Application; Chapter 2, Mutual recognition, Rev.
3.1, June 2004).
To start an MRP, the applicant requests an
assessment report of the dossier on which the
MA has been granted, or the updatingof an existing
report from the licensing authority. Then the appli-
cant requests the RMS to send the report to the
CMS; the assessment report should be made avail-
able within 90 days. Possible changes and addi-
tions to the original dossier should be processed
through the variation procedure. If a large volume
of data is involved, a suitable timetable should be
agreed with the competent authority of the RMS.
The applicant then submits the dossier to the
CMS. The application must be accompanied by a
declaration that all the dossiers filed as part of the
procedure are identical, including the SmPC. The
SmPC is the fundamental document on which
mutual recognition is based. The applicant also
informs the EMEA that MRP is started, but a
full dossier is only sent to the EMEA in case of
arbitration.
In all cases, the appropriate fees for the national
applications must be paid and all necessary trans-
lations provided, at the time of the MRP submis-
sion. Chapter 7 of the Notice to Applicants
provides, for each MS, the administrative details
such as number of hard copies of the dossier,
specified languages, samples of active substance
and finished product, electronic formats and so on.
Each CMS submits the application to a check-in
validation procedure, and the MRP starts when the
dossier is found valid and the assessment report has
been sent to CMS. The MA granted by the RMS
should be recognized within 90 days.
By day 50 of the procedure, CMS must commu-
nicate any objections to the RMS and the sponsor.
The sponsor is allowed to discuss his position
verbally or in writing. Objections are only per-
mitted for major concerns for public health (see
European Commission, 2005), and arbitration to
the community should be an exception to the gen-
eral rule of mutual recognition. The MS who fail(s)
to recognize the MA must provide an in-depth
justification of its position, also indicating what
could be done to correct the identified deficiencies.
The sponsor is not allowed to present additional
studies during the procedure; however, it is accep-
table to present additional data from studies
already included in the dossier.
If by day 90, disagreements have still not been
resolved, the matter may be referred to the EMEA
for arbitration.
The applicant is entitled to withdraw the appli-
cation in any particular MS, and so avoid arbitra-
tion. It must be noted, though, that after withdrawal
of the application from a CMS, no independent
national application in that MS is permitted.
Whenever an arbitration procedure is initiated,
the result is a decision by the European Commis-
sion, with the same pathway as for the CP (see
below). The CHMP reaches its opinion, and if nega-
tive, the applicant has the opportunity to present an
appeal, after which the Commission makes the final
decision. The Commission’s decision is binding on
the RMS and all the CMS involved, and must be
implemented within 30 days of issuance. Beginning
November 20, 2005, these Commission decisions
are being made publicly available. Any CMS that
had previously approved the RMS assessment
report, the SmPC and the labeling can, at the request
of the applicant, authorize the product within its
territory without waiting for the outcome of the
arbitration procedure. Nonetheless, if the arbitration
procedure leads to a negative outcome, then this
national approval must be revoked within the
30-day implementation period. MS should set off
the MRP on receipt of a national application for a
product that has already been approved in another
MS (Article 18, Directive 2004/27). After the
90-day agreements CMS should grant the national
registration within 30 days. Experience shows that
there are often substantial delays.
The MRP has several advantages. The processing
timeforapplicationsisrelativelyrapid,andthereare
several elements of flexibility for the applicant
(choice of RMS and CMS, and provision of a draft
report). The MRP also allows for approvals to
include different trade names in different countries
for the same product, unlike the CP (see below).
Furthermore, the MRP can be activated repeatedly
and incrementally, so as to gradually expand the
product application into increasing numbers of
MS. It should be noted, however, that MS can differ
in their recognitions in classification for supply
(prescription-only, over-the-counter, etc.).34.8 PRODUCT REGISTRATION 459