[ BFAD MEMORANDUM CIRCULAR NO. 7, s. 1994, April 12, 1994 ]
IMPLEMENTING GUIDELINES FOR CERTAIN COSMETIC REGISTRATION REQUIREMENTS
In order to provide specific guidelines which will amend and/or supplement Memorandum Circular No. 10 s. 1993, the Bureau of Food and Drugs hereby promulgates the following guidelines:
Conditional Registration as provided for under Memorandum Circular No. 19, s. 1991 shall be valid for a period of two (2) years from the date of issuance.
A. A statement of the qualitative composition of the imported cosmetic product from the highest to lowest component.
B. Approved Certificate of Registration from the Country of Origin or its duly authenticated copy.
C. If the country of origin does not have a registration scheme for cosmetic products, the cosmetic products shall comply with the documentary requirements for locally produced cosmetic products.
D. This rule, however, will not preclude any importer from complying or following the documentary requirements for locally produced cosmetic products.
1. Cosmetic products without previous CR Number may apply for Initial Registration of all the variants. This will carry a single Certificate of Product Registration (CPR) upon completion of laboratory results and evaluation. One CR Number with a subscript will be assigned to the variant.
2. Multi-variant cosmetic products with existing CR Number, with a 5-year validity remain as is until the expiry date. Application for renewal registration will be assigned the lowest CR Number. The rest will consequently be dead files.
3. Company has to inform BFAD in writing for registration of additional variants, or any change in the variants formulation, packaging, etc. This will be given the existing assigned CR number with subscript. However, company has to submit samples for laboratory analysis and pay the corresponding fees.
This Circular shall take effect immediately upon approval.
Adopted: 12 Apr. 1994
I
Validity of Conditional Registration
Validity of Conditional Registration
Conditional Registration as provided for under Memorandum Circular No. 19, s. 1991 shall be valid for a period of two (2) years from the date of issuance.
II
Documentary Requirements for Registration of Imported Cosmetic Products
Documentary Requirements for Registration of Imported Cosmetic Products
A. A statement of the qualitative composition of the imported cosmetic product from the highest to lowest component.
B. Approved Certificate of Registration from the Country of Origin or its duly authenticated copy.
C. If the country of origin does not have a registration scheme for cosmetic products, the cosmetic products shall comply with the documentary requirements for locally produced cosmetic products.
D. This rule, however, will not preclude any importer from complying or following the documentary requirements for locally produced cosmetic products.
III
Registration of Multi-Variant Products
Registration of Multi-Variant Products
1. Cosmetic products without previous CR Number may apply for Initial Registration of all the variants. This will carry a single Certificate of Product Registration (CPR) upon completion of laboratory results and evaluation. One CR Number with a subscript will be assigned to the variant.
2. Multi-variant cosmetic products with existing CR Number, with a 5-year validity remain as is until the expiry date. Application for renewal registration will be assigned the lowest CR Number. The rest will consequently be dead files.
3. Company has to inform BFAD in writing for registration of additional variants, or any change in the variants formulation, packaging, etc. This will be given the existing assigned CR number with subscript. However, company has to submit samples for laboratory analysis and pay the corresponding fees.
IV
Effectivity
Effectivity
This Circular shall take effect immediately upon approval.
Adopted: 12 Apr. 1994
(SGD.) QUINTIN L. KINTANAR
Director
Director