LAPORAN PENILAIAN LOI

PERMOHONAN PENGKELASAN PRODUK

PRODUCT CLASSIFICATION APPLICATION

SEksyen A maklumat PEMOHON/ syarikat

Section a APPLICANT/ company details

NAMA DAN ALAMAT SYARIKAT PEMOHON

nAME AND ADDRESS OF APPLICANT / COMPANY

DNA PHARMA (M) SDN BHD

NO.A-0-3 GROUND FLOOR, BLOCK A,

JALAN 2/142A, MEGAN PHOENIX,

OFF JALAN CHERAS KM10,

56000 CHERAS, WILAYAH PERSEKUTUAN

KUALA LUMPUR MALAYSIA

No. Tel : 03-9100 1853

No Fax : 03-9107 3109

Email : k_skyangel85@yahoo.com

SEksyen B maklumat PRODUK

SECTION B PRODUCT PARTICULARS

1.Nama Produk/ Product Name: TS6 Probiotic

2.Bentuk Dos/ Dosage Form: Powder form / 2g sachet

a) Indikasi/ Kegunaan Produk (Indication / Usage of Product)

Helps to boost metabolism and enhances digestion

b) Cara penggunaan/_

Take 1 sachet orally before or after meal and drink a glass of water. Adults 2-3 sachets and children 1-2 sachets daily

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

(Scientific 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)

1) Probiotics

2) Lactose

3) Maltodextrin

4) Skim milk powder

5) Sucrose

6)Oligosaccharide

7) Citric acid

8)Orange flavor

1)Lactobacillus acidophilus

Bifidobacterium bifidum

Bifidobacterium

Longum

Lactobacillus casei

Bifidobacterium infantis

Lactococcus lactis

1)Raw

2)Raw

3)(Raw or extract)

4)

5)

6)

7)

8)

(state origin /source of active ingredient)

1)Active ingredient

2) Excipient

3) Excipient

4) Excipient

5)Excipient (Sweetener)

6)Active ingredient

7)Excipient (Sour Agent)

8)Excipient (Flavor)

1) 180mg

2) 858mg

3) 400mg

4) 300mg

5) 160mg

6) 74mg

7) 22mg

8) 6mg

1. 9.0%

2. 42.9%

3. 20.0%

4. 15.0%

5. 8.0%

6. 3.7%

7. 1.1%

8. 0.3%

* 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

Health food

______________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________

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

Is this an innovator product? (If applicable)

No

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)

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( TANDATANGAN PEMOHON/ APPLICANTS SIGNATURE)

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).

Version Mei 2013- 2nd Amend

BPFK -300

Rujukan Tuan :

Rujukan Kami :

No. Siri :

Arahan/ Instruction:

Pihak tuan dinasihatkan untuk menyemak HYPERLINK "http://www.bpfk.gov.my" www.bpfk.gov.my Regulatory Information Other guidelines Guidance On Classification terlebih dahulu sebelum mengisi borang ini.

Please refer to HYPERLINK "http://www.bpfk.gov.my" www.bpfk.gov.my Regulatory Information Other guidelines Guidance On Classification, before fill in this form.

Borang yang lengkap diisi hendaklah dihantar samada melalui;

Please submit your complete form either through;

Email: HYPERLINK "mailto:classification@bpfk.gov.my" 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

Cara tindakan (Instruction of use/ Mechanism of Action)

(Cop Rasmi Syarikat/

Companys Official Stamp)

* Innovator: Pencipta : seseorang yang mencipta sesuatu kajian / teknologi yang baru.

: Pioneer : someone who helps to open up a new line of research or technology.

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