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2021
Peraturan Badan Pengawas Obat dan Makanan NO. 2, BN.2021/No. 85, peraturan.go.id : 19 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Pengawasan Periklanan Obat
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 03 Februari 2021. \n \n

","regulatory_relationship","Peraturan ini mencabut:\n1. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.05.3.02706 Tahun 2002 tentang Promosi Obat sepanjang mengatur Iklan\n2. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.05.4.0155 Tahun 2003 tentang Penandaan Khusus dan Periklanan Obat Diare sepanjang mengatur Iklan\n3. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 8 Tahun 2017 tentang Pedoman Pengawasan Periklanan Obat (Berita Negara Republik Indonesia Tahun 2017 Nomor 769)","scope_and_parties","","policy_content","

Peraturan ini bertujuan untuk melindungi masyarakat dari informasi iklan obat yang tidak objektif, tidak lengkap, dan menyesatkan. BPOM memiliki fungsi pengawasan sebelum dan selama obat beredar. Peraturan ini menggantikan peraturan sebelumnya yang sudah tidak sesuai dengan perkembangan ilmu pengetahuan dan teknologi. Kebijakan ini mengatur kewajiban persetujuan izin edar sebelum obat diiklankan, kriteria dan persyaratan iklan, serta media publikasi yang diperbolehkan. Iklan harus menggunakan bahasa Indonesia, dan dalam kondisi tertentu dapat menggunakan bahasa asing atau daerah. Pengawasan dilakukan oleh BPOM, dan masyarakat dapat berpartisipasi dalam pengawasan iklan. Pelanggaran terhadap peraturan ini dapat dikenai sanksi administratif.

","transitional_provisions","1. Permohonan persetujuan Iklan yang telah diajukan sebelum berlakunya Peraturan Badan ini tetap diproses berdasarkan ketentuan:\n a. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.05.4.0155 Tahun 2003 tentang Penandaan Khusus dan Periklanan Obat Diare; dan/atau\n b. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 8 Tahun 2017 tentang Pedoman Pengawasan Periklanan Obat.\n2. Persetujuan Iklan yang diterbitkan berdasarkan ketentuan sebagaimana dimaksud pada ayat (1), dinyatakan masih tetap berlaku sampai dengan berakhirnya masa berlaku izin edar Obat yang diiklankan.","sanctions","1. Pelanggaran terhadap ketentuan dalam Pasal 2, Pasal 3 ayat (2), Pasal 4, Pasal 5 ayat (1), Pasal 6 ayat (1), Pasal 8, Pasal 9, Pasal 10, Pasal 20 dan/atau Pasal 24 dikenai sanksi administratif berupa:\n a. peringatan;\n b. peringatan keras;\n c. penghentian sementara kegiatan Iklan;\n d. pembekuan izin edar; dan/atau\n e. pencabutan izin edar.","revokes","revoked_by","partially_revokes","partially_revoked_by","amends","amended_by","partially_amends","partially_amended_by","establishes","established_by","constitutional_review","is_verified",false,"english_excerpt","\n

STATE GAZETTE
REPUBLIC OF INDONESIA

No. 85, 2021
BPOM. Supervision. Drug Advertising. Guidelines.

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 2 OF 2021
REGARDING
GUIDELINES FOR SUPERVISION OF DRUG ADVERTISING

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n \n \n \n \n \n \n

Considering:

that the public needs to be protected from information that is not objective, incomplete, and misleading in drug advertisements;
that based on the provisions of Article 3 paragraph (1) letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency, the Food and Drug Control Agency has the function of carrying out pre-market supervision and post-market supervision;
that the provisions regarding drug advertising supervision as regulated in the Regulation of the Head of the Food and Drug Control Agency Number 8 of 2017 concerning Guidelines for Drug Advertising Supervision, are no longer in accordance with legal needs and the development of science and technology in the field of drugs so it needs to be replaced;
that based on the considerations as referred to in letters a, b, and c, it is necessary to stipulate a Regulation of the Food and Drug Control Agency concerning Guidelines for Drug Advertising Supervision;

In view of:

Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency (State Gazette of the Republic of Indonesia of 2017 Number 180);
Regulation of the Food and Drug Control Agency Number 21 of 2020 concerning the Organization and Working Procedures of the Food and Drug Control Agency (State Gazette of the Republic of Indonesia of 2020 Number 1002);
Regulation of the Food and Drug Control Agency Number 22 of 2020 concerning the Organization and Working Procedures of Technical Implementation Units within the Food and Drug Control Agency (State Gazette of the Republic of Indonesia of 2020 Number 1003);

DECIDES:

\n\n \n \n \n \n \n \n

To stipulate:

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY CONCERNING GUIDELINES FOR SUPERVISION OF DRUG ADVERTISING.

\n","pdf_url","/proxy/pdf?id=d3032a6e-3765-4d7b-9c62-0a353a9eff5a","actionData","errors"]