All concerned stakeholders may submit comments in MS word format via email to [email protected], copy furnish [email protected]. The deadline for submission of comment is on 30 June 2023.
I. RATIONALE
Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009” mandates the FDA to establish and maintain an effective health regulatory system to promote the safety, quality, and efficacy of health products. Pursuant to the mentioned, the FDA, as one of the regulatory arms of the Department of Health (DOH), is mandated to issue standards and appropriate authorizations that cover establishments, facilities, and health products under its jurisdiction. Such endeavor shall be visible in its regulation of Manufacturers, Traders, and Distributors (Importers, Exporters, and Wholesalers), among others, engaged in business and operations involving health products prior to manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship activities.
In 2018, RA No. 11032, otherwise known as the “Ease of Doing Business and Efficient Government Service Delivery Act” was issued, which aids in the promotion of streamlined and simplified transactions in the government. Hence, the FDA, congruent with RA 11032, established unified licensing guidelines to adopt a more harmonized licensing system across all health products under its jurisdiction through the issuance of Administrative Order (AO) No. 2020-0017, otherwise known as the “Revised Guidelines on the Unified Licensing Requirements and Procedures of the FDA Repealing AO No. 2016-0003”.
The implementation of AO No. 2020-0017, in parallel with the digitalization initiatives of the FDA, promotes a harmonized licensing application that encompasses all types of covered health products. While it is notably used, certain requirements that need to be complied with by the regulated entities are not given due emphasis in the implemented AO. These requirements are necessary for the evaluation of technical compliance and inspection of covered health product establishments.
Further, the compliance of the FDA with international standards shall be evident in its national regulatory systems with the use of benchmarking methodology as provided by the World Health Organization – Global Benchmarking Tool (WHO-GBT). This shall help the FDA in the self-evaluation of its processes towards reaching a level of a more strengthened regulatory oversight.
Hence, in the pursuit of achieving an updated regulatory system and aligning with the mentioned policies, this Administrative Order is hereby issued.
II. OBJECTIVES
The objectives for issuing this Administrative Order are as follows:
1. To further reengineer the FDA’s processes and automate its system for initial, renewal, and variation applications for License to Operate (LTO) through the FDA available online application platforms; and
2. To update the list of documentary requirements for LTO applications, in addition to other technical requirements that shall be presented during the inspection of the FDA-covered establishments.
III. SCOPE
A. The following establishments, whether public or private, shall be covered by this Order:
1. Manufacturers, including Packers/Repackers;
2. Refurbishers of medical devices;
3. Traders;
4. Distributors as Importers, Exporters, and/or Wholesalers;
5. Drug outlets, such as drugstores, pharmacies (community, or institutional); or boticas, and retail outlets for non-prescription drugs (RONPDs);
6. Retailers of Medical Devices
7. Clinical Research Organizations (CROs) and Sponsors
B. The scope of health products shall include, but not be limited to:
1. Under the CCHUHSRR, all cosmetic products, household/urban hazardous substances (HUHS), including household/urban pesticides, and toys and childcare articles;
2. Under the CDRR, all drugs, including but not limited to drug products for human use, biological drug products such as blood products and vaccines, radiopharmaceuticals and precursors, advance therapy drug products such as human cells, tissues, and cellular and tissue-based products, homeopathic products, medical gases, herbal and traditional medicines, orphan drugs, animal health products, and other drug products as determined by the FDA;
3. Under the CDRRHR, all medical devices, radiation-emitting devices, in-vitro diagnostic devices, and reagents; refurbished medical devices; custom-made medical devices; equipment or devices used for treating sharps, pathological, and infectious wastes, water treatment devices/systems; and other health-related devices as determined by the FDA; and
4. Under the CFRR, all processed food products, food/dietary supplements, raw materials, ingredients, and additives for food.
This does not preclude the FDA from updating the scope of health products and establishments that require regulation in accordance with the FDA rules and regulations.
IV. EXCLUSION
A. The following shall NOT be covered by this Order:
1. Organizers of national and international trade fairs and exhibits;
2. Donors, organizations, or persons involved in donations, medical missions, and other humanitarian activities;
3. Manufacturers, Traders, or Distributors of collector’s items;
4. Retailers of processed food products, cosmetics and household/urban hazardous substances, including household/urban pesticides and toys and childcare articles;
5. Groceries, convenience stores, and supermarkets without wholesale activity for foods, slaughterhouses, or abattoirs, dressing plants, fish ports, wet markets, school canteens; restaurants without importation and manufacturing/repacking activity of prepacked foods; water refilling stations, street food sale including ambulant vending, fast foods, kiosks, caterers, chandlers, and the likes;
6. Institutions and companies that provide vaccinations to their employees; and
7. Facilities covered by the DOH One Stop Shop Licensing System .
B. The licensing of the following establishments or persons shall be governed by separate rules and regulations:
1. Salt Manufacturers, Distributors, and Traders shall follow RA 8172 (ASIN Law) and its revised IRR;
2. Bottled Water Manufacturers shall follow AO No. 18-A s. 1993 ;
3. Radiation facilities shall follow AO No. 2020-0035
4. Operators of pest control for non-agricultural purposes shall follow DOH AO No. 2019-0010 ;
5. Applicators of household/urban pesticides and their training providers shall follow DOH AO No. 2019-0010; and
6. Tobacco Manufacturers and Distributors including Importers
V. DEFINITION OF TERMS
For the purpose of implementing this Order, all the identified terms used herein shall have the meaning as defined in RA 9711, its IRR, and related laws and regulations. The following terms or words and phrases shall mean or be understood as follows:
A. Authorized Person – refers to the owner, President, Chief Executive Officers (CEO) or its equivalent, or any organic or full-time employee representing the establishment in an authorized or official capacity.
B. Contract Research Organization (CRO) – refers to a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions (ICH GCP 1.20).
C. Cosmetic/HUHS Manufacturer/Refiller – a licensed Cosmetic and/or HUHS establishment engaged in the refilling of bulk cosmetic and/or HUHS products into smaller quantities in a separate container, which may include labeling and stickering, with the end view of sale of the product directly to the general public.
D. Custom-Made Medical Device – refers to any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. For the purpose of clarity, mass produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made medical devices.
E. Distributor/Exporter – refers to any establishment that exports raw materials, active ingredients and finished products for distribution to other establishments outside the country.
F. Distributor/Importer – refers to any establishment that imports raw materials, active ingredients and/or finished products for wholesale distribution to other local FDA-licensed establishments.
G. Distributor/Wholesaler – refers to any establishment that procures raw materials, active ingredients and/or finished products from local FDA-licensed establishments for local distribution on a wholesale basis.
H. Health-related device – means any device not used in health care but has been determined by the FDA to adversely affect the health of the people.
I. Initial Application – refers to the type of LTO application submitted to the FDA prior to engaging in the business or operation involving the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or sponsorship of health products.
J. Major Variation – covers changes in the operations of the establishment that may affect significantly and/or directly the aspects of safety and quality and when applicable, efficacy of the products.
K. Manufacturer – refers to any establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing, and labeling with the end in view of its storage, sale, or distribution: Provided, that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A trader shall be categorized as a manufacturer.
L. Minor Variation – covers changes in administrative matters and/or changes in the operations of the establishments but with minimal impact on the safety, quality, and when applicable, efficacy of the products.
M. Packer – refers to any establishment that packages bulk products into its immediate container with the end view of storage, distribution, or sale of the product.
N. Pre-licensing Inspection – refers to an inspection performed prior to the approval of a new license (initial application) or significant change (major variation) to facility(ies), warehouses, and/or offices of an establishment to ensure compliance to the provisions of this Order and to the FDA existing regulations.
O. Qualified Person (QP) – refers to an organic or full-time employee of the establishment who possesses technical competence related to the establishment’s activities and health products by virtue of his profession, training, or experience. A qualified person has the responsibility to comply with the technical requirements of the FDA, discuss or clarify matters with the FDA when submitting technical requirements, or engage FDA officials when conducting inspections or Post-Marketing Surveillance (PMS) activities. The qualified person may also be the duly Authorized Person of the establishment.
P. Refilling Station – refers to the branch office of the Cosmetic and/or HUHS Refiller, including outlets; and mall kiosks, where the refilling activity takes place.
Q. Refurbished Medical Device – refers to the medical device of which the whole or any part thereof has been substantially rebuilt, whether or not using parts from one or more used medical devices of that same kind, so as to create a medical device that can be used for the purpose originally intended by the product owner of the original medical device, and which may have had the following work carried out on it: a.) stripping into component parts or subassemblies; b.) checking their suitability for reuse; c.) replacement of components/sub-assemblies not suitable for reuse; d.) assembly of the reclaimed and/or replacement components/sub-assemblies; e.) testing of the assembled device against either original or revised release criteria; or f.) identifying an assembled medical device as a refurbished medical device. (ASEAN Medical Device Directive, 2015).
R. Renewal Application – refers to the type of LTO application submitted to the FDA before the expiration of the validity of the current LTO for business operation continuity involving manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of health products.
S. Repacker – refers to any establishment that repacks a finished product into smaller quantities in a separate container and/or secondary packaging, including but not limited to relabeling, stickering, and bundling for promo packs with the end view of storage, distribution, or sale of the product.
T. Retailer – refers to any establishment that sells or offers to sell any health product directly to the general public.
U. Risk Management Plan – refers to a set of health product vigilance activities and interventions designed to identify, characterize, prevent, or minimize risks relating to health products, and the assessment of the effectiveness of those interventions. The risk management plan is a requirement for the issuance of the appropriate authorization.
V. Routine Inspection – refers to the general process of physical or remote inspection of the facility(ies), warehouses, and/or offices of an establishment, which is conducted by the FDA at any time during the validity of its LTO. A routine inspection is also referred to as a post-licensing inspection.
W. Site Master File – refers to specific information about the quality assurance, production, and/or quality control of manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of an operation is carried out on the site, a Site Master File needs only to describe those operations, e.g., analysis, packaging, for documentation.
X. Sponsor – refers to an individual, company, institution, organization, or entity that takes responsibility for the initiation, management, and/or financing of a clinical trial.
Y. Trader – refers to an establishment that is a registered owner of a health product, procures the raw materials and packing components, provides the production, monographs, quality control standards, and procedures, but subcontracts the manufacture of such a product to a licensed Manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.
VI. GENERAL GUIDELINES
A. All covered establishments, whether public or private entities, engaged in business or operation on health products shall first secure an LTO issued by the FDA and, when applicable, product market authorizations, i.e., Certificate of Product Registration (CPR), Certificate of Product Notification (CPN), before engaging in any FDA regulated transactions involving health products.
B. The responsibility of ensuring the safety, efficacy, quality and/or purity of any health products identified under Section III of this Administrative Order which are sold in original packaging (container) of which the seal has not been broken or tampered with shall rest upon the establishments involved in the supply chain for sale, handling, transport, distribution, trading, and storage among others.
C. Establishments shall comply with the applicable standards, including but not limited to Good Manufacturing Practices (GMP), Good Laboratory Practices, Good Clinical Practices (GCP), Good Distribution and Storage Practices (GDSP), among others, in the conduct of their licensing activity(ies).
D. In case the health product has been banned or withdrawn for health and safety reasons in the country of origin, the importer shall immediately undertake the necessary measures to ban its sale, distribution, or donation, or its immediate recall, withdrawal, or seizure from the Philippine market.
E. Establishments engaged in the sale of health products declared by the FDA to be injurious, unsafe, or dangerous shall be required to immediately recall, withdraw, seize, or ban the sale, distribution, or donation to the public.
F. The establishment shall inform the FDA of any changes or variations made to its license and a corresponding application shall likewise be made for the issuance of an LTO reflecting the changes or variations made.
G. Manufacturers, Traders, and Distributors shall declare on their application the list of sources and the respective types and/or name of finished products, semi-finished, raw materials, active pharmaceutical ingredients, and excipients that are relevant to their licensed activity.
H. The transfer of location of a manufacturing/packing/repacking plant is considered as major variation for Manufacturer/Packer/Repacker with an application fee equivalent to an initial application fee.
I. The FDA shall continue to provide training and seminars. In lieu of FDA sponsored training and seminars, applicants may submit proof of training from other institutions offering technical courses relevant to their establishment and activity. Such certification or documentary evidence of compliance with the required training shall be sufficient compliance for purposes of application for LTO.
J. To ensure that a tamper-proof security feature is present on all issued LTO certificates, the FDA shall endeavor to provide a unique Certificate Security Seal to all FDA-issued LTO. Implementation of the FDA security seal shall be governed by separate rules and regulations.
K. All provisions stipulated in this Order shall not preclude the FDA from issuing guidelines relative to specific licensing processes of the covered health product establishments enumerated under Section III of this Order.
VII. SPECIFIC GUIDELINES
A. The following establishments shall comply with the following conditions:
1. For Drug establishments:
a. All drug or pharmaceutical establishments based on Section 31 of R.A. No. 10918 or the Philippine Pharmacy Act, whether public or private, shall be under the supervision of a registered pharmacist when operating or open for business, unless otherwise allowed by other pertinent laws or regulations.
b. All entities, whether government or non-government, that regularly procure drugs on wholesale basis from appropriate FDA-duly licensed drug establishments for distribution to their constituents shall be required to obtain a license as a drug distributor.
c. No drug distributors shall sell directly to the general public or consumer unless they have an LTO as drugstores/retailers.
d. All CROs, Sponsors and other concerned entities shall adhere to existing ethical and scientific quality standards of safety and efficacy in the conduct of clinical trials.
e. No CRO or Sponsor shall be involved in the conduct of clinical trials without a license from the FDA. Licensed CROs/Sponsors that import/export products subject to clinical trials are no longer required to secure a separate LTO.
f. All FDA-licensed drug retailers (drugstore, pharmacy, botica) or RONPD that also offer to sell medical device products shall secure a separate LTO from the FDA as Retailer of Medical Devices;
g. All FDA-required information, education, and communication campaign materials shall be displayed in the establishment’s conspicuous area.
h. All drugstores shall comply with the following:
i. Designated dispensing areas that are sufficiently secured to prevent unauthorized access during operating hours. This is also to ensure the safekeeping of specified health products to be supplied or dispensed by retail at or from the drugstores;
ii. Applicable establishment layouts that allow for the orderly arrangement of specified health products to be supplied or dispensed by retail at or from the drugstores;
iii. Appropriate storage facilities in accordance with the conditions approved by the FDA for the storage of specified health products; and
iv. A system for proper safekeeping and maintenance of the records of the specified health products stored at the drugstores, including arrangements to audit the records shall be adequately provided to ensure integrity.
2. For Cosmetic/HUHS establishments:
a. All licensed Cosmetic/HUHS establishments with refilling activity shall only be applied as a Cosmetic/HUHS Manufacturer.
b. Specific guidelines on the licensing and inspection of Cosmetic/HUHS Manufacturers/Refillers shall be issued through separate issuances.
3. For Food Business Operators:
a. All establishments shall comply with the current guidelines on general principles of food hygiene including the provisions provided for by Presidential Decree No. 856 on the Code of Sanitation and other general requirements.
b. As appropriate, all Food Business Operators (FBOs) shall comply with the relevant standards and requirements of Hazard Analysis Critical Control Point (HACCP), Sanitary Standard Operating Procedures (SSOP), and other good practice regulations and guidelines expounded in Section VI of this AO, to ensure the safety and quality of products.
c. LTO is a requirement before a food establishment can join food trade and exhibitions, conduct market research, or test unregistered processed food products. CPR shall be required if the imported product is offered for sale or for “free tasting” during the food trade and exhibitions.
d. All establishments shall comply with food safety standards recognized by applicable national regulations or by the Food and Agriculture Organization of the WHO.
4. For Medical Device establishments:
a. The following establishments are considered manufacturers of medical devices and are required to apply for an LTO:
i. All hospitals or establishments engaged in the 3D printing of medical devices such as ortho, dental, prosthesis, and others as determined by the FDA;
ii. Optical laboratories engaged in the assembly of optical lenses and frames;
iii. Dental laboratories engage in the manufacture of custom-made dental devices such as dentures, retainers, braces, etc.
b. All Distributor-Importer of devices considered “For Research Use Only” shall secure an LTO from the FDA as medical device importer/distributor.
B. The Qualified Personnel of the establishments shall ensure compliance with the following:
1. All establishments shall have at least one (1) Qualified Person. The QP, upon and during employment in the establishment, is not and shall not in any way be connected to, employed by, or engaged with any other FDA-regulated establishments.
2. A single Qualified Person may be allowed by the FDA to handle a single establishment with multiple FDA-licensed activities; Provided, that the QP remains to sufficiently carry out his/her duties and responsibilities as provided in this Order.
3. The QP shall ensure compliance with FDA procedural guidelines, the prescribed format and contents of administrative and technical documentary requirements, timely communications and coordination with the FDA pertaining to regulatory filings, PMS, pre-licensing inspections and routine inspections, as well as continuous compliance of his/her affiliated establishment with regulatory standards, rules, and regulations.
4. The QP shall ensure that all documentary and technical requirements and information provided in the application, together with all other submissions, including amendments, are true and correct based on existing records, legal documents, and other available information.
5. The QP shall inform the FDA of any changes in the submitted documentary and technical requirements including the validity of his/her license to ensure that continuous compliance with the FDA is properly observed at all times.
C. The requirements for applying for LTO shall be as follows:
1. Initial LTO
a. Accomplished eApplication Form with Declaration of Undertaking;
b. Proof of Business Name Registration;
c. Proof of Capitalization for Manufacturers and Traders (Latest Audited Financial Statement with Balance Sheet or Declaration of Capitalization);
d. Risk Management Plan;
e. For Manufacturers: Site Master File and Floor Plan; and
f. Payment of Fees
2. Renewal of LTO
a. Accomplished eApplication Form with Declaration of Undertaking; and
b. Payment of Fees
3. Variation
a. Accomplished eApplication Form with Declaration of Undertaking;
b. Documentary requirements depending on the variation or circumstances of the establishment or the product; and
c. Payment of Fees
The guidance for the above requirements is attached as Annex A (Requirements for Initial and Renewal License to Operate Application) and Annex C (List of Requirements for Specific Variation in the LTO), respectively.
D. Application Process
1. All establishments applying for initial, renewal, or variation shall submit their application through the FDA available online application platforms as guided by the latest issuances.
2. Applications lodged through the FDA available online application platforms are the responsibility and accountability of the Owner/President/CEO of an establishment, as such only the duly authorized personnel of applicant-establishments and the e-mail address and its password shall be entrusted with such FDA applications. For emphasis, all consultants, liaison officers, or freelancers doing business with the establishment or working on a per-product registration/notification basis shall not be considered duly authorized/qualified persons.
3. The applicant is expected to agree with the “Declaration of Undertaking” in order to continue with the application. Such conveys a binding agreement of the applicant-establishment with the FDA to provide accurate information, affirm primary responsibility over the products, and comply with all the rules and regulations set forth during and after the application process. Any misrepresentation of the information in this application shall be subject to administrative and criminal liabilities, provided by R.A. No. 9711, which includes, but is not limited to suspension, cancellation, or revocation of the LTO.
4. All transactions with the FDA shall be communicated to the applicant-establishment using the registered e-mail address during the initial application. The declared e-mail address is unalterable, and the FDA shall not be held liable in any way for loss of access to the official e-mail. If the applicant-establishment wishes to change the declared e-mail address, the applicant may send a request to the FDA – Food and Drug Action Center at the provided contact information found on the FDA’s official website.
5. Pre-assessment shall be conducted to determine the completeness of the submitted application. Incomplete submission shall not be accepted, and the application shall not proceed to the next step of the process.
6. A successfully pre-assessed application is not equivalent to an approved application. The evaluation of the correctness and sufficiency of the submitted documentary requirements with reference to existing administrative and technical standards, rules, and regulations shall be conducted only during the evaluation and inspection steps as determined by the FDA.
7. For applications with complete documentary requirements and posted payment, the FDA shall issue an Acknowledgement Receipt (AR). An application shall only be considered filed once the applicant receives the AR from the FDA.
8. An application for renewal shall be made within three (3) months prior to the expiration of the validity date of the LTO. Applications filed after the validity date of the LTO shall be subject to a surcharge as prescribed in R.A. No. 9711 and its IRR.
9. The automatic LTO issuance shall only take effect provided the applicant’s requirements are compliant with the conditions of automatic renewal prescribed under Republic Act No. 9711 and its IRR including other related FDA issuances.
10. No application for variation of LTO shall be made and granted when an establishment has a pending application for renewal of LTO, or vice versa.
11. Applications filed after the FDA working hours (Monday-Friday; 7:00 AM – 6:00 PM) shall be considered filed on the next working day on a first-in-first-out basis.
D. Payment
1. Payment of prescribed fees as indicated in the Order of Payment shall be done through the following payment channels based on existing FDA issuances:
a. Through Over-the Counter at Landbank of the Philippines (LBP) using the LBP Oncoll Payment Slip;
b. Through Online LBP Link.BizPortal; or
c. Through Online Bills payment (Bancnet)
2. The deadline of payment shall be reflected in the generated Order of Payment following the successful application, wherein seven (7) calendar days shall be provided for all applications.
3. For renewal application, the establishment shall ensure that the payment shall be made before the expiration date of the LTO, otherwise, rule under Section VII.D.8 of this Order shall be applied.
4. Application payments made including but not limited to the following, shall not be
accepted and posted in the system:
a. Application payments with incomplete/insufficient amounts paid;
b. Application payments with an incorrect reference number provided;
c. Application payments made through an unauthorized payment channel;
d. Application payments made beyond the validity of the issued FDA Order of Payment; and
e. Such other cases as determined by the FDA.
5. Changes and/or addition to the existing FDA payment channels shall be announced through a separate issuance.
E. Inspection
1. The conduct of pre-licensing inspection to all FDA-covered establishments under Section III of this Order shall be required, wherein initial verification of compliance with technical requirements and applicable standards of the establishments shall be checked.
2. Pre-licensing inspection for all FDA-covered establishments applying for applicable major variations as enumerated under Annex C of this Order shall also be conducted as determined by the FDA.
3. For renewal application and minor variation, routine inspection shall be conducted within the validity period of the existing LTO. Likewise, the risk-based inspection for all types of establishments within the validity of the LTO shall be conducted in reference to the criteria and risk matrixes provided by the FDA.
4. All FDA-covered establishments shall ensure that the Site Master File, Risk Management Plan, and Floor plan, if applicable, are developed and readily available at all times.
5. The FDA shall have the authority to enter any covered establishment engaging in FDA-regulated activities involving health products during operating hours to conduct routine or spot check inspections.
6. All covered establishments shall ensure that physical sites where the FDA-licensed activities take place are always readily accessible for the conduct of applicable site inspections prior, during, and after the issuance of the LTO. The absence of the declared physical site during inspection shall be one of the grounds for disapproval of the application for LTO.
7. All licensed Manufacturers shall be granted an LTO based on the satisfactory compliance to the administrative and technical requirements set by the FDA in order to operate a manufacturing plant. A Certificate of GMP Compliance shall only be issued upon demonstration of satisfactory compliance with GMP standards and effective within the validity of the current LTO, following the conduct of a facility inspection. Thereafter, the Certificate of GMP Compliance shall be issued upon every renewal of the LTO; provided an inspection has been conducted by the FDA upon a favorable recommendation on the GMP Compliance of the facility.
F. Evaluation
The veracity of the application and compliance with all the documentary requirements and appropriate standards shall be further assessed.
G. Checking of Application Status
The applicant may check and verify the status of application on the FDA available online application platforms. The simplified checking of application status through online transactions is compliant with the Zero-Contact policy provided under RA 11032.
H. Releasing and Printing of LTO
The FDA shall send the approved LTO to the registered e-mail address of the applicant. Likewise, it shall be officially accessed through the FDA available online application platforms. The printing of the emailed and approved LTO shall be the sole responsibility of the owner of the establishment, thus the FDA shall no longer re-issue or provide certified true copies of the authorization/s.
I. Validity of the LTO
1. The validity of the issued LTO shall be as follows:
INITIAL LTO 5 YEARS
RENEWAL LTO 10 YEARS
2. The validity period of the existing LTO provided to the establishments corresponds to the same validity period as the variations made by the establishments.
3. Corresponding fees and other charges for the application of LTO shall be governed by FDA existing issuances.
J. Cancellation of the issued LTO
1. Effect of LTO Cancellation
Any cancelled LTO shall have the effect of non-possession of an LTO as an establishment. Thus, any establishment found to be operating their business without the necessary LTO upon inspection shall be in violation of the provision of RA 9711 and other related FDA Issuances and shall be penalized under existing laws, rules, and regulations.
2. The LTO shall be cancelled due to the following instances:
a. The application requirements submitted show that the establishment does not meet the required technical requirements or appropriate standards;
b. The applicant made misrepresentations, false entries, or withheld any relevant data contrary to the provisions of the law, RA 9711, and its IRR, or appropriate rules and regulations;
c. The owner has violated any of the terms and conditions of its license;
d. Non-compliance with any of the provided guidelines of this Order; and
e. Such other analogous grounds or causes as determined by the FDA.
When the license is cancelled, either through an inspection verification or voluntarily, the FDA shall retain jurisdiction over violations committed by the establishments while it was in operation.
VIII. PENALTY CLAUSE
Sanctions over violations of any of the provisions of this Administrative Order shall be based on the Rules of Administrative Procedure provided in the IRR of RA 9711.
IX. TRANSITORY PROVISION
A. All existing applications for LTO of establishments enumerated in Section III received prior to the effectivity date of this Order shall be processed according to DOH AO No. 2020-0017.
B. All major and minor variation applications received upon the effectivity of this Order for LTOs previously issued based on DOH AO No. 2020-0017 shall be subject to the updated guidelines as stipulated in this Order.
C. Pre-licensing inspections for Manufacturers are still to be required. The conduct of pre-licensing inspections for other covered establishments shall be on pilot implementation, which shall be initially conducted to all covered drug establishments during the period of one (1) year from the effectivity of this Order. Post-implementation review shall be conducted to assess the effectiveness of the pilot implementation.
D. The implementing guidelines for the conduct of pre-licensing inspections for all FDA-covered establishments shall be issued through separate guidelines.
X. REPEALING CLAUSE
AO No. 2020-0017 entitled, “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003” and Section III.Last Par. of FDA Circular No. 2021-0021 are hereby repealed. Other issuances or parts thereof, pertaining to specific guidelines for certain establishments which are found to be inconsistent with the provisions of this AO are hereby repealed accordingly.
XI. SEPARABILITY CLAUSE
If any portion or provision of this Order is declared invalid, unenforceable, or unconstitutional, the validity or enforceability of the remaining portions or provisions shall not be affected, and this Order shall be construed as if it did not contain the particular invalid or unenforceable or unconstitutional portion or provision.XII. MONITORING AND EVALUATION
Within three (3) years of its implementation, this Order shall be reviewed and evaluated
to determine whether the policy’s objectives, impact, and effectiveness are achieved.XIII. EFFECTIVITY
This Administrative Order shall take effect fifteen (15) days after its publication in a newspaper of general circulation and upon filing with the University of the Philippines Office of the National Administrative Register.