With the issuance of the Food and Drug Monitoring Agency Regulation No. 10 of 2024 (hereinafter referred to as “PerBPOM 10/2024”, all business actors established and domiciled in Indonesia and who carry out business activities in the field of Products (including Product importers) are now required to comply with Product marking obligations by June 7, 2026 (24 months after PerBPOM 10/2024 is promulgated). This marking can be in the form of images, writing (must be clear, easy to read, and proportional), a combination of images and writing, or other forms in accordance with innovation and technological developments in the field of marking and Products, and must be in accordance with the distribution permit from BPOM. This marking must appear on:
- Primary packaging;
- Secondary packaging; and
- Brochures/leaflets.
Business actors who violate the provisions in PerBPOM 10/2024 will be subject to administrative sanctions in the form of:
Warning, if:
- In the findings of not implementing the full aspects of Good Traditional Medicine Manufacturing Practices (CPOTB):
i. There are more than 5 (five) major findings indicating that the quality system is not running properly; and/or
ii. There is no follow-up to the improvement letter on the inspection result from the previous technical guidance; - The findings do not implement the fulfillment of CPOTB aspects;
- On the findings of not meeting safety requirements, if there are findings of Traditional Medicines, Quasi-Medicines, and Health Supplements containing medicinal chemicals, and/or prohibited substances, and/or containing pathogenic bacteria in Distribution Facilities that are not Holders or Owners of the Distribution License Number (NIE);
- On findings of inconsistency between the composition of ingredients and those approved by the Food and Drug Administration in the distribution permit document;
- On the findings of not meeting quality requirements, if there are findings that Traditional Medicines, Quasi Medicines, and Health Supplements do not meet quality requirements;
- On the Findings of non-compliance with Marking and Advertisement, if there are repeated findings of Traditional Medicines, Quasi-Medicines, and Health Supplements not meeting the requirements;
- On Findings related to the system and implementation of Side Effect Monitoring of Traditional Medicines, Quasi Medicines, and Health Supplements;
- There are Findings of Products containing medicinal chemicals, and/or prohibited ingredients, and/or pathogenic bacteria in Production Facilities;
- There were findings of products without distribution permits; and
- Data/product falsification.
Product Recall, if there is a major or critical Finding of a Product Marking for a first-time Finding or Product Advertisement in certain Media for a first-time Finding.
Product Destruction, if it is proven that it does not meet the approved safety, efficacy/utilization, quality, Marking and Advertising requirements.
Temporary suspension of activities, if:
- Based on the risk evaluation, it is necessary to reduce the risk of safety, quality, Advertising, and Marking of certain Products by considering the compliance history of IOT, IEBA, IF, Food Industry producing Health Supplements, UKOT, or UMOT with the sanctions that have been given; and/or;
- There is no improvement to the previous sanction of a hard warning; and/or
- When applying for Registration, intentionally providing false or falsified Registration documents.
Revocation of certain types of certification (certificate of Good Manufacturing Practice of Traditional Medicine or certificate of fulfillment of aspects of Good Manufacturing Practice of Traditional Medicine, certificate of Good Manufacturing Practice of Cosmetics or certificate of fulfillment of aspects of Good Manufacturing Practice of Cosmetics and Joint facility approval letter), if:
- No significant improvement has been made when sanctioned with Temporary Suspension of Activities;
- One of the leaders and/or key personnel has been proven to have committed a criminal offense related to Traditional Medicine, Quasi Medicine, and Health Supplements and has a permanent legal decision;
- Proven to carry out production during the sanction period of Temporary Suspension of Production Activities;
- Has been sanctioned with Temporary Suspension of production activities and re-committed violations of laws and regulations; or
- Throughout the product life cycle data, it is proven that the data owned is incomplete, inconsistent and inaccurate repeatedly.
Cancellation or revocation of distribution license number, if:
- There is a finding that Traditional Medicines, Quasi-Medicines, and Health Supplements contain medicinal chemicals, and/or prohibited ingredients in the Production Facility;
- There is a third Finding of Traditional Medicines, Quasi-Medicines, and Health Supplements containing medicinal chemicals, and/or prohibited ingredients in Distribution Facilities not belonging to the Circulation License Number Owner;
- There is a critical Finding that based on Risk Management has the potential to threaten the safety of life or cause a significant risk to consumer health and/or is unlawful; and/or
Announcement to the public if there is a finding that the product contains medicinal chemicals and/or prohibited substances and/or critical findings that based on risk management have the potential to threaten the safety of life or cause significant risks to consumer health and/or are unlawful and the product’s distribution license number has been canceled.
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