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Annex 2 Notification Template for Toys and CCAs Conformity
FDA notification form template for toys and child care articles
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: If appropriate, the maximum number of children that may safely use the equipment simultaneously:
5.
For toys subject to exemption
Exemption for the reason that:
The toy is intended for children fourteen (14) years and above
The toy is for display or exhibit purposes and is not to be marketed in the Philippines
The toy is for personal or adult collector’s use
6.
Product Description (e.g. blue remote controlled race car, doll in pink dress, shoes and bags)
PARTICULARS OF FOREIGN SOURCE(S)/ SUPPLIER (S)/ MANUFACTURER(S)1
[Please attach in a separate sheet if there are more than foreign source/ supplier/ manufacturer]
7.
Name of Foreign Source(s)/ Supplier(s)/ Manufacturer(s):
Complete Address of Foreign Source(s)/ Supplier(s)/ Manufacturer(s):
Tel: _________________________ Fax: ____________________________E-mail Address:___________________
PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE PRODUCT IN THE MARKET
8.
Name of Company:
License to Operate (LTO) Number
Validity
Complete Address of Company:
Tel: _________________________ Fax: ____________________________E-mail Address:___________________
PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY
9.
Name of Person:
Tel: ______________________Fax: ____________________________ E-mail Address:___________________
1
”Manufacturer”, in relation to a health product, means an establishment engaged in any and all operations involved in the production of
health products including preparation, processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing
and labeling with the end in view of its storage, sale or distribution.
Position/ Designation in the Company
PARTICULARS OFDISTRIBUTOR/ IMPORTER/ RETAILER2
[Please attach in a separate sheet if there are more than one distributor/ importer/retailer]
10. Name of Distributor/ Importer/ Retailer:
Address of Distributor/ Importer/ Retailer:
Tel: _________________________ Fax: ____________________________E-mail Address:___________________
DECLARATION
□ I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post-marketing
activity initiated by the authority.
□ I undertake to ensure that the product’s technical and safety information is made readily available to the regulatory authority
concerned (“the Authority”) and to keep records of the distribution of the products for product recall purposes.
□ I undertake to notify the Authority of fatal or life threatening serious adverse event as soon as possible by telephone, facsimile
transmission, e-mail or in writing, and in any case, not later than 7 calendar upon knowledge of the adverse event.
□ I declare that the particulars given in this notification are true and correct.
□ I undertake to ensure that if and when directed by the regulatory authority I will recall the product from the market, and
discontinue selling/ supplying the product
□ I understand that I shall be responsible for ensuring that each consignment of my product continues to meet all the legal
requirements, and conforms to all the standards and specifications of the product that I have declared to the Authority.
□ I declare that our product does not contain any restricted or banned substances that can be harmful/ hazardous/ life
threatening to children and infants.
□ I understand that I cannot place reliance on the acceptance of my product notification by the authority in any legal proceedings
concerning my product, in the event that my product has failed to conform to any of the standards or specifications that I had
previously declared to the Authority.
-----------------------------------------------------------------------------------[Name and Signature of person representing the local company]
[Company Stamp]
2
[Date]
“Distributor/Importer means any establishment that imports raw materials, active ingredients and/or finished products for its own use or for
wholesale distribution to other establishments or outlets.
