introduction and general principles
as defined in Directive 2001/83/EC of the European Parliament and of the Council of…
Due to the specific nature of advanced therapy medicinal products, a risk-based approach may be applied to determine the extent of quality, non-clinical and clinical data to be included in the marketing authorisation application, in accordance with the scientific guidelines relating to the quality, safety and efficacy of medicinal products referred to in point 4 of the ‘Introduction and general principles’.