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1:
H
ome
(ALT-H)
2:
H
M
A Joint
(ALT-M)
3:
H
u
man Medicines
(ALT-U)
3.1:
H
e
ads of Agencies
(ALT-E)
3.2:
C
MDh
(ALT-C)
3.3:
M
R
I Product Index
(ALT-R)
3.4:
D
i
rectory
(ALT-I)
4:
V
eterinary Medicines
(ALT-V)
You are here:
Human Medicines
>
CMDh
>
Templates
>
AR
> Paediatric Data
3.2.1:
Ab
o
ut CMDh
(ALT-O)
3.2.2:
S
tatistics
(ALT-S)
3.2.3:
P
ress Releases
(ALT-P)
3.2.4:
Procedura
l
Guidance
(ALT-L)
3.2.5:
CMDh-Referrals
3.2.6:
Produc
t
Information
(ALT-T)
3.2.7:
Advice from CMDh
3.2.8:
Templates
3.2.8.1:
Q
RD
(ALT-Q)
3.2.8.2:
AR
3.2.8.2.1:
DCP
(AR/Comme
n
ts)
(ALT-N)
3.2.8.2.2:
MRP
3.2.8.2.3:
Rene
w
als
(ALT-W)
3.2.8.2.4:
Variations
3.2.8.2.5:
Art
6
1.3 Procedure
(ALT-6)
3.2.8.2.6:
Public AR
3.2.8.2.7:
Paediatric Data
3.2.8.3:
Applications for
MA
3.2.8.4:
Art.
2
9 Referrals
(ALT-2)
3.2.8.5:
Variations
3.2.9:
CMD sub
g
roups / working groups
(ALT-G)
3.2.10:
Paediatric Regulation
3.2.11:
Questions & Answers
3.2.12:
Contact Form
3.2.13:
Contact Points
3.2.14:
What's new histor
y
(ALT-Y)
Assessment on Paediatric Data
Template for the Paediatric assessment report
[
.dot
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Paediatric Regulation: Article 45
Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (
EC
) No 1901/2006, as amended
(Latest update: October 2011)
[
.dot
]
Public AR for paediatric studies submitted in accordance with Article 45 of Regulation (
EC
) No 1901/2006, as amended
(Latest update: October 2011)
[
.dot
]
Paediatric Regulation: Article 46
Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (
EC
) No 1901/2006, as amended
(Latest update: July 2010)
[
.dot
]
Public AR for paediatric studies submitted in accordance with Article 46 of Regulation (
EC
) No 1901/2006, as amended
Latest update: July 2010)
[
.dot
] [
Track version
]
Comments from the Competent authority on the Paediatric work sharing Preliminary assessment report
Comments from the Competent authority on the Paediatric work sharing Preliminary assessment report for Article 45 and / or Article 46
(June 2009)
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dot.
]
