In the interest of service, the FDA informs all establishments and stakeholders that the Center for Drug Regulation and Research (CDRR) regulates the manufacture, importation, exportation, distribution sale, offer for sale, transfer, promotion, advertisement, sponsorship of veterinary medicine, vaccines and biologicals pursuant Book I, Article VII Sec. 8 of the rules and regulations implementing RA No. 9711 – The Food and Drug Administration Act of 2009. In addition, other veterinary products and medical devices shall from hereon be handled exclusively by the CDRR.
Previously approved applications by the Department of Agriculture-Bureau of Animal Industry (DA-BAI) shall only be honored by this Office until 30 September 2022, provided that the same licensing and registration had been filed with this Office on or before 31 December 2021 as per FDA Circular No. 2021-025: Guidelines for Application of Authorizations at the Food and Drug Administration in the Light of Extended State of Public Health Emergency dated 09 December 2021.
The FDA does not recognize any contrary circulars and/or issuances from other government agencies inconsistent with this Advisory.
For guidance of all concerned. Dissemination of this advisory is hereby requested.