Pharmaceutical preparations are drugs, medicinal materials, traditional medicines and cosmetics.

Medicine is a substance or combination of substances, including biological products, used to affect or investigate a physiological system or a state of pathology in order to establish diagnosis, prevention, cure, recovery, health promotion and contracepti

Traditional medicine is a material or combination of materials in the form of plant materials, animal materials, mineral materials, galenic preparations, or a mixture of these materials that have been used for generations for treatment, and can be applied

Medical devices are instruments, apparatus, machines and/or implants that do not contain drugs used to prevent, diagnose, cure and alleviate diseases, treat the sick, restore health in humans, and/or form structures and improve body functions.

Household Health Supplies, hereinafter abbreviated as PKRT is a device, material, or mixture of materials for the maintenance and care for human health, which is intended for use in households and public facilities.

Medical Consumables are medical devices intended for single use

A pharmacist is a pharmacy graduate who has graduated as a pharmacist and has taken the pharmacist oath of office.

Pharmaceutical Technical Personnel are personnel who assist pharmacists in carrying out Pharmaceutical Work, consisting of Bachelor of Pharmacy, Pharmacy Intermediate Experts, Pharmaceutical Analysts, and Pharmacy Intermediate Personnel/Assistant Pharmaci

Ditjen Farmalkes stands for Directorate General of Pharmaceuticals and Medical Devices. Ditjen Farmalkes is an executive element in the Ministry of Health which is under and responsible to the Minister of Health.

Ditjen Farmalkes has tasks and functions that can be seen here

Ditjen Farmalkes melakukan pelayanan dalam bidang kefarmasian dan alat kesehatan meliputi:

1. Perizinan Industri Farmasi, Industri Obat Tradisional (IOT) dan Industri Ekstrak Bahan Alam (IEBA)
2. Perizinan Pedagang Besar Farmasi
3. Izin Edar serta Izin Penyalur Alat Kesehatan (Alkes) dan Perbekalan Kesehatan Rumah Tangga (PKRT)
4. Perizinan Impor Narkotika, Psikotropika dan Prekursor Farmasi
5. Perizinan Kosmetika
6. Pelayanan Surat Keterangan untuk Alat Kesehatan dan PKRT meliputi:
   – Sertifikat Bebas Jual ( Certificate of Free Sale/CFS)
   – Sertifikat Pemberitahuan Ekspor (Certificate of Exportation)
   – Sertifikat Kesehatan (Health Certificate)
   – Surat keterangan Impor (SKI ) khusus (Special Access scheme/ SAS)
   – Surat keterangan Impor (SKI) untuk sampel dalam rangka izin edar
   – Surat keterangan Impor (SKI) untuk bahan baku
   – Surat keterangan Impor (SKI) untuk spare part
   – Surat Keterangan Produk (SKP)  untuk pengadaan sektor pemerintah
   – Surat Keterangan Produk (SKP) untuk perusahaan/perorangan
   – Surat Keterangan Impor (Bea dan Cukai)
   – Surat Keterangan sedang dalam proses perpanjangan/perubahan izin edar
   – Surat Keterangan sedang dalam proses perpanjangan/perubahan IPAK dan Sertifikat Produksi Alkes/PKRT
   – Surat Rekomendasi/ Keterangan Lain

1. Licenses for Pharmaceutical Industry, Natural Extract Industry, Traditional Medicine Industry, Cosmetics Production and Pharmaceutical Wholesalers through this page.
2. Distribution permit for medical devices and PKRT through this page.
3. Import and Export License and Reporting of Production and Distribution of Narcotics, Psychotropic Substances and Pharmaceutical Precursors through this page.
4. Certificate of Production of Medical Devices, Certificate of Production of Household Health Supplies (PKRT), and Certificate of Distribution of Medical Devices (Medical Device Distributor License/IPAK) through this page.
5. Certificate services related to medical devices and PKRT through this page.

You can download it on this page.

You can download it on this page.

Medical device distribution license can be processed through the page www.regalkes.kemkes.go.id

Please contact IT Helpdesk at 0821 2406 5570. (WhatsApp only)

Please contact our Helpdesk via email pemdansert@gmail.com ; 0813 8642 6018 (WhatsApp only)

Please contact IT Helpdesk 0813 1984 4200 (WhatsApp only)

The distribution permit for medical devices and PKRT consists of an 11-digit number preceded by AKD/PKD for domestic medical devices/PKRT and AKL/PKL for imported medical devices/PKRT. Data on distribution permits for medical devices and PKRT can be checked on http://infoalkes.kemkes.go.id/ or download the Mobile Alkes app here