Registration Application Form for Veterinary Product

REGISTRATION APPLICATION FORM FOR VETERINARY PRODUCT

(NEW CHEMICAL ENTITY, SCHEDULED POISON AND NON-SCHEDULED POISON)

* All electronic copy (attachment) in CD should be named according to this format :

ACTD No_ACTD Requirement_Product Name_Date eg P8_Stability Data_ABC Tablet 500mg_01082016

Please indicate the attachment name accordingly in the registration form.

Product Classification □ New Chemical Entity

□ Scheduled Poison

□ Non Scheduled Poison

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Product Validation : Product Information

1. / Product Name / :
2. / Dosage Form / : / in form of ______
If capsule form
(i). Source of capsule shell:
(ii). Colouring agent used in capsuleshell:
No. / Coloring Agent
1.
3. / Active Ingredient(s)
No. / Active Ingredient Name / Strength / Overage / Remarks
1.
2.
4. / Excipient(s)
No. / Excipient Name / Strength / Function / Overage / Remarks
1.
2.
3.
4.
5.
5. / Other Information
i. Animal parts used in the product / :
6. / Manufacturer(name & address) / :
i) Contract manufacturer / : / YES/NO
7. / Second Source / : / YES/NO
If Yes , to submit
i. Letter of declaration:
ii. Registration number:
iii. Product Name of the First Source :
8. / Replacement Product / : / YES/NO
If Yes , to submit
i. Letter of declaration:
ii. Registration number:
iii. Product Name to be replaced:
9. / Imported Product / : / YES/NO

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Section A : Product Particulars

A1. / Name of Product / :
A2. / Name and Strength of Active Ingredient(s)
No. / Active Ingredient Name / Strength / Overage / Remarks
1
2.
Name and Strength of Excipient(s)
No. / Excipient Name / Strength / Function / Overage / Remarks
1
2
3
4
5
6
7
A3. Dosage form : in form of ______
A4. / Product Description / :
A5.1 / Pharmacodynamics / :
A5.2 / Pharmacokinetics / :
A6.1 / Indication / :
A6.2 / Target Species :
A7. / Recommended Dose / :
A8. / Route of Administration / :
A9. / Contraindication / :
A10. / Warning and Precautions / :
A11. / Interactions With Other Medicaments / :
A12. / Pregnancy and Lactation / :
A13. / Side Effects / :
A14. / Symptoms and Treatment of Overdose / :
A15. / Storage Condition / :
A16.1
A16.2
A16.3 / PROPOSED SHELF LIFE(as packaged for sale)
Proposed shelf life (after first opening of container, where relevent)
Proposed shelf life (after reconstitution or dilution, where relevent)
/ :
:
:
A17. / Therapeutic Code
A18.
A18.1
A18.2 / No. / Therapeutic Name / Therapeutic Code
1
Is the product for food producing animals? YES / NO
Withdrawal Period:
Maximum Residual Limit (MRL) :

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Section B : Product Formula

B1.1 / Batch Manufacturing Formula
Batch Size / :
Unit / :
List of Active Ingredient(s):-
No. / Active Ingredient Name / Strength / Overage / Remarks
1.
List of Excipient(s):-
No. / Excipient Name / Function / Strength / Overage / Remarks
1.
2.
3.
4.
5.
6.
7.
B1.2 / Does the product contain or consist of Genetically Modified Organisms (GMO)? (where relevent)
YES / NO
B1.3 / Batch Manufacturing Formula Documentation(attachment) / :

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Section C : Particular of Packing

No. / Pack Size / Measurement Type / Container Type / Container Type Description / Barcode/Serial No. / Distributor Price(RM) / Retail Price(RM)
1

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Section D : Label (Mockup) For Immediate Container, Outer Carton, and Proposed Package Insert

D1. / Label (mockup) for immediate container(attachment) / :
D2. / Label (mockup) for outer carton
(attachment) / :
D3. / Proposed package insert(attachment) / :

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Section E : Supplementary Documentation

E1.1 / Product Owner / : / PRODUCT HOLDER
PRODUCT HOLDER & MANUFACTURER
MANUFACTURER
OTHERS
No. / Product owner / Address
1
E1.2 / Letter of Authorization From Product Owner(attachment) / :
E2.1 / Letter of Appointment of Contract Manufacturer From Product Owner(attachment) / :
E2.2 / Letter of Acceptance From Contract Manufacturer(attachment) / :
E3 / Is the Active Ingredient(s) patented in Malaysia? / : / YES/NO
E4 / Certificate of Pharmaceutical Product (CPP)(attachment) / :
E4.1 / Certificate of Pharmaceutical Product (CPP) Issuing Body / : / Country :
Issuing Body :
E4.2 / Is this product licensed to be placed on the market for use in the exporting country? / : / YES/NO
E4.3 / Is the product on the market in the exporting country? / : / YES/NO
E4.4 / Date of issue of Certificate of Pharmaceutical Product (CPP) / :
E4.5 / Date of expiry of Certificate of Pharmaceutical Product (CPP)(* if any) / :
E5 / Certificate of Free Sale (CFS) / Second Certificate of Pharmaceutical Product (CPP)(attachment) / :
E5.1 / Certificate of Free Sale (CFS) Issuing Body / : / Country :
Issuing Body :
E5.2 / Date of issue of Certificate of Free Sale (CFS) / :
E5.3 / Date of expiry of Certificate of Free Sale (CFS)(* if any) / :
E6 / Certificate of Good Manufacturing Practice (GMP)(* if any)(attachment) / :
E6.1 / Certificate of Good Manufacturing Practice (GMP) Issuing Body(* if any) / : / Country :
Issuing Body :
E6.2 / Date of issue of Certificate Good Manufacturing Practice (GMP)(* if any) / :
E6.3 / Date of expiry of Certificate Good Manufacturing Practice (GMP)(* if any) / :
E7 / Summary of Product Characteristics (Product Data Sheet - if any)(attachment) / :
E8 / Patient Information Leaflet (PIL)(attachment) / :
E9 / Attachment of Protocol Analysis(attachment) / :
E10 / Attachment of Analytical Validation Report (if any)(attachment) / :
E11 / Attachment of Certificate Analysis (Minimum 2 batches)(attachment) / :
E12 / Other Supporting Document (if any)(attachment) / :
E13 / Manufacturer / :
E13.1 / Importer(* if any) / : / Imported by other than applicant
List of importer(s):-
No. / Importer Name / Address
1
E14 / Other Manufacturer(s) Involved (if any)
No. / Manufacturer / Address / Manufacturing Type / GMP Certificate(attachment)
1
2
E15 / Store Address (if any)
No. / Store Name / Address
1
E16 / Worldwide registration status (Please specify country and date registered, entry is COMPULSARY for imported product )
No. / Country / Date Registered
1

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Section P : Drug Product

P1 / Description and Composition
P2 Pharmaceutical Development
P2.1 / Information on Development Studies
P2.2 / Components of the Drug Product
P2.3 / Finished Products
P2.4 / Manufacturing Process Development
P2.5 / Container Closure System
P2.6 / Microbiological Attributes
P2.7 / Compatibility
P3 MANUFACTURER
P3.1 / Batch Formula
List of Active Ingredient(s)
No. / Active Ingredient Name / Strength / Overage / Remarks
1
List of Excipient(s):-
No. / Excipient Name / Strength / Function / Overage / Remarks
1
2
3
4
5
6
7
P3.2 / Manufacturing Process and Process Control
P3.2.1 / Manufacturing Proces Flowchart (attachment)(If any) / :
P3.3 / Control of Critical Steps and Intermediates
P3.4 / Process Validation and / or Evaluation(attachment) / :
P4 CONTROL OF EXCIPIENTS
P4.1 / Specifications
P4.2 / Analytical Procedures (attachment)(If any) / :
P4.3 / Validation of Analytical Procedures (attachment)(If any) / :
P4.4 / Justification of Specifications
P4.5 / Excipient of Human or Animal Origin
P4.6 / Novel Excipients
P5 CONTROL OF FINISHED PRODUCTS
P5.1 / Specification
P5.2 / Analytical Procedures(attachment) / Refer E9
P5.3 / Validation of Analytical Procedures(attachment) / Refer E10
P5.4 / Batch Analysis(attachment)
P5.5 / Characterisation of Impurities (If any)
P5.6 / Justification of Specification(s)
P6 Reference Standards or Material
P7 / Container Closure System
:
P8 / Stability Data(attachment)
:
P9 / Product Interchangeability / Equivalence Evidence(attachment) (* if any)
:

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Section S : Drug Substance (Active Pharmaceutical Ingredient)

* For Scheduled Poison and Non Scheduled Poison, only S1, S2.1, S4.1, and S4.4 are required.

* For product with two or more active ingredients, please use separate form of Section S : Drug Substance for each active ingredient

List of Active Ingredient(s):-
No. / Active Ingredient Name / Strength / Overage / Remarks
1

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S1 / GENERAL INFORMATION
S1.1 / Nomenclature
S1.2 Structure
S1.2.1 Attachment forStructure
S1.3 General Properties
S2 / MANUFACTURER
S2.1 / Manufacturer Name
No. / Manufacturer Name / Manufacturer Address
1
2
S2.2Description of Manufacturing Process and Process Controls:
S2.3Controls of Materials:
S2.4Controls of Critical Steps and Intermediates:
S2.5Process Validation and / or EvaluationGeneral Properties:
S2.6Manufacturing Process Development:
S3CHARACTERISATION
S3.1Elucidation of Structure and Characteristics:
S3.2Impurities
S4CONTROL OF DRUG SUBSTANCE
S4.1Specifications
S4.2Analytical Procedures:
S4.3Validation of Analytical Procedures:
S4.4Batch Analysis(attachment):
S4.5Justification of Specification:
S5REFERENCE STANDARDS OR MATERIALS
S6CONTAINER CLOSURE SYSTEM
S7STABILITY DATA /

FEE PEMPROSESAN

Fee Pemprosesan perlu dikemukakan bersama 2 salinan Borang BPFK 001 (boleh dimuat turun dari laman sesawang NPRA) setelah permohonan penyaringan ('screening') diluluskan.

Semua jenis keluaran Ubat Veterinar: RM 1,500.00 (Satu ribu lima ratus ringgit sahaja)

Semua jenis pembayaran hendaklah dibuat di atas nama ‘Biro Pengawalan Farmaseutikal Kebangsaan’

PERAKUAN PEMOHON

Saya yang bernama dan beralamat di bawah sebagai mewakili syarikat yang memohon mengaku bahawa :

Saya akan mematuhi semua peruntukan-peruntukan dalam Akta Jualan Dadah 1952 (Disemak 1989) dan Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984.

Semua kenyataan-kenyataan di atas dan lampiran-lampiran yang disertakan adalah benar.

Saya menyedari dan mematuhi peruntukan-peruntukan di dalam Akta Paten 1983.

Saya mengaku akan bertanggungjawab sepenuhnya terhadap produk ini.

Tandatangan Pemohon :

Nama Penuh Pemohon :

(Huruf Besar)

Nombor Kad Pengenalan :

Jawatan dalam Syarikat :

Nama dan Alamat Syarikat :

Cop Rasmi Syarikat :

No. Telefon :

No. Faks :

Alamat e mel :

Tarikh :