Escolar Documentos
Profissional Documentos
Cultura Documentos
DEPARTMENT OF HEALTH
OFFICE OF THE SECRETARY
San Lazaro Compound, Rizal Avenue,
Sta. Cruz, Manila
Pursuant to Executive Order No. 197, s. directing all departments, bureaus, offices,
agencies and units, including government owned or controlled corporations to review and
upgrade their rates of fees and charges by not less than twenty percent (20%), the new fees and
charges for the corresponding services rendered by the Bureau of Food and Drugs are hereby
prescribed.
A.
1. Drug Outlets
1.1 Drugstore, Hospital Pharmacy
1.2 Chinese Drugstore
1.3 Retail outlet for non-prescription drugs only
1,000.00
2,000.00
2. Drug Distributors
Importer, Exporter, Wholesaler
5,000.00
10,000.00
4,000.00
8,000.00
4,000.00
8,000.00
1,000.00
2,000.00
6. Cosmetics Distributors
Importer, Exporter, Wholesaler
3,000.00
6,000.00
3,000.00
6,000.00
8. Drug Manufacturer
8.1 20 Million and below
8.2 over 20 Million but below 50 Million
8.3 50 Million and above
10,000.00
15,000.00
20,000.00
20,000.00
30,000.00
40,000.00
9. Drug Trader
9.1 20 Million and below
9.2 over 20 Million but below 50 Million
9.3 50 Million and above
3,000.00
5,000.00
7,000.00
6,000.00
10,000.00
14,000.00
4. Food Distributors
Importer, Exporter, Wholesaler
5,000.00
10,000.00
15,000.00
10,000.00
20,000.00
15,000.00
3,000.00
5,000.00
7,000.00
6,000.00
10,000.00
14,000.00
5,000.00
7,000.00
10,000.00
10,000.00
14,000.00
20,000.00
3,000.00
5,000.00
7,000.00
6,000.00
10,000.00
14,000.00
1,000.00
2,000.00
3,000.00
5,000.00
10,000.00
15,000.00
2,000.00
4,000.00
6,000.00
10,000.00
20,000.00
30,000.00
1,000.00
2,000.00
3,000.00
5,000.00
10,000.00
15,000.00
2,000.00
4,000.00
6,000.00
10,000.00
20,000.00
30,000.00
Note:
1.
The fees charged for manufacturers and traders of products regulated by BFAD are
based on the capital invested.
2.
Renewal of LTO shall be on the anniversary of its issuance and shall be valid for two
years.
A surcharge of 25% of annual fee shall be charged per quarter (every three
months) of delay in filing an application for renewal of the LTO
3.
B.
1. Drugs
1.1 New Drug / Monitored Release
1.2 Unbranded
1.3 Branded
20,000.00 / 3 yrs
2,000.00
3,000.00
7,500.00
10,000.00
2. Medical Device
1,500.00
5,000.00
3. Diagnostic Reagent
1,500.00
5,000.00
4. Food
4.1 Category 1
4.2 Category 2
4.3 Food Supplement
4.4 Bottled Water
200.00
250.00
1,000.00
1,000.00
1,000.00
1,250.00
5,000.00
5,000.00
500.00
750.00
+ 100.00 per variant or
50.00 per variant if
more than 6
2,500.00
3,750.00
500.00
2,500.00
5. Cosmetics
5.1 Listing
5.2 Registration
(per product)
7. Others:
7.1
500.00
7.2
500.00
7.3
7.4
Re-application
7.3.1 Drug, Device, Reagent
7.3.2 Food
7.3.3 Cosmetics
7.3.4 HHS
Amendment of CPR
7.4.1 Food
7.4.2 Drug, Devices, Reagent
(Change of business name/address; change of importer or
distributor; or additional package size)
7.4.3 Cosmetics / HHS
1,000.00
200.00
250.00
250.00
200.00
500.00
7.5
300.00
7.6
Extension of Shelf-life
500.00
7.7
7.8
Drug
1,000.00
200.00 / document
7.8.1
7.8.2
10,000.00 / year
7.8.2
Review by ACB
a. New Chemical Entity
5,000.00 / audit
g. Amendment of Protocol
h. Monitored Release Extension
i.
5,000.00
2,500.00
2,500.00
2,500.00
2,500.00
2500.00 / phase
1,000.00 / phase
6,000.00 / year
500.00
j.
3,000.00
k.
3,000.00
7.8.3
7.8.4
7.8.5
7.9
Cosmetics
7.9.1 Approval for product / label claim (by ACB)
500.00
2,500.00
500.00/ product /
year
500.00
Note:
1.
Initial registration for the different categories of products may be valid for 2, 3, 4 or 5
years with payment of corresponding fees, except food supplement for which maximum is
2 years.
2.
Renewal of registration is for a five-year duration starting on the date of expiration of the
CPR.
3.
4.
Local or imported food products shall be classified according to Category 1 and Category
2 of Bureau Order No. 163, s.1997
FEES
300.00
1,500.00
2,000.00
Dissolution Test
2,000.00
Disintegration Test
350.00
Hardness Test
350.00
Identification Test
500.00
500.00
Moisture content
300.00
Loss on Drying
300.00
pH
300.00
Vitamins
Vitamin A
1,000.00
2,000.00
500.00
Vitamin E
500.00
Other Vitamins
500.00
Minerals
800.00
1,000.00
1,500.00
1.4 Cosmetics
Assay
1,200.00
Identification Test
500.00
500.00
300.00
1,000.00
Fat / Oil
500.00
Starch
500.00
Glucose
500.00
Sucrose
500.00
Lactose
500.00
Crude Fibers
500.00
Dietary Fibers
Total Solids
2,000.00
300.00
Soluble Solids
300.00
Water-Insoluble Solids
300.00
Ash
300.00
Acid-Insoluble Ash
500.00
Saponification Number
500.00
Viscosity
300.00
Refractive Index
300.00
Peroxide Value
500.00
500.00
500.00
Total Acidity
300.00
Water Activity
500.00
Vacuum
300.00
Minerals
1,000.00
2,000.00
Proline
500.00
Additives
Nitrate
500.00
Nitrite
500.00
Sodium Benzoate
500.00
Sorbic Acid
500.00
Food color
300.00/ color
Sodium metabisulfite
500.00
Bromates
500.00
BHT
500.00
BHA
500.00
Aspartame
500.00
Saccharin
500.00
Monosodium Glutamate
500.00
Micronutrients:
Vitamin A
1,000.00
Vitamin E
1,000.00
Beta Carotene
1,000.00
Vitamin C
500.00
Vitamin B1, B6
1,000.00
1,000.00
Iodine
500.00
Iron
500.00
Contaminants:
Borax
Aflatoxin
300.00
2,000.00
500.00
Lead
500.00
Cadmium
300.00
Chromium
300.00
Arsenic
300.00
Mercury
300.00
Tin
300.00
Cyanide
300.00
Histamine
1,500.00
Filth
500.00
Formalin
500.00
Pesticide Residue
2,000.00
Alcohol Content
1,000.00
Gas Volume
300.00
300.00
pH
300.00
Caffeine
500.00
4,000.00
1.7 Beverages
Alcohol Content
1,000.00
Gas Volume
300.00
300.00
pH
300.00
Caffeine
500.00
1.8
Bottled Water
1.9
2,000.00
1,000.00
500.00
1,000.00
500.00
1,500.00
500.00
2,500.00
3. Sterility Test
(Injectables, Medical Devices and Large Volume Parenterals)
2,500.00
500.00
500.00
500.00
500.00
500.00
Fecal Streptococci
600.00
500.00
500.00
600.00
Pseudomonas aeruginosa
600.00
Identification of Microorganisms
Presumptive Test
Confirmatory Test (complete biochemical reaction)
Commercial sterility of thermally processed foods in hermetically
sealed containers
600.00
2,000.00 /
organism
1,000.00
5. Bioassay Tests
Depressor Substance Test
5,500.00
5,500.00
5,700.00
1,000.00
Safety Test
1,500.00
22,000.00
10,000.00
Pyrogen Test
5,200.00
4,000.00
(per page)
1.1
Express Lane
100.00
1.2
Regular Lane
50.00
(per certificate)
2.1
Medical Director
500.00
2.2
500.00
2.3
500.00
2.4
50.00
2.5
50.00
2.6
500.00
1.00 / page
Existing issuances and orders related to the subject which are inconsistent with this
Administrative Order are hereby rescinded or revoked.
This Order shall take effect fifteen (15) days after publication in a newspaper of general
circulation.