Pharmaceutical industries that utilize 2D barcodes through the use of the authentication method are required to implement the aggregation system within one year of the promulgation of this Regulation. Furthermore, any 2D barcodes that use the identification method and that were issued prior to the enforcement of this Regulation may still be utilized, provided that the relevant distribution licenses remain valid

Drugs that that are found to not meet the applicable Standards will now be subject to the imposition of administrative sanctions by the Head of the BPOM in accordance with the relevant laws and regulations

Cosmetics businesses that hold notification numbers and that own several production facilities or those that have entered into production contracts with other cosmetics businesses within the territory of Indonesia can be granted distribution permits through the issuance of single notification numbers. The issuance of said notification numbers should be implemented based on the following provisions: 1) Electronic applications that are submitted by cosmetic businesses that are already holders of notification numbers; 2) Notification numbers should be issued to cosmetics businesses that have already secured certificates of Good Cosmetics Manufacturing Practices (Cara Pembuatan Kosmetika yang Baik/CPKB)

The BPOM is currently soliciting inputs on the subject of the Draft Regulation until a deadline of 14 October 2022. Said inputs may be submitted via the following email address: [email protected] by downloading the format available at: https://sites.google.com/view/konblikrevperbpomregpo

All healthcare service facilities (e.g. hospitals, drug dispensaries, clinics, etc.), including facilities that offer telemedicine services, are now obliged to store electronic medical records, which should be provided for patients commencing from the time of their admission and extending until they leave, are referred or pass away

Any health supplement claims which were affixed to packaging before 8 August 2022 should now be brought into line with the claim guidelines addressed under this new Regulation before 8 August 2024

Legal entities that have secured certain permits to undertake the processing, multiplication, differentiation and storage of cell-based products and human tissues that are to be used for the provision of healthcare services and clinical testing should apply guidelines on good drug manufacturing practices (CPOB) whenever engaging in the manufacture of said products

Calculations of TKDN value should be completed based on the accumulation of domestic components (Komponen Dalam Negeri) which represent the relevant production costs that are incurred during the production of one single product unit. Said production costs encompass: 1) Manufacturing aspect with a weight of 80% of the relevant TKDN value; and 2) Development aspect with a weight of 20% of the relevant TKDN value

Holders of licenses/approvals to circulate drugs (including Emergency Use Authorizations and/or approvals for the importation of drugs under special access schemes) within the territory of Indonesia are required to recall any drugs that do not meet safety, efficacy, quality and labeling standards and/or requirements. Said license holders also required to destroy such drugs in ways that present no threat to human health and that do not result in any environmental pollution

Determines a comprehensive set of guidelines for Good Drug Manufacturing Practices (CPOB) that apply to hospitals that manufacture finished drugs. Said finished drugs do not include biological products but do encompass total or partial processing (from the receipt of materials until the packaging stage) as implemented by pharmaceutical installations in hospitals and facilities that undertake the manufacture of radiopharmaceutical provisions