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

Type of application
Primary activity
Name of establishment
Address of the establishment
Name of owner
LTO numbers and validity
Payment details (date and amount)

Second Page

(should be made readily available upon request by stakeholders)

For drugs manufacturers, list of key personnel in accordance with GMP
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 : Philippines Pre-market Approval

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Angelita Hu
ChemLinked Content Manager

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