Legal basis and regulatory linkage
- The Circular implements new rules and regulations on licensing of drug distributors following Administrative Order No. 2014-0034 dated 13 October 2014.
- The Circular frames coordination consistent with regulatory powers referenced under (3), c, Sec. 2, Article III, Book I of the implementing rules and regulations of Republic Act No. 9711.
- It aligns licensing evaluation with requirements on Good Distribution and Storage Practices (GDP and GSP), including cold-chain management (where applicable).
- It requires use of relevant reference materials such as Republic Acts and the World Health Organization (WHO) GDP and GSP Guide.
Policy rationale and regulatory intent
- The Circular implements updates to licensing approaches for drug establishments classified as drug distributor as importers, exporters, or wholesalers.
- The Circular is intended to update and streamline regulatory approaches, provide faster access of drug products to the public, and promote transparency.
- The Circular directs universal use of electronic transaction through the FDA’s electronic systems and forms, including electronic fillable forms.
Scope and covered licensing actions
- The Circular prescribes requirements for application for initial and renewal issuance of License to Operate (LTO) for drug distributors.
- The Circular prescribes guidelines for variations to an approved LTO.
- The Circular provides additional guidelines for reissuance of lost or destroyed LTO and voluntary cancellation through listed documentary requirements in Annex A.
- The Circular covers drug distributors carrying vaccines, biologics, and other temperature-sensitive products, where compliance with cold-chain management is required.
LTO applications: documents and submission
- Applications must include a completely filled-out and notarized application form signed by the pharmacist and the owner/authorized representative.
- Proof of business name registration must be submitted and must specify the exact and complete address (e.g., unit number, floor, building, lot, block, phase, street, barangay, city/municipality, province, where applicable).
- Proof of business name registration must be provided as follows:
- For single proprietorship: a Certificate of Business Registration issued by the Department of Trade and Industry (DTI).
- For corporation, partnership, and other juridical person: a Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation.
- For cooperative: a Certificate of Registration issued by the Cooperative Development Authority and approved by-laws.
- For government-owned or controlled corporation: a proof of business name registration governed by the provision creating such establishments (as required by law).
- Credentials of the pharmacist-in-charge for a specific activity must be submitted, including:
- Valid PRC ID.
- Certificate of Attendance to appropriate FDA Licensing Seminar.
- Resignation letter of the pharmacist from previous employer (if previously employed).
- Credentials of other qualified personnel must be listed, including the pharmacovigilance officer, and their credentials are not submitted during application for these other qualified personnel but may be verified during inspection.
- Each establishment must submit a general Risk Management Plan (RMP) containing details on how to identify, characterize, prevent, or minimize risks relating to the products engaged with, including pharmacovigilance activities and interventions.
- Each application must include a location plan consisting of a sketch showing clear directions with identified landmarks, plus Global Positioning System (GPS) Coordinates in decimal degrees (DD) [Latitude and Longitude].
- Each application must include proof of payment, such as an official receipt or authorized bank payment slip, as proof of filing.
- A Self-Assessment Toolkit (SATK) must be submitted to guide and facilitate submission and to serve as the worksheet during FDA evaluation.
- Documentary requirements for initial and renewal applications, reissuance of lost or destroyed LTO, and voluntary cancellation are attached as Annex A.
LTO evaluation and inspections
- FDA Regional Field Offices conduct an initial desktop evaluation to determine compliance with administrative and technical requirements.
- During evaluation, FDA may require additional or supplemental documents showing proof of compliance with existing regulations.
- After evaluation of the LTO application, the establishment must undergo a pre-opening inspection to determine compliance with GDP and GSP, including cold-chain management (where applicable).
- During pre-opening inspection, FDA verifies (in addition to submitted documentary requirements) the following:
- Quality Management System.
- Quality Manual and Standard Operating Procedures.
- Distributorship Agreement with foreign source/supplier/manufacturer, authenticated by the Territorial Philippine Consulate (e.g., between local importer and foreign manufacturer, local supplier and local wholesaler).
- GMP Certificates or equivalent document of contracted foreign manufacturers issued by the drug regulatory authority in the country of origin.
- Credentials of other qualified personnel.
- Proof of Ownership/Lease Agreement of the space/building occupied by the establishment.
- Relevant reference materials (e.g., Republic Acts, WHO GDP and GSP Guide, standard practice guidelines).
- FDA issues a report after inspection to serve as the basis for further decision/action, including approval/disapproval of an application for LTO and other purposes.
- Drug distributors with approved LTO are subject to routine inspection following the applicable provisions described for pre-opening inspection.
- Major variation applications may require post-licensing inspection prior to approval of the variation.
- Drug distributors subject to regulatory action triggered by violations, adverse drug reactions, or other quality/safety/efficacy issues are also subject to inspection.
Variations to an approved LTO
- A drug distributor must file for variations applicable to an approved LTO.
- Major variations include:
- Change of Ownership.
- Transfer of Location.
- Minor variations requiring prior approval include:
- Change of Activity.
- Expansion of Establishment.
- Change of Business Name.
- Zonal Change in Address.
- Minor variations requiring notification include:
- Change of the Pharmacist or other Qualified Personnel.
- Deletion of Activity.
- Transfer/Addition of Warehouse.
- FDA must be informed of any changes to the approved LTO whether or not these changes fall within the listed variation categories.
- FDA may include other changes within variations through appropriate regulation.
- Variations are subject to the applicable variation/amendment fee, except that transfer of location is subject to initial payment for two (2) years validity of LTO.
- Drug distributors applying for minor variations may continue business operations if an application for the minor variation has already been filed.
- Documentary requirements for the listed variations are attached as Annex B.
Electronic access and application forms
- FDA makes all electronic fillable forms accessible at the FDA Website.
Pharmacist coverage exemption for additional activity
- An exemption may be granted to a drug distributor pharmacist to handle retailing activity for an additional licensed activity.
- The exemption applies only if the activities sought to be licensed belong to one establishment only, meaning a single business entity with the same business name registration and ownership that may engage in more than one licensed business activity.
- The pharmacist’s activities must be confined to one office and warehouse within the same premises.
- The exemption must be reflected in the application, indicating:
- the pharmacist’s duties and responsibilities, and
- the schedule and hours of supervision for each establishment,
- signed by both the pharmacist-in-charge and the owner/authorized representative.
Responsibilities of implementing offices and LGUs
- The FDA and its Regional Field Offices, through the Director General, may call on the assistance of any department office and/or government agency to effectively implement the rules and regulations.
- Local Government Units (LGUs) are enjoined to monitor licensed drug distributors in their localities to ensure compliance with existing laws and their respective rules and regulations.
- LGUs must report violations found inconsistent with FDA rules and regulations to FDA for regulatory action.
Transitory, repealing, separability, and effectivity
- Existing licensed establishments must submit their Risk Management Plan and GPS Coordinates upon renewal of their LTO.
- Provisions of previous FDA circulars and memoranda inconsistent with FDA Circular No. 2014-026 are withdrawn, repealed, and/or revoked accordingly.
- If any part, term, or provision of the Circular is declared contrary to law or unconstitutional, the remaining provisions continue to be in force and effect.
- The Circular takes effect upon approval and signature by the FDA Director General.