Philippine FDA New Requirements for the Licensing of Drug Distributors (as per FDA Circular 2014-026)
The FDA has released Circular 2014-026 which states the new set of guidelines on the licensing of drug distributors, following AO No. 2014-0034.
For initial LTO application, the new set of guidelines may seem similar to the old list however with new requirements such as "Risk Management Plan" (RMP) and "Self-Assessment Toolkit". Please refer to the information below for the summary of requirements:
For initial LTO application, the new set of guidelines may seem similar to the old list however with new requirements such as "Risk Management Plan" (RMP) and "Self-Assessment Toolkit". Please refer to the information below for the summary of requirements:
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| Requirements for LTO Applications |
1. Application Form - Integrated FDA application form, signed and by the pharmacist and owner.
2. Proof of Business Registration - DTI or SEC Registration Certificate
3. Credentials of Pharmacist - PRC ID, Cert. of Attendance for AO 56 seminar, resignation letter of pharmacist from previous employee (if applicable).
4. The Risk Management Plan in this sense is for the establishment. As described in the circular, "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
6. Proof of payment or receipt
7. With regard to Self-Assessment Toolkit, please download the file by using this link:
In applying for major and minor variations/changes, please refer to details below:
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| Major Variation/Changes |
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| Minor Variations/Changes requiring prior approval |
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| Minor Variations - Notification |
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