1. 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

2. 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

3. 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