E-EDPMS Data Upload Compliance

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Title Supreme Court: E-EDPMS Data Upload Compliance

Law: Fda Circular No. 2010-017

Decision Date: Oct 4, 2010

The Department of Health and the Food and Drug Administration mandate the uploading of data to the Electronic Essential Drug Price Monitoring System by October 15, 2010, with non-compliance resulting in administrative penalties, including potential non-renewal of licenses under the Universally Accessible, Cheaper and Quality Medicines Act.

administrative law

drug regulation

Legal basis and related DOH actions

FDA Circular No. 2010-017 enjoins compliance with Department Memorandum No. 2010-0096 dated 05 May 2010.
FDA Circular No. 2010-017 enjoins compliance with Department Circular No. 2010-0200 dated 16 July 2010.
The circular ties enforcement and sanctions to the Implementing Rules and Regulations (IRR) of Republic Act No. 9502 (the Universally Accessible, Cheaper and Quality Medicines Act of 2008).

Coverage: data upload obligation

All concerned entities are required to upload all data for the Electronic Essential Drug Price Monitoring System (E-EDPMS).
The obligation applies to all data needed for E-EDPMS, not partial or selective uploads.

Deadline and place of compliance

Entities must upload their data in the e-EDPMS website.
The uploading must be completed on or before 15 October 2010.

Monitoring and verification

The Department of Health (DOH)-National Center for Pharmaceutical Access and Management (NCPAM) and the Food and Drug Administration (FDA) will conduct a nationwide joint monitoring.
Monitoring targets compliance with the implementation of the E-EDPMS data-upload requirement.

Administrative sanctions and license consequence

Non-compliance with the circular’s data-upload requirement will be met with administrative sanctions and penalties.
The administrative sanctions and penalties are those imposed under the IRR of Republic Act No. 9502.
The circular recognizes non-renewal of the License to Operate (LTO) as an example of an administrative consequence for non-compliance.

END