Division B

As described in the document referred to under 1(B), F1RL recognises the modularity of a method. According to this principle, the applicant is allowed to refer to existing methods for a certain module(s), if available and appropriate. This could be, for instance, a DNA extraction method from a certain matrix. In such a case, the applicant shall provide experimental data from an in-house validation in which the method module has been successfully applied in the context of the application for authorisation.