QuestionsQuestions (FDA CIRCULAR NO. 2010-017)
The circular cites Department Memorandum No. 2010-0096 dated 05 May 2010 and Department Circular No. 2010-0200 dated 16 July 2010, which require uploading of all data for the Electronic Essential Drug Price Monitoring System (E-EDPMS).
All parties are enjoined to upload their data on the e-EDPMS website on or before 15 October 2010.
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.
The main compliance requirement is uploading of all data to the Electronic Essential Drug Price Monitoring System (E-EDPMS) website within the deadline stated in the circular.
Non-compliance may be meted with administrative sanctions and penalties under the Implementing Rules and Regulations (IRR) of Republic Act No. 9502.
The circular bases sanctions and penalties on the IRR of Republic Act No. 9502, also known as the Universally Accessible, Cheaper and Quality Medicines Act of 2008.
It explicitly mentions non-renewal of your License to Operate (LTO), including but not limited to this consequence.
It is an administrative issuance (FDA circular) directing regulated parties to perform a specific compliance action—uploading E-EDPMS data by a specified date—under the relevant DOH/FDA memoranda and in relation to RA 9502’s IRR.
The circular references the Electronic Essential Drug Price Monitoring System (E-EDPMS), a system used to monitor essential drug prices through electronically uploaded data.
It states that non-compliance may result in administrative sanctions and penalties, explicitly including non-renewal of the regulated entity’s LTO.
It implies an enforcement process where DOH-NCPAM and FDA will conduct nationwide joint monitoring to check implementation, which can lead to sanctions for non-compliance.
The circular is dated 04 October 2010 (Adopted: 04 October 2010), and it sets a compliance deadline of 15 October 2010.
The signatory is NAZARITA T. TACANDONG, RPH, MPA, Acting Director IV.
Yes. The circular itself enjoins uploading of all data on or before 15 October 2010 and warns of sanctions for non-compliance; lack of claimed receipt of prior memoranda would not negate the circular’s own directive.
The regulated entity should ensure complete and timely uploading of all E-EDPMS data on or before 15 October 2010 to avoid administrative sanctions under the IRR of RA 9502, including potential non-renewal of its LTO.