|FREQUENTLY ASKED QUESTIONS|
1. Frequently asked questions in Pharmacovigilance - Click Here
ESTABLISHMENT LICENSING and PRODUCT REGISTRATION
|1. What types of establishments
are required to apply for a License to Operate with BFAD?|
Establishments involved in the manufacture, packaging, re-packaging, importation, exportation, distribution, and retailing of processed foods, drugs, medical
devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance products must secure a License to Operate from BFAD.
|2. What types of products are
registered with FDA?|
FDA handles the registration of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance products.
3. How do we register our products?A local company in the Philippines must secure a License to Operate (LTO) from FDA before applying for product registration. All issuances and guidelines,
checklists of requirements, and forms pertaining to licensing of establishments and product registration may be downloaded from the BFAD Website:
How do we know which type of checklist to use for establishment
licensing and product registration? How do we know whether our
will be classified by FDA as food, drug, or cosmetic?
Clients may apply for product classification at FDA. Application documents with sample and complete product information and proof of payment may be
submitted at the Policy, Planning, and Advocacy Division - Public Assistance and Compliance Division (PPAD-PAICS), Room 101.
5. Where can we get a copy of the
guidelines for licensing of establishment and product registration?
|6. How much is the processing fee
for licensing or product registration?|
Fees are listed in Administrative Order No. 50 s. 2001: Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the
Bureau of Food and Drugs. This is available thru http:// www.fda.gov.ph/AO/ao 50 2001.pdf.
|7. We need to conduct a specific
test analysis for our products. How can we have our products tested?|
Clients may access the FDA Website for the list of recognized laboratories (http://www.fda.gov.ph/laboratories_modified.htm). The list contains the addres
contact numbers, and types of analysis offered by the laboratories.
PUBLIC / CONSUMER INFORMATION
|1. How do we know if a certain
product is registered with FDA?|
For product registration verification, consumers may contact the Policy, Planning, and Advocacy Division at telephone number 8425606. Consumers
are advised to provide details such as the complete product name, registration number, and name of manufacturer or distributor
[Note: FDA assigns unique registration numbers for processed food (FR-#), drug (DR-#, BR-#, VR-#, HMR-#, HDL-#), medical device (DVR-#), diagnostic
reagent (RR-#), cosmetic (CR-#, CL-#), and household hazardous products (HHR-#). This registration number must be indicated on the label or
packaging of products except for some food products.]
|2. How can we avoid purchase of
Consumers are advised to verify the existence of the License to Operate (LTO) of the establishment/outlet which should be conspicuously displayed
and the existence of the applicable FDA Product Registration Number on the label of the products intended to be bought. The absence of such information
is indicative of possible illegal source/product.
Furthermore, consumers must ask for receipts of payment of purchased products reflecting the business name and address, Tax Identification Number (TIN),
and name of printer (BIR Permit No.) with inclusive serial number of booklets and date of issuance of receipts and the description of the goods bought.
3. How does FDA process consumer
|Q: How to spot false claims?|
A: Typical fraudulent health claims will use the following promotional techniques to fool their customers:
|Q: What are some precautions in taking dietary supplements?|
A: Some dietary supplements have documented benefits; the advantages of others are unproven and claims about those products may be false or misleading.
Oftentimes, these products are imported without the necessary papers and there are claims that they are US FDA approved or Japan FDA approved. The US FDA does not regulate health supplements like these. Endorsements frequently come from foreign-authoritatively looking individuals.
|Q: What are the requirements to avail the 20% discount in the purchase of medicines for personal use of the Senior Citizen?|
A: Requirements to avail of the 20% discount in the purchase of medicines for personal use are:
1. Patient name, age, address, and date
2. Generic name of the medicine prescribed
3. Name and address of the doctor; his PTR number and S2 license (if prohibited and regulated drug)
3. National ID number of Senior Citizen
4. Generic Name of the drug/medicine
5. Number of units dispensed