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_01082016Please indicate the attachment name accordingly in the registration form.

Product Classification □ New Chemical Entity□ Scheduled Poison □ Non Scheduled Poison

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 capsule shell:

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 Remarks1.2.3.4.5.

   

1

REF. NO :

5. Other Informationi. 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 / NOIf Yes , to submit

    i. Letter of declaration : ii. Registration number : iii. Product Name to be replaced :

9. Imported Product : YES / NO

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) 

2

No. Excipient Name Strength Function Overage Remarks1234567

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:

            

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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 Code1

Is the product for food producing animals? YES / NO

Withdrawal Period :

Maximum Residual Limit (MRL) :

 

Section B : Product Formula 

B1.1 Batch Manufacturing Formula

  Batch Size :    

4

  Unit :    

         

  List of Active Ingredient(s):-No. Active Ingredient Name Strength Overage Remarks1.

         

  List of Excipient(s):-No. Excipient Name Function Strength Overage Remarks1.2.3.4.5.6.7.

 

B1.2

 

Does the product contain or consist of Genetically Modified Organisms (GMO)? (where relevent)YES / NO

B1.3 Batch Manufacturing Formula Documentation (attachment)

:

 

Section C : Particular of Packing No. Pack Size Measurement

TypeContainer Type

Container Type Description

Barcode/Serial No.

Distributor Price(RM)

Retail Price(RM)

1

         Section D : Label (Mockup) For Immediate Container, Outer Carton, and Proposed Package Insert D1. Label (mockup) for immediate :

5

container (attachment) D2. Label (mockup) for outer carton

(attachment):

 D3. Proposed package insert

(attachment):

    

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)

:

 

6

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 :

 

 

7

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 Address1

 

E14 Other Manufacturer(s) Involved (if any)No.Manufact

Address

 

8

urer

12

 E15 Store Address (if any)

No. Store Name Address1

E16 Worldwide registration status (Please specify country and date registered, entry is COMPULSARY for imported product )

 

No. Country Date Registered1

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       

9

       P2.7 Compatibility    

  

P3 MANUFACTURERP3.1 Batch Formula        List of Active Ingredient(s) No. Active Ingredient

NameStrength Overage Remarks

1 

List of Excipient(s):- No. Excipient Name Strength Function Overage Remarks1234567

         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):

10

 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)   :  

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

NameStrength Overage Remarks

1

  

11

           S1 GENERAL INFORMATION

S1.1 Nomenclature

S1.2 Structure

S1.2.1 Attachment for Structure

S1.3 General Properties

S2 MANUFACTURER

S2.1 Manufacturer Name No. Manufacturer Name Manufacturer Address

12

S2.2 Description of Manufacturing Process and Process Controls:

S2.3 Controls of Materials:

S2.4 Controls of Critical Steps and Intermediates: S2.5 Process Validation and / or Evaluation General Properties:

S2.6 Manufacturing Process Development:

S3 CHARACTERISATION

S3.1 Elucidation of Structure and Characteristics:

S3.2 Impurities

S4 CONTROL OF DRUG SUBSTANCE

S4.1 Specifications

S4.2 Analytical Procedures : S4.3 Validation of Analytical Procedures :

12

S4.4 Batch Analysis (attachment) : S4.5 Justification of Specification : S5 REFERENCE STANDARDS OR MATERIALS

S6 CONTAINER CLOSURE SYSTEM S7 STABILITY DATA

FEE PEMPROSESAN

1. 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)

2. 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 :

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

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

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

4. 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                         :

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