All comments may be sent at [email protected]. The deadline for submission of comments is on 02 June 2022.
I. RATIONALE
The Republic Act (RA) No. 11223, otherwise known as the “Universal Health Care Act” mandates the State to adopt a framework that fosters a whole-of-system, whole-of-government, and whole-of-society approach in the development, implementation, monitoring, and evaluation of health policies, programs and plans.
Further, the RA 9711, otherwise known as the “Food and Drug Administration Act of 2009”, amending certain provisions of RA 3720, series of 1963, otherwise known as the “Foods, Drugs and Devices, and Cosmetics Act” regulates all establishments, namely manufacturers, traders, and distributors (importers, exporters and wholesalers), among others, engaged in business and operations involving health products and issues product market authorization on all health products prior to manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship.
Consistent with these laws and with the Department of Health (DOH) F1+ Strategic Goals that are geared to more responsive health systems by developing innovative regulatory mechanisms, the FDA is currently undertaking efforts to streamline its processes and requirements and to automate and reengineer its systems.
In the interest of public health and welfare protection, this Administrative Order (AO) is hereby issued to repeal Administrative Order 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”.
II. OBJECTIVES
The objectives for issuing this Administrative Order are as follows:
1. To reengineer and streamline the FDA’s processes and automate its system for initial, renewal, and variation application for License to Operate (LTO) through the FDA available electronic systems; and
2. To identify the documentary requirements for pre-license application, in addition to other technical requirements that shall be presented during inspection of certain FDA regulated establishments.
III. SCOPE OF APPLICATION
A. The following establishments, whether public or private, shall be covered by this Order:
1. Manufacturers, including packers/repackers, refurbishers, and Cosmetic/HUHS Manufacturers/Refillers as applicable;
2. Traders;
3. Distributors as importers, exporters, and/or wholesalers;
4. Drug outlets, such as drugstores, pharmacies (community, hospital or institutional); or boticas, and retail outlets for non-prescription drugs (RONPD);
5. Outlets for Medical Devices including groceries, convenience stores, and supermarkets; and
6. Clinical Research Organizations (CROs) and Sponsors
B. The scope of the 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 vaccines, biologics, veterinary medicines and animal health products, medical gases, traditional medicine, and herbal medicines;
3. Under the CDRRHR, all medical devices, radiation-emitting devices, in-vitro diagnostic device and reagents; refurbished medical devices; equipment or devices used for treating sharps, pathological and infectious waste, water treatment devices/systems; and other health-related devices as determined by the FDA; and
4. Under the CFRR, all processed food products, food supplements, raw materials, ingredients and additives for food.
This does not preclude the FDA from updating the scope of health products and establishments which requires regulation in accordance with the FDA rules and regulations.
C. 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 cosmetics and household/urban hazardous substances, including household/urban pesticides and toys and childcare articles;
5. Groceries, convenience stores and supermarkets (except for establishments which offer to sell medical devices), slaughterhouses or abattoirs, dressing plants, fish ports, wet markets, supermarkets, school canteens, fast foods, restaurants, kiosks, caterers, chandlers, and the likes; and
6. Facilities covered by the DOH One Stop Shop Licensing System.
D. The licensing of the following establishments or persons shall be governed by separate rules and regulations:
1. Salt manufacturers and distributors 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;
4. Electronic nicotine/non-nicotine delivery system (ENDS/ENNDS) and Heated Tobacco Products shall follow Department of Health (DOH) AO No. 2019-0010;
5. Operators of pest control for non-agricultural purposes shall follow DOH AO No. 2019-0010;
6. Applicators of household/urban pesticides and their training providers shall follow DOH AO No. 2019-0010; and
7. Other establishments that may not be covered under the scope and coverage such as applicability to medical devices, etc.
IV. DEFINITION OF TERMS
For the purpose of implementing this Order, the terms used shall have the meaning as defined in RA 9711, its IRR, and related laws and regulations. However, the following terms are hereby defined for greater clarity:
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 the sponsor’s trial-related duties and functions, such as supplying and importing investigational products and ancillary supplies.
C. Distributor/Importer/Exporter – refers to any establishment that imports or exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets.
D. Distributor/Wholesaler – refers to any establishment that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on a wholesale basis.
E. FDA Academy – refers to an office under the Policy and Planning Service of the FDA that offers health regulatory webinar and technical training to Stakeholders.
F. Initial Application or Original Application – refers to the LTO applied to 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.
G. 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.
H. 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, the efficacy of the products.
I. 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.
J. Packer/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.
K. Pre-licensing Inspection – refers to an inspection, which may be physical or remote, of the facility(ies), warehouses, and/or offices of an establishment, which is conducted by the FDA in relation to an initial application of a new establishment or an application for a major variation of a license.
L. Post-licensing Inspection refers to an inspection, which may be physical or remote, of the facility(ies), warehouses, and/or offices of an establishment, which is conducted by the FDA at any time during the validity of a license of an establishment.
M. 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 or discuss or clarify matters with the FDA when submitting technical requirements or engage the FDA officials when conducting inspection or post-market surveillance activities. The qualified person may also be the duly Authorized Person of the establishment.
N. Renewal Application refers to the LTO applied to FDA before the expiration of the validity of the current LTO for the 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.
O. 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).
P. Retailer – refers to any establishment which sells or offers to sell any health product directly to the general public.
Q. Risk Management Plan refers to the document that contains the details on how to identify, characterize, prevent or minimize the risk relating to the products that the establishment is engaged in. It shall include post-market surveillance activities and interventions to manage identified risks.
R. Site Master File – refers to the specific information about the quality assurance, the 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 describe those operations, e.g., analysis, packaging, for documentation.
S. Sponsor – refers to an individual, company, institution, organization or an entity which takes the responsibility for the initiation, management, and/or financing of a clinical trial.
T. Trader refers – to an establishment which is a registered owner of a health product and procures the raw materials and packing components and provides the production, monographs, quality control standards and procedures, but subcontract the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in distribution and/or marketing of its products.
U. Virtual Office refers – to an off-site business location where certain services of the establishments are provided.
V. GENERAL GUIDELINES
A. All establishments, whether public or private entity, engaged in business or operation on health products shall first secure a License to Operate (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 the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship activities.
Likewise, no CRO and Sponsor shall be involved in the conduct of clinical trials without a license from the FDA.
B. All establishments shall have a Qualified Person who has the authority to supervise the establishment during its business hours. 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.
The QP shall ensure good quality submissions, by following updated procedural guidelines, prescribed format and contents of administrative and technical documentary requirements, and through effective and efficient communications with the FDA pertaining to regulatory filings. Further, the QP shall ensure continuous compliance of his/her affiliated establishment to regulatory standards, rules, and regulations, and timely coordination in inspections and post-market surveillance activities.
C. The FDA shall have the authority to enter any FDA-licensed establishments and establishments selling FDA-regulated health products during operating hours to conduct routine or spot check inspections. It is the responsibility of the licensed establishments to immediately recall, withdraw or remove health products from the market that are banned or declared injurious, unsafe or dangerous by the FDA or products or batches of product that have been found to pose imminent danger to public health or consumer safety.
D. 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 its 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.
E. Establishments must comply to the applicable standards, including but not limited to Good Manufacturing Practices (GRP), Good Laboratory Practices, Good Clinical Practices (GCP), Good Distribution and Storage Practices (GDSP), among others, in the conduct of their licensed activity(ies).
F. 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 in banning its sale, distribution, or donation, or its immediate recall, withdrawal or seizure from the market.
G. Establishments engaged in health products declared by FDA to be injurious, unsafe, or dangerous are required to immediately recall, withdraw, seize the product, or ban its sale, distribution, or donation to the public.
H. For Drug establishments:
1. All drug establishments, including drugstores, whether privately owned or government-owned, shall be under the supervision of a registered pharmacist when operating or open for business, unless otherwise allowed by other pertinent laws or regulations.
2. 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 must be licensed as a drug distributor. All drug distributors shall not sell directly to the general public or consumer, unless they have an LTO as a drugstore.
3. 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.
4. All FDA-required information, education, and communication campaign materials shall be displayed in the establishment’s conspicuous area.
I. For Cosmetic/HUHS establishments:
1. All establishments engaged in the compounding/mixing of Cosmetic/HUHS products shall secure an LTO as Cosmetic/HUHS Manufacturer. (e.g., Customized lipstick).
2. All licensed Cosmetic/HUHS establishments with refilling activity should only be applied to a Cosmetic/HUHS manufacturer.
3. All Cosmetic/HUHS establishments applying for an initial application as a manufacturer should declare the refilling activity if applicable. On the other hand, all Cosmetic/HUHS manufacturers with existing LTO should apply a variation application to add refilling activity, if applicable.
4. Specific guidelines on the licensing and inspection of Cosmetic/HUHS Manufacturers/Refillers and establishments manufacturing customized cosmetics shall be issued through separate issuances.
J. For Food establishments:
1. All establishments shall comply with the general principles of food hygiene including the provisions provided for by Presidential Decree No. 856 on the Code of Sanitation and other general requirements.
2. As appropriate, all Food Business Operators shall comply with the relevant standards and requirements of Hazard Analysis Critical Control Point (HACCP), Sanitary Standard Operating Procedures (SSOP), and other good practice regulation and guidelines expounded in Section V.5 of this AO, to ensure safety and quality of products.
3. The LTO and CPR shall be considered as general requirements prior to the attendance on food trade and exhibitions, creation of market research, and on the testing of unregistered processed food products. For Foreign Exhibitors, joining local food expositions or exhibits may be done prior to the issuance of an LTO to their consignees provided that the sample products to be imported for exhibition shall be secured with clearance from the Bureau of Customs.
4. All establishments shall comply with food safety standards recognized by the Food and Agriculture Organization of the World Health Organization.
K. Attendance to trainings and seminars of the FDA Academy shall no longer be a requirement in the application for FDA LTO. Stakeholders may provide proof of training from other institutions offering technical courses relevant to their establishment and activity. However, stakeholders may still avail of trainings and seminars offered by the FDA Academy as provided in separate issuances.
L. This Order shall be reviewed by the FDA after three (3) years of implementation or as deemed necessary.
VI. SPECIFIC GUIDELINES
A. 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. Payment of Fees; and
e. For Manufacturers: Site Master File, Risk Management Plan, and Floor Plan
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 as shown in Annex C of this Order; and
c. Payment of Fees
Note: The transfer of location of a manufacturing plant is considered as major variation for Drug Manufacturer/Packer/Repacker and shall be applied and paid as an Initial Application for LTO
4. For Food establishments, additional requirements must be submitted for initial application including the following:
a. Franchise agreement – The business name of the establishment reflected in the LTO shall be based on the trade name indicated in the franchise agreement. In addition, this must be consistent with the business name registration.
b. Contract of agreement – A copy of the contract of agreement is recommended to be submitted for the appropriate determination of activity to be indicated in the LTO. The basis for the LTO activity shall depend on the legally binding contract agreement between the applicant and its client/supplier.
5. For manufacturers and for establishments applying for LTO or for major variations, as applicable, the following documents shall be presented to the FDA inspector for examination or review, when required:
a. Risk Management Plan (RMP) – which shall be required for medium and large food manufacturers, and all drug, cosmetics, HUHS, including household/urban pesticides (HUP) and toys and childcare articles (TCCA), medical device manufacturers, traders, and distributors (importer, exporter and/or wholesaler), among others.
b. Site Master File (SMF) – which shall be required for applicants applying for LTO as manufacturers of drugs, cosmetic, household/urban hazardous substances, including household/urban pesticides and toys and childcare articles, medical device manufacturers, and large and medium food manufacturers, among others.
All Manufacturing Establishments must ensure that the RMP and SMF documents are created and readily available at all times to provide necessary information for risk assessment matrix and manufacturing operations.
Guidance for the above requirements is attached as Annex A.
B. The procedure for application for LTO shall be as follows:
1. Filing of Applications
a. All establishments applying for initial, renewal, or variation shall submit their application through the applicable FDA online application systems as guided by the latest issuances.
Online transactions shall not be entrusted to a person who is not the duly authorized person since valid applications should be owned by the licensed establishment or the owner/President/CEO. For emphasis, consultants, liaison officers, or freelancers doing business with FDA or work on a per product registration/notification basis shall not be considered as duly authorized/qualified persons.
b. An evaluator/assessor from the concerned FDA Center shall conduct a pre-assessment on the submitted application and documentary requirements with regards to its completeness and correctness. Incomplete submission will not be accepted and the application will not proceed to the next step of the process.
The submission of an application following a successful pre-assessment does not guarantee an approved application. The evaluation of the submitted documentary requirements against existing administrative and technical standards, rules, and regulations will be conducted during the evaluation and inspection steps.
c. For applications with complete and correct documentary requirements and payment, the FDA shall issue an Acknowledgement Receipt containing the name of the employee who received the application, reference number, agency logo, the date and time of application, payment, and the statement of completeness of the documents submitted. An application is considered filed once the applicant receives the Acknowledgement Receipt.
d. All transactions with the FDA shall be communicated to the applicants using the registered e-mail address provided during the initial application. The applicant shall be responsible in making sure that the e-mail address is within the scope and access of the Authorized Person/s and/or Qualified Personnel of the establishment.
e. Application for renewal shall be done within three (3) months prior to the validity date of the LTO. Applications filed after the validity date of the LTO shall be subject to surcharge as prescribed in RA 9711 and its IRR.
f. No application for variation of LTO shall be done when an establishment has a pending application for renewal of LTO, or vice versa.
g. The applicant shall receive the LTO in their registered e-mail address and may also be accessed through the applicable FDA online application systems. Upon receipt of the LTO, the establishments shall print the LTO on a standard A4 size (21 cm x 29.7 cm) paper, on full-colored page and in portrait orientation. It shall be positioned on the most conspicuous place within the business establishments.
C. Payment
Payment of prescribed fees as indicated in the Order of Payment may be done through the FDA Cashier, Landbank of the Philippines (LBP) Over-the-Counter payment or LBP Online Payment Link.biz Portal and BANCNET online bills payment based on AO No. 50 series 2001 and its latest amendment and other existing FDA issuances. Incomplete payment will not be accepted and the application will not proceed to the next step of the process.
D. Evaluation
1. The veracity of the application and compliance with all the documentary requirements and appropriate standards shall be further assessed;
2. Any of the following or similar instances shall be a ground for disapproval:
a. The documentary requirements submitted show that the establishment does not meet the required technical requirements and/or appropriate standards;
b. The applicant made misrepresentations, false entries, or withhold any relevant data contrary to the provisions of the law or appropriate standards;
c. The owner has violated any of the terms and conditions of its license; and
d. Such other analogous grounds or causes as determined by the FDA.
3. The action on the application shall be Approval or Disapproval as provided by RA No. 11032 otherwise known as the Ease of Doing Business and Efficient Government Service Delivery Act of 2018.
4. Automatic renewal as provided for by the IRR of RA No. 11032, specifically Rule VIII. Section 1. On When Shall Automatic Approval of an Original Application or Request be Granted, shall apply; and
5. Evaluation shall be done within the prescribed working days and office hours. Applications filed after the working hours and during weekends/holidays shall be considered filed on the next working day.
E. Inspection
1. Pre-licensing inspection of the facility shall be mandatory for all Manufacturers prior to the issuance of an LTO and/or applicable variations to the LTO, wherein further verification of compliance to documentary requirements and an assessment of the compliance to applicable standards of the establishment shall be checked/audited.
2. Food, Device, and Cosmetic establishments, except manufacturing plants or facilities, shall not require pre-licensing inspection. Inspection shall be conducted after the issuance of the LTO. However, for Drug establishments, pre-licensing inspection and routine inspection are to be conducted prior to the issuance and re-issuance of the LTO.
3. All Manufacturing and Non-Manufacturing establishments shall be subject to Post-Marketing Surveillance (PMS) and post-licensing inspections respectively during the duration of the validity of the LTO to determine the satisfactory and continuous compliance of the establishments to FDA standards, rules, and regulations. The period for reinspection shall be determined by the FDA, wherein a Certificate of Compliance following a satisfactory reinspection shall be required for any coinciding application for the renewal of the LTOs of the establishments.
4. Other covered establishments shall be inspected by FDA at any time within the validity of its license as part of its post-licensing inspection and post-marketing surveillance activities. All establishments shall ensure that technical requirements must be presented during the inspection.
5. The FDA may conduct inspections in collaboration with the Local Government Units and other agencies or offices under the DOH, Department of Agriculture, and Department of Interior and Local Government or other enforcement agencies as deemed necessary based on RA 9711 and other applicable laws.
6. All Establishments with virtual offices are accepted, provided that there are physical offices to be declared where the licensed activities prior, during and after the issuance of FDA marketing authorizations are conducted. The FDA will not recognize the virtual office as the address to be reflected in all the documentary requirements when transacting with the agency. The FDA must ensure appropriate record and traceability of the physical address for the purposes of licensing, inspection, and post-marketing surveillance.
7. Guidelines outlining the parameters for inspection shall be issued through separate issuances.
F. Checking of Application Status
The status of the application may be checked or viewed by the applicant through the available FDA online application systems.
G. Releasing of LTO
The FDA shall send the approved LTO to the registered e-mail address of the applicant. The applicant may also access the approved LTO through the FDA online application systems.
H. The validity of LTOs and the applicable fees and other charges shall be covered by the latest FDA issuance.
I. An LTO may be canceled through the following:
1. Automatic cancellation if the establishment failed to file an application for renewal after one-hundred twenty (120) days from the date of expiration;
2. Upon verification of the actual status of the establishment through inspection;
3. Imposed by the FDA as a penalty, if warranted; and
4. Voluntary filing through a formal notification with the FDA.
When the license is canceled either through an inspection verification or voluntarily, the FDA shall retain jurisdiction over violations committed by the establishments while it was in operation.
VII. PENALTY CLAUSE
Sanctions over violations of any of the provisions of this Administrative Order shall follow the Rules of Administrative Procedure provided in the IRR of RA 9711.
VIII. 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 Memorandum Circular No. 15 s. 90 entitled “Exemption From the Requirement Providing One Pharmacist For Each Licensed Activity” are hereby repealed. Other issuances or part thereof, pertaining to specific guidelines for certain establishments which are found to be inconsistent with the provisions of this AO are hereby repealed accordingly.
IX. SEPARABILITY CLAUSE
If any portion or provision of this Order is declared invalid or 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.
X. EFFECTIVITY
This Administrative Order shall take effect fifteen (15) days after its publication in at least two (2) national papers of general circulation and upon filing at the Office of the National Administrative Register (ONAR) at the UP Law Center, Diliman Quezon City.