Version 2 - January, 2014 - moph · Current Procedure for Registration of an Imported ... AMM r AMM...

Version 2 - January, 2014

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


Requested documents ............................................................................................................ 24

Requested Fees ........................................................................................................................ 26

................................................................ 27

(Flow Chart 3) ..................................................................................................................... 29

I.4 33 ................................................. يميائيك نظامي محليًا مصّنع مستحضرصيدالني تسجيل ملف تقديم



Requested Fees ....................................................................................................................... 33

.................................................................. 34

(Flow Chart 4) ..................................................................................................................... 36

5I ................................................. 38



Requested Fees ....................................................................................................................... 41

..................................... 42

(Flow Chart 5) ..................................................................................................................... 44

6.I 45 ....................................................... كيميائي نظامي بإجازة محليًا موضب أو/ مصّنعو صيدالني مستحضر تسجيل ملف تقديم

3



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


Types of Variations and Requested Documents ............................................... 68

Requested Fees........................................................................................................................ 73

.................................... 74

Flow Chart (8) ..................................................................................................................... 77

................................................................................................................................................................. 83

III .................................................................................................................................. 83

1III ............................................................. 82


Requested documents........................................................................... 82

...................................................... 83

(Flow Chart 9) ..................................................................................................................... 84

................................................................................................................................................................. 85

IV ............................................................. 87


Requested documents ............................................................................................................. 87

.......................................................................................................................... 87

(Flow chart 10) ................................................................................................................... 88

............................................................................................................................................................... 89

V ....................................................................... 89

4

1V ............................................................. 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

-

10

55

956382

2121995

-

- .

- .

-

AMM

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

12

n

o

i

ii

p

q

r AMM

s AMM

t SMS)

u

v AMMTWFS

w AMM

x AMM

Registration number) ( (MOH Code)

y

z

13

1.1I (Flow Chart 1)

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


-


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


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)


-

8571

-

3361962335511362335

72811152313


- 2Certificate of

analysis

Final

Release / Batch Release

Mock ups

3411

571

1.1I Requested Fees

-

55

18

956382

2121995

-

- .

- .

-

AMM

19

1.1I

Current procedure for Registration of an Imported Generic Chemical Product

a

i

TWFS

ii

b

c

i

ii

d (Module 3)


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

21

1.1I (Flow Chart 2)

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


-


Archive Box

-

-

- ATC code

-


571271323385RL1/DIED v1-2012


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


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


-

8571

-

8

571

- 3361

962335511362335

72811152313


26

- 22

Certificate of analysis

3411571

1.1I Requested Fees

-

55

956382

2121995

-

- .

- .

-

AMM

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)


e

f

g Module 3

h

i

j

k

i

RI8DIEDv1-2012

l

m

n

o

i

28

ii

p

q

r AMM

s AMM

t SMS)

u

v AMMTWFS

w AMM

x AMM


Code)

y

z

29

1.1I (Flow Chart 3)

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


-


Archive Box

-

-

- ATC code

-


571271323385RL1/DIED v1-2012


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



8 Module 3

9 Requirements for Drug Substance and finished Product Checklist (QPDIEDv1-2012

13 Bioequivalence

9

(Pharmacological Data)(Toxicological Data)Side Effects


-

8

571

- 3361

962335511362335

7281 1152313


- 22


3411571

33

1.1I Requested Fees

-

55

956382

2121995

-

- .

- .

-

AMM

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)


e Requirements


f


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


Code)

aa

bb

36

1.1I )4(Flow Chart

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



Archive Box

-

-

- ATC code

-


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



8 Bioavailability

9 (Pharmacological

Data)(Toxicological Data)Side Effects


-

8571

-

8

571

- 3361

962335511362335

72811152313

41

- Soft copy of the technical file

- 22


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)


e

f

g Module 3

h

i

j

k

i

ii

l

43

m

n

o

i

ii

p

q

r AMM

s AMM

t SMS)

u

v AMMTWFS

w AMM

x AMM


Code)

y

z

44

1.1I )5(Flow Chart

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)



Archive Box

-

-

- ATC code

-


571271323385RL2/DIED v1-2012


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



8 Bioequivalence

Originator

9 (Pharmacological

Data)(Toxicological Data)Side Effects


-

8

571

- 3361

962335511362335

72811152313

- Soft copy of the technical file

48

- 22


3411571

6.1I Requested Fees

-

55

956382

2121995

-

- .

- .

-

AMM

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)


e Requirements


f


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


Code)

aa

bb

51

6.1I )6(Flow Chart

53

II

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

57

GMP

Certificate

5

21232339

2

6

2

7

Plant Profile

GMP

2

12 :(Design))

21232339

21232339

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

60

AMM

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

63

17 AMMTWFS

18 AMM

19 AMM

Registration number) (

(MOH Code)

23

21

64


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


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

70

11

23 1

2

24 1

2

25 (Design)1

2

26 1

2

3

21232339

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

73

1.1II uested FeesReq

55

95

63822121995

AMM

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)

76

23

21

77

1.1II Flow Chart (8)

80

III

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

84

1.1III )9(Flow Chart

85

IV

86

IV

(Notification)

1IV

2IV

3IV

4IV (Flow chart 10)

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

88

1IV (Flow chart 10)

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

92

1.1V (Flow chart 11)

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

94

2

1/8/1994 167

21/2/1995 6181

21/2/1995 6181

21/7/2003 115 3/6/2005 156

336 24/1/2006 11

533

1672333

52535463367

181994

27/10/2008 171

2632642337

993114132313

22/2/2011 181

16111511159

Version 2 - January, 2014 - moph · Current Procedure for Registration of an Imported ... AMM r AMM...

Documents

Transcript of Version 2 - January, 2014 - moph · Current Procedure for Registration of an Imported ... AMM r AMM...