Title
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.
A

Q&A (FDA CIRCULAR NO. 2010-017)

The main purpose is to require the uploading of all data for the electronic Essential Drug Price Monitoring System (E-EDPMS) to ensure monitoring of drug prices.

All concerned parties must upload their data on or before October 15, 2010.

The Department of Health (DOH)-National Center for Pharmaceutical Access and Management (NCPAM) and the Food and Drug Administration (FDA) are responsible.

Republic Act No. 9502, also known as the Universally Accessible, Cheaper, and Quality Medicines Act of 2008, including its Implementing Rules and Regulations (IRR).

Non-compliance may result in administrative sanctions and penalties such as the non-renewal of the License to Operate (LTO).

The License to Operate (LTO) is a mandatory license for drug establishments, and failure to comply with data uploading requirements can lead to non-renewal of the LTO, effectively halting operations.

The E-EDPMS is designed to electronically collect and monitor drug price data to promote accessibility to affordable medicines.

The Implementing Rules and Regulations (IRR) of Republic Act No. 9502 authorize the imposition of administrative sanctions for non-compliance.


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