Republic of the Philippines  
Department of Health  
OFFICE OF THE SECRETARY  
 
 
 
Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila ● Trunk Line 651 -7800 local 1108, 1111, 1112, 1113 Direct Line: 
711-9502; 711 -9503 Fax: 743 -1829 ● URL: http://www.doh.gov.ph ● dohosec@doh.gov.ph  
 
 1 
ADMINISTRATIVE  ORDER  2 
No. 2023 - _________________  3 
 4 
 5 
           SUBJECT : Implementing Guidelines on the Schedule of Fees and Charges of  6 
the Food and Drug Administration for Licensing, Registration 7 
and Other Authorizations and Regulatory Services Repealing 8 
Administrative Order No. 50s. 2001, entitled, “Revised 2001 9 
Schedule of Fees and Charges for the Corresponding Services 10 
Rendered by the Bureau of Food and Drugs” and its Amendments  11 
  12 
 13 
I.        RATIONALE   14 
 15 
The Food and Drug Administration (FDA) is mandated by Republic Act No. 9711 also 16 
known as the “Food and Drug Administration Act of 2009”, to license all the establishments or 17 
facilities and issue product market authorization on all health products prior to manufacture, 18 
importation, exportation, sale, offering for sale, distribution, transfer, non -consumer use, 19 
promotion, advertising, or sponsorship. Accordingly, to protect public health and uphold 20 
consumer safety, the FDA conducts post -market surveillance of health products and 21 
establishments or facilities to ensure that adulterated, unregistered, or misbranded health 22 
products are not offered for sale or use.    23 
 24 
Pursuant to Article II A. Section 2.s. of the Implementing Rules and Regulations of the 25 
Republic Act (RA) No. 9711, the FDA is authorized to review its fees periodically and propose 26 
any increase and promulgate rules and regulations governing the collection of other related 27 
regulatory fees. Accordingly, under Article II B. Section 3 of the said Act, the FDA is 28 
authorized to collect, retain, and utilize or apply all fees, fines, royalties, and other charges 29 
collected by it under Section 31 of the Republic Act No. 9502 also known as the "Universally 30 
Accessible Cheaper and Quality Medicines Act of 2008" which includes upgrading of its 31 
facilities, equipment outlay, human resource development, and expansion; acquisition of the 32 
appropriate office space, as well as purchases of laboratory equipment and motor vehicles; 33 
upgrading of its current facilities and equipment and maintenance; funding for operating 34 
expenses of the central office laboratory divisions and satellite laboratories; and other activities 35 
or services of the FDA in the performance of its mandate  36 
 37 
With the current innovations in technology and the improvement of the country’s 38 
economy evidenced by the flourishing volume of industries in health products, a commensurate 39 
increase in the fees and charges is considerably needed to be able to meet and sustain the 40 
increasing demands of providing the FDA stakeholders quality and efficient services. For more 41 
than twenty (20) years, the rate of fees and charges of the Food and Drug Administration has 42 
been referred to the Administrative Order No. 50 s.2001 or the Revised 2001 Schedule of Fees 43 
and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs. Thus, 44 
in view of the foregoing, a revisit and consequent repeal of Administrative Order No. 50 s. 2001 45 
is deemed in order.  46 
 47  
Page 2 of 8 
 In the interest of the service and pursuant to the DOF -DBM -NEDA Joint Circular No. 48 
1-2013, also known as the “Implementing Rules and Regulations of Administrative Order No. 49 
31 s. 2012 on the Rationalization of Rates of Fees and Charges, Increase in Existing Rates and 50 
Imposition of New Fees and Charges”, the FDA is restructuring its fees and charges at a level 51 
commensurate with the cost of regulating health products, establishments or facilities to protect 52 
consumer safety and public health.  Thus, the following guidelines are hereby adopted.  53 
 54 
II.        OBJECTIVE   55 
 56 
This Administrative Order is issued to prescribe the schedule of fees and charges for 57 
the services rendered by the FDA and provide the guidelines for its implementation.    58 
  59 
  60 
III.       SCOPE   61 
 62 
The new schedule of fees and charges shall apply to all persons, establishments or 63 
facilities and health products under FDA’s jurisdiction whether public or private, including but 64 
not limited to national and local government agencies, state colleges and universities, and 65 
schools, availing of FDA’s services.   66 
  67 
  68 
IV.       DEFINITION OF TERMS   69 
  70 
For the purpose of implementing this Order, all terms used in this Order that are 71 
already  defined in RA No. 3720 as amended by EO No. 175 and RA No. 9711 shall  have the  72 
same meaning as defined therein. For emphasis, the following terms shall be defined as follows: 73 
  74 
A. Accreditation  refers to the  attestation conveying a formal demonstration of a 75 
laboratory's competence and capability to carry out specific scientific and technical tests 76 
or analytical services with respect to health products.  77 
 78 
B. Authorization  refers to the  permission embodied in a document granted by the FDA  79 
to a natural or juridical person who has submitted an application to implement the  80 
manufacture, importation, exportation, sale, offer for sale, distribution transfer, and or 81 
where appropriate, the use, testing, promotion, advertising, or sponsorship of health 82 
products.  The authorization can take the form of a permit, a license, a  certificate of 83 
registration,  of accreditation, of compliance, or of exemption or any similar document.  84 
 85 
C. Center  refer s to any of the following: Center for Cosmetics and Household/Urban 86 
Hazardous Substances Regulation and Research (CCHUHSRR), Center for Food  87 
Regulation and Research (CFRR), Center for Drug Regulation and Research (CDRR) 88 
and Center for Device Regulation, Radiation Health and Research (CDRRHR) of the 89 
FDA.   90 
 91 
D. Establishment refers to the  sole proprietorship, a partnership, a corporation an  92 
institution, an association or an organization engaged in the manufacture,  importation, 93 
exportation, sale, offer for sale, distribution, donation transfer, use,  testing, promotion, 94  
Page 3 of 8 
 advertising, or sponsorship of health products, including the  facilities and installation  95 
needed for its activities.  96 
 97 
E. Evaluation  refers to the  process of reviewing submitted regulatory documents by  98 
applicants based on existing standards, rules, and regulations of the FDA.   99 
 100 
F. Health Products  refers to  food, drugs, cosmetics, devices, biologicals, vaccines, in -  101 
vitro diagnostic reagents , and household/urban hazardous substances and/or a   102 
combination of and/or a derivative thereof. It shall also refer to products that may  have 103 
an effect on health which require regulations as determined by the FDA.   104 
 105 
G. Health Product Vigilance refers to  the science and activities relating to the detection, 106 
assessment , understanding, and prevention of adverse effects or any other possible 107 
problems from Health Products.  108 
 109 
H. Initial application  refers to  the term used for a first-time or original application for any  110 
authorization as defined by RA No. 9711.  111 
 112 
I. Micro Small Medium Enterprises (MSMEs ) refers to the  defin ition according to 113 
Republic Act No. 9501 as any business activity or enterprise engaged in industry, 114 
agribusiness and/or services, whether single proprietorship, cooperative, partnership or 115 
corporation whose total assets, inclusive of those arising from loans but exclusive of the 116 
land on which the particular business entity’s office, plant and equipment are situated, 117 
must have value falling under the following categories: a.) Micro, not more than 118 
P3,000,000, b.) Small, P3,000,001 but not more than P15,000,000, and c.) Medium, 119 
P15,000,001  but not more than P100,000,000. More than P100,000,000 is considered a 120 
large enterprise.   121 
 122 
J. Re-issuance  refers to  the process of granting a duplicate copy of a valid authorization  123 
due to loss or damage of the original authorization. This is only applicable when  the 124 
document issued by the FDA is a hard copy and not an electronic copy.   125 
 126 
K. Renewal  refers to  the process of filing an application for the extension of the validity 127 
of  an authorization.  128 
 129 
L. Risk -based Regulation  refers to the  approach on regulating health products, 130 
establishments , and facilities by targeting  activities that pose the highest risk to the 131 
public well -being, and in turn lowers the burden for a variety of lower -risk sectors and 132 
firms.  Lowering burdens improves compliance and allows firms to benefit from a more  133 
level playing field. By directing the government resources towards the highest -risk 134 
areas, risk -based approaches also make the most of limited public resources and     135 
further improve  accountability by enhancing transparency and predictability of  136 
requirements in given sectors and as applied to different establishments.   137 
 138 
M. Variation and/or Amendment  refers to post-license changes in the status,  139 
circumstances, conditions, claims, or activities of authorized establishments, in 140 
accordance with existing guidelines.   141 
  142 
 143  
Page 4 of 8 
 V.   GUIDELINES   144 
  145 
A. The new schedule of fees and charges is attached as Annexes A to F, as follows:   146 
1. Annex A for Fees on General Certification (Common to all Centers)   147 
2. Annex B for Center for Cosmetics and Household/Urban Hazardous    148 
Substances Regulation and Research (CCHUHSRR)    149 
3. Annex C for Center for Drug Regulation and Research (CDRR)   150 
4. Annex D for Center for Device Regulation Radiation Health and Research  151 
(CDRRHR)   152 
5. Annex E for Center for Food Regulation and Research (CFRR)   153 
6. Annex F for Common Services Laboratory (CSL)   154 
 155 
B. The application fees for granting an authorization/accreditation prescribed in this 156 
issuance shall cover but is not limited to the following activities :  157 
       158 
   1.  Receiving of application documents;   159 
 2.  Pre and Post Licensing Inspection of facilities for medical device ; 160 
 3.  Pre-marketing activities, including but not limited to assessment, technical   161 
     evaluation and pre -licensing inspection of establishment;   162 
 4.  Post-marketing surveillance of products and establishments, but not limited   163 
                        to the following:  164 
a. Collection of samples;   165 
b. Laboratory testing;   166 
c. Complaints and reports processing;   167 
d. Safety monitoring;   168 
e. Post-licensing inspection;   169 
f. Routine/special inspection;   170 
g. Health Product Vigilance  171 
h. Post evaluation;   172 
i. Product verification;   173 
j. Advertisement monitoring;    174 
 5.  Printing;   175 
6.  Records management, archiving and administrative support;   176 
7.  Government Courier services to deliver the authorization, if applicable;   177 
8.  IT systems, maintenance, and development;   178 
9.  Security Seal; and  179 
          10.  And all other related activities  180 
 181 
C.  The application  fees shall not cover the following expenses:    182 
1. UP Law Center’s Legal Research Fee (LRF) which is equivalent to P10.00 183 
or 1% of the application fee, whichever is higher, as imposed by Republic 184 
Act (RA) No. 3870, as amended by Presidential Decree (PD) No. 200 and 185 
further amended by PD 1856, of which FDA is only the collecting agent as 186 
per Letter of Instruction No. 1182 dated 16 December 1981.   187 
2. Other fees incurred from the use of payment collection facilities, such as 188 
service fees charged by banks authorized by the FDA to collect its fees.   189 
3. Private/ Special Courier used for the conveyance of the certifications.  190 
 191  
Page 5 of 8 
 D.  The FDA shall issue updated guidelines regarding new payment modes and methods 192 
as necessary.   193 
1.  Through Over -the-Counter at Landbank of the Philippines (LBP) using the      194 
     LBP Oncoll Payment Slip;  195 
2.  Through Online LBP Link.BizPortal; or  196 
3.  Through Online Bills payment (Bancnet)  197 
4.  Other payment channels as may be determined by the FDA.  198 
  199 
E.   All payments shall be made not later than the date reflected in the Order of Payment 200 
(OP). Payments beyond the validity of the OP shall be automatically forfeited.  201 
 202 
F.   Application payments made including but not limited to the following, shall not be 203 
accepted and posted in the system:  204 
 205 
1.  Application payment with incomplete/insufficient amount paid;  206 
2.  Application payment with an incorrect reference number provided;  207 
3.  Application payment made through an unauthorized payment channel;  208 
4.  Application payment made beyond the validity of the issued FDA Order of      209 
     Payment; and  210 
5.  Such other cases as determined by the FDA.  211 
 212 
Application s with deficiency payment shall be posted after the proof of the full 213 
payment is made.    214 
 215 
G.  Changes and/or additions to the existing FDA payment channels shall be announced   216 
      through a separate issuance.  217 
 218 
H.  The size of business operation used by CCHUHSRR and CFRR for licensing  219 
      purposes (by asset) shall be in accordance with RA No. 9501 and its amendments .  220 
  221 
I.    Provision of support and assistance to MSMEs may be provided under the  222 
      coordination of government efforts stipulated in RA No. 9501 Section 5c and its   223 
      future amendments . Future related provisions will be carried out.  224 
  225 
J.   Flexibility in payment of fees and charges may be applied by the FDA  in lieu of 226 
       Public Emergency or State of Calamity declaration , provided, however, the     227 
       following directives may be applied:  228 
 229 
               1. Upon recommendation of the FDA Director General for local public health 230 
         emergency to be imposed by the DOH Secretary  as declared by the Local 231 
         Government  Unit; or 232 
    2. Upon recom mendation of the D OH Secretary and the FDA Director General 233 
                    to be imposed by the Office of the President following Republic Act 11517  234 
         entitled “An Act Authorizing the President to Expedite the Processing and 235 
         Issuance of National and Local Permits, Licenses and Certifications in 236 
         Times of National Emergency ” 237 
  238 
  239 
VI. VALIDITY   240  
Page 6 of 8 
  241 
The validity period for authorization s, permits, and certificates  shall follow existing 242 
FDA issuance s.  243 
 244 
 245 
VII. SURCHARGE OR PENALTY  246 
 247 
Consistent with R.A. No. 9711 and its IRR and other relevant FDA regulations, the 248 
conditions for the imposition of surcharge or penalty are provided below as follows:  249 
 250 
A. Pursuant to Section 3, Paragraph (A) (2) and (B) (2) of Article 1, Book II on 251 
 Licensing of Establishments and Registration of Health Products of IRR of RA 9711, 252 
 applicable  surcharge or penalty shall be imposed  for applications for renewal  of 253 
 LTO or CPR received after the date of their expiration . This rule shall apply even in  254 
succeeding renewal applications.  255 
   256 
B.  An application for renewal of an LTO or CPR received after its date of expiration  257 
shall be subject to a surcharge or penalty equivalent to twice the renewal licensing fee  258 
and an additional 10% per month or a fraction thereof of continuing non -submission of  259 
such application within the  maximum of one hundred twenty (120) days from its  260 
original expiry date.  261 
 262 
C.  The LTO  or CPR  shall be considered valid and existing until a decision or  resolution 263 
by the FDA is rendered on the application for renewal . 264 
 265 
D. LTO or CPR applications filed beyond the 120-day period shall be  considered  266 
expired and the application shall be subject to a fee equivalent to the  total surcharge or  267 
penalty plus the initial filing fee and the application shall  undergo the corresponding  268 
filing and evaluation procedure.  269 
 270 
 271 
VIII . MANDATORY REVIEW   272 
  273 
The fees and charges shall be subject to mandatory review every three (3) years. The 274 
Policy and Planning Service shall undertake periodic review, conduct consultations with 275 
stakeholders, and recommend amendments to this Administrative Order to the Office of the 276 
Director -General for approval of the Secretary of Health, as may be deemed necessary.    277 
  278 
  279 
IX. REPEALING CLAUSE   280 
 281 
This Administrative Order effectively repeals the following issuances:   282 
 283 
A. Administrative Order No. 50 s. 2001 entitled “Revised 2001 Schedule of Fees and 284 
Charges for the Corresponding Services Rendered by the Bureau of Food and 285 
Drugs”;  286 
 287 
B. A.O. No. 18 -A s. 1993 entitled “Standards of Quality and Requirements for the 288 
Processing, Packaging and Labelling of Bottled Drinking Water”;   289  
Page 7 of 8 
  290 
C. A.O. No. 15 -A s. 1995 entitled “Guidelines Governing the Implementation of the 291 
Sangkap Pinoy Seal (SPS) Program and the Collection and Disbursement of Fees  292 
Generated from the Program”;  293 
 294 
D. A.O. No. 29, s.2000 entitled “Amendment to AO No. 23 s 1999 and AO No. 50, 295 
s.1999 Fees and Charges to be Collected by the Radiation Health Service ”; 296 
 297 
E. DOH A.O. No.   47A s 2001 entitled “Rules and Regulations on the Registration, 298 
Including Approval and Conduct of Clinical Trials, and Lot or Batch Release 299 
Certification of Vaccines and Biologic Products”;  300 
 301 
F. A.O. NO. 82 s. 2003 entitled “Guidelines on the Granting of Diamond Sangkap 302 
Pinoy Seal to Manufacturers of Fortified Products”;   303 
 304 
G. A.O. No. 2008 -0033 entitled “Rules and Conditions in Exempting Antibiotic Drug 305 
Products from Batch Certification Requirement Amending for this purpose Item III 306 
(C) and (D) of AO No. 103 s. 2002 “Batch Certification of Antibiotics” and for 307 
Other Purposes”;   308 
 309 
H. A.O. No. 2012 -0024 entitled “Amendment to A.O. No. 50 s. 2001 Covering Fees 310 
and Charges for Accreditation of Bioequivalence Testing Centers and Private 311 
Testing Laboratories, as well as, Audits and Inspection”;  312 
  313 
I. FDA Circular No. 2011 -004 entitled “Computation of Surcharge or Penalty 314 
Imposable in case of Submission of Renewal Applications Covering License of 315 
Establishments and Registration of Health Products After  Their Date of Expiration 316 
Pursuant to Section 3, Paragraphs (A)(2) and (B)(2) of Article I of Book II of the 317 
RA 9711 Implementing Rules and Regulations, and Other Purposes”;  318 
 319 
J. FDA Circular No. 2013 -001- entitled “ Revised  Notification Template for Cosmetic 320 
Products” and its amendment; 321 
 322 
K. FDA Circular No. 2023 -003 entitled “ Guidelines on the Filing and Submission of 323 
Acceptable Variations on Protocols and Non -standard Protocols for the Review and 324 
Pre-Approval by the Food and Drug Administration Prior to the Conduct of Bio - 325 
efficacy Test Studies of Household Pesticides for the Purposes of Securing a 326 
Certificate of Product Registration ”;  327 
 328 
L. FDA Circular No. 2015 -001 entitled “Clarifications on the Regulations Governing 329 
Principal and Identical Drug Products as defined under Administrative Order No. 330 
2005 -0031”.  331 
 332 
 333 
 334 
 335 
 336 
 337 
X. SEPARABILITY CLAUSE   338  
Page 8 of 8 
   339 
If any provision is declared unauthorized or rendered invalid by any court of law or 340 
competent authority, those provisions not affected thereby shall remain valid and effective.   341 
 342 
 343 
XI.         EFFECTIVITY DATE   344 
  345 
This Order  shall take effect fifteen (15) days after its publication in the Official 346 
Gazette or in any newspaper of general circulation and upon filing with the University of the 347 
Philippines Law Center Office of the National Administrative Register.   348 
  349 
  350 
  351 
  352 
TEODORO J. HERBOSA, MD   353 
Secretary of Health   354 
 355 
  356 
Food and Drug Administration  
 
 Food and Drug Administration  
 
IRENE F. FLORENTINO -FARIÑAS, RPh, MD, MNSA  SAMUEL A. ZACATE, MD  
OIC Director III, Policy and Planning Service  Director General  
  
 357 
 358 
Keywords     
Related Issuances, laws, 
directives from other 
government agencies   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”   
 359 
 360