1. Paediatric medicines

1.5. Exemptions

The Paediatric Regulation allows exceptions to articles 7 and 8, such that a PIP or waiver is NOT required in case of:

  • “Off-patent” medicines authorised in the EU (authorised products that do not have a valid Supplementary Protection Certificate (SPC) or a valid patent that qualifies for it.). A voluntary PIP is possible.
  • New medicines belonging to some specific groups (Artl. 10 and 16 of Directive 2001/83):
    • Traditional herbal medicinal products
    • Homeopathic products
    • Generic products
    • Hybrid products (a PIP can optionally be agreed for future PUMA application)
    • Biosimilar products
    • Well-established medicinal use
  • a class-waiver exists for a class of products in a condition

In all these cases, the necessity for paediatric studies is determined case-by-case under the responsibility of the CHMP.

 

Legal basis:

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use;
Regulation (EC) No 1902/2006, and amending regulation in which changes to the original text were introduced relating to decision procedures for the European Commission.
Directive 2001/83 where applicable