Declaration Letter

TO WHOM IT MAY CONCERN

We would like to clarify that GMP Certificates issued via the Online Single Submission

(OSS) platform remain official and legally valid certificates of the Indonesian FDA

(Badan POM).

The OSS system functions solely as a national electronic licensing platform

mandated by the Government of Indonesia to facilitate the administrative issuance of

permits and certificates. Notwithstanding the use of OSS as the delivery system, we

hereby confirm that:

● The technical evaluation, GMP assessment, inspection, and compliance

decision are fully conducted by Badan POM in accordance with applicable

regulations and GMP standards.

● The authority, responsibility, and accountability for GMP certification remain

entirely under GMP Inspectorate of Badan POM.

● The GMP Certificates issued through OSS are based on on-site inspections

and/or regulatory assessments performed by qualified GMP inspectors of

Badan POM.

● The use of OSS does not alter, delegate, or diminish the regulatory oversight

and technical control exercised by Badan POM.

Accordingly, GMP Certificates bearing issuance through OSS should be regarded as

equivalent in validity, credibility, and regulatory standing to GMP Certificates

issued through Badan POM.

This clarification is provided to support registration/GMP clearance with the relevant

regulatory authority(ies). Should further information or clarification be required, we

would be pleased to provide additional support.

We appreciate your kind attention and look forward to continued collaboration in

ensuring the quality, safety, and efficacy of medicinal products.

Jakarta, January, 19^th2026

Acting Director for Production Control of Drug,

Narcotic, Psychotropic and Precursor

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Dr. Shanti Marlina, S.Si, Apt, M.Sc.

Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik

yang diterbitkan oleh Balai Besar Sertifikasi Elektronik (BSrE), Badan Siber dan Sandi Negara (BSSN).