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 to 13  
  Direct Line: 711 -9502 to 03 Fax: 743 -1829 ● URL: http://www.doh.gov.ph ; e-mail: ftduque@doh.gov.ph  
  1 
 2 
ADMINISTRATIVE ORDER  3 
No. _____________________  4 
 5 
SUBJECT:  Updated Guidelines on the Application for License to Operate of 6 
Health Product Establishments with the Food and Drug 7 
Administration  8 
  9 
 10 
I. RATIONALE  11 
 12 
Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Administration 13 
(FDA) Act of 2009” mandates the FDA to establish and maintain an effective health regulatory 14 
system to promote the safety, quality, and efficacy of health products. Pursuant to the 15 
mentioned, the FDA, as one of the regulatory arms of the Department of Health (DOH), is 16 
mandated to issue standards and appropriate authorizations that cover establishments, facilities, 17 
and health products under its juri sdiction. Such endeavor shall be visible in its regulation of 18 
Manufacturers, Traders, and Distributors (Importers, Exporters, and Wholesalers), among 19 
others, engaged in business and operations involving health products prior to manufacture, 20 
importation, ex portation, sale, offering for sale, distribution, transfer, non -consumer use, 21 
promotion, advertising, or sponsorship activities.  22 
  23 
In 2018, RA No. 11032, otherwise known as the “Ease of Doing Business and Efficient 24 
Government Service Delivery Act” was issu ed, which aids in the promotion of streamlined and 25 
simplified transactions in the government. Hence, the FDA, congruent with RA 11032, 26 
established unified licensing guidelines to adopt a more harmonized licensing system across 27 
all health products under its  jurisdiction through the issuance of Administrative Order (AO) 28 
No. 2020 -0017, otherwise known as the “Revised Guidelines on the Unified Licensing 29 
Requirements and Procedures of the FDA Repealing AO No. 2016 -0003”.  30 
 31 
The implementation of AO No. 2020 -0017 , in parallel with the digitalization initiatives 32 
of the FDA, promotes a harmonized licensing application that encompasses all types of covered 33 
health products. While it is notably used, certain requirements that need to be complied with 34 
by the regulated e ntities are not given due emphasis in the implemented AO. These 35 
requirements are necessary for the evaluation of technical compliance and inspection of 36 
covered health product establishments.  37 
 38 
Further, the compliance of the FDA with international standards  shall be evident in its 39 
national regulatory systems with the use of benchmarking methodology as provided by the 40 
World Health Organization – Global Benchmarking Tool (WHO -GBT). This shall help the 41 
FDA in the self -evaluation of its processes towards reachin g a level of a more strengthened 42 
regulatory oversight.  43 
 44 
Hence, in the pursuit of achieving an updated regulatory system and aligning with the 45 
mentioned policies, this Administrative Order is hereby issued.  46 
 47 
 48 
 49  
2 II. OBJECTIVES  50 
 51 
The objectives for issuing this Administrative Order are as follows:  52 
 53 
1. To further reengineer the FDA’s processes and automate its system for initial, renewal, and 54 
variation applications for License to Operate (LTO) through the FDA available online 55 
application platforms; and  56 
2. To update the list of documentary requirements for LTO applications, in addition to other 57 
technical requirements that shall be presented during the inspection of the FDA -covered  58 
establishments.  59 
 60 
 61 
III. SCOPE  62 
 63 
A. The following establishments, whether public or private, shall be covered by this 64 
Order:  65 
 66 
1. Manufacturers, including Packers/Repackers;  67 
2. Refurbishers of medical devices;  68 
3. Traders;  69 
4. Distributors as Importers, Exporters, and/or Wholesalers;  70 
5. Drug outlets, such as drugstores, pharmacies (community, or institutional); or 71 
boticas,  and retail outlets for non -prescription drugs (RONPDs);  72 
6. Retailers of Medical Devices  73 
7. Clinical Research Organizations (CROs) and Sponsors  74 
 75 
B. The scope of health products shall include, but not be limited to:  76 
 77 
1. Under the CCHUHSRR, all cosmetic products, househo ld/urban hazardous 78 
substances (HUHS), including household/urban pesticides, and toys and childcare 79 
articles;  80 
 81 
2. Under the CDRR, all drugs, including but not limited to drug products for human 82 
use, biological drug products such as blood products and vaccines,  83 
radiopharmaceuticals and precursors, advance therapy drug products such as 84 
human cells, tissues, and cellular and tissue -based products, homeopathic products, 85 
medical gases, herbal and traditional medicines, orphan drugs, animal health 86 
products, and other  drug products as determined by the FDA;  87 
 88 
3. Under the CDRRHR, all medical devices, radiation -emitting devices, in -vitro 89 
diagnostic devices, and reagents; refurbished medical devices; custom -made 90 
medical devices; equipment or devices used for treating sharps,  pathological, and 91 
infectious wastes, water treatment devices/systems; and other health -related 92 
devices as determined by the FDA; and  93 
 94 
4. Under the CFRR, all processed food products, food/dietary supplements, raw 95 
materials, ingredients, and additives for food . 96 
 97 
This does not preclude the FDA from updating the scope of health products and 98 
establishments that require regulation in accordance with the FDA rules and regulations.  99  
3  100 
IV. EXCLUSION  101 
 102 
A. The following shall NOT be covered by this Order:  103 
 104 
1. Organizers of national and international trade fairs and exhibits;  105 
2. Donors, organizations, or persons involved in donations, medical missions, and 106 
other humanitarian activities;  107 
3. Manufacturers, Traders, or Distributors of collector’s items;  108 
4. Retailers of processed food products, co smetics and household/urban hazardous 109 
substances, including household/urban pesticides and toys and childcare articles;  110 
5. Groceries, convenience stores, and supermarkets without wholesale activity for 111 
foods, slaughterhouses, or abattoirs, dressing plants, fish ports, wet markets, school 112 
canteens; restaurants without importation and manufacturing/repacking activity of 113 
prepacke d foods; water refilling stations, street food sale including ambulant 114 
vending, fast foods, kiosks, caterers, chandlers, and the likes;  115 
6. Institutions and companies that provide vaccinations to their employees; and  116 
7. Facilities covered by the DOH One Stop Shop  Licensing System1. 117 
 118 
B. The licensing of the following establishments or persons shall be governed by separate 119 
rules and regulations:  120 
 121 
1. Salt Manufacturers, Distributors, and Traders shall follow RA 8172 2(ASIN Law) 122 
and its revised IRR;  123 
2. Bottled Water Manufactur ers shall follow AO No. 18 -A s. 19933; 124 
3. Radiation facilities shall follow AO No. 2020 -00354 125 
4. Operators of pest control for non -agricultural purposes shall follow DOH AO No. 126 
2019 -00105; 127 
5. Applicators of household/urban pesticides and their training providers shall follow 128 
DOH AO No. 2019 -0010; and  129 
6. Tobacco Manufacturers and Distributors including Importers  130 
 131 
 132 
V. DEFINITION OF TERMS  133 
 134 
For the purpose of  implementing this Order, all the identified terms used herein shall 135 
have the meaning as defined in RA 9711, its IRR, and related laws and regulations.   The 136 
following terms or words and phrases shall mean or be understood as follows:  137 
 138 
A. Authorized Person - refers to the owner, President, Chief Executive Officers (CEO) 139 
or its equivalent, or any organic or full -time employee representing the establishment 140 
in an authorized or official capacity.  141 
 142 
                                                 
1 A strategy of the DOH to harmonize the licensure of hospitals, their ancillary and other health facilities.  
2 An Act Promoting Salt Iodization Nationwide (ASIN)  
3 Standards of Quality and Requirements for the Processing, Packaging, and Labelling of Bottled Drinking Water  
4 Rules and Regulations on the Licensing and Registration of Radiation Facilities Involved in the Use of Radiation 
Devices and Issuance of Other Related Authorization  
5 Guidelines on the Regulation of Operators of Pest Control, Certification of Pesticide Handlers, and Accreditation 
of their Training Providers   
4 B. Contract Research Organization (CRO) – refers to a person or an org anization 143 
(commercial, academic, or other) contracted by the sponsor to perform one or more of 144 
a sponsor’s trial -related duties and functions (ICH GCP 1.20).  145 
 146 
C. Cosmetic/HUHS Manufacturer/Refiller  – a licensed Cosmetic and/or HUHS 147 
establishment engaged in the refilling of bulk cosmetic and/or HUHS products into 148 
smaller quantities in a separate container, which may include labeling and stickering, 149 
with the end view of sale of the product directly to  the general public.  150 
 151 
D. Custom -Made Medical Device – refers to any device specifically made in accordance 152 
with a duly qualified medical practitioner’s written prescription which gives, under his 153 
responsibility, specific design characteristics and is intended  for the sole use of a 154 
particular patient. For the purpose of clarity, mass produced devices which need to be 155 
adapted to meet the specific requirements of the medical practitioner or any other 156 
professional user shall not be considered to be custom -made med ical devices.  157 
 158 
E. Distributor/Exporter - refers to any establishment that exports raw materials, active 159 
ingredients and finished products for distribution to other establishments outside the 160 
country.  161 
 162 
F. Distributor/Importer  – refers to any establishment that im ports raw materials, active 163 
ingredients and/or finished products for wholesale distribution to other local FDA - 164 
licensed establishments.  165 
 166 
G. Distributor/Wholesaler - refers to any establishment that procures raw materials, 167 
active ingredients and/or finished pr oducts from local FDA -licensed establishments 168 
for local distribution on a wholesale basis.  169 
 170 
H. Health -related device  – means any device not used in health care but has been 171 
determined by the FDA to adversely affect the health of the people.  172 
 173 
I. Initial Applicati on - refers to the type of LTO application submitted to the FDA prior 174 
to engaging in the business or operation involving the manufacture, importation, 175 
exportation, sale, offer for sale, distribution, transfer, and where applicable the use, 176 
testing, promoti on, advertisement, and/or sponsorship of health products.  177 
 178 
J. Major Variation - covers changes in the operations of the establishment that may 179 
affect significantly and/or directly the aspects of safety and quality and when 180 
applicable, efficacy of the products . 181 
 182 
K. Manufacturer - refers to any establishment engaged in any and all operations 183 
involved in the production of health products including preparation, processing, 184 
compounding, formulating, filling, packing, repacking, altering, ornamenting, 185 
finishing, and la beling with the end in view of its storage, sale, or distribution: 186 
Provided, that the term shall not apply to the compounding and filling of prescriptions 187 
in drugstores and hospital pharmacies. A trader shall be categorized as a manufacturer.  188 
 189 
L. Minor Variat ion - covers changes in administrative matters and/or changes in the 190 
operations of the establishments but with minimal impact on the safety, quality, and 191 
when applicable, efficacy of the products.  192  
5  193 
M. Packer  – refers to any establishment that packages bulk pr oducts into its immediate 194 
container with the end view of storage, distribution, or sale of the product.  195 
 196 
N. Pre-licensing Inspection – refers to an inspection performed prior to the approval of 197 
a new license (initial application) or significant change (major variation) to 198 
facility(ies), warehouses, and/or offices of an establishment to ensure compliance to 199 
the provisions of this Order and to the FDA existing regulations.  200 
 201 
O. Qualified Person (QP) - refers to an organic or full -time employee of the 202 
establishment w ho possesses technical competence related to the establishment’s 203 
activities and health products by virtue of his profession, training, or experience.   A 204 
qualified person has the responsibility to comply with the technical requirements of 205 
the FDA, discuss o r clarify matters with the FDA when submitting technical 206 
requirements, or engage FDA officials when conducting inspections or Post - 207 
Marketing Surveillance (PMS) activities.   The qualified person may also be the duly 208 
Authorized Person of the establishment.  209 
 210 
P. Refilling Station  – refers to the branch office of the Cosmetic and/or HUHS Refiller, 211 
including outlets; and mall kiosks, where the refilling activity takes place.  212 
 213 
Q. Refurbished Medical Device - refers to the medical device of which the whole or any 214 
part th ereof has been substantially rebuilt, whether or not using parts from one or more 215 
used medical devices of that same kind, so as to create a medical device that can be 216 
used for the purpose originally intended by the product owner of the original medical 217 
device, and which may have had the following work carried out on it: a.) stripping into 218 
component parts or subassemblies; b.) checking their suitability for reuse; c.) 219 
replacement of components/sub -assemblies not suitable for reuse; d.) assembly of the 220 
reclai med and/or replacement components/sub -assemblies; e.) testing of the 221 
assembled device against either original or revised release criteria; or f.) identifying 222 
an assembled medical device as a refurbished medical device. (ASEAN Medical 223 
Device Directive, 2015 ). 224 
 225 
R. Renewal Application - refers to the type of LTO application submitted to the FDA 226 
before the expiration of the validity of the current LTO for business operation 227 
continuity involving manufacture, importation, exportation, sale, offer for sale, 228 
distribut ion, transfer, and where applicable, the use, testing, promotion, advertisement, 229 
and/or sponsorship of health products.  230 
 231 
S. Repacker - refers to any establishment that repacks a finished product into smaller 232 
quantities in a separate container and/or secondar y packaging, including but not 233 
limited to relabeling, stickering, and bundling for promo packs with the end view of 234 
storage, distribution, or sale of the product.  235 
 236 
T. Retailer - refers to any establishment that sells or offers to sell any health product 237 
direc tly to the general public.  238 
 239 
U. Risk Management Plan  - refers to a set of health product vigilance activities and 240 
interventions designed to identify, characterize, prevent, or minimize risks relating to 241 
health products, and the assessment of the effectiveness of those interventions. The 242  
6 risk management plan is a requirement for the issuance of the appropriate 243 
authorization.  244 
 245 
V. Routine Inspection - refers to the general process of physical or remote inspection of 246 
the facility(ies), warehouses, and/or offices of an  establishment, which is conducted 247 
by the FDA at any time during the validity of its LTO. A routine inspection is also 248 
referred to as a post -licensing inspection.  249 
 250 
W. Site Master File - refers to specific information about the quality assurance, 251 
production, a nd/or quality control of manufacturing operations carried out at the 252 
named site and any closely integrated operations at adjacent and nearby buildings. If 253 
only part of an operation is carried out on the site, a Site Master File needs only to 254 
describe those  operations, e.g., analysis, packaging, for documentation.  255 
 256 
X. Sponsor - refers to an individual, company, institution, organization, or entity that 257 
takes responsibility for the initiation, management, and/or financing of a clinical trial.  258 
 259 
Y. Trader - refers  to an establishment that is a registered owner of a health product, 260 
procures the raw materials and packing components, provides the production, 261 
monographs, quality control standards, and procedures, but subcontracts the 262 
manufacture of such a product to a lic ensed Manufacturer. In addition, a trader may 263 
also engage in the distribution and/or marketing of its products.  264 
 265 
 266 
VI. GENERAL GUIDELINES  267 
 268 
A. All covered establishments, whether public or private entities, engaged in business or 269 
operation on health products shall first secure an LTO issued by the FDA and, when 270 
applicable, product market authorizations, i.e., Certificate of Product Registration 271 
(CPR), Certificate of Product Notification (CPN), before engaging in any FDA 272 
regulated transactions involving health products.  273 
 274 
B. The responsibility of ensuring the safety, efficacy, quality and/or purity of any health 275 
products identified under Section III o f this Administrative Order which are sold in 276 
original packaging (container) of which the seal has not been broken or tampered with 277 
shall rest upon the establishments involved in the supply chain for sale, handling, 278 
transport, distribution, trading, and st orage among others.  279 
 280 
C. Establishments shall comply with the applicable standards, including but not limited 281 
to Good Manufacturing Practices (GMP), Good Laboratory Practices, Good Clinical 282 
Practices (GCP), Good Distribution and Storage Practices (GDSP), among  others, in 283 
the conduct of their licensing activity(ies).  284 
 285 
D. In case the health product has been banned or withdrawn for health and safety reasons 286 
in the country of origin, the importer shall immediately undertake the necessary 287 
measures to ban its sale, dist ribution, or donation, or its immediate recall, withdrawal, 288 
or seizure from the Philippine market.  289 
 290  
7 E. Establishments engaged in the sale of health products declared by the FDA to be 291 
injurious, unsafe, or dangerous shall be required to immediately recall, wit hdraw, 292 
seize, or ban the sale, distribution, or donation to the public.  293 
 294 
F. The establishment shall inform the FDA of any changes or variations made to its 295 
license and a corresponding application shall likewise be made for the issuance of an 296 
LTO reflecting th e changes or variations made.  297 
 298 
G. Manufacturers, Traders, and Distributors shall declare on their application the list of 299 
sources and the respective types and/or name of finished products, semi -finished, raw 300 
materials, active pharmaceutical ingredients, and e xcipients that are relevant to their 301 
licensed activity.  302 
 303 
H. The transfer of location of a manufacturing/packing/repacking plant is considered as 304 
major variation for Manufacturer/Packer/Repacker with an application fee equivalent 305 
to an initial application fee.  306 
 307 
I. The FDA shall continue to provide training and seminars. In lieu of FDA sponsored 308 
training and seminars, applicants may submit proof of training from other institutions 309 
offering technical courses relevant to their establishment and activity. Such 310 
certifi cation or documentary evidence of compliance with the required training shall 311 
be sufficient compliance for purposes of application for LTO.  312 
 313 
J. To ensure that a tamper -proof security feature is present on all issued LTO certificates, 314 
the FDA shall endeavor to  provide a unique Certificate Security Seal to all FDA -issued 315 
LTO. Implementation of the FDA security seal shall be governed by separate rules and 316 
regulations.  317 
 318 
K. All provisions stipulated in this Order shall not preclude the FDA from issuing 319 
guidelines rela tive to specific licensing processes of the covered health product 320 
establishments enumerated under Section III of this Order.  321 
 322 
 323 
VII. SPECIFIC GUIDELINES  324 
 325 
A. The following establishments shall comply with the following conditions:  326 
 327 
1. For Drug establishments:  328 
 329 
a. All drug or pharmaceutical establishments based on Section 31 of R.A. 330 
No. 10918 or the Philippine Pharmacy Act, whether public or private, 331 
shall be under the supervision of a registered pharmacist when operating 332 
or open for business, unless otherwise allowed b y other pertinent laws 333 
or regulations.  334 
b. All entities, whether government or non -government, that regularly 335 
procure drugs on wholesale basis from appropriate FDA -duly licensed 336 
drug establishments for distribution to their constituents shall be 337 
required to ob tain a license as a drug distributor.  338 
c. No drug distributors shall sell directly to the general public or consumer 339 
unless they have an LTO as drugstores/retailers.  340  
8 d. All CROs, Sponsors and other concerned entities shall adhere to existing 341 
ethical and scientif ic quality standards of safety and efficacy in the 342 
conduct of clinical trials.  343 
e. No CRO or Sponsor shall be involved in the conduct of clinical trials 344 
without a license from the FDA. Licensed CROs/Sponsors that 345 
import/export products subject to clinical tria ls are no longer required to 346 
secure a separate LTO.  347 
f. All FDA -licensed drug retailers (drugstore, pharmacy, botica) or 348 
RONPD that also offer to sell medical device products shall secure a 349 
separate LTO from the FDA as Retailer of Medical Devices;  350 
g. All FDA -required information, education, and communication 351 
campaign materials shall be displayed in the establishment’s 352 
conspicuous area.  353 
h. All drugstores shall comply with the following:  354 
i. Designated dispensing areas that are sufficiently secured to 355 
prevent unauthorized access during operating hours. This is 356 
also to ensure the safekeeping of specified health products to 357 
be supplied or dispensed by retail at or from the drugstores;  358 
ii. Applicable establishment layouts that allow for the orderly 359 
arrangement of specified health products to be supplied or 360 
dispensed by retail at or from the drugstores;  361 
iii. Appropriate storage facilities in accordance with the 362 
conditions approved by the FDA for the storage of specified 363 
health products; and  364 
iv. A system for proper safekeeping and maintenance  of the 365 
records of the specified health products stored at the 366 
drugstores, including arrangements to audit the records shall 367 
be adequately provided to ensure integrity.  368 
 369 
2. For Cosmetic/HUHS establishments:  370 
 371 
a. All licensed Cosmetic/HUHS establishments with refi lling activity shall 372 
only be applied as a Cosmetic/HUHS Manufacturer.  373 
b. Specific guidelines on the licensing and inspection of Cosmetic/HUHS 374 
Manufacturers/Refillers shall be issued through separate issuances.  375 
 376 
3. For Food Business Operators:  377 
 378 
a. All establishments  shall comply with the current guidelines on general 379 
principles of food hygiene including the provisions provided for by 380 
Presidential Decree No. 856 on the Code of Sanitation and other general 381 
requirements.  382 
b. As appropriate, all Food Business Operators (FBOs) shall comply with 383 
the relevant standards and requirements of Hazard Analysis Critical 384 
Control Point (HACCP), Sanitary Standard Operating Procedures 385 
(SSOP), and other good practice regulations and guidelines expounded 386 
in Section VI of this AO, to ens ure the safety and quality of products.  387 
c. LTO is a requirement before a food establishment can join food trade 388 
and exhibitions, conduct market research, or test unregistered processed 389  
9 food products. CPR shall be required if the imported product is offered 390 
for sale or for “free tasting” during the food trade and exhibitions.  391 
d. All establishments shall comply with food safety standards recognized 392 
by applicable national regulations or by the Food and Agriculture 393 
Organization of the WHO.  394 
 395 
4. For Medical Device establ ishments:  396 
 397 
a. The following establishments are considered manufacturers of medical 398 
devices and are required to apply for an LTO:  399 
i. All hospitals or establishments engaged in the 3D printing of 400 
medical devices such as ortho, dental, prosthesis, and others 401 
as det ermined by the FDA;  402 
ii. Optical laboratories engaged in the assembly of optical 403 
lenses and frames;  404 
iii. Dental laboratories engage in the manufacture of custom - 405 
made dental devices such as dentures, retainers, braces, etc.  406 
b. All Distributor -Importer of devices conside red “For Research Use 407 
Only” shall secure an LTO from the FDA as medical device 408 
importer/distributor.  409 
 410 
B. The Qualified Personnel of the establishments shall ensure compliance with the 411 
following:  412 
 413 
1. All establishments shall have at least one (1) Qualified Person . The QP, upon and 414 
during employment in the establishment, is not and shall not in any way be 415 
connected to, employed by, or engaged with any other FDA - 416 
regulated  establishments.  417 
 418 
2. A single Qualified Person may be allowed by the FDA to handle a single 419 
establi shment with multiple FDA -licensed activities; Provided, that the QP 420 
remains to sufficiently carry out his/her duties and responsibilities as provided in 421 
this Order.  422 
 423 
3. The QP shall ensure compliance with FDA procedural guidelines, the prescribed 424 
format and contents of administrative and technical documentary requirements, 425 
timely communications and coordination with the FDA pertaining to regulatory 426 
filings, PMS, pre -licensing inspections and routine inspections, as well as 427 
continuous  compliance of his/her aff iliated establishment with regulatory 428 
standards, rules, and regulations . 429 
 430 
4. The QP shall ensure that all documentary and technical requirements and 431 
information provided in the application, together with all other submissions, 432 
including amendments, are true a nd correct based on existing records, legal 433 
documents, and other available information.  434 
 435 
5. The QP shall inform the FDA of any changes in the submitted documentary and 436 
technical requirements including the validity of his/her license to ensure that 437 
continuous compliance with the FDA is properly observed at all times.  438 
 439  
10 C. The requirements for applying for LTO shall be as follows:  440 
 441 
1. Initial LTO  442 
 443 
a. Accomplished eApplication Form with Declaration of Undertaking;  444 
b. Proof of Business Name Registration;  445 
c. Proof of Capitalizatio n for Manufacturers and Traders (Latest Audited 446 
Financial Statement with Balance Sheet or Declaration of 447 
Capitalization);  448 
d. Risk Management Plan;  449 
e. For Manufacturers: Site Master File and Floor Plan; and  450 
f. Payment of Fees  451 
 452 
2. Renewal of LTO  453 
 454 
a. Accomplished eApplication Form with Declaration of Undertaking; 455 
and 456 
b. Payment of Fees  457 
 458 
3. Variation  459 
 460 
a. Accomplished eApplication Form with Declaration of Undertaking;  461 
b. Documentary requirements depending on the variation or 462 
circumstances of the establishment or the product; and  463 
c. Payment of Fees  464 
 465 
The guidance for the above requirements is attached as Annex A (Requirements for 466 
Initial and Renewal License to Operate Application) and Annex C (List of Requirements for 467 
Specific Variation in the LTO), respectively.  468 
 469 
D. Application Process  470 
 471 
1. All establishments applying for initial, renewal, or variation shall submit their 472 
application through the FDA available online application platforms as guided by 473 
the latest issuances.  474 
 475 
2. Applications lodged through the FDA available online application platforms are 476 
the responsibility and accountability of the Owner/President/CEO of an 477 
establishment, as such only the duly authorized personnel of applicant - 478 
establishments and the e -mail address and its password shall be entrusted with such 479 
FDA applications . For emphasis, all consultants, liaison officers, or freelancers 480 
doing business with the establishment or working on a per -product 481 
registration/notification basis shall not be considered duly authorized/qualified 482 
persons.  483 
 484 
3. The applicant is expected to agr ee with the “Declaration of Undertaking” in order 485 
to continue with the application. Such conveys a binding agreement of the 486 
applicant -establishment with the FDA to provide accurate information, affirm 487 
primary responsibility over the products, and comply wi th all the rules and 488 
regulations set forth during and after the application process. Any 489  
11 misrepresentation of the information in this application shall be subject to 490 
administrative and criminal liabilities, provided by R.A. No. 9711, which includes, 491 
but is  not limited to suspension, cancellation, or revocation of the LTO.  492 
 493 
4. All transactions with the FDA shall be communicated to the applicant - 494 
establishment using the registered e -mail address during the initial application. The 495 
declared e -mail address is unalt erable, and the FDA shall not be held liable in any 496 
way for loss of access to the official e -mail. If the applicant -establishment wishes 497 
to change the declared e -mail address, the applicant may send a request to the FDA 498 
– Food and Drug Action Center at the  provided contact information found on the 499 
FDA’s official website.  500 
 501 
5. Pre-assessment shall be conducted to determine the completeness of the submitted 502 
application. Incomplete submission shall not be accepted, and the application shall 503 
not proceed to the next  step of the process.  504 
 505 
6. A successfully pre -assessed application is not equivalent to an approved 506 
application. The evaluation of the correctness and sufficiency of the submitted 507 
documentary requirements with reference to existing administrative and technical  508 
standards, rules, and regulations shall be conducted only during the evaluation and 509 
inspection steps as determined by the FDA.  510 
 511 
7. For applications with complete documentary requirements and posted payment, 512 
the FDA shall issue an Acknowledgement Receipt (AR) . An application shall only 513 
be considered filed once the applicant receives the AR from the FDA.  514 
 515 
8. An application for renewal shall be made within three (3) months prior to the 516 
expiration of the validity date of the LTO. Applications filed after the validit y date 517 
of the LTO shall be subject to a surcharge as prescribed in R.A. No. 9711 and its 518 
IRR.  519 
 520 
9. The automatic LTO issuance shall only take effect provided the applicant’s 521 
requirements are compliant with the conditions of automatic renewal prescribed 522 
under R epublic Act No. 9711 and its IRR including other related FDA issuances.  523 
 524 
10. No application for variation of LTO shall be made and granted when an 525 
establishment has a pending application for renewal of LTO, or vice versa.  526 
 527 
11. Applications filed after the FDA work ing hours (Monday -Friday; 7:00 AM – 6:00 528 
PM) shall be considered filed on the next working day on a first -in-first-out basis.  529 
 530 
D.  Payment  531 
 532 
1. Payment of prescribed fees as indicated in the Order of Payment shall be done 533 
through the following payment channels  based on existing FDA issuances:  534 
 535 
a. Through Over -the Counter at Landbank of the Philippines (LBP) using 536 
the LBP Oncoll Payment Slip;  537 
b. Through Online LBP Link.BizPortal; or  538 
c. Through Online Bills payment (Bancnet)  539  
12  540 
2. The deadline of payment shall be reflected in the generated Order of Payment 541 
following the successful application, wherein seven (7) calendar days shall be 542 
provided for all applications.  543 
 544 
3. For renewal application, the establishment shall ensure that the payment shall be 545 
made before the expiration date of the LTO, otherwise, rule under Section VII.D.8 546 
of this Order shall be applied.  547 
 548 
4. Application payments made including but not limited to the following, shall not be  549 
accepted and posted in the system:  550 
a. Application payments with incomplete/insufficient amoun ts paid;  551 
b. Application payments with an incorrect reference number provided;  552 
c. Application payments made through an unauthorized payment channel;  553 
d. Application payments made beyond the validity of the issued FDA 554 
Order of Payment; and  555 
e. Such other cases as determined by the FDA.  556 
 557 
5. Changes and/or addition to the existing FDA payment channels shall be announced 558 
through a separate issuance.  559 
 560 
E. Inspection  561 
 562 
1. The conduct of pre -licensing inspection to all FDA -covered establishments under 563 
Section III of this Order s hall be required, wherein initial verification of 564 
compliance with technical requirements and applicable standards of the 565 
establishments shall be checked.  566 
 567 
2. Pre-licensing inspection for all FDA -covered  establishments applying for 568 
applicable major variations  as enumerated under Annex C of this Order shall also 569 
be conducted as determined by the FDA.  570 
 571 
3. For renewal application and minor variation, routine inspection shall be conducted 572 
within the validity period of the existing LTO. Likewise, the risk -based inspec tion 573 
for all types of establishments within the validity of the LTO shall be conducted in 574 
reference to the criteria and risk matrixes provided by the FDA.  575 
 576 
4. All FDA -covered establishments shall ensure that the Site Master File, Risk 577 
Management Plan, and Flo or plan, if applicable, are developed and readily 578 
available at all times.  579 
 580 
5. The FDA shall have the authority to enter any covered establishment engaging in 581 
FDA -regulated activities involving health products during operating hours to 582 
conduct routine or spot check inspections.    583 
 584 
6. All covered establishments shall ensure that physical sites where the FDA -licensed 585 
activities take place are always readily accessible for the conduct of applicable site 586 
inspections prior, during, and after the issuance of the LTO.  The absence of the 587 
declared physical site during inspection shall be one of the grounds for disapproval 588 
of the application for LTO.  589  
13  590 
7. All licensed Manufacturers shall be granted an LTO based on the satisfactory 591 
compliance to the administrative and technical  requirements set by the FDA in 592 
order to operate a manufacturing plant. A Certificate of GMP Compliance shall 593 
only be issued upon demonstration of satisfactory compliance with GMP standards 594 
and effective within the validity of the current LTO, following th e conduct of a 595 
facility inspection. Thereafter, the Certificate of GMP Compliance shall be issued 596 
upon every renewal of the LTO; provided an inspection has been conducted by the 597 
FDA upon a favorable recommendation on the GMP Compliance of the facility.  598 
 599 
F. Evaluation  600 
 601 
The veracity of the application and compliance with all the documentary requirements and 602 
appropriate standards shall be further assessed.  603 
 604 
G. Checking of Application Status  605 
 606 
The applicant may check and verify the status of application on the FDA available online 607 
application platforms.  The simplified checking of application status through online 608 
transactions is compliant with the Zero -Contact policy provided under RA 11032.  609 
 610 
H. Releasing and Printing of LTO  611 
 612 
The FDA shall send the approved LTO to the  registered e -mail address of the applicant. 613 
Likewise, it shall be officially accessed through the FDA available online application 614 
platforms. The printing of the emailed and approved LTO shall be the sole responsibility of the 615 
owner of the establishment, thus the FDA shall no longer re -issue or provide certified true 616 
copies of the authorization/s.  617 
 618 
I. Validity of the LTO  619 
 620 
1. The validity of the issued LTO shall be as follows:  621 
 622 
INITIAL LTO  5 YEARS  
RENEWAL LTO  10 YEARS  
       623 
2. The validity period of the existing LTO provided to the establishments corresponds 624 
to the same validity period as the variations made by the establishments.  625 
 626 
3. Corresponding fees and other charges for the application of LTO shall be governed 627 
by FDA existing issuances.  628 
 629 
J. Cancellation of the issu ed LTO  630 
 631 
1. Effect of LTO Cancellation  632 
Any cancelled LTO shall have the effect of non -possession of an LTO as an 633 
establishment. Thus, any establishment found to be operating their business without 634 
the necessary LTO upon inspection shall be in violation of the provision of RA 9711 635  
14 and other rela ted FDA Issuances and shall be penalized under existing laws, rules, 636 
and regulations.  637 
 638 
2. The LTO shall be cancelled due to the following instances:  639 
 640 
a. The application requirements submitted show that the establishment 641 
does not meet the required technical requi rements or appropriate 642 
standards;  643 
b. The applicant made misrepresentations, false entries, or withheld any 644 
relevant data contrary to the provisions of the law, RA 9711, and its IRR, 645 
or appropriate rules and regulations;  646 
c. The owner has violated any of the terms  and conditions of its license;  647 
d. Non-compliance with any of the provided guidelines of this Order; and  648 
e. Such other analogous grounds or causes as determined by the FDA.  649 
 650 
When the license is cancelled, either through an inspection verification or voluntarily , 651 
the FDA shall retain jurisdiction over violations committed by the establishments while it was 652 
in operation.  653 
 654 
 655 
VIII.  PENALTY CLAUSE  656 
 657 
Sanctions over violations of any of the provisions of this Administrative Order shall be 658 
based on the Rules of Administrative Procedure provided in the IRR of RA 9711.  659 
 660 
 661 
IX. TRANSITORY PROVISION  662 
 663 
A. All existing applications for LTO of establishments enumerated in Section III received 664 
prior to the effectivity date of this Order shall be processed according to DOH AO No. 665 
2020 -0017.  666 
 667 
B. All major and minor variation applications received upon the effectivity of this Order 668 
for LTOs previously issued based on DOH AO No. 2020 -0017 shall be subject to the 669 
updated guidelines as stipulated in this Order.  670 
 671 
C. Pre-licensing inspections for Manufacturers  are still to be required. The conduct of 672 
pre-licensing inspections for other covered establishments shall be on pilot 673 
implementation, which shall be initially conducted to all covered drug establishments 674 
during the period of one (1) year from the effectiv ity of this Order. Post - 675 
implementation review shall be conducted to assess the effectiveness of the pilot 676 
implementation.  677 
 678 
D. The implementing guidelines for the conduct of pre -licensing inspections for all FDA - 679 
covered establishments shall be issued through s eparate guidelines.  680 
 681 
 682 
 683 
 684  
15 X. REPEALING CLAUSE  685 
 686 
AO No. 2020 -0017 entitled, “Revised Guidelines on the Unified Licensing Requirements 687 
and Procedures of the Food and Drug Administration Repealing Administrative Order No. 688 
2016 -0003” and Section III.Last Par. of FDA  Circular No. 2021 -00216 are hereby repealed. 689 
Other issuances or parts thereof, pertaining to specific guidelines for certain establishments 690 
which are found to be inconsistent with the provisions of this AO are hereby repealed 691 
accordingly.  692 
 693 
 694 
XI. SEPARABILITY CLAUSE  695 
 696 
If any portion or provision of this Order is declared invalid, unenforceable, or 697 
unconstitutional, the validity or enforceability of the remaining portions or provisions shall not 698 
be affected, and this Order shall be construed as if i t did not contain the particular invalid or 699 
unenforceable or unconstitutional portion or provision.  700 
 701 
 702 
XII. MONITORING AND EVALUATION  703 
 704 
Within three (3) years of its implementation, this Order shall be reviewed and evaluated  705 
to determine whether the policy’s obje ctives, impact, and effectiveness are achieved.  706 
 707 
 708 
XIII.  EFFECTIVITY  709 
 710 
This Administrative Order shall take effect fifteen (15) days after its publication in a 711 
newspaper of general circulation and upon filing with the University of the Philippines Office 712 
of the National Administrative Register.  713 
 714 
 715 
 716 
 717 
       DR. MARIA ROSARIO S. VERGEIRE, MPH, CESO II  718 
                      Officer -in-Charge - Secretary of Health  719 
  720 
                                                 
6 Guidelines on the Licensing of Retailers of Medical Devices in the Philippines (Section III, last par. “In 
consonan ce with AO No. 2020 -0017, this FDA Circular shall not cover grocery stores, supermarkets, convenience 
stores, chandler, kiosks, and other similar stores. However, although these establishments are exempted from 
securing the LTO, they shall be held liable a nd shall be considered violating the FDA regulations if they sell 
unregistered/unnotified medical devices”)