Regulation Watch · Tourism and Health · Indonesia. The regulation applies nationally to holders of a marketing authorisation, conditional approval, emergency-use authorisation or special-access-scheme import approval. Its recall chain reaches pharmaceutical wholesalers and government pharmaceutical-management facilities, pharmacies, hospital and clinic pharmacies, health-centre pharmacies, drug stores, hypermarkets, supermarkets, minimarkets, independent medical or health-professional practices and, depending on risk, the public, research bodies and education institutions.
BPOM Replaces Medicine Recall and Destruction Rules
PerBPOM 12/2026 expands Indonesia's medicine-recall regime to special-access medicines, drug substances, labels and product information, with class-based reporting, public-notice and destruction duties backed by licence sanctions.
- Published
- Established in Jakarta on 30 June 2026 and promulgated on 9 July 2026 in State Bulletin 2026 No. 458. It was first recorded by Regulation Watch on 10 October 2026 as a late-discovered instrument.
- Effective
- 9 July 2026, the date of promulgation specified by Article 32. Recalls or destruction already in progress before that date continue under PerBPOM 14/2022.
- Added to Watch
- 10 October 2026
Who is affected
PT PMA and PT PMDN pharmaceutical manufacturers and marketing-authorisation holders; holders of conditional approval, emergency-use authorisation or special-access-scheme approval; importers and local representatives; pharmaceutical wholesalers and other distribution facilities; pharmacies, hospitals, clinics, health centres, retailers and independent practices; foreign manufacturers and suppliers supporting an Indonesian authorisation holder; shareholders and directors; and pharmacovigilance, quality, regulatory, supply-chain, communications, environmental and legal teams.
Practical impact
PerBPOM 12/2026 replaces the 2022 recall rule and widens the controlled perimeter beyond ordinary registered medicines. Authorisation holders must recall non-compliant medicines, including products admitted through the special-access scheme, and must cover failures involving safety, efficacy, quality, labels or approved product information. The rule establishes mandatory and voluntary recalls, three risk classes, broader recall destinations, electronic initial, periodic and final reports, compulsory public notices for class I and II recalls, destruction controls for recalled or stocked medicines and non-compliant drug substances, and evidence requirements when a third party performs destruction.
PerBPOM 12/2026 was established on 30 June 2026, promulgated on 9 July in State Bulletin 2026 No. 458 and took effect on promulgation. It revokes PerBPOM 14/2022, but a recall or destruction process already underway before the new rule took effect continues under the 2022 instrument.
The recall duty belongs principally to the Indonesian authorisation holder. That term now expressly covers a marketing-authorisation holder, including a conditional approval or EUA, and the holder of an approval to import a medicine through the special-access scheme. Recall grounds cover safety, efficacy, quality, labels and approved product information, and can apply to one, several or all Batches or Lots.
A mandatory recall begins with a written BPOM instruction, while a voluntary recall begins with the holder's own risk detection and written recall plan or initial report to BPOM. Both routes require a recall letter and are classified as class I, II or III according to health risk. The recall reach can include wholesalers, pharmacies and other healthcare facilities, drug stores and modern retailers, independent practices and the public; class III does not ordinarily extend to the public.
The reporting clocks depend on risk. The initial report is due within 1x24 hours for class I, five working days for class II and ten working days for class III. Final reports for recalls at distribution facilities are due within 10, 20 or 40 working days respectively. Where the reach includes pharmacies, other facilities or independent practices, the final deadlines are 40, 80 or 120 working days. Periodic reports must be sent whenever progress develops between the initial and final reports.
Public communication is now a defined compliance step. The holder must submit a publication plan with the initial report and, after BPOM evaluates it, publish the affected product and Batch/Lot, the reason and risk, recall reach and instructions for the public and health professionals. A class I notice is due within 1x24 hours and a class II notice within three working days after BPOM approves the publication plan, using the holder's official website and at least one other print, electronic or digital medium.
Destruction covers recalled or stocked medicines, packaging, labels and product information that fail the applicable requirements, as well as stocked drug substances that fail quality requirements and present efficacy or safety issues. The process must protect human health and the environment, be witnessed by a BPOM inspector and be recorded in a destruction report. The electronic filing must include that report and photographic or video evidence. If a third party is used, the holder must ensure complete destruction and may pre-destroy by damaging packaging and removing product identity.
The expanded rule turns traceability and recall readiness into board-level risk controls. A holder should be able to move from defect detection to classification, customer notification, electronic reporting, public communication, reconciliation and witnessed destruction without rebuilding the data set during the event. Foreign manufacturers and suppliers should ensure their Indonesian agreements provide the local holder with rapid access to investigation, batch, distribution, label and corrective-action information.
Administrative sanctions escalate from warnings and severe warnings to temporary suspension of medicine manufacture, freezing of a marketing authorisation, conditional approval or EUA, and revocation of that authorisation or approval. Investors and operators should test their recall workflow against the shortest class I clock and reconcile any case opened after 9 July 2026 to the new reporting and publication framework.
Required action
- Update the recall procedure, quality agreements and crisis plan to cover registered, conditionally approved, emergency-use and special-access medicines, plus defects in approved labels and product information as well as safety, efficacy and quality.
- Assign every recall to class I, II or III, define the distribution and public reach, issue the recall letter, and preserve BPOM's instruction or response, the risk assessment, affected Batch/Lot list, customer traceability and corrective-and-preventive-action evidence.
- Configure electronic reporting so the initial report can be filed within 1x24 hours for class I, five working days for class II or ten working days for class III, followed by progress reports whenever the status changes and a final report within the applicable reach-and-class deadline.
- Require distribution facilities to report each customer-level recall execution to the authorisation holder within five working days and to file electronic return and receipt data with BPOM under the applicable distribution rules.
- Prepare a BPOM-reviewable public notice containing product identity, affected Batch/Lot, recall reason and risk, recall reach, and instructions for the public and health professionals; publish class I notices within 1x24 hours and class II notices within three working days after BPOM approves the publication plan.
- Segregate recalled and non-compliant stock, packaging, labels, product information and affected drug substances; arrange environmentally compliant destruction witnessed by a BPOM inspector; and retain the destruction record plus photographs or video for electronic submission.
- Where a licensed third party destroys material, conduct documented oversight to confirm complete destruction, define any pre-destruction step and chain of custody, and do not treat outsourcing as transferring the authorisation holder's responsibility.
- Identify recalls and destruction actions that began before 9 July 2026 and keep those files under PerBPOM 14/2022 while applying PerBPOM 12/2026 to later cases.