BPFK -300

Rujukan Tuan :
Rujukan Kami :
No. Siri
:
PERMOHONAN PENGKELASAN PRODUK
PRODUCT CLASSIFICATION APPLICATION
SEKSYEN A MAKLUMAT PEMOHON/ SYARIKAT
SECTION A APPLICANT/ COMPANY DETAILS
Arahan/ Instruction:
Pihak tuan dinasihatkan untuk menyemak www.bpfk.gov.my
Regulatory Information Other guidelines Guidance On
Classification terlebih dahulu sebelum mengisi borang ini.
Please refer to www.bpfk.gov.my Regulatory Information
Other guidelines Guidance On Classification, before fill in this
form.

NAMA DAN ALAMAT SYARIKAT PEMOHON

NAME AND ADDRESS OF APPLICANT / COMPANY

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------No. Tel :_____________________

No Fax
:_____________________
Email :______________________

Borang yang lengkap diisi hendaklah dihantar samada melalui;

Please submit your complete form either through;
Email: classification@bpfk.gov.my atau/or
Fax : 03 - 7958 1312 atau/or
Mail : Centre for Product Registration, National Pharmaceutical
Control Bureau, Lot 36, Jalan Universiti, 46200 Petaling
Jaya, Selangor.
Sebarang pertanyaan & maklumbalas / Any enquiries &
correspondence, Sila emailkan kepada/ please email to
classification@bpfk.gov.my

SEKSYEN B MAKLUMAT PRODUK

SECTION B PRODUCT PARTICULARS

1.
Nama Produk/ Product
Name:________________________________________________________________
2.
Bentuk Dos/ Dosage
Form:____________________________________________________________________
3.
a) Indikasi/ Kegunaan Produk (Indication / Usage of Product)
__________________________________________________________________________________________________________________
____
__________________________________________________________________________________________________________________
____

b) Cara penggunaan/ Cara tindakan (Instruction of use/ Mechanism of Action)

__________________________________________________________________________________________________________
___________
__________________________________________________________________________________________________________________
____

4.

Formula Lengkap Produk / Complete Product Formulation:

(Sila nyatakan kandungan setiap bahan ,nama saintifik, bentuk ramuan, bahagian digunakan, fungsi setiap bahan tersebut
samada sebagai bahan aktif / eksipien/bahan sampingan seperti pewarna, perasa dan sebagainya, kuantiti dan peratus
komposisi)
(Please state each ingredients, scientific names, form of substance, part used, function of each ingredient either as active or
excipients, quantity and percentage of each ingredients)

Ramuan/
Kandungan
Setiap
Bahan
(Ingredients)

Nama
Saintifik
(Scientifi
c names)

*Bentuk ramuan
(cth:ekstrak,raw)
(Form of
substance )

*Bahagian
digunakan
(Part used
eg: fruit,
bark,
leaves)

Fungsi
Setiap
Bahan
(Function
of each
ingredient)

Kuantiti/ Kekuatan
dalam mg/g
(Quantity/Strength
in mg/g)

Peratus
Ramuan/Kandungan
(Percentage
of
Ingredients)

* Kolum ini hanya perlu diisi bagi ramuan/bahan dari sumber semulajadi cth: tumbuhan, haiwan, herba dll.
This column to be filled for substance/ingredient derived from natural sources eg: plant, animal, herbal

5.

Sila lampirkan label produk, sisip bungkusan atau maklumat berkaitan lain.
Please attach product label, package insert or other relevant data.

6.

Sila nyatakan jenis pendaftaran /kelas produk tersebut di negara pengeluar

Please state the category of product at country of origins

__________________________________________________________________________________________________________________
____
__________________________________________________________________________________________________________________
____
__________________________________________________________________________________________________________________
____

7.

Adakah produk ini merupakan produk innovator*? (Jika Berkenaan)

Is this an innovator product? (If applicable)

___________________________________________________________________________________________
____
___________________________________________________________________________________________
____
SEKSYEN C PERAKUAN PEMOHON
SECTION C APPLICANT DECLARATION
Saya yang bernama dan beralamat di bawah mengaku bahawa semua kenyataan di atas dan dalam lampiran yang
disertakan adalah benar.
(I, as per name and address stated above declared that all informations written and attached is proven to be true)

-----------------------------------------------(Cop Rasmi Syarikat/

( TANDATANGAN PEMOHON/ APPLICANTS SIGNATURE)
Companys Official Stamp)
Nama Pemohon : ___________________________
(Applicants Name)
Tarikh : ____________________
Jawatan dalam : ____________________________
(Date)
Syarikat (Applicants Designation)
Penafian/ Disclaimer :
1. Maklumat yang dinilai hanya untuk tujuan pengkelasan produk sahaja. Sila pastikan produk hendaklah
mematuhi Akta dan Peraturan serta garispanduan yang berkaitan setelah produk ditetapkan
pengkelasannya (The information provided is to be used solely for classification purposes. Please be

informed that registration of a product is based on Laws & Regulations and other requirement, where your
product has been classified).
2. Data permohonan yang tidak lengkap boleh mengakibatkan permohonan pengkelasan produk ditolak dan
permohonan baru perlu dikemukakan (Incomplete data may result in product classification rejection and
new application is required).
* Innovator: Pencipta : seseorang yang mencipta sesuatu kajian / teknologi yang baru.
: Pioneer : someone who helps to open up a new line of research or technology.

Version Mei 2013- 2nd Amend