QuestionsQuestions (FDA Circular No. 2014-026)
It was issued to (1) update and streamline regulatory approaches in licensing drug establishments, (2) promote faster access of drug products to the public, and (3) enhance transparency through universal electronic transactions, in line with Administrative Order No. 2014-0034.
To obtain initial issuance, renewal, and approval of licensing for drug distributors classified as importers, exporters, or wholesalers, including compliance with documentary and technical requirements such as GDP/GSP (and cold-chain when applicable).
The application form must be completely filled out and notarized; it must be signed by the pharmacist and the owner/authorized representative.
A valid Certificate of Business Registration issued by the Department of Trade and Industry (DTI), and it must specify the exact and complete address.
A Certificate of Registration issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporation (or equivalent foundational documents), with the exact and complete address specified.
A Certificate of Registration issued by the Cooperative Development Authority, approved by-laws, and with the exact complete address.
A law highlighting the provision creating such establishments, since the Circular requires proof of business name registration appropriate to the establishment type.
A valid PRC ID, a Certificate of Attendance to the appropriate FDA Licensing Seminar, and a resignation letter from the previous employer (if previously employed).
No. Other qualified personnel (e.g., pharmacovigilance officer) must be listed, but their credentials generally are not submitted during application; they may be verified during inspection.
A general RMP for the establishment that details how the establishment identifies, characterizes, prevents or minimizes risks related to products they engage with, including pharmacovigilance activities and interventions to manage risks.
A sketch of the establishment’s location indicating clear directions and identified landmarks for inspection purposes, including GPS coordinates in decimal degrees (latitude and longitude).
A Self-Assessment Toolkit must be submitted to guide and facilitate submission and to serve as the worksheet during FDA evaluation of the LTO application.
It conducts desktop evaluation through the respective FDA Regional Field Offices to determine compliance with administrative and technical requirements. FDA may require additional or supplemental documents to prove compliance.
After desktop evaluation, a pre-opening inspection is conducted to verify compliance with Good Distribution and Storage Practices (GDP and GSP), including cold-chain management where applicable.
Examples include the Quality Management System (Quality Manual and SOPs), distributorship agreement authenticated by the Philippine consulate, GMP certificates or equivalent of contracted foreign manufacturers, credentials of other qualified personnel, proof of ownership/lease of space, and relevant reference materials such as RA and WHO GDP/GSP guides.
Routine inspections for those with approved LTO; major variation applications may require post-licensing inspection; and additional inspections may occur when triggers arise such as violations of FDA laws/rules, adverse drug reactions, or other quality/safety/efficacy issues.
(a) Change of ownership = Major Variation. (b) Transfer of location = Major Variation. (c) Change of business name = Minor Variation requiring prior approval.
When (1) the activities sought belong to one establishment only (single business entity with the same business name registration and ownership), and (2) the activities handled are confined to one office and one warehouse within the same premises. The application must note the pharmacist’s duties/responsibilities and schedule of supervision for each establishment.
Under the transitory provisions, existing licensed establishments must submit their Risk Management Plan and GPS coordinates upon renewal of their LTO.