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. (Major Variation - MaV)
/

. (Minor VariationMiV)

. (Minor Variation
(Prior Approval) MiV-PA)
. (Minor Variation
(Notification) MiV-N)
- Major Variation (MaV)

MaV-1
1. (Package insert)
/ /

2.
Summary of Product Characteristics (SmPC)
USPI
1.
2.

3.
4. (Clinical expert reports) /
( )
5. (Package insert) Summary of
Product Characteristics (SmPC)

( )
6
()
7.
ASEAN (ACTD) 4 ()
MaV-2
1. (Package insert)
/ /

2. (MiV)
MaV-1
3.
Summary of Product Characteristics (SmPC)
USPI
1.
2.

3.
4. (Package insert) Summary of

Product Characteristics (SmPC)

( )
MaV-3
/
[ European Pharmacopoeial Certificate of Suitability:
CEP]
1.
2. /
CEP MiV-PA4
1. S1 S7
ASEAN (ACTD) (Drug Master File)

2.
()
3. (Batch analysis)

2 (Pilot batch)
4.
(accelerated) (long term)

(
)
MaV-4
1.

2.
MiV-PA3
3. MaV-9
1.
GMP CPP
GMP
2. (Batch analysis)
2 ( 1 2 )
3
(Batch analysis)
2
()
3. ASEAN Guideline On Stability Study
Of Drug Product
()
4. ()
5. /
ASEAN Guideline on Submission of
Manufacturing Process Validation Data for Drug Registration
6.

7.
8.
9. ( )
10.
11. (Holding time) bulk pack

()
12.
(
)
5
MaV-5
(
)
1.
()
1.
GMP
CPP GMP
2.

()
3. /

ASEAN Guideline on Submission of Manufacturing Process
Validation Data for Drug Registration
4. ()
5. ASEAN Guideline On Stability
Study Of Drug Product
()
6. (Holding time) bulk pack

()
MaV-6
/
[ European Pharmacopoeial Certificate of
Suitability: CEP]
)
)
1.
2. /
3. CEP MiVPA12
4.
1.
2. /
3. /
4. (Batch analysis) /
2

Of Drug Product
()
)
1-4
6. /
MaV-7
1.
2.

3. /
3

4.
1. /

2.
3. (Batch analysis)
2
4.

Of Drug Product
()
MaV-8
1. 10
10
MiV-PA13
2.
3.

4. /
3

1. /

2.
3. (Batch analysis)
1
1
Of Drug Product
()
5.
6.
1 (
)
MaV-9
1.
MaV-4
2.
3.
MiV-PA20
1.
2. /
ASEAN Guideline on Submission of Manufacturing

Process Validation Data for Drug Registration
3.

4. (Batch analysis)
1

Of Drug Product
()
6.

7. ASEAN Guidelines
for the Conduct of Bioavailability and Bioequivalence Studies ( )
10
MaV-10
) ( 2 3
Part III Components and Composition, SUPAC guideline)
)
) (critical dosage forms)
1.

2. /
3
ASEAN
Guideline on Submission of Manufacturing Process Validation Data for Drug
Registration
3.

4.
5.

(non-critical dosage forms) MiV-PA15
1.
Of Drug Product
()
3.
1 (
)
4. ASEAN
Guidelines for the Conduct of Bioavailability and Bioequivalence Studies (
)
5.
(
)
6.
7. (Batch analysis)
2
11
( 1 (Production batch) 2 (Pilot batch))

8. ()
9.
10.
Transmitting Animal Spongiform Encephalopathy (TSE)
(Bovine Spongiform Encephalopathy (BSE))
( )
11.
12. /
ASEAN Guideline on Submission
of Manufacturing Process Validation Data for Drug Registration
13. P3.1 P3.4 ASEAN
(ACTD) ( )
12
MaV-11
1.

2.
(
)
3. /

MiV-PA 16
1.
2. ASEAN
Guidelines for the Conduct of Bioavailability and Bioequivalence Studies (
)
3.
4.
5.
6. ()
Of Drug Product
()
13

) (Qualitative and Quantitative)/
MaV-12
) /
)
1.

2.
MiV-PA28
1. /


Of Drug Product
()
3. ( )
4.

5. ()
6. P3 / P7 ASEAN
(ACTD) ( )
7.
(permeability)

14
/
MaV-13
1.
/

2.
3.
4. /

MiV-PA30
1.

2.
()
Of Drug Product
()
4. ()
15
/ (solvent/diluent)
1.

2. / (solvent/diluent)
MiV-PA18
3. /
/
MaV-15/MiV-PA34 / MaV-16/MiV-PA35 ()
1. / (solvent/diluent) P S
2. / (solvent/diluent)
(GMP) ()
3. ( )
4. /
(solvent/diluent) ()
5.
6.
MaV-14
16

) /
MaV-15
) /
)
1. () ()

2. ()

3. MiV-PA34
1.
2 /
ASEAN Guideline On Stability

) /
) /
)
2. ()
3.
4.
()
17
(
)
MaV-16
) /
) /
)
1. () ()

2. ()

3. (
) MiV-PA 35
1.
2 /
ASEAN
Guidelines on Stability Study of Drug Product

2. ()
3.
18

Minor Variation - Prior Approval (MiV-PA)
MiV- PA1
1. (

)
2.
3.
(1)
(2)
(3)
(4)
1.

( )
2. (
)
3.
4. (CPP) ()
5. ( )
19
MiV-PA2
(
)
) /
) // /
) / /

)
)
)
1. (Package insert)
/
2. (MaV)
(MaV)
MaV-2
1.
2.
3.

4. / (
)
20
MiV-PA3
1.
2.

3.
1.
()
2.
()
GMP CPP GMP
3. ()
MiV-PA4
/
European Pharmacopoeial Certificate of Suitability : CEP
1.
2. / /
CEP MaV-3
1. CEP
European Directorate for the Quality of medicines (EDQM)
2. (Batch analysis)

2 (Pilot batch)
3. CEP
(long term (accelerated)

2
4.
(accelerated) (long term)

(
)
21
MiV-PA5
(
European Pharmacopoeial Certificate of Suitability : CEP)
1.
2.
3. CEP
MiV-PA12
1. (Batch analysis)
1 1

(Batch analysis) 2

()
2.

3. S
ASEAN (ACTD) ( )
22
MiV-PA6

(
1. (in-process limits)
2. CEP
MiV-PA12
3.
4.
(new unqualified impurity)
5.
(novel non-standard technique)
(novel way)
1.
()
2.
3. (Batch analysis)
2
( )
23
MiV-PA7
(
1. /
2.
3. ( (intermediate)
)
4.
5.
6. CEP
MiV-PA12
1. (Drug Master File)

2.
( )
3. 2
4. (Batch analysis)

2 (/ )
5.

6.
(
)

7.
the ASEAN Guideline On Stability Study of Drug Product

()
8. (Process Validation
Report) ()
24
MiV-PA8
)
)
1.
CEP
2. ()
3. CEP
MiV-PA12
4.
MaV-6
5.
6.
)
1. /
2. (Batch analysis)
2
3.
)
1-3
4.
MiV-PA9
1.

2. CEP
MiV-PA12
1.

()
2.
25
MiV-PA10

1.
2.
3. CEP
MiV-PA12
1. 2

2.
MiV-PA11
MiV-PA12
1.
2. /
3. CEP
MiV-PA12
1. 2
2.
European Pharmacopoeial Certificate of Suitability
(CEP)
1. CEP
2. ( )
3. *
Ph.Eur Monograph
CEP ()
4. CEP
(S7), /
( (polymorphism)
5.


()
* CEP
( USP, JP, In-house )
S4.1 S4.5
26
MiV-PA13
1. 10

2.
3.
(end-of-shelf-life specifications)
4. /

3
5.
MaV-7 10
MaV-8
1. /
ASEAN Guideline on Submission
of Manufacturing Process Validation Data for Drug Registration

2.
3. (Batch analysis)
1
1

()
5.
6. P3.1 P3.4
ASEAN (ACTD) ( )
27
MiV-PA14
overage
1.
overages
2.
1.
2.
3. 2
()
28
MiVPA15
) ( 1 Part
III Components and Composition, SUPAC guideline)
) (non-critical dosage forms)

1.
2. /
3
ASEAN Guideline on Submission of Manufacturing Process Validation Data
for Drug Registration
3.

4. ()
5.
(critical dosage forms)

MaV-10
1.


()
3.
1
4. ASEAN
Guidelines for the Conduct of Bioavailability and Bioequivalence Studies
( )
5.
(

)
6.
7. (Batch analysis)
2
29
( 1 2)
8. ( )
9.
10.
( )
11.
12.
( )
13. P3.1 P3.4
ASEAN (ACTD) ()
14. /
ASEAN Guideline on
Submission of Manufacturing Process Validation Data for Drug Registration
( )
30
MiVPA16
1.
2.

3. /
MaV-11
1.
1
2. ASEAN
( )
3.
4.
5.
6. ()
()
/

ASEAN Guideline On Stability Study Of
Drug Product
31
MiV-PA17
// (
//)
1.
2. //
3.
//
1. (Qualitative and Quantitative)
//
2.
3.
4. ()
()
6.
()
7.

8.
()
MiV- PA18
/ (solvent/diluent)
1.
1. /(solvent/diluent)
/
2. ()
3. P
ASEAN (ACTD) ( )
32
MiV-PA19
1.
2.
3.
(new unqualified impurity)
4.
(novel non-standard technique)
(novel way)
1.
( )
2.

3. (Batch analysis)
2 /
4.
33
MiV-PA20
1.
2.
3.
4.
5.

6.
MaV-9
1.

2. semi-solid /

3.
1

4.

5. ASEAN
( )
6. (Batch analysis)
1
(Batch analysis)
2
7.
34

()
8.

MiV-PA21

)
)
1.
MiV-N9
2.
3.
1.

2. (Batch analysis)
3.
()
MiV-PA22
1.
ASEAN Guideline For Validation of Analytical Procedures
2.

3.
4.
5. (new unqualified impurity)

6.
1.

2.

35
MiV-PA23
1. (TSE-risk
material)
2.
3.
4.
(end of shelf-life specifications)
1. 1

( )
2.
3.

()
5.

6.

36
MiV-PA24
)
)
1.
2.
3.
4. MiV-PA27
5.
MaV-6
)
1.

2. (Batch analysis)
2
3.
)
1-3
4.

() ( )
37
MiV-PA25
(imprints) (bossing)
(other markings)
) (score) (break-line)
1.
2.
(food grade)
3.

1-3
4.
5.

1. (
)
2.
(pharmaceutical grade) (food grade) (
)
3.

4. ()
5.
6.
( )
1-6
7. (
)
8. 2
9. content uniformity

38
MiV-PA26
)

1.
2.
/
)

1.
2.
3. ( )
4. 1
/
5. content uniformity
( (score)
(break-line) )
)

1-5
6. ASEAN
( )
39
MiV-PA27
1.
2. (verification/validation)

3.
1.
2. (verification/validation)

3. 2
4.
5.

40
MiV-PA28
) (Qualitative and Quantitative)

/ ) /
)
1.
2.

3.
blister blister
4.
MaV-12
1.

2. semi-solid
(

)
3.

()
4. ()
()
41
MiV-PA29

(secondary packaging)
1.
()
GMP CPP GMP

2.
(secondary
packaging) ()
3. ()
MiV-PA30
1.
2.
3. ( / /)
()
4. /

MaV-13
5.
1.
2. ()
3.

()
42
MiV-PA31
1.
2.
3.

1. ()
2.
MiV-PA32

ampoules
1.

1. ASEAN
(ACTD)
MiV-PA33
1.
2. (compatible)
1. ( )
2.
3.
4. ()
43
MiV-PA34

) /
) /
)
1. () ()
2. ()

3. MaV-15
1.
/
) /
) /
)
2. ()
3.
4.
()
MiV-PA35
(
)
) /
) /
)
1. () ()
2. ()

3. (
) MaV-16
1.
2 /
() ASEAN Guidelines
on Stability Study of Drug Product
2. ()
3.
44

Minor Variation - Notification(MiV-N)
MiV-N1
/ ( )
1.
2.
3. /

MaV-2 MiV-PA3
1.

2. /
3. ()
MiV-N2
(product owner)
1.
2.
1.
2.

3.

4.

5. ()
45
MiV-N3
1.
2.
MiV-N4
1.
GMP
2.
( )
3.

4.

5. ()
/ ( )
()
1.
2.
MiV-N3
3. /
1.
2. GMP CPP GMP
/
3. ()
46
MiV-N5
/ ( )

1.
2.
MiV-N3
3.
1.
/
2. GMP CPP GMP

/ ()
3. ()
4.
MiV-N6
/ ( )
1.
2. /
1.
2.
MiV-N7
(alternative manufacturer) (
/ /)
1.
1.
47
MiV-N8
European Pharmacopoeia Certificate of

Suitability (CEP)
1. CEP
1. CEP
MiV-N9
/ /

1.
2. monograph
1.

2. (Batch analysis)
2
3.
MiV-N10
1.
2.
MaV-13 MiV-PA30
MiV-PA31
1.
2. ()
48

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..

- Major Variation (MaV)

4. (Package insert) Summary of

5. ASEAN Guideline On Stability Study

ASEAN Guideline on Submission of

5. ASEAN Guideline On Stability Study

ASEAN Guideline on Submission of

ASEAN Guideline on Submission of Manufacturing

5. ASEAN Guideline On Stability Study

2. ASEAN Guideline On Stability Study

( 1 (Production batch) 2 (Pilot batch))

ASEAN Guideline on Submission of

Study Of Drug Product

Guidelines on Stability Study of Drug Product

(long term (accelerated)

of Manufacturing Process Validation Data for Drug Registration

4. ASEAN Guideline On Stability

(critical dosage forms)

2. ASEAN Guideline On Stability

ASEAN Guideline on Submission of

5. (new unqualified impurity)

4. ASEAN Guideline On Stability

5. ASEAN Guideline On Stability

) (Qualitative and Quantitative)

GMP CPP GMP

2. GMP CPP GMP

European Pharmacopoeia Certificate of

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