Documents agreed by the CG CA-March29-Doc.4.7.b Documents agreed by the CG Document Agreed Applicable as of Grouping of co-formulants CG-30 3 July 2018 Best practices for BPF pre-submission meetings Splitting of families 26 September 2018

Documents tabled for agreement during the CG-34 Applicable as of Similarity of composition To be agreed by the CA meeting…. ….. input from CG members at CG-34 Similarity of uses (including matrix) Similar level of risk and efficacy

Applicability of documents agreed by the WP Approach agreed in the CA document CA-July12-Doc.6.2d-Final: the 2 years cut-of applies Lack of harmonised approach in the short/mid-term. MSs may apply different approaches May result in high number of referrals Lack of level playing field between applicants Option 1: Option 2: Earlier application* of the documents to BPF applications: to be submitted after CA agreement on an earlier application? still under evaluation (e.g. “x” months before the draft PAR is sent to the applicant)? Products/uses failing the similarity check can be handled according to document “splitting of families” For applications being in the latest steps of the evaluation phase (see above) or in the MR phase, no referrals are submitted based on the latest documents; the structure of the family is reconsidered at the renewal * This might require a slight amendment of document CA-July12-Doc.6.2d-Final