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For medicinal products for human use, the EMEA plans to implement electronic-only
submission of applications for marketing authorisation with electronic Common Technical
Document (e-CTD) as the required format. The EMEA currently accepts electronic only
submissions in e-CTD or another format. From July 2009 use of e-CTD format will be
strongly recommended by the Agency 90 .
6.7 Submission and validation of the application dossier
The date and time of delivery of the dossier to the EMEA should be arranged between the
applicant and the EMEA. Target dates for submission for human 91 and veterinary
medicinal products 92 are published on the EMEA website.
If the original indicated submission date cannot be met, the applicant should immediately
inform the EMEA, Rapporteur and Co-Rapporteur. A delayed submission can have
consequences for already planned activities of the assessment teams of the Rapporteurs
and Co-Rapporteurs.
The EMEA will check if the application meets all relevant legal (procedural) EU
requirements (‘validation’), before the start of the scientific evaluation. The EMEA will
issue an invoice on the date of the notification of the administrative validation to the
applicant, and fees will normally be payable within 45 days of the date of the said
notification. For SME applicants, a deferral of the fee payment may be granted (see
Section 2.3)
6.8 Evaluation of the application
Once the application is validated, the EMEA starts the evaluation procedure at the
monthly starting date published on the EMEA website. The EMEA will ensure that the
evaluation is finalised within 210 days (less any clock-stops for the applicant to
provide a response to questions from the CHMP/CVMP).
The procedure can be summarised as follows:
In the first evaluation phase, the Rapporteur and Co-Rapporteur prepare assessment
reports on the application within 80 days (85 days for veterinary products). The
assessment reports are sent to all other CHMP/CVMP members for comment. Following
discussion of the assessment reports, the CHMP/CVMP usually adopts a “list of
questions”, identifying ‘major objections’ and/or ‘other concerns’, which will be sent to
the applicant by day 120. The Rapporteur and Co-Rapporteur then assess the applicant’s
response (second evaluation phase), submit them for discussion to the CHMP/CVMP and,
taking into account the conclusions of this debate, prepare a final assessment report
which also includes the draft SmPC, labelling and package leaflet. Once the evaluation is
completed within the 210 days, the CHMP/CVMP adopts a favourable or unfavourable
opinion on whether to grant the authorisation.
A more detailed standard timetable for the evaluation of an application in the
centralised procedure is provided below:
DAY
1
80
(85 Vet)
100
90
ACTION
Start of the procedure
Receipt of the assessment report(s) from Rapporteur and Co-Rapporteur(s) by
CHMP/CVMP members and EMEA.
Rapporteur, Co-Rapporteur, other CHMP/CVMP members and EMEA receive
comments from members of the CHMP/CVMP.
http://esubmission.emea.europa.eu/
http://www.emea.europa.eu/htms/human/submission/submission.htm
http://www.emea.europa.eu/ – Veterinary Medicines – Regulatory Guidance - ‘Pre-Submission Guidance’
© EMEA 2009
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