CMDh POSITION PAPER ON
PROCESSING OF GENERIC APPLICATIONS
WHEN THE GENERIC HAS MORE INDICATIONS OR FEWER INDICATIONS
THAN THE REFERENCE PRODUCT IN THE CMS
Doc. Ref.: CMDh/087/2006/Rev2
July 201
07.08.2014
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EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Brussels, November 2007
GUIDANCE ON ELEMENTS REQUIRED TO
SUPPORT THE SIGNIFICANT CLINICAL
BENEFIT IN COMPARISON WITH E
07.08.2014
Datei
PD
March 2013
EMEA/CHMP/225411/2006
Committee for Human Medicinal Products (CHMP)
EMA Procedural advice for users of the centralised
procedure for generic/hybrid applications
This integrated ver
07.08.2014
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2008/11-25zulassung
Vortrag von
Dr. Hermann Kortland
Geschäftsführer
Bundesverband der Arzneimittel-Hersteller e.V. - BAH
anlässlich der BAH-Informationsveranstaltung
"15. AMG-Novelle und EG-Pharm
07.08.2014
Datei
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AM\P7_AMA(2012)0165(007-007)_EN.doc 1/21 PE493v562
EN United in diversity EN
5.9.2012 A7-0165/7
Amendment 7
Linda McAvan
on behalf of the S&D Group
Pilar Ayuso
on behalf of the PPE Grou
07.08.2014
Datei
PD
P
U
B
L
IC
Conseil UE
11728/12 LES/ns 1
DG B 4B LIMITE E�
COU�CIL OF
THE EUROPEA� U�IO�
Brussels, 26 June 2012
Interinstitutional File:
2012/0023 (COD)
2012/0025 (COD)
07.08.2014
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AM\P7_AMA(2012)0164(008-008)_EN.doc 1/15 PE493.561v01-00
EN United in diversity EN
6.9.2012 A7-0164/8
Amendment 8
Linda McAvan
on behalf of the S&D Group
Pilar Ayuso
on behalf of the PP
07.08.2014
Datei
PD
Beschleunigung von
Entscheidungen
(EU Referrals)
EU-Referrals (1/3)
ll Streichung des Bezugs zur Pharmakovigilanz
in Artikel 31
ll Einleitung von PV-Referrals: künftig Art. 107i
ll Gründe:
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EUROPEAN COMMISSION
Brussels, 10.2.2012
COM(2012) 52 final
2012/0025 (COD)
Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Directive 2001/83/EC as regard
07.08.2014
Datei
PD
EUROPEAN COMMISSION
Brussels, 10.2.2012
COM(2012) 51 final
2012/0023 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulation (EC) No 726/2004 a
07.08.2014
Datei
PD
