وزارة الصحة
الإدارة العامة للصيدلة
دائـــرة التســجيل الدوائي / / ٍState of Palestine
Ministry of Health
General Administration of Pharmacy
Drug Registration Department
Registration Requirements for
Imported Cosmetics and Medical Soaps
Every importing company is required to submit the following for the registration purposes of Cosmetics and Medical soaps
- A letter from the manufacturer showing that the importing company is the sole agent of the producing company in the Palestinian National Authority and has an authorization for registration, legalized by the chamber of commerce, the ministry of foreign affairs and the Palestinian embassy.
- A certificate issued by the relevant authorities of the country of origin stating that the manufacturer is working according to G.M.P and is supervised by the competent authorities, legalized by the ministry of foreign affairs and the Palestinian embassy.
- A declaration from the producer stating his responsibility for the good quality of his products marketed in the Palestinian national authority areas.
- A free sale certificate form the relevant authorities in the country of origin and legalized bythe ministry of foreign affairs and the Palestinian embassy in that country clarifying that the product is sold freely in the country of origin and including the name of the product, the formula, the manufacturer and his address.
- BSE/TSE and pork free certificate issued by the relevant authorities of the country of origin,legalized by the ministry of foreign affairs and the Palestinian embassy.
- Coloured artwork of the outer package, and the inner package.Labels and inserts (as applicable).
- An application form for registration of cosmetics product in four copies typed in English and filled by the responsible person of the importing company the quantities must be expressed in %W/V,%W/W OR %V/V.
- The following documents from the manufacturing company
- Monographs for each ingredient included in the manufacture of the product. The Monographs must include the physical, chemical, biological (where applicable) purity and toxicological characteristics. A photocopy of the reference must be included.
- The master formula of the product.
- The finished product specifications. (two copies)
- Methods of analysis of the finished product including chemical, physical and where appropriate biological test as.
- When colours are included in the cosmetic product, they must be according to the (the FDA or EEC lists of colours for cosmetics and the colours should be mentioned.
- For sunscreen products, the product must declare the sun protection factor (SPF) of the product and the method of calculation of the factor.
- Certificate of analysis for the batch sent for registration purposes.
- Samples from the finished product sufficient for three analysis
- Analysis fees.
Appendix(2)
Application form
Registration of Cosmetic Products
To the Director of Drug Registration Department:
I hereby request your approval to register the following cosmetic product
- Details of the applicant:
- Name of the applicant:……………………………………………………
- Details of the manufacturer:
- Name of the manufacturer: ………………………………………………
- Plant address: ……………………………………………………………..
- Tel No.:……………………………Fax No.:……………………..……….
- E-mail address/website: …………………………………………………
- Details of the local agent:
- Name of the agent: ……………………………………..…………………
- Address: ………………………………………………………….………..
- Tel No.:………………………………Fax No.:…………………………….
- E-mail address: ……………………………………………………………
- Details of the cosmetic product:
- Name of the product: ………………………………….…………………
- Pharmaceutical dosage form: …………………………………………..
- Colour of the product:……………………………………………………..
- Presentation:
-Package size: ………………………………………………….
-Content: …………………………………………………………
-Type of package: ………………………………………………
- Uses of the product:……………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
- Attachments:
-Samples from the finished product.
-Samples from the secondary packaging materials containing all the printed matter/or the packaging materials artwork.
-Finished product specifications.
-The original composition of the product signed by the manufacturer.
-BSE certificate (where one of the ingredients is from biological origin).
-Bank receipt to assure that registration fees were paid.
Name of ApplicantSignature Date
……………………. …………… …………
*****************************************************************************************************
For office use only
- Application number: …………………………………………………..….
- Name of a application receiver: …………………………………………
- Date of receipt: …………………………………………………………...
- Decision:
( ) Approved ( ) To be completed ( ) Rejected
Registration Number: …………… Registration Date: ......
Appendix (5)
Application Form: Renewal of the registration of cosmetic product
To: The Director of Drug Registration Department
We hereby request that the registration of the following cosmetic product to be renewed.
-Applicant information:
- Applicant's Name (Responsible Technical Person):………………………....
- Manufacturer name and address:……………………………………………….…………………………………………………………………………………………………
- Name and address of the importer (for imported cosmetic products only): ………………….…………………………………………………………………………………………………………………………………………
-Product information:
- Name of the cosmetic product: …………………..……………..
- Registration No:…………………
- License validity date:…………………………..
- Dosage form : …………………………………………..
- Quantity (weight/volume) per pack: ……………………
- Primary packaging materials type:………………….
- Purpose of re-registration:
- ( ) Manufacturing and marketing.
- ( ) Import and marketing.
Signature of the responsible technical person Date
………………………….. ………….
********************************************************
Attachments:
□ Original receipt confirming payment of re-registration fees.
□ Latest master formula of the product
□ Latest method(s) of analysis (when applicable)
□ The latest coloured artwork illustration of the packaging materials
□ The latest finished product specifications
□ Sufficient samples from finished products for analysis purposes.
************************************************************************************
For Office use only:
- Name of receiver:……………………………
- Date of receiving …………………………….
- Remarks:………………………………………………………………………
Signature: …………… Date:………………………
Appendix (6)
Application Form: Amendments to the Registration of Cosmetic Products.
- Product information:
- Name of the product:……………………………………
- Registration No.:………………………………
- Registration validity date:………………..
- Name of the local agent: ………………………..
2. Type of change:
□ Change in the name of product.
□ Addition of new pack size.
□ Change in the master formula or finished product specification
□ Addition of new colour or fragrance
□ Change in packaging materials(type, colour ,etc.)
□ Other change specify ………………………………………………………………………………………………………………………………………………
3. Attachments (please specify)
- ……………………………
- ……………………………
- …………………………….
- ……………………………
For office use only
- Date of receiving the application:
- Name of the receiver:
- Decision
( ) Approved ( ) rejected ( ) Others
*******************************************************
Name: ………………….
Date: …………………….
Signature: ………………………
متطلبات تسجيل مستحضرات تجميل
المصنعه محلياً
- تعبأة نموذج طلب التسجيل وتقديمه الى قسم الرقابة الدوائية والتسجيل بحيث تكون اسماء المكونات (Ingredients) مكتوبة باللغة الانجليزية والكميات على صورة (% V/V, % W/W, %W/V).
- نسخة من شهادة ترخيص المصنع سارية المفعول صادرة عن وزارة الصحة الفلسطينية.
- مواصفات المستحضر الجاهز (Finished Product Specifications) من حيث (pH, Microbial Load, Viscosity, Density, Stability, …).
- مقالة (Monograph) عن المواد الاولية الداخلة في تصنيع المستحضر مشتملة على الخواص الفيزيائية، الكيميائية، الحيوية، درجة النقاوة والسمومية. مع ذكر المرجع الذي اخذت منه هذه المعلومات وصورة منه.
- طريقة التصنيع (Manufacturing Method)
- طرق تحليل المستحضر الجاهز (الكيماوية، الفيزيائية، الحيوية)، حسب القائمة المرفقة والخاصة بكل شكل من اشكال المستحضرات.
- في حالة استخدام الوان في تصنيع مستحضر التجميل فيجب ذكر رقم اللون المعتمد في (FDA) او ( E.E.C.).
- مواصفات مواد التعبئة والتغليف موضحاً فيها جميع المعلومات المطبوعة.
- نشرة تحتوي على تعليمات الاستعمال وتحديداته واية تحذيرات بخصوص الاستعمال باللغتين العربية والانجليزية حينما كان ذلك ضرورياً.
- عينات تكفي لثلاثة تحاليل، حسب القائمة المرفقة.
- رسوم تسجيل مستحضر تجميل (800 شيقل) ورسوم تحليل مدفوعة لحساب وزارة الصحة.
- في حالة المستحضرات المصرح بها كواقي من اشعة الشمس (Sunscreen Products) يتوجب على المنتج ان يصرح بمعامل الوقاية من الشمس (Sun Protection Factor) وطريقة حساب المعامل.