Question & AnswerQ&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.