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Philippines Adopts New License to Operate Format

Jun 12, 2016
Angelita Hu
On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. The new mandatory format requirement is a supplement to the Order No. 2016-003 “Guidelines on the Unified Licensing Requirements and Procedures” (See CL news on May 6 2016).

On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. The new format requirement is a supplement to the Order No. 2016-003 “Guidelines on the Unified Licensing Requirements and Procedures” (See CL news on May 6 2016).

The new LTO includes two pages:

Content

Information

First Page
  1. Type of application
  2. Primary activity
  3. Name of establishment
  4. Address of the establishment
  5. Name of owner
  6. LTO numbers and validity
  7. Payment details (date and amount)

Second Page

(should be made readily available upon request by stakeholders)
  1. For drugs manufacturers, list of key personnel in accordance with GMP
  2. Additional activity (when applicable)

The new LTO will be issued after establishments apply for modification of any information on the license, regardless of the validity.

Tags : PhilippinesPre-market Approval
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