Jumat, Maret 24, 2023

Registrations for Quasi-Drugs Regulated

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has issued Regulation No. 7 of 2023 on Criteria and Governance for the Procedures for the Registration of Quasi-Drugs ("Regulation 7/2023"), which has been in force since 3 March 2023.
Business actors (i.e. pharmaceutical industries, traditional drugs industries, small-scale traditional drugs enterprises, micro-scale traditional drugs enterprises and cosmetics industries) are required to ensure that all produced or imported quasi-drugs that are to be circulated within Indonesia fulfill various criteria that relate to the following areas: 1) Security, efficacy and quality; and 2) Markings (penandaan). Said quasi-drugs may take the form of external; and oral medicines which have pharmacological effects that are non-systemic or local in nature.
After fulfilling the above-listed criteria for quasi-drugs, business actors are required to secure distribution permits, which can be obtained through the submission of registration applications. Said registration applications encompass the following: 1) Domestic registrations; 2) Export registrations; and 3) Import registrations.

......

Subscribe to read more legal analysis.

Hukumonline Pro Intelligence

Platform AI hukum terpercaya sebagai solusi komprehensif riset Anda

Professional Solutions

University Solutions

Pro

Rp 5.000.000 /bulan

Lihat Detail

Pro AI

Terfavorit

Rp 8.200.000 /bulan

Lihat Detail

Pro Compliance

New

Rp 12.500.000 /bulan

Lihat Detail

*Syarat dan ketentuan berlaku

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has issued Regulation No. 7 of 2023 on Criteria and Governance for the Procedures for the Registration of Quasi-Drugs ("Regulation 7/2023"), which has been in force since 3 March 2023.
Business actors (i.e. pharmaceutical industries, traditional drugs industries, small-scale traditional drugs enterprises, micro-scale traditional drugs enterprises and cosmetics industries) are required to ensure that all produced or imported quasi-drugs that are to be circulated within Indonesia fulfill various criteria that relate to the following areas: 1) Security, efficacy and quality; and 2) Markings (penandaan). Said quasi-drugs may take the form of external; and oral medicines which have pharmacological effects that are non-systemic or local in nature.
After fulfilling the above-listed criteria for quasi-drugs, business actors are required to secure distribution permits, which can be obtained through the submission of registration applications. Said registration applications encompass the following: 1) Domestic registrations; 2) Export registrations; and 3) Import registrations.

......