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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
>
Procedural Guidance
> Generics
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)
3.2.4.1:
G
eneral Info
(ALT-G)
3.2.4.2:
Applica
t
ion for
MA
(ALT-T)
3.2.4.3:
eSubmissio
n
s
(ALT-N)
3.2.4.4:
Generics
3.2.4.5:
Applicant´s Responses
3.2.4.6:
Rene
w
al
(ALT-W)
3.2.4.7:
Variation
3.2.4.8:
USR
3.2.4.9:
Art
6
1.3 Procedure
(ALT-6)
3.2.4.10:
Consultation with target patient groups
3.2.4.11:
Post Referral Phase
3.2.4.12:
Pandemic Plan
3.2.5:
CMDh-Referrals
3.2.6:
Product Information
3.2.7:
Advice from CMDh
3.2.8:
Templates
3.2.9:
CMD subgroups / wor
k
ing groups
(ALT-K)
3.2.10:
Paediatric Regulation
3.2.11:
Q
uestions & Answers
(ALT-Q)
3.2.12:
Contact Form
3.2.13:
Contact Points
3.2.14:
What's new histor
y
(ALT-Y)
Generics in
MRP
and
DCP
List of
MRP
/
DCP
finalised in 2006-2010 with new active substances
(November 2011)
CMDh Position paper on processing of generic applications when the generic has more indications or fewer indications than the reference product in the
CMS
(November 2009)
[
Track version
]
Information to be submitted by the Member State of the European Reference Medicinal Product
(June 2010)
[
Track version
]
Annex II: Standard form to be sent by the
RMS
to the MS of the ERP
(June 2010)
[
.dot
]
CMDh Recommendations for Applications submitted according to Article 10 when the strength and/or pharmaceutical form of the reference medicinal product differs between
RMS
/
CMS
(s)
(May 2009)
[
Track version
]
CMDh Recommendations on implementation of Article 30 Decisions cf. Directive 2001/83/
EC
, as amended for Generic/Hybrid/Biosimilar Medicinal Products approved through
MRP
/
DCP
(June 2010)
[
Track version
]
