. This is requested for the validation of such applications for variation or extension. This obligation applies 24 months after entry into force of the Paediatric Regulation, i.e. as of 26 January 2009 .
This includes fixed-combination products, but not generics, well-established use or informed consent applications.
c) For a Paediatric Use Marketing Authorisation (PUMA)
The application for a Paediatric Use Marketing Authorisation is voluntary. This provision is applicable since 26 July 2007 . However, an application for a PUMA would have to contain the results of studies conducted in compliance with a paediatric investigation plan.
- Ivowen Limited can advise on the requirement for a PIP for all products.
- Ivowen Limited can prepare and submit the PIP/PUMA for your company.
- Ivowen Limited has access to qualified medical personnel who are familiar with PIPs and their requirements.
|
