{"id":3196,"date":"2014-09-16T10:21:05","date_gmt":"2014-09-16T03:21:05","guid":{"rendered":"https:\/\/binfar.kemkes.go.id\/?page_id=3196"},"modified":"2024-05-31T14:44:47","modified_gmt":"2024-05-31T07:44:47","slug":"faq","status":"publish","type":"page","link":"https:\/\/farmalkes.kemkes.go.id\/en\/faq\/","title":{"rendered":"FAQ"},"content":{"rendered":"

Home<\/a><\/span><\/i> FAQ<\/span><\/p>\n\n\n\n

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Frequently Asked Questions<\/h1>\n\n\n\n
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Thank you for your visit to our website. Hopefully through this site you will find out more about everything related to the Directorate General of Pharmaceutical and Medical Devices (Ditjen Farmalkes), and all the information we convey can be useful.
Here's a list of our most frequently asked questions.<\/p>\n

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\n\t\t\t\tWhat are Pharmaceutical Preparations?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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Pharmaceutical preparations are drugs, medicinal materials, traditional medicines and cosmetics.<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat is Medicine?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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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<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat is Traditional Medicine?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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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<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat is a Medical Device?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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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.<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat are Household Health Supplies?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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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.<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat are Medical Consumables?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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Medical Consumables are medical devices intended for single use<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat is a Pharmacist?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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A pharmacist is a pharmacy graduate who has graduated as a pharmacist and has taken the pharmacist oath of office.<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat is a Pharmaceutical Technical Personnel?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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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<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat is Ditjen Farmalkes?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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Ditjen Farmalkes stands for Directorate General of Pharmaceutical and Medical Devices. Ditjen Farmalkes is an executive element in the Ministry of Health which is under and responsible to the Minister of Health.<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat are the tasks and functions of Ditjen Farmalkes?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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Ditjen Farmalkes has tasks and functions that can be seen here<\/a><\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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\n\t\t\t\tWhat services are provided by Ditjen Farmalkes?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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Ditjen Farmalkes performs services in the field of pharmaceutical and medical devices including:<\/p>\n\n\n\n

  1. Licensing of Pharmaceutical Industry, Traditional Medicine Industry (IOT) and Natural Extract Industry (IEBA)<\/li>
  2. Licensing of Pharmaceutical Wholesalers<\/li>
  3. Distribution Permit and Distributor Permit for Medical Devices (Alkes) and Household Health Supplies (PKRT)<\/li>
  4. Import Licensing of Narcotics, Psychotropic Substances and Pharmaceutical Precursors<\/li>
  5. Licensing of Cosmetics<\/li>
  6. Certificate Services for Medical Devices and PKRT include:\n
    - Certificate of Free Sale (CFS)\n
    - Export Notification Certificate (Certificate of Exportation)\n
    - Health Certificate\n
    - Special Access scheme (SAS) Import certificate (SKI)\n
    - Import certificate (SKI) for samples in the context of distribution permit\n
    - Import certificate for raw materials\n
    - Import certificate (SKI) for spare parts\n
    - Product Certificate (SKP) for government sector procurement\n
    - Product Certificate (SKP) for companies\/individuals\n
    - Import Certificate (Customs and Excise)\n
    - Certificate of being in the process of extending\/changing distribution license\n
    - Certificate of being in the process of renewal\/change of IPAK and Production Certificate of Medical Device\/PKRT\n
    - Letter of Recommendation\/Other Information<\/li><\/ol>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>
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    \n\t\t\t\tWhere can I get licensing services from Ditjen Farmalkes?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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    1. Licenses for Pharmaceutical Industry, Natural Extract Industry, Traditional Medicine Industry, Cosmetics Production and Pharmaceutical Wholesalers through\u00a0this page<\/a>.<\/li>\n\n\n\n
    2. Distribution permit for medical devices and PKRT through\u00a0this page<\/a>.<\/li>\n\n\n\n
    3. Import and Export License and Reporting of Production and Distribution of Narcotics, Psychotropic Substances and Pharmaceutical Precursors through\u00a0this page<\/a>.<\/li>\n\n\n\n
    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<\/a>.<\/li>\n\n\n\n
    5. Certificate services related to medical devices and PKRT through this page<\/a>.<\/li>\n<\/ol>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>
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      \n\t\t\t\tWhere can I find laws and regulations related to pharmaceuticals and medical devices?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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      You can download it on\u00a0this page<\/a>.<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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      \n\t\t\t\tWhere can I get books and guidelines related to pharmaceuticals and medical devices?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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      You can download it on\u00a0this page<\/a>.<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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      \n\t\t\t\tWhat is the procedure for obtaining a medical device distribution license?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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      Medical device distribution license can be processed through the page www.regalkes.kemkes.go.id<\/u><\/a><\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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      \n\t\t\t\tHow do I obtain information about the licensing of medical devices and PKRT products?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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      Please contact IT Helpdesk at 0821 2406 5570. (WhatsApp only<\/em>)<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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      \n\t\t\t\tHow do I obtain information about the licensing of manufacturers and distributors of medical devices and PKRT?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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      Please contact our Helpdesk via email pemdansert@gmail.com<\/u><\/a>\u00a0; 0813 8642 6018 (WhatsApp only<\/em>)<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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      \n\t\t\t\tHow do I obtain information on licensing for the pharmaceutical industry, PBF, cosmetics industry, traditional medicine industry and natural extract industry?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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      Please contact IT Helpdesk 0813 1984 4200 (WhatsApp only<\/em>)<\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>

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      \n\t\t\t\tHow do I know if a medical device distribution license is fake or not?\t\t\t<\/h4>\n\n\t\t<\/div>\n\n\t\t
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      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\/<\/u><\/a>\u00a0or download the Mobile Alkes app here<\/a><\/p>\n<\/div>\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\n\t\t\n\t<\/div>\n\n<\/div>\n\t<\/div>\n\n\t\n<\/div>\n\n\n

      Follow @farmalkesRI<\/a>