7 Westferry Circus
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Canary Wharf
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London E14 4HB
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United Kingdom
An agency of the European Union
Telephone
+44 (0)20 7418 8400
Facsimile
+44 (0)20
7418 8416
E
-
mail
info@ema.europa.eu
Website
www.ema.europa.eu
12
June
2012
EMA/358526/2012
Patient Health Protection
EMA
/EC
websit
e references
substituting information previously available in Notice to
Applicants
–
Chapter 7 of Volume 2A
NtA, Chapter 7 (Volume 2A)
Section heading
Name of the updated
EMA/EC
document
EMA/EC website references
location
1.
FORMAT FOR
APPLICATION IN THE EU
The Rules Governing Medicinal Products in the
European Union, Vol. 2B and Vol. 2C
Dossier Submission: Regulatory and procedural
guidance
Dossier Format: Regulatory and procedural
guidance
http://ec.europa.eu/health/documents/eudralex/
vol
-
2/index_en.htm
http://
www.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/document_listing/document_lis
ting_000121.jsp&mid=WC0b01ac0580027255
http://www.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/document_listing/document_lis
ting_000102.jsp&mid=WC0
b01ac058002c599
2.
LANGUAGES TO BE USED FOR DOSSIER,
EMA pre
-
authorisation procedural advice for users
http://www.ema.europa.eu/ema/index.jsp?curl=
EMA/EC website references substituting information previously available in Notice to Applicants
–
Chapter 7 of Volume 2A
Page
2
/
5
NtA, Chapter 7 (Volume 2A)
Section heading
Name of the updated
EMA/EC
document
EMA/EC website references
location
RESPONSES, VARIATIONS AND
RENEWALS
of the centralised procedure
-
Question 23
pages/regulation/general/general_content_0001
57.jsp&mid=WC0b01ac058002251f
European Medicines Agency post
-
authorisation
procedural
advice for users of the centralised
procedure
Type IA Variations
–
Q1.11
Type IB Variations
–
Q2.9
Type II Variations
–
Q3.11
Type II Variations/Ext. app
–
Q4.10
Worksharing of variations
–
Q6.10
Annual Re
-
assessment
–
Q8.11
Renewal
–
Q9.11
Art 61(3)
Notifications
–
Q15.9
http://www.ema.europa.eu/ema/index.jsp?curl=pages/
regulation/general/general_content_000166.jsp&mid=
WC0b01ac0580023399
3.
NUMBER OF COPIES OF THE DOSSIER,
RESPONSES, VARIATIONS AND
RENEWALS
EMA pre
-
authorisation procedura
l advice for users
of the centralised procedure
-
Question 23
http://www.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/general/general_content_0001
57.jsp&mid=WC0b01ac058002251f
European Medicines Agency post
-
authorisation
procedural
advice for users of the centralised procedure
Type IA Variations
–
Q1.4
Type
IB Variations
–
Q2.4
Type II Variations
–
Q3.4
Type II Variations/Extension app.
–
Q4.4
Grouping of Variations
–
Q5.3
Worksharing of variations
–
Q6.4
Changing the Name
–
Q7.3
ht t p://www.ema.europa.eu/ema/index.jsp?curl=pages/
regulat ion/general/general_content_000166.jsp&mid=
WC0b01ac0580023399
EMA/EC website references substituting information previously available in Notice to Applicants
–
Chapter 7 of Volume 2A
Page
3
/
5
NtA, Chapter 7 (Volume 2A)
Section heading
Name of the updated
EMA/EC
document
EMA/EC website references
location
Annual Re
-
assessment
–
Q8.3
Renewal
–
Q9.3
FUMs & SOs
–
Q10.4
PSURs
–
Q11.9
Art
46
–
Q12.3
Transfer of MA
–
Q13.2
Art 61(3) Notifications
–
Q15.4
Marketing & Cessation notification
-
Q16.6
4.
DOSSIER
CHECK
-
IN PROCEDURE
EMA pre
-
authorisation procedural advice for users
of the centralised procedure
-
Question 23
http://w
ww.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/general/general_content_0001
57.jsp&mid=WC0b01ac058002251f
5.
MOCK
-
UPS, SPECIMENS AND SAMPLES
EMA pre
-
authorisation procedural advice for users
of the centralised procedure
-
Question 14
http://www.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/general/general_content_0001
57.jsp&mid=WC0b01ac058002251f
European Medicines Agency post
-
authorisation
procedural
advice for users of the centralised
procedure
Type IA Variations
–
Q1.9
Type IB Variations
–
Q2.8
Type II Variations
–
Q3.10
Type II Variations/Extension app.
–
Q4.9
Changing the Name
–
Q7.4
Annual Re
-
assessment
–
Q8.10
Renewal
–
Q9.10
Transfer of MA Q13.9
Art 61(3) Notifications Q15.8
ht t p://www.ema.europa.eu/ema/index.jsp?curl=pages/
regulat ion/general/general_content_000166.jsp&mid=
WC0b01ac0580023399
EMA/EC website references substituting information previously available in Notice to Applicants
–
Chapter 7 of Volume 2A
Page
4
/
5
NtA, Chapter 7 (Volume 2A)
Section heading
Name of the updated
EMA/EC
document
EMA/EC website references
location
6.
NATIONAL PROCEDURE AFTER A
COMMISSION DECISION ON A REFFERAL
N/A
N/A
7.
LIST OF OFFICIAL JOURNALS
N/A
N/A
8.
ADDRESSES FOR DELIVERY OF THE
DOSSIER AND SUBSEQUENT
CORRESPONDENCE
EMA pre
-
authorisation procedural advice for users
of the centralised procedure
-
Question 23
http://www.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/general/general_content_0001
57.jsp&mid=WC0b01ac0
58002251f
European Medicines Agency post
-
authorisation
procedural
advice for users of the centralised
procedure
Type IA Variations
–
Q1.4
Type IB Variations
-
Q2.4
Type II Variations
–
Q3.4
Type II Variations/Extension app.
–
Q4.6
Worksharing of
variations
–
Q6.5
Annual Re
-
assessment
–
Q8.4
Renewal
–
Q9.5
FUMs & SOs
–
Q10.5
PSURs
–
Q11.12
Art 46
–
Q12.4
Transfer of MA
–
Q13.3
Art 61(3) Notifications
–
Q15.5
Marketing & Cessation notification
–
Q16.4, Q16.5
ht t p://www.ema.europa.eu/ema/index.jsp?curl
=pages/
regulat ion/general/general_content_000166.jsp&mid=
WC0b01ac0580023399
9.
ADDRESSES FOR RECEIPT OF FEES AND
TERMS OF PAYMENT
EMA pre
-
authorisation procedural advice for users
of the centralised procedure
-
Questions 10, 11, 12, 13
http://www.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/general/general_content_0001
57.jsp&mid=WC0b01ac058002251f
E
uropean Medicines Agency post
-
authorisation
procedural
advice for users of the centralised
procedure
ht t p://www.ema.europa.eu/ema/index.jsp?curl=pages/
regulat ion/general/general_content_000166.
jsp&mid=
EMA/EC website references substituting information previously available in Notice to Applicants
–
Chapter 7 of Volume 2A
Page
5
/
5
NtA, Chapter 7 (Volume 2A)
Section heading
Name of the updated
EMA/EC
document
EMA/EC website references
location
Type IA Variations
–
Q1.8
Type IB Variations
–
Q2.7
Type II Variations
–
Q3.9
Type II Variations/Extension app.
–
Q4.8
Grouping of Variations
–
Q5.8
Worksharing of variations
–
Q6.9
Annual Re
-
assessment
–
Q8.8
Renewal
–
Q9.7
FUMs & SOs
–
Q10.8
Art 46
–
Q12.6
Transfer of MA
–
Q13.6
Art 61(3) Notifications
–
Q15.7
WC0b01ac0580023399
10.
‘BLUE
-
BOX’ REQUIREMENTS
EMA pre
-
authorisation procedural advice for users
of the centralised procedure
-
Question 14
-
Question 6
http://www.ema.europa.eu/ema/index.jsp?curl=
pages/regulation/general/general_content_0001
57.jsp&mid=WC0b01ac058002251f
GUIDELINE ON THE PACKAGING
INFORMATION OF MEDICINAL PRODUCTS
FOR HUMAN USE AUTHORISED BY THE
COMMUNITY
http://ec.europa.eu/health/documents/eudralex/vol
-
2/index_en.htm
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