Principles and Practice of Pharmaceutical Medicine

The EMEA will validate the dossier within
10 working days. The project manager will consult
with the Rapporteur or Co-rapporteur for the need
for GMP and GCP inspections, necessity for anad
hocexpert group and so on. The applicant provides
any additional information, on request, within a
specified time limit. If the application is found
valid, the applicant is notified in writing and a
timetable for the evaluation is set. However, if the
dossier is found severely deficient, the applicant
will be requested to either collect it or indicate
whether it should be destroyed by the EMEA. In
the latter case, the EMEAwill retain part of the fee
(less for an abridged application) as an adminis-
trative charge, but otherwise return the application
fee.

Scientific evaluation

The CHMP renders its scientific opinion with an
overall deadline of 210 days. The Rapporteur and
Co-rapporteur prepare draft assessment reports
during the first 70 days, and send them to the
CHMP, the EMEA secretariat and the applicant.
After exchange of comments and opinions between
the Rapporteurs and the CHMP, a collated list of
questions is sent to the applicant by day 120. The
review clock is stopped at this point, and restarts
with the applicant’s response. If the applicant
believes that more than six months are needed to
answer the list of questions, then the application
should be withdrawn.
On the day when written responses are received
the review clock restarts with day 121. The Rap-
porteurs assess the responses, and submit their final
assessment report by day 150. The final assessment
is again sent to the CHMP, the EMEA and the
applicant. CHMP members have until day 170 to
file any comments. Outstanding issues are dis-
cussed at a CHMP meeting by day 180.
If any unresolved issues remain at this stage,
then the CHMP or the applicant can request a
meeting for oral explanation. The review clock is
stopped (usually not for more than a month), so that
the applicant can prepare for this meeting.
After the oral explanation the clock is restarted
at day 181. The applicant sends the final draft

SmPC, package leaflet and labeling (revised as

needs may be) to the Rapporteurs, the CHMP and

the EMEA. The CHMP adopts a final opinion,

either positive or negative, by a single majority

vote at a CHMP meeting on or before day 210.

In case of a positive opinion, between days 210

and 240, the applicant prepares the final SmPC and

labeling in all the 22 required languages. Between

days 240 and 300 the European Public Assessment

Report (EPAR) is finalized in agreement with the

applicant. The EPAR is published, after the Com-

mission decision, on the EMEA web site.

A negative opinion may be subject to appeal.

The EMEA informs the applicant of the reasons for

an unfavorable conclusion and provides details on

the divergent opinions of the CHMP members (if

any). The applicant then has 15 days within which

to notify an intent to appeal to the EMEA. The

detailed grounds for the appeal must then be pro-

vided within 60 days, and the applicant may also

request a meeting at the CHMP to provide justifi-

cation for the appeal. The CHMP may or may not

appoint new Rapporteurs, and within 60 days of the

receipt of the grounds for appeal will consider

whether the opinion can be revised. No meeting

is granted within this 60-day time frame. During

the appeals process, no new study can be presented,

and a revised opinion may only be issued concern-

ing the same data as originally presented.

Decision-making procedure

The European Commission (or when relevant the

Council) converts the scientific opinion of the

EMEA into a legally binding decision for the

MS. In this last phase of the CP the Commission

is assisted by its Standing Committee of Medicinal

Products, whose members, appointed by MS,

receive the documents. The draft decision must

occur within 15 days of receipt of the EMEA

opinion (Regulation 726/2004), and is forwarded

to MS and the applicant. Verification of the draft

decision must then be completed in 22 days.

A MS may still raise objections to the Commis-

sion’s draft decision, and ask for a meeting of the

Standing Committee of Medicinal Products. If the

objections identify important issues not addressed

462 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION