(NAR) VOL. 26 NO. 1/ JANUARY - MARCH 2015
1) | Application Form | |
A completely filled-out and notarized application form signed by the pharmacist and owner/authorized representative must be submitted. | ||
2) | Proof of Business Name Registration | |
A valid proof of business name registration must be submitted: | ||
(a) | For single proprietorship - Certificate of Business Registration issued by the Department of Trade and Industry (DTI) | |
(b) | For corporation, partnership and other juridical person - Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation | |
(c) | For cooperative – Certificate of Registration issued by the Cooperative Development Authority and the approved by-laws | |
(d) | For government-owned or controlled corporation – the law highlighting the provision creating such establishments. | |
The proof of business name registration must specify the exact and complete address, e.g., unit number, floor, building, lot, block, phase, street, barangay, city/municipality, province, where applicable. | ||
3) | Credentials of the Pharmacist and Other Qualified Personnel | |
The credentials of the identified pharmacist-in-charge for a specific activity shall be submitted, which include: | ||
(a) | Valid PRC ID | |
(b) | Certificate of Attendance to appropriate FDA Licensing Seminar | |
(c) | Resignation letter of the pharmacist from previous employer (if previously employed). | |
The other qualified personnel shall be listed, which include the pharmacovigilance officer, among others. The credentials will not be submitted during application for these other qualified personnel but may be verified during inspection. | ||
4) | Risk Management Plan | |
A general Risk Management Plan (RMP) for the establishment must be submitted. The RMP shall contain details on how to identify, characterize, prevent or minimize risk relating to the products they engage with. These shall include pharmacovigilance activities and interventions of the establishment to manage the risks. | ||
5) | Location Plan | |
A sketch of the location of the establishment must be submitted which shall be used for inspection purposes. This sketch must indicate clear directions with identified landmarks to locate the establishment. | ||
In addition, the Global Positioning System (GPS) Coordinates in decimal degrees (DD) [Latitude and Longitude] must be indicated in the submission. | ||
6) | Proof of Payment | |
Proof of payment (e.g., official receipt or authorized bank payment slip) shall be included as proof of filing of application. | ||
7) | Self-assessment Toolkit | |
To guide and facilitate the submission, a Self-Assessment Toolkit (SATK) must be submitted, which will also serve as the worksheet during evaluation of FDA. | ||
The list of documentary requirements for initial and renewal applications of LTO, reissuance of lost or destroyed LTO, as well as voluntary cancellation is attached as Annex A[*]. |
1) | Desktop Evaluation |
All applications shall be initially reviewed by the respective FDA Regional Field Offices to determine compliance with the administrative and technical requirements. | |
The FDA, in the course of its evaluation may require additional or supplemental documents that will show proof of compliance to the existing regulations. | |
2) | Pre-opening Inspection |
After evaluation of the LTO application, the establishment shall be subjected to pre-opening inspection to determine compliance with the existing guidelines on Good Distribution and Storage Practices (GDP and GSP) including cold-chain management (where applicable). | |
In addition to the documentary requirements submitted during application (Section II, A of this Circular), the following documents shall be verified during inspection: | |
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The abovementioned additional documents will serve as proof of compliance by the establishment with the existing regulations on licensing. | |
A report shall be issued to the drug establishment after inspection, which shall be the basis for further decision/action of FDA (e.g., approval/ disapproval of an application for LTO, and/or for such other purposes). | |
Compliance with cold-chain management is also required for drug distributors carrying vaccines, biologics, and other temperature-sensitive products. |
1) | Major Variation | |
(a) | Change of Ownership | |
(b) | Transfer of Location | |
2) | Minor Variation – Prior Approval | |
(a) | Change of Activity | |
(b) | Expansion of Establishment | |
(c) | Change of Business Name | |
(d) | Zonal Change in Address | |
3) | Minor Variation –Notification | |
(a) | Change of the Pharmacist or other Qualified Personnel | |
(b) | Deletion of Activity | |
(c) | Transfer/Addition of Warehouse |
1) | The activities sought to be licensed belong to one establishment only; establishment herein shall refer to a single business entity with the same business name registration and ownership who may engage in more than one licensed business activity; |
2) | The activities to be handled by the pharmacist are confined only in one office and warehouse within the same premises. |