Business actors who fail to affix health warnings and product information to their tobacco and electronic cigarette products (collectively referred to as "Tobacco Products"), specifically to both their packaging and advertisements, may now face administrative sanctions that range from the withdrawal of tobacco products to fines and temporary bans on the advertising of tobacco products.
While maintaining the list of mandatory information that must be affixed to regular cosmetics products that features under the current regulatory frameworks, the Draft Regulation has now specified a list of information that is required to be affixed to refillable cosmetics products. Said information includes: 1) The name of the cosmetics product; 2) Detailed name and address of the relevant cosmetics refilling facility; 3) Refill date; 4) Batch number; and 5) Expiration date
Packaging labels for tobacco and electronic cigarette products (collectively referred to as Products) are to be subject to stricter requirements, particularly in terms of statements on the minimum legal age for consumers and the number of harmful chemicals that are contained within Products. Both conventional tobacco products and electronic cigarettes must comply with these updated labeling provisions.
The outsourcing of drug manufacturing can now be conducted not only by pharmaceutical industries through the securing of Guidelines for Good Manufacturing Practices for Drugs (Cara Pembuatan Obat yang Baik "CPOB") certification but also by accredited research institutions through good laboratory practice accreditation and CPOB certification. Meanwhile, the outsourcing of drug testing can be conducted by CPOB-certified pharmaceutical industry laboratories or by laboratories that have been accredited for a specific testing scope by the relevant authorities.
Flight captains and vessel captains are categorized as persons in charge of the transportation of narcotics and pharmaceutical precursors in transit and are required to report any damage to original packaging to the Head Customs and Excise Office, as follows: 1) Name; 2) Form; 3) Content; 4) Weight; 5) Quantity; and 6) Type and class of narcotics and pharmaceutical precursors.
The government has established maximum limits for the sugar, salt and fat (Garam, Gula dan Lemak GGL) content of processed foods, including ready-to-eat items. These maximum GGL levels will be determined based on risk assessments and/or international standards. Additionally, the government may impose excise taxes on certain processed foods in an effort to regulate GGL levels. Business operators involved in the production, import and/or distribution of processed foods, including ready-to-eat items, must adhere to these maximum GGL levels and ensure that the nutritional content of ready-to-eat processed foods is clearly labeled on food packaging or in information media.
By June 2026, all business actors that are established and located within Indonesia and that organize business activities within the natural material drugs (i.e. jamu, standardized herbal drugs, phytopharmaca and other natural material drugs), quasi-drugs and health supplements sector will be required to comply with the various labeling obligations that are set out under this Regulation
A total of 33 types of information are now required to be included in Product Characteristic Summaries, including: 1) The composition of drugs (names and properties of active substances); 2) Posology and method of administration; and 3) Physical and chemical incompatibilities of the Product. Meanwhile, a total of 21 types of information are now required to be included in Product Information for Patients, including: 1) Drug interactions that must be avoided when taking the drug; 2) Pregnancy and breastfeeding-related information; 3) Effects during driving and the operation of machinery; 4) Overdose and treatment options; and 5) Stability/limits of use after reconstitution or after a container has been opened
If ultimately enforced, the guidelines for the verification of analysis methods for drugs and drug materials ("Guidelines") will serve as a reference during verifications of analysis methods for drugs and drug materials (collectively referred to as "Drugs") (i.e. procedures for analysis of the identities, purities physical properties and potentials of certain Drugs)
Business actors are now required to choose electronic systems in order to distribute their Products in accordance with their respective forms of business. For example, business actors operating within the food and drug sectors are required to run their electronic systems independently or in collaboration with Electronic Systems Operators (Penyelenggara Sistem Elektronik/PSE)/Organizers of Trading Through Electronic Systems (Penyelenggara Perdagangan Melalui Sistem Elektronik/PPMSE)