Charmaine Roson - Philippines

“Veterinary products are now being overseen by the Center for Drug Regulation and Research (CDRR).”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Philippines FDA Issues New Guidance for Veterinary Products

Published on: April 8th, 2022

CDRR is Now Responsible for Oversight of Veterinary Products

On March 14, 2022, the Philippines FDA released Advisory 2022-0159 informing its stakeholders that veterinary products and medical devices will now be handled exclusively by the Center for Drug Regulation and Research (CDRR). The license to operate, product registrations, and other requirements will be based on the Center for Drugs guidance. This includes the manufacture, importation, exportation, distribution, sale, transfer, promotion, advertisement, and sponsorship of medicines, vaccines, biologicals, and medical devices used by veterinarians. These requirements are in accordance with Book I, Article VII Sec. 8 of the rules and regulations implemented by RA No. 9711 – The Food and Drug Administration Act of 2009. The Advisory can be found here.

As of the time of publishing, the CDRR has not provided a specific list of devices or a final vet medical device checklist of requirements. For more information on the medical device registration process, please see our page on the topic here.

Eligibility of Previously Approved Licenses

Applications approved previously by the Department of Agriculture-Bureau of Animal Industry (DA-BAI) will only be honored by the CDRR until September 30, 2022 as long as a new application has been submitted on or before December 31, 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 December 9, 2021.

Definitions

Non-Medicated Veterinary Product/Cosmetics

any substance or preparation intended to be placed in contact with various external parts of the animal body or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition. This excludes products applied to eyes or the teats of animals producing milk.

Veterinary Medical Device

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease, in animals or intended to affect the structure or any function of the body of animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of other animals and not dependent upon being metabolized for the achievement of any of its principal intended purposes.

Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today to see how new regulatory developments may affect your business in the Philippines.

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