Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004

Based on the experience gathered by reviewing the approach taken to the assessment of past applications since the last version of the guideline in July 2006, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the justifications provided by the applicant that the medicinal product falls within the scope of the accelerated assessment.

Keywords: Accelerated Assessment