version 2 - january, 2014 - moph · current procedure for registration of an imported ... amm r amm...
TRANSCRIPT
2
.................................................................................................................................................................... 5
I ..................................................................................................................... 5
1.I ............................................................... 6
Applicant for Registration ................................................................................................................ 7
Requested documents ............................................................................................................... 7
Requested Fees ......................................................................................................................... 9
............................................................. 11
(Flow Chart 1) ..................................................................................................................... 13
2I ............................................................. 14
Applicant for Registration ............................................................................................................. 15
Requested documents ........................................................................................................... 15
Requested Fees ........................................................................................................................ 17
.................................................................... 19
(Flow Chart 2) ...................................................................................................................... 21
3 I ............................................................. 23
Applicant for Registration ............................................................................................................. 24
Requested documents ............................................................................................................ 24
Requested Fees ........................................................................................................................ 26
................................................................ 27
(Flow Chart 3) ..................................................................................................................... 29
I.4 33 ................................................. يميائيك نظامي محليًا مصّنع مستحضرصيدالني تسجيل ملف تقديم
Applicant for Registration ............................................................................................................. 31
Requested documents ........................................................................................................... 31
Requested Fees ....................................................................................................................... 33
.................................................................. 34
(Flow Chart 4) ..................................................................................................................... 36
5I ................................................. 38
Applicant for Registration ............................................................................................................. 39
Requested documents ........................................................................................................... 39
Requested Fees ....................................................................................................................... 41
..................................... 42
(Flow Chart 5) ..................................................................................................................... 44
6.I 45 ....................................................... كيميائي نظامي بإجازة محليًا موضب أو/ مصّنعو صيدالني مستحضر تسجيل ملف تقديم
3
Applicant for Registration ............................................................................................................. 46
Requested documents ........................................................................................................... 46
Requested Fees ........................................................................................................................ 48
............................................. 49
(Flow Chart 6) ..................................................................................................................... 51
................................................................................................................................................................. 53
II ................................................................ 53
1II 54
Applicant for Registration .............................................................................................................. 55
Types of Variations and Requested Documents ............................................... 55
Requested Fees........................................................................................................................ 59
.......................................... 61
(Flow Chart 7) ..................................................................................................................... 64
2II ............................................................. 66
Applicant for Registration .............................................................................................................. 68
Types of Variations and Requested Documents ............................................... 68
Requested Fees........................................................................................................................ 73
.................................... 74
Flow Chart (8) ..................................................................................................................... 77
................................................................................................................................................................. 83
III .................................................................................................................................. 83
1III ............................................................. 82
Applicant for Registration .............................................................................................................. 82
Requested documents........................................................................... 82
...................................................... 83
(Flow Chart 9) ..................................................................................................................... 84
................................................................................................................................................................. 85
IV ............................................................. 87
Applicant for Registration .............................................................................................................. 87
Requested documents ............................................................................................................. 87
.......................................................................................................................... 87
(Flow chart 10) ................................................................................................................... 88
............................................................................................................................................................... 89
V ....................................................................... 89
4
1V ............................................................. 91
Applicant for Registration .............................................................................................................. 91
Requested Documents ........................................................................................................... 91
...................................... 91
(Flow chart 11) ................................................................................................................... 92
.....................................................................................................................................................95
6
1I
(Registration of an Imported Pharmaceutical Originator Compound and
Biotechnology product)
1.1I
1.2I
1.3I
1.4I
1.5I (Flow Chart 1)
7
1I
Registration of an Imported Pharmaceutical Originator Compound
and Biotechnology product
1.1I Applicant for Registration
-
1.1I Requested documents
Archive Box
-
-
- (ATC code
- Responsible Party
Administrative and Organizational Information
-
171271323384
RI1/DIED/v1-2012
Documents related to the parties involved in the manufacturing and
marketing of the product
17127/10/20084:
1
12571
8
2 Profile of the Responsible
Party2(RI2/DIED/v1-2012)(9571
3
9571
Plant Profile3((RI3/DIED/v1-
2012
GMP Certificate
Plant Profile
GMP Certificate
GMP
4
5 5
571
Technical file
571
271323386
1 Methods of Analysis
2 Stability DataStorage
Conditions
9
3 Side Effects
4
Toxicological Data
5 Module 3
6 Requirements for Drug Substance and finished Product Checklist
(QPDIEDv1-2012)
7 Bioavailability
8
Pharmacological & Clinical Data
Additional Information
-
8571
-
8571
-
3361962335511362335
72811152313
- Technical file Soft copy of the
- 2Certificate of
analysis
Final
Release / Batch Release
Mock ups
3411
571
1.1I Requested Fees
-
11
1.1I
Current Procedure for Registration of an Imported Pharmaceutical Originator
Compound and Biotechnology product
a
i
TWFS
ii
b
c
i
ii
d (Module 3)
Requirements for Quality study checklist
e
f
g Module 3
h
i
j
k
i
RI4DIEDv1-2012
ii
(RI8DIEDv1-2012
l
m
14
2I
(Registration of an Imported Generic Chemical Product)
2.1I
2.2I
2.3I
2.4I
2.5I (Flow Chart 2)
15
1I
Registration of an Imported Generic Chemical Product
1.1I Applicant for Registration
-
1.1I Requested documents
Archive Box
-
-
- ATC code
-
Administrative and Organizational information
57127132338
4RI1/DIED/v12012-
Documents related to the parties involved in the manufacturing and marketing of
the product
571271323384
1
12571
2Profile of the Responsible Party
2RI2/DIED/v1-20129571
39
16
571
Plant Profile3(RI3/DIED/v1-
2012
Plant Profile
Plant Profile
GMP Certificate
GMP Certificate
GMP
4
55
571
Technical File
57127
1323386
1 Methods of Analysis
2 Stability DataStorage
Conditions
3 Bioequivalence
Originator
4 Module 3
17
Requirements for Drug Substance and finished Product Checklist (QPDIEDv1-2012)
Requirements for Bioequivalence Study
checklist) (RI5/DIED/v1-2012).
Bioequivalence Study
(RI6/DIED/V1-2012)
(Comparative in vitro dissolution)
Bioequivalence(RI7/DIED/v1-2012)
Additional Information
-
8571
-
3361962335511362335
72811152313
- Technical file Soft copy of the
- 2Certificate of
analysis
Final
Release / Batch Release
Mock ups
3411
571
1.1I Requested Fees
-
55
19
1.1I
Current procedure for Registration of an Imported Generic Chemical Product
a
i
TWFS
ii
b
c
i
ii
d (Module 3)
Requirements for Quality study checklist
e Requirements
for Bioequivalence study checklist
f
Comparative dissolution
g
h
i Module 3
Bioequivalence
j
k
l
m
-
RI4DIEDv1-2012
-
(RI8DIEDv1-2012
20
n
o
p
q
i
ii
r
s
t AMM
u AMM
v SMS)
w
x AMMTWFS
y AMM
z AMM
Registration number) ( (MOH
Code)
aa
bb
23
3I
Registration of a Locally Manufactured Innovator or Biological Product
3.1I
3.2I
3.3I
3.4I
3.5I (Flow Chart 3)
24
1I
Registration of a Locally Manufactured Innovator or Biological Product
1.1I Applicant for Registration
-
1.1I Requested documents
Archive Box
-
-
- ATC code
-
Administrative and Organizational information
571271323385RL1/DIED v1-2012
Documents related to the parties involved in the manufacturing and marketing of
the product
571
27132338
5
1 Plant Profile1) (2012-1v/DIED/3RI
2 GMP Certificate
GMP
25
Technical File
57127/10/2008
5
1 Description
2
3
4
5
6 Methods of Analysis
7 Stability DataStorage Conditions
8 Module 3
9 Requirements for Drug Substance and finished Product Checklist (QPDIEDv1-2012)
13 Bioavailability
9
(Pharmacological Data)(Toxicological Data)Side Effects
Additional Information
-
8571
-
8
571
- 3361
962335511362335
72811152313
- Technical file Soft copy of the
27
1.1I
Current Procedure for Registration of a Locally Manufactured Innovator or Biological
Product
a
i
TWFS
ii
b
c
i
ii
d (Module 3)
Requirements for Quality study checklist
e
f
g Module 3
h
i
j
k
i
RI8DIEDv1-2012
l
m
n
o
i
30
4I
Registration of a Locally Manufactured Generic Chemical Product
4.1I
4.2I
4.3I
4.4I
4.5I (Flow Chart 4)
31
1I
Registration of a Locally Manufactured Generic Chemical Product
1.1I Applicant for Registration
-
1.1I Requested documents
Archive Box
-
-
- ATC code
-
Administrative and Organizational information
571271323385RL1/DIED v1-2012
Documents related to the parties involved in the manufacturing and marketing of
the product
571
27132338
5
1 Plant Profile 3) ( 2012-RI3/DIED/v1
2 GMP Certificate
GMP
32
Technical File
57127/10/2008
5
1 Description
2
3
4
5
6 Methods of Analysis
7 Stability DataStorage Conditions
8 Module 3
9 Requirements for Drug Substance and finished Product Checklist (QPDIEDv1-2012
13 Bioequivalence
9
(Pharmacological Data)(Toxicological Data)Side Effects
Additional Information
-
8
571
- 3361
962335511362335
7281 1152313
- Technical file Soft copy of the
- 22
Certificate of analysis
3411571
34
1.1I
Current Procedure for Registration of a Locally Manufactured Generic Chemical
Product
a
i
TWFS
ii
b
c
i
ii
d (Module 3)
Requirements for Quality study checklist
e Requirements
for Bioequivalence study checklist
f
Comparative dissolution
g
h
i Module 3
Bioequivalence
j
k
l
m
i
RI8DIEDv1-2012
n
35
o
p
q
i
ii
r
s
t AMM
u AMM
v SMS)
w
x AMMTWFS
y AMM
z AMM
Registration number) ( (MOH
Code)
aa
bb
38
5I
Registration of a Locally Manufactured and/or packed under License Innovator or
Biological Product
5.1I
5.2I
5.3I
5.4I
5.5I (Flow Chart 5)
39
1I
Registration of a Locally Manufactured and/or Packed under License
Innovator or Biological Product
1.1I Applicant for Registration
1.1I Requested documents
Archive Box
-
-
- ATC code
-
Administrative and Organizational information
571271323385RL2/DIED v1-2012
Documents related to the parties involved in the manufacturing and marketing of the
product
57127132338
5
1 Plant Profile3 2012)-(RI3/DIED/V1
40
2 Plant Profile/Licensor Profile
3 RI3/DIED/V1-2012 (RI2/DIED/V1-2012 - 2
3 GMP Certificate
GMP
4
5
Technical File
57127132338
5
1 Description
2
3
4
5
6 Methods of Analysis
7 Stability DataStorage Conditions
8 Bioavailability
9 (Pharmacological
Data)(Toxicological Data)Side Effects
Additional Information
-
8571
-
8
571
- 3361
962335511362335
72811152313
41
- Soft copy of the technical file
- 22
Certificate of analysis
3411571
1.1I Requested Fees
-
55
956382
2121995
-
- .
- .
-
AMM
42
1.1I
Current procedure for Locally Manufactured and/or Packed under License Innovator
or Biological Product
a
i
TWFS
ii
b
c
i
ii
d (Module 3)
Requirements for Quality study checklist
e
f
g Module 3
h
i
j
k
i
ii
l
45
6I
Registration of a Locally Manufactured and/or packed under License Generic Chemical
Product
6.1I
6.2I
6.3I
6.4I
6.5I (Flow Chart 6)
46
6I
(Registration of a Locally Manufactured and/or packed under License
Generic Chemical Product)
6.1I Applicant for Registration
6.1I Requested documents
Archive Box
-
-
- ATC code
-
Administrative and Organizational information
571271323385RL2/DIED v1-2012
Documents related to the parties involved in the manufacturing and marketing of
the product
57127132338
5
47
1 Plant Profile32012-RI3/DIED/V1
2 Plant Profile/Licensor Profile
3 RI3/DIED/V1-2012 (RI2/DIED/V1-2012- 2
3 GMP Certificate
GMP
4
5
Technical File
57127132338
5
1 Description
2
3
4
5
6 Methods of Analysis
7 Stability DataStorage Conditions
8 Bioequivalence
Originator
9 (Pharmacological
Data)(Toxicological Data)Side Effects
Additional Information
-
8
571
- 3361
962335511362335
72811152313
- Soft copy of the technical file
49
6.1I
Current Procedure for Registration of a Locally Manufactured and/or packed under
License Generic Chemical Product
a
i
TWFS
ii
b
c
i
i
d (Module 3)
Requirements for Quality study checklist
e Requirements
for Bioequivalence study checklist
f
Comparative dissolution
g
h
i Module 3
Bioequivalence
j
k
l
m
i
50
ii
n
o
p
q
i
ii
r
s
t AMM
u AMM
v SMS)
w
x AMMTWFS
y AMM
z AMM
Registration number) ( (MOH
Code)
aa
bb
54
1II
(Change in the content of the registration file of imported registered pharmaceutical
products)
1.1II
1.2II
1
2
1.3II
1.4II
1.5II (Flow Chart 7)
55
1II
(Change in the content of the registration file of imported registered
pharmaceutical products)
1.1II Applicant for Registration
-
1.1II and Requested Documents Types of Variations
1 Types of Variations
Type I Variations
1 .
2 .
3
4 .
5 .
6 .
7
12:(Design)) 21232339
Type II Variations
8
56
9
13
1 Requested Documents
a (Type I Variations)
VI1/DIED/v1-2012
Type I Variations
8571
1
2
2
Methods of
Analysis
Stability
Data Storage Conditions
Bioequivalence
Originator
Bioavailability
2
21232339
3
Stability
DataStorage Conditions
2
4
58
55376181994
4
63822121995
b Type II Variations
VI1/DIED/v1-2012
Type II Variations
13571
8 Company Profile :
2
9 Plant Profile
Methods of Analysis
Stability Data
Storage Conditions
Bioequivalence
Originator
Bioavailability
59
2
13
Methods of Analysis
Stability Data
Storage Conditions
Bioequivalence
Originator
Bioavailability
2
1.1II ted FeesuesReq
55
95
63822121995
61
1.1II
Change in the content of the registration file of Current procedure for the
imported registered pharmaceutical products
1
i
TWFS
ii
2
3
i
ii
4
a Type I Variation
5 2
Bioequivalence
6
7
8
9 12367
(RI8DIEDv1-2012)
13
5
62
b Type II VariationType I Variation
5
6
913
2
Bioequivalence
7
8
9
12567
13
i
25
11
12
13 AMM
14 AMM
15
SMS)
16
67
2II
(Change in the content of the registration file of locally manufactured registered
pharmaceutical products)
2.1II
2.2II
1
2
2.3II
2.4II
2.5II (Flow Chart 8)
68
1II
(Change in the content of the registration file of locally manufactured
registered pharmaceutical products)
1.1II Applicant for Registration
-
1.1II Types of Variations and Requested Documents
1 Types of Variations
Type I Variations
21 .
22 .
23
24 .
25 Design)
26 .
Type II Variations
28
29 Under License Joint
Venture33
69
1 Requested Documents
a (Type I Variations)
VL1/DIED/v1-2012
Type I Variations
9571
21 1
2
22 1 Description
2
3
4
5
6
Methods of Analysis7 Stability Data
Storage Conditions
8 Bioequivalence
Originator
Bioavailability
9
(Pharmacological
Data)(Toxicological Data)
Side Effects
13
71
55376181994
4
63822121995
b Type II Variations
VL1/DIED/v1-2012
Type II Variations
11571
28
Plant Profile
GMP Certificate
Certificate of Analysis
Methods of
AnalysisStability Data
Storage Conditions
2
29
Under
72
License
Joint VentureUnder LicenseJoint
Venture
Description
2
33 1 Methods of
Analysis2 Stability Data
Storage Conditions
3 Bioequivalence
Originator
Bioavailability
4
5 2
1 33
2 28
Under LicenseJoint Venture
29
3
74
1.1II
Current procedure for the Change in the content of the registration file of locally
manufactured registered pharmaceutical products
1
i
TWFS
ii
2
3
i
ii
4
a Type I Variation
5 Bioequivalence
6
7
8
9
21222326
(RI8DIEDv1-2012
13
i 24
ii
75
b Type II VariationType I Variation
5
6
33
22
Bioequivalence
7
8
9
21222326
13
2224
11
12
13 AMM
14 AMM
15 SMS)
16
17 AMMTWFS
18 AMM
19 AMM
Registration number) ( (MOH Code)
81
III
1III
(Classification as similar to drugs for an imported or locally manufactured product)
1.1III
1.2III
1.3III
1.4III (Flow chart 9)
82
1III
Classification as similar to drugs for an imported or locally manufactured
product
1.1III Applicant for Registration
-
1.1III Requested documents
- C1/DIED/V1-2012
-
- Plant Profile DIED/V1-2012RI2
- GMP GMP
- 2
- Stability data
- Storage conditions
-
-
-
83
1.1III
Current Procedure for Classification as similar to drugs for an imported or locally
manufactured product
a
i
TWFS
ii
b
c
i
ii
d
e
f
g
i
ii
h
i
87
IV
(Notification)
1IV Applicant for Registration
-
1IV Requested documents
1 (N1DIEDv1-2012)
2
1IV
Current Procedure for Notification
a TWFS
b
c
d
e
90
1V
(Objection on the Technical or Pricing Committee’s decision)
1.1V
1.2V
1.3V
1.4V (Flow chart 11)
91
1V
(Objection on the Technical or Pricing Committee’s decision)
1.1V Applicant for Registration
-
1.1V Requested Documents
1 (O1DIEDv1-2012)
2
3
1.1V
Current Procedure for the Objection on the Technical or Pricing Committee’s decision
a TWFS
b
c
d
e
93
1
Reference # Application Form
RI1DIEDv1-2012
RI2DIEDv1-2012 Companies Profile
RI3DIEDv1-2012 Plant Profile
RI4DIEDv1-2012 List of Reference Countries
RI5DIEDv1-2012 Requirements for Bioequivalence Study checklist
RI6DIEDv1-2012 Waiver Request for submitting Bioequivalence Studies
QPDIEDv1-2012 Requirements for Drug Substance and finished Product Checklist
RI7DIEDv1-2012 Comparative in vitro
dissolution
RI8DIEDv1-2012 List of Reference Laboratories
(
RL1DIEDv1-2012
RL2DIEDv1-2012
VI1DIEDv1-2012
VL1DIEDv1-2012
C1DIEDv1-2012
N1DIEDv1-2012 Notification
O1DIEDv1-2012 Objection