Pharmaceutical industries and pharmaceutical wholesalers are required to submit various types of reports to the Head of BPOM. These reports should be submitted online in line with the periods determined under this regulation through the official website for the reporting of the activities of pharmaceutical industries and PBF operated by the BPOM
During the formulation of cosmetics, cosmetics industries are required to implement CPKB guidelines as proven with CPKB certificates or CPKB aspect fulfillment certificates, which are issued by the Head of BPOM
In general, the various facilities outlined herein are to be granted from the January 2022 tax period until the June 2022 tax period
Holders of notifications for any cosmetics products that were advertised prior to the enforcement of Regulation 32/2021 must make the appropriate adjustments in order to bring themselves into line with provisions set out under the new regulatory framework within six months of 13 December 2021
The distribution of Vitamin D in dosages of between 1,000 IU and 4,000 IU products requires the securing of a distribution permit for special-purpose health supplements. In order to secure this type of permit, the relevant business actors (i.e. pharmaceutical industries, traditional drugs industries/small entities, importers and/or business entities operating within the health supplement distribution sector) are required to follow a registration process by first submitting a registration application to the Head of BPOM
Business actors that produce and/or import processed foods are permitted to add nutritional and non-nutritive substances to their products. Said nutritional and non-nutritive substances encompass 12 sources of nutritional substances along with their derivatives (in the form of carbohydrates, fat and protein derivatives) and 16 sources of non-nutritive substances
SAS will be implemented in order to facilitate imports of drugs and drug-related materials without the need to secure distribution permits after approvals have first been secured from either the head of the BPOM or Minister of Health
Nutritional Value Information (ING) should be affixed to products in the form of tables that set out the following information: 1) Serving size; 2) Number of servings per package; 3) Types and amounts of nutrients (e.g. energy, protein, sugar, etc.); 4) Types and amounts of non-nutritional substances; and 5) Nutritional Adequacy Rate; and 6) Footnotes
The basis for the imposition of administrative sanctions has now been expanded
Producers of processed foods are now required to secure implementation licenses for good manufacturing practices for processed foods (cara produksi pangan olahan yang baik - "CPPOB") instead of the previous CPPOB certificates, although CPPOB certificates that were issued prior to the promulgation of this new regulation will remain valid until their expiration dates