Principles and Practice of Pharmaceutical Medicine

Pre-submission activities

Four to six months before a planned CP submission
the applicant has to notify the EMEA of the inten-
tion to file an application and provide an estimate
for the date of submission. The notification should
include information on the product (a draft SmPC),
the legal basis for the application (whether com-
plete or abridged), proposal for classification for
supply, justification for request of MA using the
CP, information on manufacturing and batch
release arrangements that may be linked to pre-
authorization inspections, the proposed product
trade name and a stated preference regarding Rap-
porteur and Co-rapporteur (see below).
Only one trade name can be proposed within the
CP (unlike for the MRP, see above), although a
second may exceptionally be permitted when there
is good reason to show that a single name cannot be
used throughout the EU. Trade name proposals can
be submitted to the EMEA even 12 months before
filing the application, in case of any doubt on this
point, where they are evaluated by the Name
Review Group (NRG), which will check with
national authorities whether the name may be mis-
leading for its therapeutic use or could otherwise
generate confusion, create safety problems or
offend against local antipromotional regulations.
The NRG ignores anyaspect relating to intellectual
property rights. CP applications without suitable
trade names can be filed using a generic or chemi-
cal name, together with the name of the manufac-
turer.
Pre-submission meetings are held with the
Agency, primarily to receive advice on preparing
a submission in compliance with procedural, reg-
ulatory and legal requirements. These meetings are
also an important opportunity to establish a good
working relationship with the personnel who will
handlethe application and, in particular, theproject
manager who will coordinate all the review activ-
ities.
Next, three to four months before submission,
the CHMP will appoint the Rapporteur and Co-
rapporteur. These are the members of the CHMP
who will be responsible for the scientific assess-
ment of the dossier. The preference of the appli-
cant, the specific expertise of CHMP members and

the overall workload distribution among the

CHMP members are taken into account for the

appointment of the Rapporteurs. The sponsor can-

not appeal these appointments.

Submission and validation of the dossier

The submission date should be agreed with the

EMEA and planned in such a way as to match,

following the predefined review schedule, with

CHMP meetings. The applicant must submit one

full copy of the dossier, two copies of Module I

(including the draft SmPC). The proposed labeling

must be submitted in each of the 22 official lan-

guages of the EU plus Norwegian and Icelandic.

This information is also submitted in electronic

format. For EMEA applications, the dossier is

first validated, and then identical copies are sent

to the Rapporteur and Co-rapporteur (see below).

The Agency will not begin validating the applica-

tion until receipt of its fees.

Applicants for a MA must have a legal represen-

tative resident within the EU. Furthermore, the

application must identify persons with the follow-

ing responsibilities (including relevant addresses

and phone numbers):

QP for pharmacovigilance

A responsible person for scientific communica-

tions and in overall charge of the information on

the product

QP responsible for batch release and contact

person for product defects and recalls

If the application is for a product containing

or consisting of genetically modified organisms

(GMOs), then it is also required to provide

evidence that the relevant competent authorities

approve of the use of the GMO for this research

and development purpose and

the complete technical dossier for the GMO

itself (per Directive 2001/18) together with the

environmental risk assessment.

34.8 PRODUCT REGISTRATION 461