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The Department of Health and the Food and Drug Administration issued new guidelines simplifying the export process for pharmaceutical products and active pharmaceutical ingredients (APIs)
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DOH Administrative Order No. 2024-0012 prescribes the rules on the registration of pharmaceutical products and APIs intended solely for exports
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As a transitory provision, all current Certificate of Product Registration holders of pharmaceutical products for export-only approved under previous guidelines will be valid until expiration
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Manual application will be implemented until full implementation of digital platforms
The Department of Health (DOH) and the Food and Drug Administration (FDA) have issued new guidelines simplifying the export process for pharmaceutical products and active pharmaceutical ingredients (API).
DOH Administrative Order (AO) No. 2024-0012, signed by Health Secretary Teodoro Herbosa, prescribes rules on the registration of pharmaceutical products and APIs wholly manufactured in the country and intended solely for exports. The AO, dated August 19, was published on October 9 and took effect on October 24.
The order covers FDA-licensed manufacturers and traders with a corresponding authorization for exportation of pharmaceutical products and APIs. It does not apply to the following:
- pharmaceutical products and APIs for local distribution, sale, offer for sale, transfer, promotion, advertising, or sponsorship
- pharmaceutical products and APIs manufactured abroad and subsequently imported for re-exportation.
- pharmaceutical products for investigational use, clinical trials, product development, and/or research, samples for registration, and products for personal use
- pharmaceutical products intended for export to Association of Southeast Asian Nations members or other countries requiring registration for FDA marketing authorization for local sale
Under the AO, only holders of a valid license to operate issued by FDA can apply for export-only authorization. The manufacturer of the pharmaceutical product or API should also be a holder of a valid Certificate of Good Manufacturing Practice Compliance issued by the FDA. Further, the pharmaceutical product or API should be wholly manufactured in the country.
The validity of export-only registration certificate is six years for the initial application, and six or 12 years for renewal.
In case of a declared public health emergency in the country or in anticipation of an actual critical shortage of pharmaceutical product or API covered in AO 2024-0012, which may affect the country’s pharmaceutical supply and healthcare system, local manufacturers and traders of such products shall prioritize the country’s pharmaceutical supply needs.
As a transitory provision, all current Certificate of Product Registration holders of pharmaceutical products for export-only approved under previous guidelines will be valid until expiration. Renewal applications, however, should be applied and covered by rules under AO 2024-0012.
All pending applications that qualify for export-only authorization, and which were received on or before the effectivity of AO 2024-0012, if so desired shall submit the additional requirement/s as required in the order.
FDA in an advisory also said that to facilitate compliance with the AO, manual application will be implemented until the full implementation of digital platforms.
Eligible applicants should submit application to the FDA Food and Drug Action Center following FDA Circular No. 2020-026. All forms can be downloaded from the FDA website.
The FDA said AO 2024-0012 complies with President Ferdinand Marcos, Jr.’s directive during a sectoral meeting last February to strengthen the country’s healthcare system and make quality medicine accessible to the public.
The AO is aligned with Executive Order (EO) No. 175 series 1987 (amending Republic Act [RA] No. 3720, or the Food, Drug, and Cosmetic Act), which was further amended by RA No. 9711 (Strengthening of the FDA Act of 2009), which prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product (which includes drugs) that is adulterated or misbranded or the adulteration or misbranding of any health product.
It is also aligned with policies adopted under RA 11981 (Tatak Pinoy [Proudly Filipino] Act), with emphasis on the policy of promoting and safeguarding the quality of Philippine products and services in both the domestic and global markets as means for encouraging economic growth and consumer and business confidence in Philippine industries. – Roumina Pablo
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