{"id":1854,"date":"2026-11-13T02:20:18","date_gmt":"2026-11-13T02:20:18","guid":{"rendered":"https:\/\/dglaw.co.id\/?p=1854"},"modified":"2026-11-13T07:04:49","modified_gmt":"2026-11-13T07:04:49","slug":"panduan-perizinan-bpom","status":"publish","type":"post","link":"https:\/\/dglaw.co.id\/zh\/panduan-perizinan-bpom\/","title":{"rendered":"Perizinan BPOM: Jalur Tepat untuk Pangan, Kosmetik &#038; Obat"},"content":{"rendered":"<h2 id=\"section-1\">\u4ea7\u54c1\u5206\u7c7b\u51b3\u5b9a\u5ba1\u6279\u8def\u5f84<\/h2>\n<p>\u52a0\u5de5\u98df\u54c1\u3001\u5316\u5986\u54c1\u548c\u836f\u54c1\u4e0d\u9002\u7528\u540c\u4e00\u79cd\u5ba1\u6279\u3002\u51c6\u5907\u6587\u4ef6\u524d\uff0c\u5e94\u5ba1\u67e5\u6210\u5206\u3001\u529f\u80fd\u3001\u7528\u6cd5\u3001\u5ba3\u79f0\u3001\u4ea7\u5730\u53ca\u4ea7\u54c1\u5f62\u6001\u3002\u4f8b\u5982\uff0c\u4ee5\u5316\u5986\u54c1\u9500\u552e\u7684\u4ea7\u54c1\u82e5\u5ba3\u79f0\u6cbb\u7597\u4f5c\u7528\uff0c\u987b\u4f9d\u636e\u5206\u7c7b\u53ca\u5ba3\u79f0\u89c4\u5b9a\u8fdb\u4e00\u6b65\u6838\u67e5\u3002<\/p>\n<div class=\"dgl-table-scroll\" role=\"region\" tabindex=\"0\" aria-label=\"Tabel perbandingan\">\n<table>\n<thead>\n<tr>\n<th scope=\"col\">\u7c7b\u522b<\/th>\n<th scope=\"col\">\u4ea7\u54c1\u8def\u5f84<\/th>\n<th scope=\"col\">\u6587\u4ef6\u91cd\u70b9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u52a0\u5de5\u98df\u54c1<\/td>\n<td>\u9700\u6ce8\u518c\u7684\u56fd\u4ea7\u98df\u54c1\u9002\u7528MD\uff0c\u8fdb\u53e3\u98df\u54c1\u9002\u7528ML\uff1b\u8c41\u514d\u987b\u6309\u7c7b\u522b\u5224\u65ad\u3002<\/td>\n<td>\u6210\u5206\u3001\u751f\u4ea7\u5546\u3001\u6807\u7b7e\u3001\u5b89\u5168\u3001\u8d28\u91cf\u53ca\u4fdd\u8d28\u671f\u3002<\/td>\n<\/tr>\n<tr>\n<td>\u5316\u5986\u54c1<\/td>\n<td>\u5bf9\u7b26\u5408\u89c4\u5b9a\u7684\u4ea7\u54c1\u529e\u7406\u5316\u5986\u54c1\u901a\u62a5\u3002<\/td>\n<td>\u914d\u65b9\u3001\u76f8\u5173CPKB\uff0fGMP\u3001\u6807\u7b7e\u3001\u5ba3\u79f0\u53ca\u4ea7\u54c1\u4fe1\u606f\u6863\u6848\uff08DIP\uff09\u3002<\/td>\n<\/tr>\n<tr>\n<td>\u836f\u54c1<\/td>\n<td>\u7531\u5177\u5907\u8d44\u683c\u7684\u7533\u8bf7\u4eba\u529e\u7406\u836f\u54c1\u6ce8\u518c\u3002<\/td>\n<td>CPOB\u53ca\u76f8\u5e94\u7c7b\u522b\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7533\u62a5\u8d44\u6599\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h2 id=\"section-2\">\u8fdb\u53e3\u98df\u54c1\uff1a\u6838\u67e5\u4f01\u4e1a\u4e0e\u59d4\u6258\u65b9<\/h2>\n<p>\u51c6\u5907NIB\u3001KBLI\u3001\u8fdb\u53e3\u5546\u6216\u7ecf\u9500\u5546\u8d44\u8d28\u3001\u59d4\u6258\u65b9\u6388\u6743\u53ca\u76f8\u5173\u4ed3\u50a8\u8bbe\u65bd\u8d44\u6599\u3002\u4ea7\u54c1\u6587\u4ef6\u53ef\u80fd\u5305\u62ec\u6210\u5206\u3001\u751f\u4ea7\u5de5\u827a\u3001\u5370\u5c3c\u8bed\u6807\u7b7e\u3001\u89c4\u683c\u3001\u4fdd\u8d28\u671f\u548c\u751f\u4ea7\u5546\u6587\u4ef6\u3002SMKPO\u3001\u536b\u751f\u8bc1\u4e66\u53ca\u5176\u4ed6\u8981\u6c42\u5e94\u4f9d\u4ea7\u54c1\u7c7b\u522b\u4e0e\u73b0\u884c\u89c4\u5b9a\u6838\u5b9a\u3002<\/p>\n<h2 id=\"section-3\">\u56fd\u4ea7\u3001\u59d4\u6258\u751f\u4ea7\u53ca\u8fdb\u53e3\u5316\u5986\u54c1<\/h2>\n<p>\u786e\u8ba4\u7533\u8bf7\u4eba\u3001\u751f\u4ea7\u8bbe\u65bd\u53ca\u59d4\u6258\u751f\u4ea7\u5b89\u6392\u7b26\u5408\u8981\u6c42\u3002\u51c6\u5907\u914d\u65b9\u3001\u9002\u7528\u65b9\u6848\u4e0b\u7684CPKB\u5408\u89c4\u8bc1\u660e\u3001\u4ea7\u54c1\u4fe1\u606f\u6863\u6848\uff08DIP\uff09\u3001\u6807\u7b7e\u53ca\u5ba3\u79f0\u4f9d\u636e\u3002\u8fdb\u53e3\u4ea7\u54c1\u8fd8\u987b\u6838\u67e5\u6388\u6743\u4e66\u3001\u53ef\u63a5\u53d7\u7684GMP\u6587\u4ef6\u53ca\u9002\u7528\u7684\u81ea\u7531\u9500\u552e\u8bc1\u4e66\uff08CFS\uff09\u3002\u5883\u5916\u6587\u4ef6\u53ef\u80fd\u987b\u6309\u89c4\u5b9a\u7ffb\u8bd1\u6216\u8ba4\u8bc1\u3002<\/p>\n<h2 id=\"section-4\">\u836f\u54c1\uff1a\u7533\u8bf7\u8d44\u683c\u4e0e\u7533\u62a5\u8d44\u6599\u8981\u6c42<\/h2>\n<p>\u4e00\u822c\u8d38\u6613\u516c\u53f8\u5e76\u4e0d\u5f53\u7136\u5177\u6709\u836f\u54c1\u6ce8\u518c\u8d44\u683c\u3002\u987b\u6838\u67e5\u5236\u836f\u4f01\u4e1a\u8981\u6c42\u3001CPOB\u8bbe\u65bd\u53ca\u751f\u4ea7\u5546\u8eab\u4efd\u3002\u6309\u836f\u54c1\u7c7b\u522b\u51c6\u5907\u8d28\u91cf\u3001\u7a33\u5b9a\u6027\u3001\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u4ea7\u54c1\u4fe1\u606f\u8d44\u6599\uff0c\u5e76\u9075\u5faa\u76f8\u5e94\u9884\u6ce8\u518c\u3001\u8bc4\u5ba1\u53ca\u8865\u5145\u8d44\u6599\u7a0b\u5e8f\u3002<\/p>\n<h2 id=\"section-5\">\u4ea7\u54c1\u83b7\u6279\u540e\u4ecd\u6709\u5de5\u4f5c\u8981\u505a<\/h2>\n<p>\u4e00\u822c\u6d41\u7a0b\u5305\u62ec\u5206\u7c7b\u3001\u8bbe\u65bd\u4e0e\u7533\u8bf7\u4eba\u6838\u67e5\u3001\u8d44\u6599\u7f16\u5236\u3001\u7533\u8bf7\u3001\u7f34\u7eb3\u5b98\u65b9\u8d39\u7528\u53ca\u56de\u590d\u8bc4\u5ba1\u610f\u89c1\uff0c\u6ee1\u8db3\u8981\u6c42\u540e\u65b9\u53ef\u83b7\u6279\u3002\u8fdb\u53e3\u4ea7\u54c1\u8fd8\u987b\u6838\u67e5\u8fdb\u53e3\u8bc1\u660e\uff08SKI\uff09\u53ca\u6d77\u5173\u8981\u6c42\u3002\u4e0a\u5e02\u540e\u5e94\u6309\u7c7b\u522b\u7ba1\u7406\u53d8\u66f4\u3001\u6295\u8bc9\u3001\u53ec\u56de\u548c\u76d1\u7763\u4e49\u52a1\u3002<\/p>\n<h2 id=\"section-6\">\u6ce8\u518c\u524d\u6e05\u5355<\/h2>\n<ul>\n<li>\u4ea7\u54c1\u540d\u79f0\u3001\u7c7b\u522b\u3001\u539f\u4ea7\u5730\u3001\u751f\u4ea7\u5546\u3001\u53d8\u4f53\u6570\u91cf\u3001\u914d\u65b9\u3001\u89c4\u683c\u548c\u5ba3\u79f0\u3002<\/li>\n<li>\u7533\u8bf7\u4eba\u8d44\u8d28\u3001\u59d4\u6258\u65b9\u6587\u4ef6\u3001\u8bbe\u65bd\u6807\u51c6\u3001\u5370\u5c3c\u8bed\u6807\u7b7e\u53ca\u76f8\u5173DIP\u6216\u7533\u62a5\u8d44\u6599\u3002<\/li>\n<\/ul>\n<h2 id=\"section-7\">Pisahkan legalitas pendaftar, fasilitas dan produk<\/h2>\n<div class=\"dgl-table-scroll\" role=\"region\" tabindex=\"0\" aria-label=\"Tabel panduan\">\n<table>\n<thead>\n<tr>\n<th scope=\"col\">\u7c7b\u522b<\/th>\n<th scope=\"col\">Kesiapan fasilitas \/ pemohon<\/th>\n<th scope=\"col\">Berkas produk<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u52a0\u5de5\u98df\u54c1<\/td>\n<td>Legalitas produsen\/importir; CPPOB atau standar sarana distribusi\/SMKPO sesuai kewajiban.<\/td>\n<td>Komposisi, proses, masa simpan, label, dokumen produsen dan data uji yang diperlukan.<\/td>\n<\/tr>\n<tr>\n<td>\u5316\u5986\u54c1<\/td>\n<td>Industri, importir atau pemohon yang memenuhi ketentuan; CPKB\/aspek CPKB dan hubungan maklon bila relevan.<\/td>\n<td>Formula, spesifikasi, label\/klaim, DIP dan dokumen prinsipal untuk produk impor.<\/td>\n<\/tr>\n<tr>\n<td>\u836f\u54c1<\/td>\n<td>Pendaftar yang memenuhi kewenangan industri farmasi; pemenuhan CPOB dan ketentuan impor bila relevan.<\/td>\n<td>Dossier mutu, keamanan, khasiat, stabilitas, informasi produk dan data tambahan sesuai kategori.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h2 id=\"section-8\">Alur registrasi yang dapat dipersiapkan<\/h2>\n<ul>\n<li>Tentukan klasifikasi dan klaim produk; jangan memilih jalur hanya berdasarkan bentuk kemasan.<\/li>\n<li>Verifikasi pemohon, sarana, penanggung jawab dan dokumen hubungan dengan produsen\/prinsipal.<\/li>\n<li>Susun data produk serta label bahasa Indonesia sesuai ketentuan.<\/li>\n<li>Ajukan melalui sistem yang tepat, penuhi PNBP dan tanggapi evaluasi dengan dokumen yang konsisten.<\/li>\n<li>Setelah disetujui, penuhi kewajiban pemasukan, distribusi, perubahan data dan pengawasan pascapemasaran.<\/li>\n<\/ul>\n<h2 id=\"section-9\">Kesalahan yang sering menghambat evaluasi<\/h2>\n<p>Contohnya KBLI tidak sesuai, surat penunjukan tidak mencakup produk yang dimohon, formula berbeda antarberkas, klaim melampaui kategori, bahan dilarang\/dibatasi, label keliru atau fasilitas belum memenuhi standar. Perbaikan dokumen dan kesiapan sarana perlu berjalan beriringan.<\/p>\n<p>Untuk obat impor, perusahaan perdagangan umum tidak otomatis berhak menjadi pendaftar. Untuk kosmetik, notifikasi produk berbeda dari sertifikasi fasilitas. Untuk pangan, jalur SPP-IRT hanya digunakan bila produk dan kegiatan memenuhi kriterianya.<\/p>\n<h2 id=\"section-10\">Checklist penapisan produk<\/h2>\n<div class=\"dgl-prep-list\"><label><input type=\"checkbox\"><span>Nama\/merek, kategori, negara asal dan produsen.<\/span><\/label><label><input type=\"checkbox\"><span>Produksi sendiri, maklon atau impor; jumlah varian\/SKU.<\/span><\/label><label><input type=\"checkbox\"><span>NIB\/KBLI serta dokumen sarana yang relevan.<\/span><\/label><label><input type=\"checkbox\"><span>Formula, spesifikasi, klaim dan rancangan label.<\/span><\/label><label><input type=\"checkbox\"><span>Surat prinsipal, CFS\/health certificate bila diperlukan.<\/span><\/label><label><input type=\"checkbox\"><span>DIP kosmetik atau dossier obat serta data uji sesuai kategori.<\/span><\/label><\/div>\n<p><small>Checklist ini dapat digunakan saat membaca atau dicetak. Pilihan tidak dikirim dan tidak disimpan oleh halaman ini.<\/small><\/p>\n<h2 id=\"section-11\">Pertanyaan yang sering diajukan<\/h2>\n<details class=\"dgl-guide-faq\">\n<summary>Apakah satu izin dapat dipakai untuk seluruh varian?<\/summary>\n<p>Cakupan produk dan perubahan yang dapat diajukan bergantung pada kategori serta ketentuan registrasi. Periksa komposisi, merek, produsen dan varian sebelum mengelompokkan permohonan.<\/p>\n<\/details>\n<details class=\"dgl-guide-faq\">\n<summary>Apakah izin edar menyelesaikan semua persyaratan impor?<\/summary>\n<p>Tidak. Periksa SKI, kepabeanan dan persyaratan sektoral lain pada setiap pemasukan yang relevan.<\/p>\n<\/details>","protected":false},"excerpt":{"rendered":"<p>\u533a\u5206\u4f01\u4e1a\u8d44\u8d28\u3001\u8bbe\u65bd\u6807\u51c6\u53ca\u4ea7\u54c1\u6279\u51c6\uff0c\u6309\u6b63\u786e\u8def\u5f84\u51c6\u5907BPOM\u7533\u8bf7\u3002<\/p>","protected":false},"author":1,"featured_media":1893,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[74],"tags":[],"class_list":["post-1854","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-produk-sertifikasi"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Perizinan BPOM: Jalur Tepat untuk Pangan, Kosmetik &amp; 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