1

Merging and Splitting

of MRP/DCPs
PRESENTED BY: DOLITA MISTRY
12.02.2019
AGENDA 2

 Introduction
 Splitting
- Process for the MAHs
- Timetable
 Merging
- Process for the MAHs
 Some key points related to
Merging & Splitting pilot phase
Introduction 3

 EGA (Medicines for Europe) proposal

 Company’s Strategies for getting MAs & Future of MAs.
 Merging
 Splitting
Introduction 4

CMDh
CMDh Meeting with
Meeting with Interested
Interested Parties
Parties on MRP/DCP
on MRP/DCP Improvements
Improvements - 23 May 2016 December
– and
16 November 7 November 2015 -
2015 2016 CMDh
Working
Document
on Merging
Publication of CMDh
and
guidance for extension of Splitting of
pilot the pilot for MRP/DCPs
procedure in splitting of
December procedures- was
2015 Dec 2017 published
further on July
2018
extended up
to Dec 2018
Splitting 5

 Splitting is separation of DCP/MRP due sold of Marketing

Authorisations for specific member states to different MAHs.

 Sometimes the MAs of a MRP or DCP are sold to different

MAHs for specific member states and the new MAHs are
planning different development routes for these products. In
these cases a splitting of a MRP/DCP into several smaller lines
seems to be reasonable for preventing MAHs from
unnecessary variation procedures for their products and for
keeping the dossiers clear.
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The CMDh has started a pilot procedure in January 2016 for 10 procedures
which has been finalized in November 2016.

The outcome of the pilot was quite successful but the number of procedures
too low for being able to decide on a transfer into a general procedure.

The CMDh therefore decided to extend the pilot phase for another year until
December 31, 2017 without restriction of the number of procedures involved in
the pilot in order to learn more about this procedure and to have sufficient time
for evaluating the legal possibility for a permanent procedure.

Also in the extended pilot the number of procedures has been too low to take a
final decision on this procedure, however, the requested splitting's were
successfully finalized. Further, CMDh decided to prolong the pilot phase for a
further year until December 31 2018 & now until June 30, 2019.
Conditions for splitting 7
 The initial MRP/DCP should be finalised;
 Different MAHs in the different MS are a prerequisite for the splitting.
Splitting into several lines is only possible per different MAHs.
 The new RMS(s) have to be CMS in the MRP/DCP before. They have to
agree to act as new RMS in the split procedure;
 Splitting is allowed only once in the lifecycle of a product; splitting into
several lines (i.e. more than two RMS) is allowed.
 All regulatory procedures have to be completed before the splitting
can take place;
 It is not acceptable to split single strengths of a procedure to a new
RMS. Example:
XX/H/9999/001/DC: CMS = MS1, MS2, MS3, MS4
XX/H/9999/002/DC: CMS = MS1, MS2, MS3, MS4, MS5
A split of the procedure 002 alone would only be possible for splitting MS5
out and MS5 becoming the new RMS.
Procedure for Splitting 8

 The proposed procedure for splitting should be sent by

the MAH via email (see email addresses listed in
Annex) to the current RMS and proposed new RMS
with a request for splitting and it should contain the
following information:
CTS status for splitting 9

 In case of agreement between old and new RMSs, the old RMS
introduces the splitting in CTS by using the splitting function.
 The new RMS(s) will issue new procedure number(s) and inform
the old RMS, who includes it in CTS and informs the MAH and the
new CMS(s) accordingly.
 For the splitting request and all communication during the
splitting procedure specific email addresses should be used that
are listed in the annex.
 The RMS of the initial procedure will keep the previous procedure
number but the CMS(s) that are switched to the new procedure
will no longer be involved in the initial procedure from the CTS
product sheet. Both procedures will remain as active procedures
in CTS.
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 The current RMS provides the new RMS with the PAR in word
format, if applicable.

 The package leaflet should be updated at the time of the next

variation/notification affecting the package leaflet to update
the list of product names in section 6.

 Variations of the newly created lines with new RMS and new
procedure number should be submitted starting with the
sequential number XX/H/nnnn/vvv /001.
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 In case of eCTD submissions, each procedure will afterwards be

handled in its own dossier lifecycle.

 The existing eCTD lifecycle should continue for the existing (old)
procedure number with the existing dossier UUID.

 A new eCTD lifecycle should be created for each new procedure

number, by either copying the existing eCTD dossier with all
sequences to a new eCTD dossier and assign a new dossier UUID
(preferred option);

 or generating a new baseline (0000) from the existing eCTD

lifecycle and assigning a new dossier UUID for this new dossier;
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 No regulatory activities are allowed during the splitting of the

procedures.
 In case all conditions as mentioned above are considered by
the applicant the splitting procedure as such should be
finalized by old and new RMS within 30 days after the
application.
 Fees for this procedure are a national issue.
Splitting Procedure time 13

table
14
Merging 15

 Merging is to merge standalone MRP/DCPs (within the

same or a different RMSs) and the respective MAs into a
single DCP

 In specific situations the merging of several parallel

MRPs or DCPs belonging to the same or different MAHs
helps in the handling of post-authorisation procedures
such as renewals or variations for the Marketing
Authorisation Holder.
Conditions for Merging 16

 The initial MRP/DCP should be finalised.

 One of the existing RMS will become the new RMS and has
to agree to this new role;
 All member states may have only one licence in the new
merged procedure, i.e. duplicate licences in the MS have
to be withdrawn before the merger;
 During the pilot the merging is only possible for former
duplicate procedures/dossiers;
 In case these former duplicates have developed differently
they have to be harmonised by using variation or
worksharing procedures in advance of the merger. The
identity of the dossiers before the merger has to be
confirmed by the MAH(s);
 Merging and/or splitting is allowed only once in the lifecycle
of a product
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 The choice of MR or DC procedures for merging in the pilot is to

be submitted by all Industry associations in a table
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 It was decided that the CMDh will collect the 10 pilot
procedures during the CMDh meeting in March 2016 and will
discuss and decide on these procedures
 In case of agreement, the “new” RMS will inform the MAH and
CMS about the outcome by email.
 The MRP or DCP number of the “new” RMS is kept for the
merged procedure.
 The new CMS will be added in the CTS product sheet by the
RMS.
 The package leaflet should be updated at the time of the next
variation/notification affecting the package leaflet to include
the product names in the new CMS(s) in section 6.
 During the pilot procedure the MA number will remain the
same.
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In case of eCTD submissions, the MAH will continue with the

sequence numbering of the existing dossier of the kept procedure
number. Any country-specific documents of the new CMS(s)
should be transferred to this eCTD at the time of submission of the
next regulatory activity.
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General information for pilot
 The CMDh regards the merging/splitting as a purely administrative
procedure
 National MA numbers: CMDh working document confirms that
retaining national license numbers possible; should be maintained
if pilot formalised
 CMS NCA confirmed no further action was required but RMS NCA
required additional confirmation of cancellation of CMS licenses
in their original procedure; if this is a requirement could this be
included in the administrative dossier to streamline process
 CMS will be transferred (merged/splitted) into the new procedure
number.
 Administrative process handled by (old and new) RMS in CTS.
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 No need for MAHs to contact RMS, RMS will contact MAH in case
of questions

 No additional data is necessary, the given confirmation of identical

dossiers in case of merger is trusted.

 RMS will inform MAHs and CMS when merging/splitting is

completed.

 Fees are national issue. In pilot phase probably no fees are raised
but maybe afterwards in permanent handling when this causes an
increased workload.
 Guidance 22

 CMDh Working Document on Merging and Splitting of

MRP/DCPs -
Doc. Ref.: CMDh/343/2015, Rev.0 , December 2015

 CMDh extension of the pilot for splitting of procedures

January 2019
CMDh/354/2017, Rev.5
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Thank you for your

attention