Skip to main content

Table 1 Implementation phases of the Paediatric Drug Regulation (EC) No 1901/2006

From: The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children

Category

Application

Jurisdiction

Implementation

Off-patent medicine

MA for a paediatric use

Article 30

26 July 2007

New medicine

MA that includes a paediatric indication

Article 7

26 July 2008

On-patent medicine

To include a paediatric indication in an existing MA*

Article 8

26 January 2009

  1. *New indications, pharmaceutical forms and/ or routes of administration which are protected by a supplementary protection certificate or by a patent which qualifies for the granting of a supplementary protection certificate.
  2. All three categories need to comply with the requirements of Article 7: application for MA should include the results of all studies conducted in compliance with an agreed PIP or a decision of the EMA granting a (partial) waiver or deferral [1].
Back to article page

Orphanet Journal of Rare Diseases

ISSN: 1750-1172