The DOH AO No. 2021-0036 entitled “Guidelines on Compliance with Section 35 (b) of Republic Act No. 11223 (Universal Health Care Act): All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Health Care Providers and Health Care Professionals”, dated 08 June 2021, directed all FDA-licensed manufacturers, traders, repackers, distributor-importers and distributor-wholesalers of drugs, medical devices and biological products, including vaccines, and medical supplies to submit their first Disclosure Report through the FDA Online Disclosure Report System by 15th of July of the current year.
On 09 July 2021, A.O. No. 2021-0036 was published in the Philippine Star and became effective on 24 July 2021. Thus, in the interest of service and to ensure compliance by all affected stakeholders, the Food and Drug Administration (FDA) shall accept disclosure reports for the 1st half of the current year (January-June 2021), until 15 September 2021. The FDA advises and directs all affected stakeholders to utilize the FDA Online Disclosure Report System at odrs.fda.gov.ph in submitting the Disclosure Report.
Notwithstanding, the deadline for submission of the Disclosure Reports covering the 2nd half of the year and thereafter, shall remain the same, following A.O. No. 2021-0036.
For any comments and suggestions on this compliance, please email them to the FDA Information and Communication Technology Management Division at [email protected].