AMM Template 7.1 - ANSM

incandescentnonBiotechnology

Dec 10, 2012 (4 years and 6 months ago)

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NOTICE TO APPLICANTS

FOR MARKETING
AUTHORISATIONS FOR M
E
DICINAL PRODUCTS FOR

HUMAN
USE*



REVISION :
DECEMBER

201
1


TRACK
ING

CHANGES

GENERAL INFORMATION

PRACTICA
L RECOMMENDATIONS FO
R SUBMISSION OR SEND
ING

Electronic

submission

Copies A and B

Copy C


PAYMENT OF FEES

Payment by cheque

Payment

by bank transfer


REQUEST FOR INFORMAT
ION

Regarding
marketing

authorisation application

Regarding variation application




TERMS OF SUBMISSION

INFORMATION RELATIVE

TO THE PROGRESS OF T
HE PROCESSING
OF DOSSIERS


LETTER TEMPLATES AND

DOWNLOADABLE FORMS



143/147, bd Anatole France


F
-
93285 Saint
-
Denis cedex


tél. + 33 (0) 1.55.87.30.00
-

www.afssaps.sante.fr



REQUEST FOR FRANCE A
CTING AS THE REFEREN
CE MEMBER
STATE IN A PROCEDURE

P
re
-
submission form
:

MRP
:


FR
/
EN

DC
P
:

cm
dh_036_2009_rev0_request_form.doc




Submission cover letters

o

Electronic submission

FR
/
EN

o

Paper submission

FR
/
EN



Electronic submission form

EU
-
NeeS
/
eCTD



Application identification form

FR/
EN



Payment transmission form

FR
/
EN



*

This notice to app
licants also applies to herbal
medicinal products

subject to registration.

.

PRESENTATION OF THE
SUBMISSION


ELECTRONIC SUBMISSIO
N


ELECTRONIC SUBMISSIO
N (EU
-
NEES/
e
CTD)



Electronic submission form

EU
-
NeeS
/
eCTD


PAPER SUBMISSION

Marketing Authorisation Application



Variation, Renewal,…


Additional

dossiers


CONTENTS

IN FORCE FOR APPLICATIONS RECEIVED

BY
AFSSAPS
UNTIL

3
1
-
12
-
2
011.


Notice to Applicants


December

2011

CONTENTS

TRACK
ING

CHANGES

GLOSSARY

GENERAL INFORMATION

................................
................................
................................
................................
....

1

REQUEST FOR FRANCE A
CTING AS

THE

REFERENCE

MEMBER STATE

IN A PROCEDURE

.........

2

TERMS OF SUBMISSION

................................
................................
................................
................................
.......

3

1


PRESENTATION OF THE
SUBMISSION

................................
................................
................................
.......

3

1.1. ELECTRONIC SUBM
ISSION

................................
................................
................................
................................

4

1.
1.1.

Content and format of the electronic CTD: harmonised European recommendations

............................

4

1.1.2.

Conditions specific to the computer admissibility of an electronic submission to AFSSAPS
................

5

1.1.3. Documents constituting an electronic submission to AFSSAPS

................................
...............................

6

1.1.4. Additional dossiers (response to questions, additional reques
t, etc.)

................................
.......................

7

1.1.5. Translation proposal

................................
................................
................................
................................
........

8

1.2. PAPER SUBMISSIO
N

................................
................................
................................
................................
...........

8

1.2.1.

Initial application for Marketing Authorisation

................................
................................
..............................

8

1.2.2. Variation, renewal, etc.

................................
................................
................................
................................
.....

9

1.2.2.1. DMIs (national variations)

................................
................................
................................
.............................

9

1.2.2.2.

Applications for MA transfer, change of company name and holder/"exploitant"/manufacturer

.........

9

1.2.3. Additional dossier
s (response to questions, additional request, etc.)

................................
.......................

9

1.2.4. Translation proposal

................................
................................
................................
................................
........

9

1.2.5. Additional CD

................................
................................
................................
................................
..................

10

1.3. POSSIBLE SWITCH

OF TYPE OF SUBMISSIO
N IN POST
-
AMM
................................
................................
....

10

2


PRACTICAL RECOMMENDA
TIONS FOR SUBMISSION

OR SENDING

................................
.............

10

2.1.

Address for sending an electronic submission

................................
................................
..........................

10

2.2.

Address for sending a paper submission
................................
................................
................................
....

11

2.2.1.

Copies A and B (every type of dossier)

................................
................................
................................
.......

11

2.2.2.

Copy C (marketing authorisation application or variation application on pharmaceutical quality)

......

11

3


PAYMENT OF FEES

:

IN

FORCE

FOR

APPLICATIONS

RECEIVED

BY

AFSSAPS

UNTIL 3
1
-
12
-
2011

................................
................................
................................
................................
................................
.......

11

3.1. Payment by cheque (made out in euros)

................................
................................
................................
........

12

3.2. Payment by bank transfer (in euros)

................................
................................
.....

Error! Bookmark not defined.

INFORMATION RELATIVE

TO THE PROGRESS OF T
HE PROCESSING OF DOS
SIERS

....................

13




Notice to Applicants


December

2011


TRACK
ING

CHANGES


Version

N
r

D
ate

Description of changes

01

JULY

2008

Added information
since

version 2003
:



El
ectronic submission



Information

rela
tive

to the progress of the processing of the
dossier



Variations concerning Holder and/or "
Exploitant
"



Distribution by project manager
and therapeutic class (
DARP/GESPARE
)



Letter

templates


02

SEPTE
MB
E
R

2008

Information which has been mod
ified

since version July 2008
:



Distribution by project manager
and therapeutic class (DARP/GESPARE
)

03

AP
RIL 2009

Information which has been modified

since version September 2008
:



Information relative to the progress of the processing of the dossier



Distribution by project manager
and therapeutic class (DARP/GESPARE
)

04

SEPTEMBER

2009

Information which has been modified

since v
ersion April 2009
:



GLOSSARY



GENERAL INFORMATION



Request for France acting as the reference member state in a procedure

(modification
of the forms
)



Terms o
f s
u
bmission
:

o

1.

Pre
sentation
of the s
u
b
mission

o

1.1.

Electronic submission

o

1.1.1.

Content and format of the electronic CTD
:
harmonised European
recommendations


o

1.1.2.

Conditions
specific to the computer

admissibility of an

electronic
submission

to
AFSSAPS



S

-
s散瑩潮s″ ‴ 㔠5nd

6



S畢
-
s散瑩潮



䍯C灵瑥物s敤
V慬id慴a潮
(敃e䐠潲

乥敓)


o

1.3

Possibl
e switch of type of submission in

post
-
AMM



Number of paper copies of the dossier
:
table
s 1 to

4



E
lectronic submission

form
:
NeeS

and

eCTD



Payment transmission form


05

MAY 2010



Payment of fees

o

3.2

Payment

by bank transfer

(
in euros
)

o

F
orm

of submission identification

(
FR
/
EN
)

o

Payment transmission form

06

NOVEMBER 2010



Sub
-
section 8. Computerised Validation
(eCTD or NeeS)



A
nnexe 11

cancelled
:
user guide validator available via hypertext link
.



Terms of su
bmission

:

o

1.

Presentation

of

the

su
b
mission



2


PRACTICAL RECOMMENDATIONS FOR SUBMISSION OR SENDING

(opening hours)


07

DÉCEMBRE 2011



Fees

o

3


Payment of fees

o

Pay
ment transmission form




In force for applications received by Afssaps until 3
1
-
12
-
2011
.



Distribution by project manager
and therapeutic class (DARP/GESPARE
)








Notice to Applicants


December 2011

1

This glossary has been drawn up from the terms used in the European texts relative to electronic submission.

i

GLOSSARY
1

Regulatory Activity

Object of the s
ubmission for a dossier, particularly a new marketing authorisation application, type IA, IB or II
variation, periodic safety update report (PSUR), renewal, or follow
-
up measure (as part of
drug safety
assessment after the marketing authorisation is grante
d).

Application (type of)

Characterisation of the object of the submission defined by the regulatory activity, for example new chemical
entity or extension to the range/different strength, or new pharmaceutical form for a new marketing
authorisation applic
ation, extension of indication or
variation application of

section 4.6 of the Summary of
Product Characteristics (SPC) for a type II variation, etc.

DMI (request for modification of information)

National variation application
of the information regarding t
he pharmacological and clinical data of the
marketing authorisation.

Dossier

The dossier contains together all information submitted in support of the application in compliance with the
recommendations of the CTD (Common Technical Document) published by th
e European Commission.

eCTD (electronic CTD)

Electronic submission in which the information provided in support of the application complies with the structure
and file formats of eCTD

(refer to section
1.1.1
).

EU
-
NeeS (Eur
opean Union Non eCTD electronic Submission)

Electronic submission in which the information provided in support of the application complies with the structure
and file formats of EU
-
NeeS

(refer to section
1.1.1
).

Envelope

Sp
ecific to the eCTD format, this dossier contains around ten pieces of structured information specific to the
product and the application (full name, applicant, regulatory activity, type of application, procedure number,
etc.).

Linked Modifications

When a m
ain modification entails, by its nature, one or more other modifications, they are deemed to be linked.

Therefore, all these modifications
putting together

form
a single regulatory activity and the modifications are
submitted
in

one
dossier

only

(refer to
the section
1.2.2.1
).

The applicant should justify
that the modifications are linked
.

Sequence


Specific to the eCTD
format, a sequence corresponds to a submission whereby the numbering is defined as
follows: 0000 first s
ubmission, 0001 second submission, etc. Generally the 0000 sequence corresponds to the
marketing authorisation application and the subsequent sequences to variation applications, PSUR or renewal.
Nevertheless, it is possible to adopt the eCTD format during

the product life cycle, for example upon a major
variation.




Notice to Applicants


December 2011

1

This glossary has been drawn up from the terms u
sed in the European texts relative to electronic submission.


Submission


A submission corresponds to all (simultaneous) application(s) submitted by a company. The submission may
concern several products; the documentation common to all these applicatio
ns is then submitted within the

framework of a single submission.

Electronic submission

Submission in which the CTD information provided in support of the application is submitted on an electronic
support, following the harmonised European recommendations
for file formats and tables of contents (refer to

section
1.1.1
).

Validator

The
validator

is a t
ool
which is
freely download
able

since the AFSSAPS website

at the following address
:

http://www.afssaps.fr/Previsu/Constitution
-
de
-
dossier
-
d
-
AMM/(offset)/0#paragraph_20749

This tool allows the applicant

check
the
conformity

of the electronic submission
according to
the criteria
specified

in the European
guidelines
:

structure,
naming conventions
, format
and

PDF
file
version
.

V
alidation
report

The validation
report
is a document generated from the
validator
and the electronic submission
.
The
report is
one

of
the requested
documents

that must be
attached

to the
electronic submission.
However
, it
does not
imply
the
acceptance of the
electronic
submission.

WORM (Write Once Read Many)

Support informatique non ré
-
inscriptible





Notice to Applicants


December

201
1


1

GENERAL INFORMATION

This notice to applicants for marketi
ng authorisations
for medicinal products for

human use amends and
replaces the one published in January 2003. It is available on the AFSSAPS website
(
http://afssaps.sante.fr/pdf/3/avammfr.pdf
)

and sp
ecifies the practical terms for submission of marketing
authorisation application dossiers in France and those submitted after the marketing authorisation.

Moreover, this notice also includes the form which has to be sent to AFSSAPS by companies wishing to

submit
a marketing authorisation application through the mutual recognition and decentralised procedures, with France

acting as the Reference Member State.

With regard to the terms of submission, the standard CTD (Common Technical Document) format for
pre
sentation of the marketing authorisation application dossier is common to
all Member States

of the
European Economic
Area, both for

applications assessed within the framework of European procedures
(mutual recognition procedure, decentralised procedure and

centralised procedure) and national applications.
The description of the format and the content of the dossier is available on the website of the
Enterprise and
Industry DG of the European Commission at the following address
:

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm
.


The applicant must refer to the texts published by the European Commission within the framework of
“Regulation of medicinal pro
ducts in the European Community, volumes IIA and IIB


Notice to applicants for
marketing authorisations for medicinal products for human use in the Member States of the European
Community”, (Eudralex, volume 2, Pharmaceutical Legislation: Notice to Applic
ants).

These documents, published by the European Commission, are available on the website of the
Enterprise and
Industry DG of the European Commission at the address

mentioned above.

This document does not apply to the centralised procedure nor Referral
procedures, for which
information is available at the following addresses:

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol
-
2/a/chap4rev200604%
20.pdf

http://emea.europa.eu

Initially, it is stated that any submission to AFSSAPS relative to the marketing authorisation must comprise the
following documents:



original of the submission cover letter
(
paper submis
sion

FR
/
EN

;
electronic submission

FR
/
EN
) ;



3 copies of the submission cover letter
;



2 paper copies

of
the application identification form for the paper or electronic submission
(
FR
/
EN
) ;



2 paper copies

of the validation report ("best
-
report") in case of e
lectronic submission;



corresponding

fees, accompanied

by the
payment transmission form

;
in the event of bank transfer,
notification of transfer, in the event of payment by cheque, the cheque itself;



copy of the cheque or not
ification of transfer, included in the dossier as proof of payment
;



the full dossier in a
number of copies

in accordance with the

type of application and the support chosen for
the submission
;



where applicable, an addit
ional CD containing the proposed appendices I (SPC), II, IIIA (Labelling) and
IIIB

(Package Leaflet) in French for

national procedures (see section
1.1.3
) ;



and in the event of electronic submission, the electronic submissi
on form

(
EU
-
NeeS
/
eCTD
).

Furthermore, these documents must be provided simultaneously and
INDIVISIBLY
.

All the documents should be sent at this following address only:

AFSSAPS/DEMEB/DORIS/ Unité Recevabilité AMM

(voir

rubrique
2.
)

Any
incomplete submission (absence of at least one of the expected documents) shall give
rise to a request for modification. A company that does not produce the r
equested elements
within the time frame given by AFSSAPS shall be deemed to have withdrawn its application.


Detailed information relative to:



the presentation of the submissions;



the practical recommendations of submission or sending;



the payment
of fees;

are specified respectively in sections
1
,
2

and

3
.


Notice to Applicants


December

201
1


2

Concerning homeopathic medicinal products subject to registration or marketing authorisation, this notice
compl
etes the explanatory notice describing the content and layout of the

dossier, and the practical terms for
submission of the dossiers, available on the AFSSAPS website:
http://afssaps.sante.fr/htm/3
/indavmed.htm
.

Furthermore, this notice specifies the terms of
how companies

can obtain
information relative to tracking the
progress of the processing of marketing authorisation or variation application doss
ier
.

REQUEST
FOR FRANCE
ACTING
AS

THE

REFERENCE

MEMBER STATE


IN

A

PROCEDURE


When a company requests

a Marketing Authorisation A
pplication with France acting as the reference member
state
,
it is asked to send its application to the Director of the Direct
ion de l’évaluation des médicaments et des
produits Biologiques (DEMEB)
.

This request is accompanied
by
one of the following forms:



Mutual recognition

procedure
:

FR
/
EN



Decentralised
procedure:

the form is available at the following address
:
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Temp
lates/MA_Application/CMDh_036_
2009_Rev0_Request_Form.doc


The option for AFSSAPS to start a European procedure with France as reference Member State is assessed
with regard to the provisional schedules of activity linked to all marketing authorisation pro
cedures.



Notice to Applicants


December

201
1


3


TERMS OF SUBMISSION

1


PRESENTATION OF THE
SUBMISSION

Two methods of submission regarding a marketing authorisation or a post
-
marketing authorisation application
are accepted at AFSSAPS:



“Paper” submission,

accompanied by the submission of the

Common Technical Document (CTD)
*

modules concerned on paper support, remains available for all types of application. One or more electronic
supports (CD or DVD) containing all or part of the dossier
must

also be provided in addition to the paper.
However,

the reference dossier is the dossier on paper support (see section
1.2
).



“Electronic” submission,

accompanied by the submission of the CTD
*

modules concerned
on electronic
support
only
, is accepted:

o

In the case of an EU
-
Nee
S
,
exclusively

for the following regulatory activities:



new

applications,



type II variations,



periodic safety update report
(PSUR) submitted only within the framework of the drug safety
assessment after the marketing authorisation is granted.



any MRP appli
cation submitted by at least one European Union Member State

not involved
in the
first
use

and concerning a M
arketing
A
uthorisation

granted within the European Union whether
France

is
RMS or CMS

(
a start of a Mutual Recognition Procedure with France as Re
ference
Member State

and
"R
epeat use
"
)
,



renewals
.

o

In the case of an eCTD:

The first submission should be one of the regulatory activities mentioned above (in case of an EU
-
NeeS). Whatever the regulatory activity concerned, the eCTD format should be used fo
r the submission.


o

When the size of the
dossier
exceeds

one
double
-
layer

DVD
,
the
eCTD
format
only
is
accepted and
it

must not be zipped

(
see section

1.1.2.)
.

The practical details of electronic submission are detailed in s
ection
1.1

below.


For electronic submission, it is prohibited to submit some or all of
the modules on paper support.



For any request for information relative to the terms of electronic submission, please send an email to:


info.esoumission@afssaps.sante.fr


















*
I
ncluding «

mock
-
up

» proposals according to article 5121
-
25 of

Code de la Santé Publique



Notice to Applicants


December

201
1


4


1.1. ELECTRONIC SUBM
ISSION

The

electronic submiss
ion

is accepted by AFSSAPS for

the
dossiers

submitted

in national, mutual recognition
or

decentralised procedures

and

the
regulatory activities mentioned above
.

In the case of an EU
-
NeeS
, no regulatory activity other than these mentioned above may be subje
ct to EU
-
NeeS submission.

In the case of an eCTD
, once one of the regulatory activities mentioned above has been subject to electronic
submission in eCTD,
AFSSAPS will accept any later submission in eCTD, regardless of regulatory activity
concerned.

1.1.1.

Content and format of the electronic CTD: harmonised European recommendations

Two types of organisation of the CTD on electronic support exist in the European Union and are accepted by
AFSSAPS: eCTD and EU
-
NeeS. Both have common specifications throughout
the European Union and
AFSSAPS does not accept any other electronic file formats.




eCTD organisation


The format and content of the eCTD have been defined by the ICH (International Conference on
Harmonisation) and are therefore common and harmonised in th
e United States, Japan and the European
Union, with the exception of module 1 for which the content relates to regional specificities (Application
Form and product information proposals).

Data in the CTD modules concerned must be provided in
PDF

1.4 for t
he text parts. In the absence of
absolute impossibility, PDF must be generated from an electronic file (not scanned) and in "
OPEN
" format
that is to say
not protected by
a password and not encrypted.

This is
strongly recommended

for:

o

the part relative to
the Environmental Risk Assessment of module 1,

o

module 2,

o

the body of the core study reports of modules 4 and 5.


A limited number of specific formats is accepted for pictures, SAS output
: PDF, JPEG, PNG, SVG, GIF,
SAS*, RTF, XML

The eCTD is characterised
by the additional presence of two files in XML format:

o

a general and navigable index of the file,

o

an envelope with structured data which define the product and the submission.

For further information, refer to the following websites:


E
U
-
NeeS g
uidance



h
ttp://
esubmission.emea.europa.eu/doc/NeeS eGuidance Document version 2.0.pdf

eCTD guidance



http://www.emea.europ
a.eu



http://estri.ich.org/eCTD/index.htm



http://
esubmission.emea.europa.eu/doc/eCTD
Guidance Document 1.0 FINAL FOR
PUBLICATION.pdf




EU
-
NeeS organisation


This file structure
is common to all European Union
. The harmonised specifications are available on the
website of the European Medicines Agency (EMEA) at the following address:



http:
//
esubmission.emea.europa.eu/doc/NeeS eGuidance Document version 2.0.pdf

Similarly, the data of the modules concerned of the CTD must be provided in PDF 1
.4 for the text parts. In
the absence of absolute impossibility, PDF must be generated from an electronic file (not scanned) and in
"
OPEN
" format that is to say not protected by a password and not encrypted.

This is strongly recommended for:

o

part relative
to the Environmental Risk Assessment of module 1,

o

module 2,

o

body of the core study reports of modules 4 and 5.


Notice to Applicants


December

201
1


5

The EU
-
NeeS structure differs from that of the eCTD only in the absence of the general index and
envelope files.

Navigation within the dossier m
ust consequently be based on the presence of electronic
tables of contents navigable via bookmarks and hypertext links.

It is mandatory to provide tables of contents in PDF format according to the following three fixed levels:

1.

A general table of conten
ts of the file


Obligatorily

called
ctd
-
toc.pdf
, this table of contents is a general

one
.

2.

Individual tables of contents for each module


Each of these tables of contents must make it possible to link the entries to the files concerned via
hyperlinks.

3.

Individual table of contents of the document


Each document must contain bookmarks linking each entry with the files concerned via hyperlinks.

With regard to the file names, the conventions recommended by ICH must
imperatively
be followed


for
EU
-
NeeS:

see

ICH, eCTD spe
cification v3.1, "naming conventions"
http://estri.ich.org/eCTD/index.htm
.


1.1.2.

Conditions specific to the computer admissibility of an electronic submission to
AFSSAPS

In addition
to the ICH, eCTD and EU
-
NeeS recommendations, AFSSAPS has defined specific conditions as
follows:


1.

Regulatory activity
:

o

In the case of EU
-
NeeS
, the regulatory activity must
exclusively

be one of the following:



marketing authorisation applications,



type
II variations (clinical data) (sections 4 and 5 of the SPC),



PSURs submitted only within the framework of the clinical safety assessment after the marketing
authorisation is granted.


o

In the case of eCTD:

Where one of the three regulatory activities mentio
ned above has been subject to an initial electronic
submission in eCTD, AFSSAPS will accept any later submission in eCTD, regardless of regulatory
activity concerned. However, it is currently recommended that these later eCTD submissions concern
marketing
authorisation applications (extensions to the range), type II variations (clinical data) and
PSURs.

2.

The SUBMISSION must be made in
ONE COPY ONLY
.

3.

Optimisation of the number of WORM disks

is mandatory:

The

«

multi supports

»
submission are accepted
i
n case of

eCTD

only
.

o

If total file size is < 650 Mb: one single CD
-
R.

o

If total file size is < 650 Mb and
< 4.7 Go
: one single DVD
-
R or DVD+R.

o

Beyond a
n

unzipped double
-
layer
DVD
,
submission

in eCTD

only will be accepted.

o

If total file size is


4.7 Go
:
one

or more double
-
layer
DVD
-
R o
r

double
-
layer

DVD+R
(
as necessary and
identified by a
Nr

X/Y,
e.g.
1/2 or

2/2)

submission in eCTD only will be accepted.

In a general way, the rule is as follows:


All data of the dossier must be recorded
onto one single WORM d
isk

that cannot be re
-
written
and

clearly identified

(
EU
-
NeeS
/
eCTD
)

and
in one copy only
. The burning session must be
closed.

For further details, refer to the electronic submissio
n form
(
EU
-
NeeS
/
eCTD
)
.

Use one or more

double
-
layer DVDs
,
only when the dossier
exceeds

the capacity of one
DVD.


Notice to Applicants


December

201
1


6

4.

A submission must
refer to

one
procedure number only

and
must
contain

one regulatory activity only
.


5.


If several identical applications concern different products and correspond to different strengths and/or
different pharmaceutical forms of the same product and if the documentation is
shared
, it is pos
sible:

o

either to submit them within the structure of one single common dossier
:



M1
with as necessary
"applicat
ion form"
files and

"Information produc
t"
files as of strengths and
pharmaceutical forms
,



common

M2
to M5
;

o

or to submit
separately

one full dossie
r

for each strength or pharmaceutical form (one support per
strength
/
pharmaceutical form
).


Whatever the
chosen
solution will be
,
this solution should be
imperatively

followed

for the
upcoming

submission
.
The

structure "Parent/Child"

is not accepted
.


6.

U
nder any circumstances, the burned files must not be zipped or compressed or .exe files, and the burning
session must
imperatively be closed.

7.

The content of the submission must be complete as described in section
1.1.3.

below.


8.

Computerised v
alidation
(eCTD or

NeeS)

All

the
electronic submission
s

are

submitted to
a computerised

validation
performed

by
AFSSAPS
according to the criteria
specified

in the European guidelines

(
PDF file version
, structure,
naming
conventions
, MD5
for
eCTD)
.
If any error is reported, t
he electronic submission will be rejected due to the
non electronic compliance
.

In order to produce
an
electronic submission in compliance
,
a
validator

is at the disposal
of

the

applicants:

o

the
validator

is free
ly downloadable since the

AFSSAPS

website at the following address
:

http://www.afssaps.fr/Previsu/Constitution
-
de
-
dossier
-
d
-
AMM/(offset)/0#paragraph_2074
9
;

o

the
validator

is the result of the European harmonisation work on the validation criteria and

has been
developed by Extedo in partnership with European national agencies and EMA using the software
Review EURS is yours

o

this validator

must

be used by th
e applicant to test the compliance of the electronic submission
;

o

the applicant will
submit

an electronic submission to the
AFSSAPS
only if the
validation

report
("validation
report"
)

has not
identify

error
(
s
)
;
see more information on the tested criteria a
nd conditions
of acceptance in

the guidance how using the validator available on the website of the AFSSAPS
;

o

the applicant is required to
imperatively
enclose

the validation report
with
the submission; the validation
report is one of
the
mandatory document
s
;

o

the attendance

of the

validation

report

doesn't imply the whole and definitive acceptance
of the
submission.


Any submission not respecting these 8 prerequisites shall give rise to a
request for modification. Any company not complying with the time fra
me
given by AFSSAPS shall be deemed to have withdrawn its application.



1.1.3. Documents constituting an electronic submission to AFSSAPS

1.

C
oncerned
CTD modules on electronic support only

(paperless)



Refer to the references to reproduce on the disk in

appendix

EU
-
NeeS
/
eCTD
).

2.

AFSSAPS form for electronic submission

A single paper form per submission (regulatory activity), duly completed, must be attached
(see

appendix

EU
-
NeeS
/
eCTD
).


Notice to Applicants


December

201
1


7

3.

O
riginal of the submission cover letter



A single letter per regulatory activity specifying:



whether it relates to an eCTD or an EU
-
NeeS;



the sequence num
ber, if the submission is in eCTD format;



for an eCTD, the
full summary

of the regulatory activities and sequence numbers previously
submitted to AFSSAPS for one or more products concerned by the submission;



the number of supports and corresponding serial
numbers:
the serial number

of the CD, DVD or
double
-
layer DVD, written on the centre of the disk,
must be visible and legible
;



confirmation that the application is submitted in a single copy;



confirmation that the burning session has been closed;



confirmat
ion that the support has been subject to a negative virus scan before submission.

A template letter is available in appendix
FR
/
EN
.

4.

Three

copies

of the submission cover lett
er.

5.

For national procedure applications, an additional CD clearly separated and identified


For national procedure applications, supported by a proposal of appendices (I (SPC), II, IIIA (Labelling)
and IIIB (Package Leaflet)), it is requested to system
atically add one file per product in Word format,
style sheet, Template 7 (template available on the website
http://afssaps.sante.fr/htm/3/indavmed.htm
).

N.B. for each product, the proposed app
endices (I

(SPC), II, IIIA
(Labelling) and IIIB (Package Leaflet)) must constitute only one
single file in Word format, style sheet, Template 7 (template
available on the website:

http://afssap
s.sante.fr/htm/3/indavmed.htm
).

Thus, the CD must contain as many files as products concerned by
the submission.


Refer to the references to reproduce on the
additional CD

in appendix 6.

6.

Fees accompanied by the payment transmission form
(cf. appendix 8
-
FR

or 8
-
EN
)


The terms of payment are specified in
chapter 3
.

7.

Application identification form
(cf. appendix 7
-
FR

or
7
-
EN
)


8.

Two

paper copies of the
validation
report ("validation
report")


http://www.afssaps.fr/Previsu/Co
nstitution
-
de
-
dossier
-
d
-
AMM/(offset)/0#paragraph_20749


All of these documents must be sent, under the following terms, to:


AFSSAPS / DEMEB / DO
RIS/
Unité

RECEVABILITE AMM

Electronic submission

(eCTD/
EU
-
NeeS
)

143
-
147 BOULEVARD ANATOL
E FRANCE

F
-
93285 SAIN
T
-
DENIS CEDEX


Under no circumstances may the electronic submission give rise to a request for obtaining
additional

disk or paper copies when the submission has been considered
as

admissible

on

a

computer and an

administrative basis.


1.1.4. Additional dos
siers (response to questions, additional request, etc.)

Any additional file has to be submitted on the same supports and formats as those of the initial submission:



eCTD submission


new sequence according to the recommendations specified in section
1.1

(electronic
submission form
(
EU
-
NeeS
/
eCTD
)) ;



EU
-
NeeS submission


new EU
-
NeeS according to the recommendations specified in section
1.1

(electronic submission form
(
EU
-
NeeS
/
eCTD
)).


Notice to Applicants


December

201
1


8

1.1.5. Translation proposal

Within the framework of mutual recognition or decentralised proc
edures, translation proposals must be
transmitted within 5 days of the end of the European procedure
:



by email, to the email address of the project manager identified according to the therapeutic class
concerned (refer to the
flow chart

in appendix);



by post, sent in 1 copy to the DEMEB/Department of Regulatory Affairs and Management of Marketing
Authorisation Procedures (DARP), Registration Procedures and European Affairs Unit (GESPARE unit).

The subject of the emai
l must specify the name of the product, the procedure
number and the dossier code
(NL

type).

Electronic files are to be provided in Word format, style sheet, Template 7 (template available on the website:
http://www.afssaps.fr/Previsu/Constitution
-
de
-
dossier
-
d
-
AMM/(offset)/0#paragraph_20749
)
.



1.2.
PAPER SUBMISSION

1.2.1.

Initial application for Marketing Authorisation



The applicant is bound to provide
several copies
(both sides recorded
)

of the marketing authorisation
dossier intended for the assessment and archiving. The number and constitution of the paper copies to be
provided are specified in tables
1
,

2

and

4

in appendix.



Ideally,

all

documents must be
bound
,
either heat
-
bound or with “spiral binding”.



These copies are to be labelled "A", "B" or "C":

o

Copy "A"
is the copy of the dossier for archiving and it cont
ains all modules. It must be presented in
boxes labelled “Copy A”. It is intended for the
Direction de l'évaluation des médicaments et des produits
biologiques (DEMEB)
.

o

The two "B"

copies
of the dossier are used for the
as
sessment

and are presented in boxes labelled
“Copy B1” and “Copy B2”.
They are intended for the

Direction de l'évaluation des médicaments et des
produits biologiques (DEMEB)
.
Additional copies of some modules may be reques
ted
only in the case
of paper submission
(see tables
1
,

and

2

in appendix).

o

Copy "C"
is the file intended for the
Direction des Laboratoires et des Contrôle
s (DLC).

It
contains

modules 1, 2 and 3 (CTD format) of the dossier.



Upon simultaneous applications, it is possible to simplify the presentation of the dossiers submitted on
paper for national, mutual recognition and decentralised procedures:

o

for simultan
eous applications which concern several identical products and for which the regulatory
basis is the same:



only one full dossier has to be submitted,



in the application letter and in modules 1 and 2 of the other dossiers, reference must be made to
the subm
itted documentation of the first dossier. The names of all products concerned must be
mentioned on the cover page of each of the common volumes (modules 3, 4 and 5).

o

for simultaneous applications which concern several products containing the same active su
bstance(s),
presented under different strengths and/or different pharmaceutical forms:



only one full dossier has to be submitted,



in the application letter and in modules 1 and 2 of the other files, reference must be made to the
submitted documentation of
the first dossier. All strengths and/or pharmaceutical forms must be
mentioned on the cover page of each of the common volumes (modules 4 and 5).

The number and constitution of the paper copies to be provided are specified in table
2

appended.


Notice to Applicants


December

201
1


9

1.2.2. Variation, renewal, etc.

For
each variation or renewal application
, or any additional document submitted during the procedure, the
applicant is bound to provide the number of paper copies mentioned in table
3

appended.

1.2.2.1. DMIs (national variations)

For requests for modification of information (DMIs), in paper submission and regarding clinical safety data in
national procedures, the files must be presented as follows:



in the case of a non
-
linked mo
difications
, it is necessary to submit as many dossiers as modifications,
along with the corresponding forms and fees;



in the case of linked modifications
, it is necessary to submit a single dossier per product or for a range of
products based on the same
active substance, all modifications requested setting together; the laboratory
must specify, in the cover letter, the scientific argument justifying the link between the modifications.
Corresponding fees and, where appropriate, the form for each product ha
ve to be attached to the dossier.
All strengths and/or pharmaceutical forms must be mentioned on each cover page.

1.2.2.2.

Applications for MA transfer, change of company name and
holder/"exploitant"/manufacturer

In the case of a variation application conc
erning requests for MA transfer, change of company name and
holder/"exploitant"/manufacturer, the presentation of the applications submitted on paper in national procedures
may be simplified (refer to table
5

appended).


1.2.3
. Additional dossiers (response to questions, additional request, etc.)

Any additional file must be submitted under the same support and format as those of the initial submission:



paper support


paper addition (application identification form
(
FR
/
EN
)
) ;

Response files
:



These must be subject to the same methods of submission as for the initial application (see chapter
1

and
tables

1
,

2
,

3

and

4

in appendix).



In case of email exchanges giving rise to the sending of a file, a paper copy of the said file must be
sys
tematically submitted for archiving, accompanied by a letter specifying “single copy for archiving”.


1.2.4. Translation proposal

Within the framework of mutual recognition or decentralised procedures, translation proposals must be
transmitted within 5 day
s of the end of the European procedure
:



by email, to the email address of the project manager identified according to the therapeutic class
concerned (refer to the
flow chart

in appendix);



by post, sent in 1 copy to

the DEMEB/Department of Regulatory Affairs and Management of Marketing
Authorisation Procedures (DARP), Registration Procedures and European Affairs Unit (GESPARE unit).

The subject of the email must specify the name of the product, the procedure number a
nd the dossier code
(NL

type).

Electronic files are to be provided in Word format, style sheet, Template 7 (template available on the website:

http://ww
w.afssaps.fr/Previsu/Constitution
-
de
-
dossier
-
d
-
AMM/(offset)/0#paragraph_20749
).



Notice to Applicants


December

201
1


10

1.2.5. Additional CD

For national procedure applications, it is recommended to systematically add one file per product containing the
proposed appendices (I (SPC), II, IIIA (
Labelling) and IIIB (Package Leaflet)) in Word format, style sheet,
Template 7 (template available on the website:
http://www.afssaps.fr/Previsu/Constitu
tion
-
de
-
dossier
-
d
-
AMM/(offset)/0#paragraph_20749
.


N.B. for each product, the proposed appendices (I

(SPC), II, IIIA
(Labelling) and IIIB (Package Leaflet)) must constitute only one file
in Word format, style sheet, Template 7 (template available on the
w
ebsite:
http://www.afssaps.fr/Previsu/Constitution
-
de
-
dossier
-
d
-
AMM/(offset)/0#paragraph_20749

.

Thus, the CD must contain as many files as products con
cerned by
the submission.


1.
3
.
POSSIBLE
SWITCH

OF TYPE OF SUBMISSIO
N

IN

POST
-
AMM


Switch from one type of submission to another is possible
.
However
, the switch should

meet all the
requirements described

in appendix

(
EU
-
NeeS

or

eCTD
).


2


PRACTICAL RECOMMENDA
TIONS FOR SUBMISSION

OR SENDING

The procedure type, procedure number, application type, dossier code (NL type), CIS code, ATC code, and the
contact details of the person respons
ible for the dossier within the company, are to be specified in the subject of
the submission cover letter
(
paper submission

FR
/
EN

;
electronic submission

FR
/
EN
).

In all cases, whether it relates to a marketing authorisation application or a post
-
marketing authorisation dossier
(variation, renewal, etc.) including the additional files, t
he application identification form
(
FR
/
EN
)
must be duly
completed and attached to every cover letter sent in order to facilitate the administrative processing

of the case
within AFSSAPS. It is recommended that this form is affixed to the boxes or envelopes.

In the case of a submission, contact:



the marketing authorisation admissibility unit, situated on the ground floor at the rear of the main building,



From No
vember 2, 2010, opening hours are 08:00 a.
m.

to

05:
00

p.m.

Monday to Friday
(with no
i
nterruption)
.

Before any large delivery

(over twenty parcels),
notify the Marketing Authorisation Admissibility Unit
at
least 10 days before the planned delivery date, by

fax on 33 (0)1 55 87 33 11.

All volumes of a dossier must be submitted on the same day
(no splitting of the application).

2.1.

Address for sending an electronic submission

Applications submitted electronically (eCTD, EU
-
NeeS) are to be sent, in accordance

with the following
terms

to:

AFSSAPS / DEMEB / DO
RIS/
Unité

RECEVABILITE AMM


Soumission électronique (eCTD/EU
-
NeeS)

143
-
147 BOULEVARD ANATOL
E FRANCE

F
-
93285 SAINT
-
DENIS CEDEX


Notice to Applicants


December

201
1


11

2.2.

Address for sending a paper submission

2.2.1.

Copies A and B (every type
of dossier)

Dossiers of marketing authorisation applications (copies
A

and

B
) and dossiers submitted after the marketing
authorisation is granted (variation, renewal, etc.) are to be sent
si
multaneously and indivisibly

to:

AFSSAPS / DEMEB / DORIS / Unité Recevabilité AMM

143
-
147 boulevard Anatole France

F
-
93285 SAINT
-
DENIS Cedex


2.2.2.

Copy C (marketing authorisation application or variation application on pharmaceutical
quality)

Copy C of t
he dossiers must be sent to one of the following addresses:


Blood
-
derived drugs, allergens, medicines
originating from biotechnologies and proteins,
homeopathic medicines, herbal medicines

AFSSAPS

Direction des Laboratoires et de Contrôles

Unité Logistiq
ue

143


ㄴ㜬TB潵lev慲搠An慴潬攠䙲a湣e

c
-
㤳㈸R⁓A䥎f
-
䑅义k⁃ 摥x

䵥dicin慬 灲潤畣瑳 ⁣桥mic慬 潲楧i渠

AcppAmp

䑩r散瑩o渠n敳⁌ 扯r慴潩r敳 整e摥s⁃潮瑲ôl敳

啮rtéo杩sti煵e

㘳㔬Rru攠e攠e愠䝡a敮湥

c
-
㌴㜴0⁖b乄A則啅p

s慣ci湥s 潲⁩mm畮潬潧ic敤ici湡l⁰牯摵
c瑳


AcppAmp

䑩r散瑩o渠n敳⁌ 扯r慴潩r敳 整e摥s⁃潮瑲ôl敳

pit攠ee⁌y潮

啮rtéo杩sti煵攠eci敮tifi煵e

㌲ㄬN慶敮u攠e敡n
-
g慵r

c
-
㘹㜰0⁌vlk




Notice to Applicants


December

201
1


12


3


PAYMENT OF FEES


Every application relative to a marketing authorisation (MA a
pplication, renewal or variation) must be
accompanied by payment of fees in compliance with the legislation in force (see
payment transmission form
)
.

It is stated that fees must be paid for each
marketing authorisation or post
-
marketing authorisation application
.
Consequently, there must be fees attached to the application for each marketing authorisation concerned by
the application.

The terms of payment are identical regardless of the support for submission.

3.1. Payment by ch
eque (made out in euros)



Draw up the cheque(s) (made out in euros) payable to the Accounts Officer of AFSSAPS
and obligatorily
attach it to the original of the cover letter

(see
General Information
) accompanied by the
payment
transmission form
.



For homeopathic
medicinal products subject to registration or marketing authorisation, a payment
transmission form specific to these medicinal products is available on the AFSSAPS website:

http://afssaps.sante.fr/htm/3/indavmed.htm
.



The amount of the cheque(s) and the payment transmission form must correspond to the legal basis of the
application (Module 1 of the application), the number of strengths
, pharmaceutical forms, etc.

3.2. Payment by bank transfer (in euros)



Draw up the
bank transfer
(s) (made out in euros) payable to the Accounts Officer of AFSSAPS
and
obligatorily attach it to the original of the cover letter

(see
General Information
) accompanied by the
payment transmission form
.



T
he notif
ication of transfer (in euros)
must

obligatorily

specify
:

Concerning
new application
:
name of the applicant of the Marketing Authorisation
,
medici
nal product

name
,
type
of submission

(
new application
)
and

procedure number in case
of
a
European procedure
dossier
.

Concerning
modifications
and

renewal
:
name of the holder of the Marketing Authorisation,
medicinal product

name,
type of submission
,
NL cod
e and

procedure number in case of a European procedure dossier
.

Bank references of the AFSSAPS account (RIB / IBAN)
:

TRESORERIE GENERALE
DE LA SEINE SAINT
-
DENIS

13 ESPLANADE JEAN MO
ULIN

93009 BOBIGNY

Bank code:

10071

Sort code:

93000

Account n°: 000010007
37 Rib key 51

IBAN code: FR76 1007 1930 0000 0010 0073 751

BIC/SWIFT code: BDFEFRPPXXX

It is stated that bank charges
related
to the transfer
are
payable by the
ordering company
.

In both cases, the Accounts Agency will return a copy of the payment transmis
sion form, as proof of registration
of the payment, to companies that enclose
a stamped addressed envelope

for this purpose.

Under no circumstances may the fees be transferred from one application to another.

Any request for reimbursement relative to a ma
rketing authorisation application must be duly justified, either
through an obvious error by the applicant, or if the dossier is incomplete with regard to the legislation in force.

A request for reimbursement must be made within a period of one month of su
bmission in the event of obvious
error, and within a period of one month of a request by AFSSAPS for missing information when the dossier is
incomplete.

The request must be sent to the General Director of AFSSAPS.

Fees may only be reimbursed if assessment
of the dossier has not begun.

IN FORCE FOR APPLICATIONS RE
CEIVED BY
AFSSAPS UNTIL 3
1
-
12
-
2011
.


Notice to Applicants


December

201
1


13


INFORMATION RELATIVE

TO THE PROGRESS OF T
HE PROCESSING OF DOS
SIERS

Companies may get information regarding the state of progress of the dossiers submitted:



for marketing authorisation applications
in the following context:

o

from the 100
th

day after assessment in national procedures;

o

after the end of the European assessment phase in mutual recognition and decentralised
procedures.

To this end,
telephone support

(working days only and preferably in French language) is offered f
rom
2

p.m.

to
4 p.m.

on
33

(0)1 55 87 37

3
7:



Thursdays
for applications relative to generic medicinal products in national procedure ;



Mondays and Wednesdays
for any other marketing authorisation application.



for clinical variation application
:

Information

on the state of progress of clinical variation applications, according to the therapeutic class,
may be obtained from the project managers of the Department of Regulatory Affairs and Management of
Marketing Authorisation Procedures, Registration Procedure
s and European Affairs Unit (GESPARE unit).
For the distribution of the therapeutic classes allocated to each project manager, refer to the
flow chart

in
appendix.



for pharmaceutical variation application
:

Informati
on on the state of progress of pharmaceutical variation applications may be obtained:

o

for chemical substance, homeopathic and herbal medicinal products: from the
"Département de
l'Evaluation de la Qualité Pharmaceutique"

-

DEMEB,

o

for biological substance:

from the
"Département de l’Evaluation des Produits Biologiques"

-

DEMEB.


Notice to Applicants


December

201
1


14


TABLEAU 1

Number of paper copies of the dossier

To facilitate the treatment of the
dossiers,
in addition to the paper copies, it is recommended
to submit one CD containing the Word

files corresponding to the different

modules. T
he
Word

files should be

ordered in the same way as

the structure

of the
dossier.


MARKETING AUTHORISATION APPLICATION

National, mutual recognition and decentralised procedures


Copy

A

Archiving

Copies

B

Asse
ssment

Copy

C

Control

Additional B Copy(s)

Total number of
copies

A

+ B

C*

Module 1

1

2

1







1

Module 2

1

2

1







1

Module 3

1

2

1



扩ol潧ic慬敤ici湡l
灲潤畣瑳㨠:



桥r扡l敤ici湡l
灲潤畣瑳

**:





桯m敯灡瑨ic敤ici湡l
灲潤畣瑳㨠

ㄠ1敲⁴ype

潦⁳瑲慩n

5

5

1

1

Module 4

1

2

0

The applicant must be able
to provide additional copies
on request.

3

0

Module 5

1

2

0

The applicant must be able
to provide additional copies
on request.

3

0

*Paper copy "C" is to be sent to the
Direction des Laboratoires et des Contrôles (DLC).

Modules 1, 2 and 3 of
the application must be included.

** These requirements also apply to herbal medicinal products subject to registration.

For a start of a Mutual Recognition Procedur
e, with France as Reference Member State (first wave or repeat
-
use procedure), a full and updated dossier must be submitted (see
table 1
).


Notice to Applicants


December

201
1


15


TABLEAU 2

Number of paper copies of the dossier

To facilitate the treatment
of the dossiers, in addition to the paper copies, it is recommended
to submit one CD containing the Word files corresponding to the different modules. The
Word

files should be ordered in the same way as the structure of the dossier.


MARKETING AUTHORISATIO
N APPLICATION: case of simultaneous applications for
identical products or with a same active substance and same regulatory basis
1

2


National, mutual recognition and decentralised procedures


A

Archiving

B

Assessment

C

Control

Additional B
Copy(s)

Total
number of
copies

A

+ B

C*

Initial application

Full dossier

(see
table 1
)


Each
simultaneous

application (
identical

strength and pharmaceutical form)
2 3


Module 1

1

2

1



17

20

1

Module 2

1

2

1



17

20

1

Modu
le 3

1

0

0



0

1

0


Each
simultaneous

application (
different

strength and pharmaceutical form)
3


Module 1

1

2

1



17

20

1

Module 2

1

2

1



17

20

1

Module 3

1

2

1



0

3

1







1

Called “dupl
icate/multiple applications”


2

Make reference in the application letter and in modules 1 and 2 to the documentation submitted for the first application. Al
l strengths
and/or pharmaceutical forms must be mentioned on the cover page of each of the common v
olumes (modules 3, 4, and 5)
(see section
2).


Notice to Applicants


December

201
1


16


TABLEAU 3


Number of paper copies of the dossier


DEMANDE DE MODIFICATIONS d’AMM,
PSUR, Renouvellement

Procédure nationale, de
mutual recognition
, décentralisée

Type of application

Letter
1

original
+

number of
copies

Copy

A

Archiving

Copies

B

Assessment

Copy

C

Control

Total number
of copies

Variation application

1 + 3

1

2

1*

3 (+ 1*)

PSUR

1 + 2

1

1

0

2

Renewal in European
procedure

1 + 4

1

3

0

4

Renewal in national
procedure: simplified
dossier**

1 + 3

1

each module

and readability
user testing
must be
separated

1

each module
and readability
user testing
must be
separated

0

2

Re
newal in national
procedure: consolidated
dossier **

1 + 5

1

each module
and readability
user testing
must be
separated

1

each module
and readability
user testing
must be
separated

0

2

*
For all applications affecting the pharmaceutical documentation, c
opy “C” is to be sent to the

Direction des
Laboratoires et des Contrôles (DLC).

** Content of the marketing authorisation renewal application dossier in national proc
edure, specified by ruling
of
May

6,

2008 regardi
ng marketing authorisation renewals.


Notice to Applicants


December

201
1


17


TABLEAU 4


Number of paper copies of the dossier


ADDITIONAL FILE: National Procedure

Type of application

Letter
1

original
+

number of
copies

Copy

A

Archiving

Copies

B

Assessment

Total number of
copies

Response to

Notification of Negative

opinion
(following a variation application)

1 + 3

1

2

3






Response to "projet de rejet" or
"Mesure d'instruction" or any other
response document







general case

1 + 4

1

3

4



homeopathy/herbal medicinal
products

1 + 5

1

4

5

ADDITIONAL FILE:
Mutual recognition and decentralised procedures


Letter
1

original
+

number of
copies

Copy

A

Archiving

Electronic documentation
for

assessment


(ONLY if
the
initial
application has been
submitted

in paper

format
)

Document of responses
to questions

1
*

+ 1

1



1 courriel à envoyer à
ueurop
@
afssaps.sante.fr



4 CD



*
For any submission of document of responses to questions, it should be
specified
, on the cover letter,
that this
single paper cop
y «

A

» has been the subject of a

previous
email or CD

and that this
paper copy "A" takes up
the

same documentation.




Notice to Applicants


December
201
1

18

TABLEAU 5

Unité modification


Transfer of marketing
authorisation holder (art.
R 5121
-
46 of the FPHC)

Change of name and/or
address of t
he marketing
authorisation holder

Change of
“exploitant”

(art.
R.5121
-
41 and
R.5124
-
2, 3° of the
FPHC)

Change of name and/or
address of the
“exploitant”(art.

R.5121
-
41 and R.5124
-
2, 3° of
the FPHC)

Co
-
distribution
(art.

R.5121
-
41 and
R.5124
-
2, 3° of the
FP
HC)

1.

Type of additional activity


Type IA variation




2.

Content of the dossiers



1 cover letter per NL or
for all NLs concerned,
sent by the future
marketing authorisation
holder, explaining the
current situation and the
new situation proposed.



Payment tran
smission
form



Administrative
identification form



Name and address of
the future marketing
authorisation holder,
those of the
“exploitant”and the
manufacturer (where
neither the future
marketing authorisation
holder nor the
“exploitant” undertakes
the manuf
acture)



Name of the product,
and its composition



SPC



A copy of the marketing
authorisation, certified
by the holder;



The agreement of this
holder to the transfer of
the marketing
authorisation;




1 cover letter per NL or
for all NLs concerned,
sent by the marketing
authorisation holder



Variation form



A formal document from
a relevant official body
(e.g
. Chamber of
Commerce) in which
the new name or new
address is mentionned



Payment transmission
form



Administrative
identification form



1 cover letter per
NL or for all NLs
concerned, sent by
the marketing
authorisation
holder, explaining
the current situat
ion
and the new
situation proposed,
with information
about a French
-
speaking
representative (if
possible) and his
telephone number if
the proposed
“exploitant” is not
based in France.



Payment
transmission form



Administrative
identification form



Current
ph
armaceutical site
authorisation



Letter stating that
the “exploitant”
complies with the
marketing
authorisation
dossier






1 cover letter per NL
or for all NLs
concerned, sent by the
marketing
authorisation holder,
explaining the current
situation and the new
situation proposed



Payment transmission
form



Administrative
identification form



Current
pharmaceutical site
authorisation
mentioning the new
company name and/or
the new address, o
r a
formal document from
a relevant official body
(e.g. Chamber of
Commerce) in which
the new name or new
address is mentionned



Letter stating that the
“exploitant”complies
with the marketing
authorisation dossier



Copy of the marketing
authorisation



Draft

amended
marketing
authorisation



1 cover letter per NL
or for all NLs
concerned, sent by the
marketing
authorisation holder,
explaining the current
situation and the new
situation proposed
with the division of
operations by each
entity and with
information

about a
French
-
speaking
representative (if
possible) and his
telephone number if
the proposed
“exploitant”is not
based in France.



Payment transmission
form



Administrative
identification form



Current
pharmaceutical site
authorisation



Letter stating that t
he
”exploitant”(s) comply
with the marketing
authorisation dossier



Copy of the marketing
authorisation




Notice to Applicants


December
201
1

19


Transfer of marketing
authorisation holder (art.
R 5121
-
46 of the FPHC)

Change of name and/or
address of t
he marketing
authorisation holder

Change of
“exploitant”

(art.
R.5121
-
41 and
R.5124
-
2, 3° of the
FPHC)

Change of name and/or
address of the
“exploitant”(art.

R.5121
-
41 and R.5124
-
2, 3° of
the FPHC)

Co
-
distribution
(art.

R.5121
-
41 and
R.5124
-
2, 3° of the
FP
HC)



The designation of the
manufacturing, control
and packagin
g sites;



The applicant’s
agreement to submit to
all conditions to which
the marketing
authorisation has been
subject and, notably, to
respect the methods of
manufacture and
control;



Draft new labelling and,
if specified, instruction
Package Leaflet;



Curr
ent manufacturing
authorisation(s);



A formal document from
a relevant official body
(e.g. Chamber of
Commerce)





Special cases for
mergers/acquisitions.



And, where applicable:

-

Reports of the controls
performed by the applicant
with respect for the said
methods;

-

The preparation formula,
notably with all useful
indications as to the
recipient;







Copy of the
marketing
authorisation



Draft amended
marketing
authorisation



Draft amended
marketing
authorisation


Notice to Applicants


December
201
1

20


Transfer of marketing
authorisation holder (art.
R 5121
-
46 of the FPHC)

Change of name and/or
address of t
he marketing
authorisation holder

Change of
“exploitant”

(art.
R.5121
-
41 and
R.5124
-
2, 3° of the
FPHC)

Change of name and/or
address of the
“exploitant”(art.

R.5121
-
41 and R.5124
-
2, 3° of
the FPHC)

Co
-
distribution
(art.

R.5121
-
41 and
R.5124
-
2, 3° of the
FP
HC)

3.

Schedule

Silence after 60 days from
the date of receipt of the
application is valid as
authorisation

Silence aft
er 30 days from
the date of receipt of the
application means that the
holder may make the
modification

Silence after 90 days
from the date of
receipt of the
application means that
the holder may make
the modification

Silence after 90 days
from the date of
receipt
of the application means
that the holder may make
the modification

Silence after 90 days
from the date of receipt
of the application means
that the holder may make
the modification

4.

Fees

€ 1011

/NL

€ 1011 for the variation
application

€ 1011

/NL

€ 1011

/NL

€ 1011

/NL

5.

AFSSAPS unit in charge:
case monitoring


-
chemical products



Modification Unit (DEMEB)




-
biological products

Unit for Biotechnology
-
based and Biological
Medicines (DEMEB)




-
herbal and homeopathic
medicines
:

Ad Hoc Units (DEMEB)


-

chemical products



Admissibility Unit
(DEMEB) if national, or
Modification Unit (DEMEB)
if MRP

-

biological products

Admissibility Unit
(DEMEB) if national or

Unit
for Biotechnology
-
based
and B
iological Medicines
(DEMEB) if MRP


-

herbal and
homeopathic medicines
:

Ad Hoc Units (DEMEB)


-

chemical products



Modification Unit
(DEMEB)



-

biological products

Unit for Biotechnology
-
based and Biological
Medicines (DEMEB)




-

herbal and
homeopathic
medicines
:

Ad Hoc Units
(DEMEB)







-

chemical products



Modification Unit
(DEMEB)



-

biological products

Unit for Biotechnology
-
based and Biological
Medicines (DEMEB)




-

herbal and
homeopathic
medicines
:

Ad Hoc Units (DEMEB

-

chemical products



Mod
ification Unit
(DEMEB)



-

biological products

Unit for Biotechnology
-
based and Biological
Medicines (DEMEB)




-

herbal and
homeopathic
medicines
:

Ad Hoc Units (DEMEB)



Notice to Applicants


December
201
1

21


Transfer of marketing
authorisation holder (art.
R 5121
-
46 of the FPHC)

Change of name and/or
address of t
he marketing
authorisation holder

Change of
“exploitant”

(art.
R.5121
-
41 and
R.5124
-
2, 3° of the
FPHC)

Change of name and/or
address of the
“exploitant”(art.

R.5121
-
41 and R.5124
-
2, 3° of
the FPHC)

Co
-
distribution
(art.

R.5121
-
41 and
R.5124
-
2, 3° of the
FP
HC)

6.

Number of copies

3

3

3

3

3

7.

Situation according to
registration procedures

National v
ariation

Depends on the
registration procedure

-
national or MRP

National variation

National variation

National variation

8.

Modification:
SPC/Package
Leaflet/Labelling
(importance for market
access)

Decision to transfer which
impacts the SPC/Package
Leaflet/
Labelling

Modification SPC/Package
Leaflet/Labelling

Modification Package
Leaflet

/Labelling

Modification Package
Leaflet

/Labelling

Modification Package
Leaflet

/labelling

9.

Time frame for industrial
installation


in/out phase


Without delay, as far as
po
ssible at the end of the
calendar (cf.

point

3)

Without delay, as far as
possible at the end of the
calendar (cf.

point

3)

Without delay, as far
as possible at the end
of the calendar
(cf.

point

3)

Without delay, as far as
possible at the end of the
calend
ar (cf.

point

3)

Without delay, as far as
possible at the end of the
calendar (cf.

point

3)






DEMEB, DARP, GESPARE, Distribution by partner and by therape
utic class

Notice to Applicants


December
201
1


22

TABLEAU 6


DEPARTMENT OF REGULATORY AFFAIRS AND MANAGEMENT OF MARKETING AUTHORISATION PROCEDURES

MANAGER: France Rousselle (33 (0)1 55 87 32 89)

UNIT FOR MANA
GEMENT OF MARKETING AUTHORISATION PROCEDURES AND EUROPEAN LEGISLATION



Manager: Alban Dhanani 33 (0) 1 55 87 32 95



Project Man
agers: distribution by
partner

and therapeutic class

Anne Laurent

33 (0) 1 55 87 32 80

Christelle Véchot

33 (0) 1 55 87 32 96

Franç
oise
Guyard

33 (0) 1 55 87 32 85

Julie Duvernois

33 (0) 1 55 87 33
4
1

Annick Njonga

33 (0) 1 55 87 33 07

Emilie Alliez

33 (0) 1 55 87 33 46

Mathilde

Geynet


33 (0) 1 55 87 33 04

Mouna Houdon

33 (0) 1 55 87 32 90

Sylvie Meheut

33 (0) 1 55 87 33 73

Cardiol
ogy

Converting enzyme
inhibitor
s

(non associated

/i
n association)

Antiarythmics

Class

I

and

III

Thrombosis

Platelet aggregation
inhibitors

(
except he
p
arin)
Enzymes

Streptokinase i
n
association


SNC


Anti
-
epileptic drugs
Anti
-
Parkinson’s drugs

Anti
-
migrain
e drugs

Drugs used in the
treatment of dementia

Anti
-
psychotics

Botulinum toxins

Nootropics

Anti
-
vertigo drugs

Seasickness prevention
drugs

Analgesia

Hypnotics and sedatives

SNC


Muscle relaxants

Anaesthetics

Anxiolytics

Antidepressants

Psycho
-
stimulants

Drugs used in the
treatment of
dependence

Drugs used in the
treatment of multiple
sclerosis

Cardiology


Thrombos
is

Oncology


Respiratory
diseases


Antibiotics



Diabetes






Ophthalmology


ENT







Diabetes

(
centralised

procedure
)

Radiopharma
-
ceutic
als

Rheumatology


Antidotes

Immunology

Haematology

Transplants

Anti
-
fungals

Anti
-
virals

Anti
-
fungals

Gynaecology


Blood
-
derived
products



Stomatology


Vaccines


AIDS

Hepatic diseases


Gastro
-
enterology

Endocrinology


Urology
-

Haemodialysis







Perfus
e
solutions


Dermatology

Orphan
diseases
-

metabolic


e
-
mail: firstname.surname@afssaps.sante.fr (no accents, no cedillas)


Notice to Applicants


December
201
1

Demandeur

:
................................
................................
................................
.............................






Date :




Demande pour
engager

une
P
rocédure de
Reconnaissance Mutuelle

avec

la

France

comme Etat m
embre de référe
nce




NOM DU MEDICAMENT PROPOSE EN FRANCE :

<>


SUBSTANCE(S) ACTIVE(S) :

<>


Procédure

Procédure de
Reconnaissance Mutuelle


Date prévisionnelle
soumission


Classification pharmacothérapeutique,
code

ATC


Forme pharmaceutique et dosage


Nombre de dem
andes / AMM

copies
(duplicates)


Etat
s
membres concernés



Base légale de la demande


Médicament

de référence en France


Date de première autorisation de mise sur le
marché du
médicament

de référence en
France


Nom et adresse du demandeur


Personne e
n charge du dossier au cours de

la
procédure


Nom et adresse du producteur de substance
active


La

référence
se fera
-
t
-
elle
à un DMF ou un
CEP ?


Fabricant du médicament et site de
fabrication



Nom et adresse du fabricant responsable de
la libération

des lots dans l'
E
EE


Existe
-
t
-
il

des autorisations de mise sur le
marché pour cette subs
tance active dans
d'autres Etat m
embres ?


Si oui, préciser dans quels Et
at m
embres et
s'il existe des différences majeures entre les
rubriques 4.1, 4.2 et 4.3 du RC
P et celles du
RCP approuvé en France.

Joindre la proposition de RCP, si disponible.



Note: ce tableau doit être joint à une lettre officielle de demande pour
engager

une procédure de
reconnaissance mutuelle

ou décentralisée avec la France

comme Etat m
em
bre de référence.


Attention:

Il est nécessaire que la

demande
s
oit confirmée par le
laboratoire

6 mois avant la date
de

soumission
du dossier
, précis
ée par l'
AFSSAPS
. En l'absence
de
confirmation,
la procédure ne pourra être engagée
dans le délai convenu
.


Notice to Applicants


December
201
1

Name of the company
:

................................
................................
................................
............






Date:




Request to start a MRP with
FRANCE

as the Reference Member State




PROPOSED NAME OF THE PRODUCT IN FRANCE:

<>


ACTIVE(S) SUBSTANCE(S):

<>


Procedure

Mutual Recognition Procedure


Planned Submission Date


Pharmacothe
rapeutic Classific
ation,
ATC

code


Pharmaceutical Form and Strength


Number of applications / Duplicates


Concerned Member States (CMS)


Legal Basis of Application


Reference Product in France


Date of first authorisation of Reference
Product in Fran
ce


Applicant’s Name and Address


Authorised Contact Person during the
Procedure


Name and Address of the Manufacturer of the
Drug Substance


Is an ASMF or CEP to be used?


Manufacturer of the medicinal product and
site of manufacture



Name and Add
ress of Manufacturer

responsible for batch release in the EEA


Do national MAs exist with this active
substance in other Member States?


If yes, please specify in which Member States
and if there are major differences in Sections
4.1; 4.2 and 4.3 of the
SPCs compared to the
SPCs approved in France.

If available, please attached the proposed
SPC



Note: this table should be annexed to an official cover letter requesting FR to act as the RMS


Warning:

Please note that the request has to be confirmed by the

applicant 6 months before the submission date
of the dossier

communicated by
AFSSAPS
. In the absence of confirmation,
the beginning of the
procedure should be postponed
.





Notice to Applicants


December
201
1

ANNEXE 1
-
FR


ELECTRONIC SUBMISSIO
N

DU DOSSIER


Les informations suivantes sont à
faire figurer sur la lettre d'accompagnement ;
pour

les

adresses

d'expédition

voir
chapitre 3
.



MONSIEUR LE DIRECTEU
R

AFSSAPS / DEMEB

143
-
147 BOULEVARD ANATOL
E FRANCE

F
-
93285 SAINT
-
DENIS CEDEX

FRANCE



{Lieu, date}



Personne en charge du dossier

:

{Nom, numéro de téléphone et de télécopie; courriel}



Soumission électronique

:


eCTD

Numéro de séquence :



European Non
-
eCTD electronic Submission (
EU
-
NeeS
)


Objet

:

{Activité réglemen
taire}
(ex. nouvelle demande ou modification de type II ou renouvellement…)




{Type de demande}
(ex. nouvelle entité chimi
que ou extension d'indication…)

Type de procédure:

Numéro de procédure:


CMS:


Monsieur le Directeur,

Nous avons l'honneur de solli
citer une
{Activité réglementaire}
dans le cadre d'une procédure {
type de
procédure}
dont les caractéristiques sont les suivantes :


Nom du (des) médicament(s) :


Forme(s) pharmaceutique(s) et dosage (s) :

DCI/substance(s) actives(s) :

Code(s) NL
*

:

Code(s
) CIS
*

:

Code ATC :

Positionnement de la demande :


La documentation électronique est organisée conformément à la structure du CTD.


Nous confirmons que la session de gravure est close et que la soumission a été contrôlée par un antivirus
à

jour
{nom de l
'antivirus}.


A l'appui de notre demande, nous vous prions de bien vouloir trouver ci
-
joint :



3 copies de la présente lettre ;



le formulaire pour une
soumission électronique

;



le formulaire d'identification de la demande ;



le paiement et le
bordereau de t
ransmission du paiement

;



un disque:
(ex. module 1
-

5 pour tous les dosages) ;



un CD complémentaire contenant la proposition d'annexes (I (RCP), II, IIIA (étiquetage) et IIIB (Notice)) (un
fichier unique par spécialité)* ;



...

*
S'il y a lieu.


Notice to Applicants


December
201
1

ANNEXE 1
-
EN


ELECTRONIC SU
BMISSION OF THE DOSS
IER


The cover letter should mention the following information. See "
chapitre 3
" for addresses for sending.




TO THE DIRECTOR GENE
RAL

AFSSAPS / DEMEB

143
-
147 BOULEVARD ANATOL
E FRANCE

F
-
93285 SAIN
T
-
DENIS CEDEX

FRANCE



{Place, date}



Contact point:

{Name, telephone number, fax number, mail}



Electronic submission
:


eCTD

Sequence number:



European Non
-
eCTD electronic Submission (
EU
-
NeeS
)


RE:


{Regulatory activit
y}

(e.g. new application or type II variation or renewal…)


{Scope}
(e.g. new chemical entity or extension of indication…}


Type of procedure:

Number procedure:


CMS:


Dear Sirs,

We are pleased to submit a
{Regulatory activity}

for
{type of procedure}
whi
ch details are as follows:


Name of the medicinal product(s):


Pharmaceutical form(s) and strength(s):

INN/active substance(s):

NL code(s)
*
:

CIS code(s)
*
:

ATC code:

Legal Basis of the Application(s):


The electronic documentation is structured in conformit
y with the CTD structure
.


We confirm that the CD
-
burning session is closed and the submission is checked with an up
-
to
-
date and state
-
of
-
the art virus checker
{name of the antivirus}.


You will find enclosed the following documents/items:



3 copies of this

cover letter



"AFSSAPS Recommendations for eCTD or
EU
-
NeeS

submission" form



Form of submission identification



Payment and transmission form for the relevant fees



One media unit:
(e.g. module 1
-

5 for all strengths)



One additional unit containing the propo
sition of the SPC, appendix II, Labelling

and PIL (one single file for
each strength)* ;



...

*
If applicable.


Notice to Applicants


December
201
1

ANNEXE 2
-
FR


PAPER SUBMISSION

DU DOSSIER


Les informations suivantes sont à faire figurer sur la lettre d'accompagnement ;
pour

les

adresses

d'expédition

voir
chapitre 3
.





MONSIEUR LE DIRECTEU
R

AFSSAPS / DEMEB

143
-
147 BOULEVARD ANATOL
E FRANCE

F
-
93285 SAINT
-
DENIS CEDEX

FRANCE



{Lieu, date}



Personne en charge du dossier

:

{Nom, numéro de téléphone et de télécopie, courri
el}



Objet

:

{Activité réglementaire}
(ex. nouvelle demande ou modification de type II ou renouvellement…)




{Type de demande}
(ex. nouvelle entité chimique ou extension d'indication…)

Type de procédure :

Numéro de procédure :

CMS :


Monsieur le Direc
teur,

Nous avons l'honneur de solliciter une
{Activité réglementaire}
dans le cadre d'une procédure {
type de
procédure}
dont les caractéristiques sont les suivantes :


Nom du (des) médicament(s):


Forme(s) pharmaceutique(s) et dosage (s) :

DCI/substance(s)

actives(s) :

Code(s) NL
*

:

Code(s) CIS
*

:

Code ATC :

Positionnement de la demande :

Le dossier se compose des volumes et exemplaires suivants :

Nombres de volumes

Nombre d'exemplaires

Module 1 :
{nombre}

volume(s)

{Nombre}

exemplaires

Module 2 :
{nombr
e}

volume(s)

{Nombre}

exemplaires

Module 3 :
{nombre}

volume(s)

{Nombre}

exemplaires

Module 4 :
{nombre}

volume(s)

{Nombre}

exemplaires

Module 5 :
{nombre}

volume(s)

{Nombre}

exemplaires


Nous vous prions de bien vouloir trouver, également, ci
-
joint :



3 copies de la présente lettre ;



le formulaire d'identification de la demande ;



le
bordereau de transmission du paiement

;



un CD contenant la proposition de RCP, Etiquetage et Notice

pour tous les dosages

et des fichiers
au

format <Word> / <PDF> correspon
dant aux modules
{numéro des modules} ;



...

Nous vous informons qu'un exemplaire des modules 1, 2 et 3 est adressé simultanément à la Direction des
Laboratoires et des Contrôles.

...

*
S’il y a lieu.


Notice to Applicants


December
201
1

ANNEXE 2
-
EN


PAPER SUBMISSION OF
THE DOSSIER


The cover letter should m
ention the following information. See "
chapitre 3
" for addresses for sending.




TO THE DIRECTOR GENE
RAL

AFSSAPS / DEMEB

143
-
147 BOULEVARD ANATOL
E FRANCE

F
-
93285 SAINT
-
DENIS CEDEX

FRANCE



{Place, date}



Contact poi
nt:

{Name, telephone number, fax number, mail}



RE:


{Regulatory activity}

(e.g. new application or type II variation or renewal…)


{Scope}
(e.g. new chemical entity or extension of indication…}


Type of procedure:

Number procedure:

CMS:


Dear Sirs,

We a
re pleased to submit a
{Regulatory activity}

for
{type of procedure}
which details are as follows:


Name of the medicinal product(s):


Pharmaceutical form(s) and strength(s):

INN/active substance(s):

NL code(s)
*
:

CIS code(s)
*
:

ATC code:

Legal Basis of the
Application(s):


The following number of copies has been submitted:

Number of binders

Copies

Module 1 :
{number}

binder(s)

{Number}

copies

Module 2 :
{number}

binder(s)

{Number}

copies

Module 3 :
{number}

binder(s)

{Number}

copies

Module 4 :
{number}

b
inder(s)

{Number}

copies

Module 5 :
{number}

binder(s)

{Number}

copies


In addition, you will find enclosed the following documents/items:



the cover letter in 3 copies ;



Form of submission identification;



Transmission form for the relevant fees ;



One CD
containing SPC, PL

and labelling
for all

strengths
and files <Word> / <PDF> corresponding to
modules
{number modules
}

;



...

Please be informed that we sent a copy of modules 1, 2 and 3 to the Direction des Laboratoires et des
Contrôles simultaneously.

...
.

*
If applicable.


Notice to Applicants


December
201
1



ANNEXE 3

FORMULAIRE POUR UNE
ELECTRONIC SUBMISSIO
N

NeeS

AFSSAPS FORM FOR
NeeS

SUBMISSION


1.

TYPE DE
ELECTRONIC SUBMISSIO
N


e
-
SUBMISSION

TYPE


NeeS

A compléter par le demandeur

To be filled by the Applicant

Réservé

Contrôle
Afssaps

Version utilisée

pour établir le
rapport de
validation

/
Version

used
to generate the validation report


................................
................................
.................



Personne en charge de ce
NeeS


Contact point for this
NeeS

Nom/
Name

................................
................................
............................


Téléphone/
Phone

................................
................................
.................


Télécopie/
Fax

................................
................................
.......................


Courriel/
e
-
mail

................................
................................
......................


Type de support

Type of medium

CD
-
R

DVD
-
R

DVD
+R

DVD
-
R

Double
-
couche/layer

DVD+R

Double
-
couche/
layer

Réservé
Contrôle
Afssaps












N° de série du support non
réinscriptible (WORM)
3

à reporter
ci
-
contre

Serial Nr


of the non re
-
writable CD
(WORM) to be filled

4


................................
................................
.........................




Modalités

:
u
ne seule A
ctivité Réglementaire
sur un

support CD ou DVD
unique

et
non réinscriptible (WORM),
session de gravure close.

Requirements
:

o
nly one regulatory activity
on
only one


WORM support, CD
-
burning closed session.



A compléter par le demandeur

To be filled by th
e Applicant

Réservé
Contrôle
Afssaps

Demandeur/
Applicant



Nom complet de la ou des spécialité(s) (avec
dosage(s) et forme(s) pharmaceutique(s))

Full name of the medicinal product(s) (with
strength(s) and pharmaceutical form(s))



Date de dépôt/
Date of
submission



Substance(s) active(s)/
Active substance(s)



Type de procédure/
Type of procedure

N° de procédure/
Procedure Nr



Activité réglementaire
/
Regulatory activity







3

Le numéro de série à reporter est celui inscrit par le fabricant au centre du support. L'étiquette ne doit pas empêcher la le
cture du numéro
de série.
Ce numéro doit rester visi
ble et lisible.

4

The serial number to be filled is the one mentioned by the manufacturer in the middle of the medium. The serial number must n
ot been
hidden by the label.
This number must be visible and readable.


Notice to Applicants


December
201
1


A compléter par le demandeur

To be filled by th
e Applicant

Réservé
Contrôle
Afssaps

Type

de demande

ou de modification
/

Type of claim



Cod
e
(s)

dossier (type NL) (s
i connu
(s)
)
/

NL Code
(s)

(if available)



Date du NeeS (JJ/MM/AAAA)
/

Date of the NeeS (DD/MM/YYYY)



2.

COMPLÉTUDE DU DOSSIE
R


COMPLETENESS OF THE
DOSSIER



A compléter par le demandeur/
To be
filled by the Applicant


Réservé
Contrôle
Afssaps

Le demande
ur atteste que la session est close
.
/
The applicant certifies that The CD
-
burning
session is closed.



Taille (Mo)
/
Size (Mo)



Nombre de répertoires
/
Number of folders



Nombre de fichiers
/
Number of files



3.

HISTORIQUE COMPLET D
ES DÉPÔTS


COMPLETE H
ISTORY OF SUBMISSION
S


Date de dépôt

Date of submission

Date
s

précédent
e
s
NeeS

Previous NeeS dates

Activité réglementaire / type de demande

Regulatory activity / Type of claim







4.

PÉRENNITÉ DES DONNÉE
S


DURABILITY OF THE DA
TA


L'ensemble des donné
es du dossier est à déposer sur
un support unique
.
The Application must be submitted as
one
single

copy

Le disque doit être non réinscriptible (WORM) : CD
-
R, DVD
-
R ou DVD+R, éventuellement double
-
couche.
La

session de gravure doit être close. /
Each medium

must be WORM: CD
-
R, DVD
-
R or DVD+R or DVD
-
R
double
-
layer or double
-
layer

DVD+R
. The CD
-
burning session is closed.

Préciser /
Specify

:



taille du

dossier /
size of the dossier

< 650 Mo


:

un seul et
unique

CD
-
R
/
only one

CD
-
R



taille du

dossier /
size of
the dossier



650 Mo

et < 4,7 Go

:

un seul
et
unique

DVD
-
R / DVD+R




only one

DVD
-
R / DVD+R



taille du

dossier /
size of the dossier



4,7 Go
et <
8,5 Go

:

un seul et
unique

DVD
-
R / DVD+R double
couche




only one

DVD
-
R / DVD+R double layer

5
.

LOGICIE
LS


SOFTWARES


6.A Création du
NeeS

/
Generation of the
NeeS

-

Nom du logiciel /
Name

of the software

:

-

Version /
Version

:

-

Société /
Society

:

6.B Antivirus

-

Nom du logiciel /
Name

of the software

:

-

Version /
Version

:

-

Société /
Society

:


Notice to Applicants


December
201
1



ANNEXE 4

FO
RMULAIRE POUR UNE
ELECTRONIC SUBMISSIO
N

e
CTD

AFSSAPS FORM FOR
e
CTD

SUBMISSION


1.

TYPE DE
ELECTRONIC SUBMISSIO
N


e
-
SUBMISSION

TYPE


eCTD

A compléter par le demandeur

To be filled by the Applicant

Réservé
Contrôle
Afssaps

Version utilisée pour établir le
rapport de
validation

/
Version

used
to generate the validation report


................................
................................
.................



Personne en charge de cet eCTD

Contact point for this eCTD

Nom/
Name

................................
................................
............................


Tél
éphone
/
Phone
.

................................
................................
................


Télécopie/
Fax

................................
................................
.......................


Courriel/
e
-
mail

................................
................................
......................


Type de support

Type of medium

CD
-
R

DVD
-
R

DVD+R

DVD
-
R

Double
-
couche/layer

DVD+R

Double
-
couche/
layer

Réservé
Contrôle
Afssaps












N°(s) de série du support non
réinscriptible(s) (WORM)
5

à reporter
ci
-
contre

Serial Nr(s) of the non re
-
writable
CD (WORM) to be filled

6


................................
................................
.........................




Modalités

: une seule Activit
é Réglementaire (= une seule séquence pour un eCTD) par support CD ou DVD
non réinscriptible (WORM), session de gravure close.

Requirements
: only one regulatory activity per WORM support, CD
-
burning closed session.



A compléter par le demandeur

To be fill
ed by the Applicant

Réservé
Contrôle
Afssaps

Demandeur/
Applicant



Nom complet de la ou des spécialité(s) (avec
dosage(s) et forme(s) pharmaceutique(s))

Full name of the medicinal product(s) (with
strength(s) and pharmaceutical form(s))



Date de dépôt/
Date of submission



Substance(s) active(s)/
Active substance(s)



Type de procédure/
Type of procedure

N° de procédure/
Procedure Nr



Activité réglementaire
/
Regulatory activity







5

Le numéro de série à reporter est celui
inscrit par le fabricant au centre du support. L'étiquette ne doit pas empêcher la lecture du numéro
de série.
Ce numéro doit rester visible et lisible.

6

The serial number to be filled is the one mentioned by the manufacturer in the middle of the medium.
The serial number must not been
hidden by the label.
This number must be visible and readable
.


Notice to Applicants


December
201
1


A compléter par le demandeur

To be fill
ed by the Applicant

Réservé
Contrôle
Afssaps

Typ
e de demande

ou de modification
/

Type of claim



Code(s)
dossier (typ
e NL) (si connu(s))
/

NL Code(s) (if available)



N° de Séquence /
Sequence Nr



2.

COMPLÉTUDE DU DOSSIE
R


COMPLETENESS OF THE
DOSSIER



A compléter par le demandeur/
To be
filled by the Applicant


Réservé
Contrôle
Afssaps

Le demandeur a
tteste que la s
ession est close
/
The applicant certifies that
t
he CD
-
burning
session is closed.



Taille (Mo) /
Size (Mo)



Nombre de répertoires
/
Number of folders



Nombre de fichiers
/
Number of files



Clef MD5/
MD5 checksum



3.

HISTORIQUE COMPLET D
ES DÉPÔTS


COM
PLETE HISTORY OF SUB
MISSIONS


Date de dépôt

Date of submission

N° de séquence

Sequence number

Activité réglementaire / type de demande

Regulatory activity / Type of claim







4.

PÉRENNITÉ DES DONNÉE
S


DURABILITY OF THE DA
TA


L'ensemble des données du

dossier est à déposer sur
un support unique
.
The Application must be submitted as
one
single

copy

Le disque doit être non réinscriptible (WORM) : CD
-
R, DVD
-
R ou DVD+R, éventuellement double
-
couche.
La

session de gravure doit être close. /
Each medium must

be WORM: CD
-
R, DVD
-
R or DVD+R or DVD
-
R
double
-
layer or double
-
layer

DVD+R
. The CD
-
burning session is closed.

Préciser /
Specify

:



taille du

dossier /
size of the dossier

< 650 Mo


:

un seul et
unique

CD
-
R /




only one

CD
-
R



taille du

dossier /
size of t
he dossier



650 Mo

et < 4,7 Go

:

un seul et
unique

DVD
-
R / DVD+R




only one

DVD
-
R / DVD+R



taille du

dossier /
size of the dossier



4,7 Go

:

un ou plusieurs

DVD
-
R / DVD+R double
couche





one or more

DVD
-
R / DVD+R double layer

5.

LOGICIELS


SOFTWA
RES


6.A Création du eCTD /
Generation of the eCTD

-

Nom du logiciel /
Name

of the software

:

-

Version /
Version

:

-

Société /
Society

:

6.B Antivirus

-

Nom du logiciel /
Name

of the software

:

-

Version /
Version

:

-

Société /
Society

:




Notice to Applicants


December
201
1



ANNEXE
5


MENTIONS A
FAIRE FIGURER SUR LE

DISQUE

REFERENCES

TO REPRODUCE ON THE
MEDIUM

Cas d'un
EU
-
NeeS /
For
EU
-
NeeS















Date de soumission /
Submission date


JJ/MM/AAAA


EU
-
NeeS


Nom et adresse du

demandeur /
Applicant's


name and address

Code ATC /
ATC Code

DCI /
INN


Nom du produit /

Name of the medicinal
product

N° de procédure /
Procedure Nr.


Activité Régl
ementaire /
Regulatory activity



Notice to Applicants


December
201
1


ANNEXE
6


MENTIONS A FAIRE FIG
URER SUR LE DISQUE

REFERENCE
S TO REPRODUCE ON TH
E MEDIUM

Cas d'un eCTD
/
For eCTD


Date de soumission /
Submission date


JJ/MM/AAAA

Séquence /
sequence

-

-

-

-


eCTD


Nom et adresse du

demandeur /
Applicant's


name and address

Code ATC /
ATC Code

DCI /
INN


Nom du produit /

Name of the medicin
al
product

N° de procédure /
Procedure Nr.


Activité Réglementaire /
Regulatory activity



Notice to Applicants


December
201
1


ANNEXE
7


MENTIONS A FAIRE FI
GURER SUR LE DISQUE

REFERENCE
S TO REPRODUCE ON TH
E MEDIUM

Cas du CD complémentaire (RCP/Notice/étiquetage)


For

additional
CD

(SmPC/PIL/Labelling)









Date de soumission /
Submission date


JJ/MM/AAAA


Proposition
RCP/Notice/Etiquetage /
SmPC/PIL/Labelling

Template 7
-

Word FStyle


Nom et adresse du

demandeur /
Applicant's


name and address

Code ATC /
ATC Code

DCI /
INN


Nom du produit /

Name of the medicinal
product

N° de procédure /
Procedure Nr.


Activité Réglementaire /
Regulatory activity



Notice to Applicants


December
201
1

ANNEXE
8
-
FR






NOM DU PRODUIT

................................
................................
................................
................................
................................
....









NOM DU LABORATOIRE
:

................................
................................
................................
................................
..








Personne à contacter :

TYPE DE PROCEDURE


Numéro de procédure

Numéro(s) NL

(ou EH)


Numéro CIS


Centralisée (PC)


Reconnaissance mutuelle (PRM)


Décentr
alisée (PDC)


Nationale




















CODE ATC


TYPE DE DOSSIER


Nouvelle demande d’AMM


䵯摩f楣慴楯渠摥⁴ 灥é䥁


䵯摩f楣慴楯渠摥⁴ 灥é䥂


䵯摩f楣慴楯渠摥⁴ 灥é䥉


Extension d’indications


Transfert d’AMM


Changement de raison sociale / d’adresse du


瑩瑵ta楲攠


Changement d’exploitant



湯當e汬敭敮e


o敮潵ee汬敭敮琠扩敮湡l


l扬i条瑩o渠n烩c楦楱略u


réal畡瑩潮⁡湮略汬e


䵥M畲u⁤攠 畩vi


o慰灯牴a⁤攠灨慲浡mov楧楬慮ce


E湲敧ns瑲t浥湴⁈o淩潰慴桩e


A畴牥u
灲 c楳敲e







.


Complément de dossier dans le cadre d’une
procédure mentionnée ci
-
dessus

Préciser

:





.



Dossier de réponse à une procédure
contradictoire dans le cadre d
’une procédure
mentionnée ci
-
dessus

Préciser

:





.



Dossier demandé par la personne en charge
du dossier à l’AFSSAPS


Recours gracieux dans le cadre d’une
procédure mentionnée ci
-
dessus


Nom de la personn
e en charge du dossier à
l’AFSSAPS

(pour les dépôts faisant suite à une
demande de l’AFSSAPS)









TAXES



Chèque


Virement bancaire (préciser le nom de la
banque, la date et le numéro du virement)

:


Toutes les rubriques relatives au payeur, dans
le Bordereau de Transmission du Paiement
(annexe 9) doivent être complétées
impérativement.

Le cas échéant, toutes les informations devant
figurer sur l’avis du virement, précisées au
chapitre 3.2. doivent sy
stématiquement être
renseignées.

TYPE DE PRODUIT



Chimique


Biologique


Générique


Radio
-
pharmaceutique


Homéopathique


Plantes


m桹瑯瑨慰楥


m牥獣物灴楯渠䷩摩c慬e⁆慣 汴a瑩ve


A畴牥u
(préciser)

:








Dossier à adresser à l'AFSSAPS
-

DEMEB
-

DORIS
-

Unité Recevabilité AMM

143/147 Boulevard Anatole France
-

F
-
93285 Saint
-
Denis Cedex

ou à déposer de 9h à 11h30 et de 14h à 16h30 du lundi a
u vendredi

FORMULAIRE D'IDENTIFICATION DE LA DEMANDE

dûment compl
été à joindre à

toute

soumission de dossier
dans

le cadre de l'AMM


Notice to Applicants


December
201
1


ANNEXE
8
-
EN






NAME OF THE PRODUCT


................................
................................
................................
................................
.








NAME OF THE PHARMACEUTICAL COMPANY









Contact person:

TYPE OF
PROCEDURE


Procedure number

NL number(s)

(or EH)


CIS number(s)


Centralised (CP)


Mutual Recognition (MRP)


Decentralised (DCP)


National




















ATC CODE


TYPE OF DOSSIER


New application for marketing authorisation

Type IA variation

Type IB variation

Type II variation


Extension of indications


MA Transfer


Change of company name/ address of the


holder


Change of distributor


Renewal


Two
-
yearly renewal


Specific obligation

a湮畡氠牥r慬畡瑩on


䙯汬潷
-
異u浥ms畲u


m桡牭慣ov楧楬慮c攠牥e潲o


e潭敯灡瑨楣⁲ 杩s瑲慴a潮


l瑨敲
s灥é楦y⤺)





.


Additional documentation within the

framework of the above
-
mentioned procedure

Specify:





.



Written response to a “contradictory”

procedure within the framework of the above
-
mentioned procedure

Specify:





.



Dossier requested by the person in charge

of the dossier at AFSSAPS


"
Recours gracieux" within the above
-
mentioned procedure


Nom de la personne en charge du dossier à
l’AFSSAPS

(pour les d
épôts faisant suite à une
demande de l’AFSSAPS)











FEES



Cheque


Bank

transfer (specify the name of the bank and
the date of the transfer)
:


All s
ections
related to the

Paying company

in
the
Transmission form (annexe 9) must be
fully completed.

Where appropriate, all information to be
specified

on the notification of transfer, (see
section 3.2.)
must be systematically filled.

TYPE OF PRODUCT



Chemical


Bio
logical


Generic


Radio
-
pharmaceutical


Homeopathic


Herbals


e敲扡b 浥摩c楮es


p敬f
-
浥m楣慴楯n


l瑨敲t
(specify

:









FORM OF SUBMISSION IDENTIFICATION to fill and
append to any correspondence or submission in the
context of MA

Dossier to be sent to AFSSAPS
-

DEMEB
-

DORIS
-

Unité Recevabilité AMM

143/147 Boulevard Anatole France
-

F
-
93285 Saint
-
Denis Cedex

o
r to be submitted from Monday to Friday: 9.00 to 11.30 a.m. and 2.00 to 4.30 p.m.


Notice to Applicants


December
201
1


ANNEXE
9
-
FR



BORDEREAU DE TRANSMISSION DU PAIEMENT

À L’AGENCE FRANÇAISE DE SÉCURITÉ SANITAIRE DES PRODUITS DE SANTÉ


SI NOUVELLE DEMANDE D’AMM

:



N
OM ET ADRESSE DE LA
FIRME
DEMANDEUR

DE L

AMM

:


NOM ET COORDONNEES
(
TELEPHONIQUE ET
/
OU MAIL
)

DE LA PERSONNE RESPO
NSABLE DU DOSSIER

:




NOM ET ADRESSE DU
PAYEUR

:


NOM ET COORDONNEES
(
TELEPHONIQUE ET
/
OU MAIL
)

DE LA PERSONNE RESPO
NSABLE DU DOSSIER

:




N
OM DE LA
S
PECIALITE

/

D
OSAGE

:




NUMERO DE LA PROCEDU
RE
(
SI PROCEDURE EUROPEE
NNE
)

:


SI MODIFICATIO
N OU RENOUVELLEMENT D’AMM

:



N
OM ET ADRESSE DE LA
FIRME

TITULAIRE

DE L

AMM

:


NOM ET COORDONNEES
(
TELEPHONIQUE ET
/
OU MAIL
)

DE LA PERSONNE RESPO
NSABLE DU DOSSIER

:




NOM ET ADRESSE DU
PAYEUR

:


NOM ET COORDONNEES
(
TELEPHONIQUE ET
/
OU MAIL
)

DE LA PERSONNE RESPO
NSABLE DU DOSSIER

:




N
OM DE LA
S
PECIALITE

/

D
OSAGE
(
S
)

:




C
ODE DOSSIER
TYPE NL DE TOUTES LE
S AMM CONCERNEES

:



NUMERO DE LA PROCEDU
RE
(
SI PROCEDURE EUROPEE
NNE
)

:



AMM


EUROS

Cocher la ou les cases
correspondantes

1

Dossier complet

25 400



2

䑯獡D攠 潵 景
rm攠 灨慲m慣a畴楱略 獵s灬敮瑡楲攠 灲é獥s瓩t
simultanément à la première demande d’autorisation

ㄲ‷〰



3

乯當N汬敳⁩湤l捡瑩潮猠瑨慰敵瑩t略s

ㄶ‷㤰



4

Nouvelles voies d’administration

ㄶ‷㤰



5

Nouvelles associations

16 790



6

Usage thérapeutique b
ien établi (référence à la littérature scientifique)

16 790



7

Dosage ou forme pharmaceutique supplémentaire présenté
simultanément à la première demande d’autorisation et relevant des
灯楮瑳″ⰴI㔬R⁣
-
摥獳畳

㠠㌹U



8

Génériques

10 110



9

乯當N汬敳l
景fm敳⁰桡rm慣a畴楱u敳

㄰‱㄰



10

Nouveaux dosages (1 dossier par dosage)

10 110



11

Médicaments à base de plantes

10 110



12

Allergènes

10 110



13

Modification

1 011



14

Renouvellement

674



TAXE PERCUE POUR TOUTE DEMANDE D’IMPORTATION PARALLÈL
E




Demande d’autorisation

㔠〰R




Renouvellement

674



PUBLICITÉ





Dépôt

510




Visa GP

510




Visa PR (préservatifs)

510




Visa PP (publicité produits)

510




I
NTITULE DE LA BANQUE

:………………………………………………………………………...



CHEQUE DATE ET N
°………………………
……………………………………………………



VIREMENT DATE ET N
°

…………………………………………………………………………


JOINDRE

OBLIGATOIREMENT

L’AVIS

DE

VIREMENT

COMPORTANT

LES

MENTIONS

PREVUES

AU

POINT

3.2

PAGE

12


E
NREGISTREMENT

(à remplir par l’Administration)

Signature du responsable

:

VALID
FOR APPLICATIONS RECEIVED

BY
AFSSAPS
UNTIL

3
1
-
12
-
2011
.


Notice to Applicants


December
201
1


ANNEXE

9
-
EN



TRANSMISSION FORM

TO AGENCE FRANÇAISE DE SÉCURITÉ SANITAIRE

DES PRODUITS DE SANTÉ
(
AFSSAPS
)

IN CASE OF NEW APPLICATION
:



N
AME
AND
A
DDRESS OF THE
APPLICANT
:


N
AME AND
A
DDRESS AND PHONE NUM
BER
(A
ND
/
OR E
-
MAIL
)

OF THE PERSON IN CHA
RGE OF THE

DOSSIER
:




N
AME
AND
A
DDRESS OF THE
PAYING

COMPANY
:


N
AME AND
A
DDRESS AND PHONE NUM
BER
(A
ND
/
OR E
-
MAIL
)

OF THE PERSON IN CHA
RGE OF THE

DOSSIER
:




N
AME OF THE
P
RODUCT

/

S
TRENGTH
:




N
UMBER PROCEDURE
(
IF EUROPEAN PROCEDUR
E
)
:


IN CASE OF MODIFICATION OR
RENEWAL
:



N
AME
AND
A
D
DRESS OF THE
HOLDER
:


N
AME AND
A
DDRESS AND PHONE NUM
BER
(A
ND
/
OR E
-
MAIL
)

OF THE PERSON IN CHA
RGE OF THE

DOSSIER
:




N
AME
AND
A
DDRESS OF THE
PAYING

COMPANY
:


N
AME AND
A
DDRESS AND PHONE NUM
BER
(A
ND
/
OR E
-
MAIL
)

OF THE PERSON IN CHA
RGE OF THE

DOSSIER
:




N
AME OF THE

P
RODUCT

/

S
TRENGTH
(
S
)
:




NL

C
ODE OF ALL
CONCERNED
MARKETING AUTHORISAT
ION
S
:



N
UMBER PROCEDURE
(
IF EUROPEAN PROCEDUR
E
)
:


AMM


EUROS

Should be completed where
appropriate

1

Full application

25 400



2

A摤楴楯湡氠獴s敮杴g 潲 灨慲m慣a畴楣慬u景fm 獵sm楴瑥i 慴

瑨t 獡s攠瑩t攠慳
瑨t⁩湩瑩慬⁡灰汩捡l楯渠景f⁡ 瑨tr楳慴楯i

ㄲ‷〰



3

E硴敮獩潮映瑨敲慰敵瑩挠楮摩捡i楯湳

ㄶ‷㤰



4

New route of administration

16 790



5

New combinations

16 790



6

Well established use application (bibliographical application)

16

790



7

Additional strength or pharmaceutical form submitted at the same time as
the initial application for authorisation mentioned in points 3,4,5,6 above

8 395



8

Generic application

10 110



9

New pharmaceutical forms

10 110



10

New strengths (1

dossier per strength)

10 110



11

Herbal medicinal product

10 110



12

Allergens

10 110



13

Variation

1 011





剥湥睡w

㘷6



FEE FOR PARALLE IMPORTATION




New application

5 000




Renewal

674



ADVERTISING





Submission

510




Visa GP

510




Visa PR (codoms)

510




Visa PP (product advertising)

510




B
ANK REFERENCE
:………………………………………………………………………...



CHEQUE
:

DATE AND N
o.
……………………………………………………………………………



B
ANK TRANSFER
:

DATE AND N
o

…………………………………………………………………………



VISA

(to be filled by AFSSAPS)

Signature of the person in charge of the dossier:


VALID
FOR APPLICATIONS RECEIVED

BY
AFSSAPS
UNTIL

3
1
-
12
-
2011.


Notice to Applicants


December
201
1


ANNEXE
10
-
NeeS


SWITCH OF TYPE OF SUBMISSION IN POST
-
AMM



Submission in

NeeS format

is ACCEPTED ONLY

in the context of the
following regulatory
activities
:



new applications



type

II variations



PSUR



renewals



start of MRP

with France
as
RMS

or

"Repeat use"

in

MRP

or DCP


No switch of medium

(Paper

/ NeeS / eCTD)


Possibility to switch

from:



Paper to Nees



Paper to eCTD



NeeS to eCTD


In case you switch
, it is
impossible to change back.

STRUCTURE NeeS

1 general folder containing:



1 general TOC
-

1 TOC per module (optional)
-

5 modules

Specifications are available on the website:



桴h瀺p/敳畢missi潮⹥.敡⹥.r潰愮a甯u潣⽥䝵/摡湣e彄_cum敮瑟t⸴⹰.f



Notice to Applicants


December
201
1


ANNEXE 10
-

e
CTD


SWITCH OF TYPE OF SU
BMISSION

IN
POST
-
AMM


















































Submission in

eCTD

format

is ACCEPTED ONLY

in
the context of the
following regulatory
activities
:



new applications



type

II variations



PSUR



renewals



start of MRP

with France
as
RMS

or

"Repeat use"

in

MRP

or DCP


Any further applications
should be submitted in eCTD
format

No switch of medium

(Paper

/ NeeS / eCTD)


Possibility to switch

from:



Paper to Nees



Paper to eCTD



NeeS to eCTD


In case you switch, it is
impossible to change back.


STRUCT
URE eCTD

1 general folder containing:



1 index.xml


1 index
-
md5.txt
-

5 modules


1 folder «

util

»

Specifications are available on the website:



桴h瀺p/敳畢missi潮⹥.敡⹥.r潰a
⹥甯u潣⽥䝵/摡湣e彄_cum敮瑟t⸴⹰.f



Notice to Applicants


December
201
1