Persetujuan Pelaksanaan Uji Praklinik Obat Tradisional
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Plain-English explanation of this sector permit and when a business needs it.
Approval for the Implementation of Preclinical Trials for Traditional Medicine is a Perizinan Berusaha Untuk Menunjang Kegiatan Usaha (PB UMKU) — a sector-specific business permit issued by Food and Drug Supervisory Agency under Indonesia's Medicine and Food regulatory regime. PB UMKU sit on top of the foundational NIB (Nomor Induk Berusaha): the NIB lets you exist as a business and operate a KBLI activity at its risk-based scale, while a PB UMKU authorises a specific regulated function, output, or facility within that activity.
Whether your business needs this permit depends on the specific KBLI activity you operate, the products or services you produce, and the scale of operations. The issuing ministry sets eligibility, application requirements, and validity terms — review the official OSS portal (oss.go.id) for the current procedure, or engage a licensed business-services provider to handle the filing end-to-end.
2 application requirements the regulator wants to see at submission. Emerhub assembles and files the bundle on your behalf.
Source: OSS — kbli.co.id surfaces them here so you know what we'll need to gather from you. The actual filing is handled by Emerhub.
2 obligations that continue throughout the life of the permit — periodic reports, recordkeeping, technical compliance.
Lapsed obligations can trigger NIB suspension. Emerhub manages the filing calendar end-to-end as part of monthly compliance.
Indonesia's risk-based OSS licensing process — and where this PB UMKU sits within it.
Foreign investors incorporate a PT PMA (Perseroan Terbatas Penanaman Modal Asing); domestic investors use a PT lokal or PT Perorangan. The Articles of Association are drafted before a notary and registered with Kemenkumham (Ministry of Law & Human Rights).
File the OSS application with your KBLI codes and risk-based scale. The system issues an NIB (Nomor Induk Berusaha) — your foundational business identifier. For low-risk activities, the NIB alone is sufficient to begin operations.
Submit the PB UMKU application through OSS, addressed to Food and Drug Supervisory Agency. Required supporting documents and processing time are set by the ministry; expect technical review, possible site inspection, and clarification rounds before issuance.
Emerhub is a licensed corporate-services provider in Indonesia. We handle PT PMA and PT lokal incorporation, OSS NIB application, and sector-specific PB UMKU filings — including Approval for the Implementation of Preclinical Trials for Traditional Medicine via Food and Drug Supervisory Agency. Get an exact quote and timeline scoped to your specific business.
Once issued, comply with the permit's ongoing obligations: periodic reporting, renewal applications, and any sector-specific monitoring (e.g. quarterly LKPM filings for PMA, annual technical reports for regulated industries). Lapsed PB UMKU can trigger NIB suspension.