Saturday 28 May 2011

Dokumen yang dibutuhkan untuk pendaftaran kosmetik

Administrative Document
Import
Surat Penunjukan/Kuasa dari perusahaan di luar negeri/ LOA ( Leter Of Appointment
Keterangan CFS  (certificate of free sale) embassy KBRI 
Keterangan GMP (Kosmetik Lisensi)  GOOD MANUFACTURING PRACTICES Embassy KBRI
Sertifikat tes labolaturium COA (certifycate of Analysed) From Laboratory 


CARA PENGISIAN TEMPLATE NOTIFIKASI KOSMETIK KLIK   
Note 
Jangan sampai salah dalam pengisian template notifikasi, karna bisa ditolak kerja keras anda




UNTUK KOSMETIK LOKAL PEDOMAN CARA PEMBUATAN KOSMETIK YANG BAIK (CPKB) KLIK AJA


Labelling

Penandaan pada kemasan harus mencantumkan
Labelling on package should note 

1. Nama Produk
product name
2. Nama dan alamat pabrik, distributor 
importir name and address of manufacturer, distributors/importers

3. Komposisi/bahan penyusun 
composition/ingredients

4. Berat bersih, isi bersih, ukuran
Net weight, net volume, quantity of each content

5. Nomor persetujuan pendaftaran 
number of registration approval

6. Kode produksi 
production code number

7. Kegunaan dan cara penggunaan 
usage and direction of use

8. Tanggal kadaluarsa 
Expiry date

9. Data stabilitas jika kurang dari 30 bulan 
stability data if less than 30 months

10. Informasi lain yang berkaitan dengan keamanan dan atau mutu 
Other information which related to safety and or quality

11. Kegunaan dan cara penggunaan harus dalam bahasa Indonesia 
usage & direction of use should be in Indonesia language *)

*) Kecuali untuk produk-produk yang umum penggunaannya
*) Except for Common Used Product


Technical Document

Formula & Efficacy

Formula (kualitatif & Kuantitatif) 
Formula (qualitative & quantitative) include function of each substance
Petunjuk penggunaan: kegunaan dan cara penggunaan, peringatan dan perhatian jika ada 
Direction of use: usage and direction of use, warning & precaution, if any


Quality & Technology

Cara pembuatan: prosedur operasional Baku
Manufacturing process: standard operational Procedure
Spesifikasi bahan baku 
Specification of raw material
Spesifikasi produk jadi 
Spesification of finished product

Dear Suppliers & Principles

 

INDONESIA HEALTH CODE REGISTRATION PROCEDURES


CHECKLIST
No
Formula
Data


Available
Un-available
1
Letter Of Distributor Appointment from the Principle or factory (LOA)


2
Free Sale Certificate From Country Of  Origin Or Health Certificate (SFC)


3
Brand name, Product description, Packaging Count ( 1carton=? Outer/pcs) , Size (200gm?) ,


4
Packaging Specification
-         Whats the Carton box material
-         Innner packing material



5
Expiry Date Specification ( Shelf Life ?)
-         Expiry date code : DD?MM?YYYY



6
Raw Materials Specification
Eg : Preservatives E133 or coloring E120 , they want to know
-         the source & which company did U procure it from
-         Metals/ chemical properties
-         Micro – bacteria properties
-         Nomenclature Cosmetic Ingredients (INCI)





7
Product Composition
(Servings per package, Serving size
Average Quantity Per serving, Average Qty Per 100gm/100ml…etc)
Eg : Water : 20 %
Aloe vera 50 &
Alcohol 30%



8
Product Ingredients List Specification
(what ingredients goes into making this products)


9
Product Physical specification
(Appearance & Colour)
(taste & smell)
(Viscosity)


10
Production Process Flow chart


11
Lab test analysis certificate of the products ( original needed). The results validity is within 1 year from the date of the certificate.
1)    Chemical / Metals analysis
2)    Micro-biology analysis
3)    Nutrient Content
4)    Formula Content




SAMPLE OF DISTRIBUTOR LETTER OF APPOINTMENT

1)      2 Letter of appointment for my company as the importer & distributor (ORIGINAL Copy Needed).
(a)   Appointment as the authorise distributor .Ie “ We are please to confirm that we have appointed your company PT Aliest Indonesia as an authorise distributor for our range of products in Indonesia “



2)      Composition cert
Ø  Or Using your company’s letter head stating all the composition
Ø  Alcohol: 10%, Sodium: 10% …etc

3)      Ingredient certificate & Specification of the composition Report
Ø  Using your company’s letter head and state all the ingredients list

4)      Packaging Specification from factory (COPY)
Ø  A Company letter stating the
ü   Pack count of the product
ü  Description of the product
ü  The packaging material use
Ie ABC Maskara. Your letter can be written this way
“ABC MAaskara”, 1 Pack X 6 Pcs = 1 MASTER CARTON. 
ABC Maskara is a carbonated Cosmetic carton,
Carton material is: Paper/aluminium foil
Carton material is: half carton box seal with a Plastic  

5)      Expiry Date Specification,  
Ø  A Company letter stating how long is the shelf life of this product
Ø  Ie.  Just use your current company’s letter head and type the following information in  “ Our Cosmetic has a shelf life of 2 years from the date of production “

6)      Products Process flow chart ( DETAIL )
Ø  A factory certificate showing a diagram or image or in written form how this product is manufactured & with a flow chart


LAB TEST ANALYSIS ( Also know as CERTIFICATE OF ANALYSIS è COA )

7)      A Certificate or LAB Report or SGS Lab report of analysis from the
Manufacturer or from a local laboratory  (ORIGINAL REPORT NEEDED)
Ø   For local Indonesia labs, the test report is only valid for 12 months from the tested date 
Ø  The product need to be tested in Lab and the results will be submitted to the authorities
Ø  The lab report must have the following analysis
1)      Microbiological  ( 8 parameters – see attachment )
2)      Chemical & metals analysis ( 8-9 parameters – See attachment )
3)      PRESERVATIVES
4)      COLORING

COLORING & PRESERVATIVES

Needs to be tested as well for coloring & Preservatives



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