On 19 August 2024, the Department of Health of the Philippines issued Administrative Order No.2024-0012, outlining the regulations for registering pharmaceutical products and Active Pharmaceutical Ingredients (APIs) intended exclusively for export. This Order sets forth the guidelines, requirements, and procedures for the registration process of these export-only pharmaceutical products and APIs.
Eligibility Criteria
Applicant for Export-Only Authorization shall be a Holder of a valid License to Operate (LTO) issued by the FDA, while the manufacturers of the pharmaceutical products or APIs shall be holders of a valid Certificate of Good Manufacturing Practise (GMP) Compliance issued by the FDA.
All pharmaceutical products or APIs must be entirely manufactured within the country. This excludes bulk drug substances or APIs used for compounding or semi-finished pharmaceutical products that are imported for processes such as filling, packing, repacking, altering, ornamenting, finishing, or labeling.
Documentary Requirements
Manufacturers and responsible persons must ensure the availability of any or all documentary requirements during the validity of the Export-Only Registration Certificate to avoid authorization invalidation and the pharmaceutical products or APIs will be considered as unregistered, adulterated, or misbranded.
Documentary requirements covered for initial registration application, renewal application, and post-approval change(s) notification can be referred to Annex D in the Order.
Application Procedure
Only one (1) email address shall be used for applications, communications, compliances, and/or notifications and applicants must ensure the email address is unalterable to avoid any documentation loss or breach of access.
Separate registration applications are required for different manufacturers or different dosage forms and/or dosage strengths for the pharmaceutical products or APIs.
All registration applicants must undergo a pre-assessment conducted by the FDA upon submission of payment proof for the pre-assessment application fee. Applications that pass the pre-assessment will receive an order of payment for the registration application fee, along with a reference number. Unsuccessful applicants will be notified of the reasons for rejection and advised to submit a new application.
Any payment required during the registration process must be done within the stipulated time or otherwise will be considered withdrawn.
Approved applications will be granted an Export-Only Registration Certificate, while disapproved applications will receive a Letter of Disapproval (LoD).
Application & Certification Validity
The renewal of the Export-Only Registration Certificate is at the applicant’s discretion, while the certificate’s validity depends on the authorization holder maintaining a valid License to Operate (LTO) and the manufacturer holding a valid Certificate of Good Manufacturing Compliance (GMP).
Renewal application for Export-Only Authorization shall be filed by the authorization holder and automatic renewal shall be granted, if all the requirements below are met:
Renewal application is made within ninety (90) calendar days before the original validity expired
The prescribed renewal fee is paid upon filing the renewal application; and
No changes or variations established for the products
Any pharmaceutical products or APIs with a lapsed authorization may be applied only for authorization renewal within one hundred twenty (120) calendar days from the Export-Only Registration Certificate validity expired.
Reconsideration and Reapplication
Applications may file for a One-Time Request for reconsideration or reapplication of the disapproved registration applications.
Applicants may file for reconsideration within fifteen (15) calendar days after receiving a copy of the Letter of Disapproval (LOD) by specifying the findings or conclusions stipulated in the LOD. FDA shall resolve the reconsideration request within twenty (20) working days.
Applicants may file for reapplication together with the supported documents listed in the LOD and shall be filed within forty (40) working days after receiving a copy of the LOD.
Request of reconsideration or re-application would only be entertained once required fees are paid.
For more detailed information and guidelines, please refer to the original document from Philippines Food Drugs and Administration (here)
Contact us at info@arqon.com for more information.
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