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Selasa, Mei 7, 2024

Govt. Sets Halal Manufacturing Guidelines for Drugs, Biological Products and Medical Equipment

Pharmacies, Health Industry, and Foods & Drugs Standard

Following the mandate originally set out under Regulation of the Government No. 6 of 2023 ("Regulation 6/2023") on the Halal Certification of Drugs (excluding narcotics and psychotropics), Biological Products and Medical Equipment (collectively referred to as "Products"), the Minister of Health has decided to introduce a set of applicable guidelines for halal Product manufacturing practices ("Manufacturing Practices") and that also address the affixation of materials information to medical equipment through the issuance of Regulation No. 3 of 2024 ("Regulation 3/2024"), which has been in force since 2 April 2024.
In essence, any business actors who manufacture Products and who wish to submit applications for the halal certification of their Products must adhere to the Manufacturing Practices. In this regard, as comprehensively set out under Appendix I to Regulation 3/2024, the Manufacturing Practice guidelines outline five criteria that must be met by Products, including: 1) Commitment and responsibilities (i.e. halal policies, responsibilities of business actors and human resources); 2) Halal-compliant materials; 3) Halal-compliant manufacturing processes (i.e. separation between halal and non-halal product manufacturing sites, as well as well-documented, written procedures); 4) Products (including packaging and their traceability); and 5) Monitoring and evaluation.
Regulation 3/2024 also mandates that any medical equipment that fulfills either of the following criteria must include non-halal descriptions of material information relating to said equipment on their labeling prior to their being traded: 1) Contains haram materials; 2) Contains materials that have yet to be sourced from halal materials; and/or 3) Has not been manufactured through the application of halal manufacturing processes.
In this regard, any medical equipment that fulfills the criteria outlined in points (1) and (2) above is required to list the names of any materials used in different colors on the relevant Product composition labels. Meanwhile, any medical equipment that fulfills the criterion outlined in point (3) above is only required to bear a non-halal description that stipulates that the medical equipment in question contains halal materials for which halal certification is in the process of being secured.

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Following the mandate originally set out under Regulation of the Government No. 6 of 2023 ("Regulation 6/2023") on the Halal Certification of Drugs (excluding narcotics and psychotropics), Biological Products and Medical Equipment (collectively referred to as "Products"), the Minister of Health has decided to introduce a set of applicable guidelines for halal Product manufacturing practices ("Manufacturing Practices") and that also address the affixation of materials information to medical equipment through the issuance of Regulation No. 3 of 2024 ("Regulation 3/2024"), which has been in force since 2 April 2024.
In essence, any business actors who manufacture Products and who wish to submit applications for the halal certification of their Products must adhere to the Manufacturing Practices. In this regard, as comprehensively set out under Appendix I to Regulation 3/2024, the Manufacturing Practice guidelines outline five criteria that must be met by Products, including: 1) Commitment and responsibilities (i.e. halal policies, responsibilities of business actors and human resources); 2) Halal-compliant materials; 3) Halal-compliant manufacturing processes (i.e. separation between halal and non-halal product manufacturing sites, as well as well-documented, written procedures); 4) Products (including packaging and their traceability); and 5) Monitoring and evaluation.
Regulation 3/2024 also mandates that any medical equipment that fulfills either of the following criteria must include non-halal descriptions of material information relating to said equipment on their labeling prior to their being traded: 1) Contains haram materials; 2) Contains materials that have yet to be sourced from halal materials; and/or 3) Has not been manufactured through the application of halal manufacturing processes.
In this regard, any medical equipment that fulfills the criteria outlined in points (1) and (2) above is required to list the names of any materials used in different colors on the relevant Product composition labels. Meanwhile, any medical equipment that fulfills the criterion outlined in point (3) above is only required to bear a non-halal description that stipulates that the medical equipment in question contains halal materials for which halal certification is in the process of being secured.

......

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Precedent Hukumonline
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Semua Fitur Paket Standard
Terjemahan Peraturan
Peraturan Konsolidasi
Premium Stories
Monthly Law Review (MLR)
Indonesian Law Digest (ILD)

STANDARD

Rp 2.500.000

per bulan

Indonesian Legal Brief (ILB)
Daily Updates
Bantuan Layanan Pencarian Peraturan
Pusat Data Peraturan dan Putusan Pengadilan Non-Precedent

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