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PharmaBoardroom - Regulatory, Pricing, and Reimbursement: Indonesia

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The key facts about regulatory, pricing, and reimbursement of drugs in Indonesia. The regulatory authorities with specific jurisdiction over drugs, biologicals, and medical devices in Indonesia are:. The basic regulation on health including drugs, biologicals, and medical devices is Law No. Further, details on the requirements, criteria, category, as well as registration procedures of drugs and biologicals are further regulated under BPOM Regulation No. The risk assessment is classified into 4 levels: Low, Medium-Low, Medium-High and High, each with its own characteristics, and assessed using various criteria, including safety, health, the environment, resource utilization and management. Higher risk imposed higher license requirements. All licenses and permits must be applied for through the OSS system, including licenses related to drugs and biologicals. Although, in some cases, verification and assessment by the relevant ministries are still required. There is no specific regulation on the pricing of medical devices. There is no regulation on reimbursement of drugs, biologicals, and medical devices in Indonesia. The Government, however, manages a public healthcare system via an independent authority. Please refer to Question No. The Development and testing of drugs differs between generic and new drugs. Development and testing of new drugs, on the other hand, must adhere to the regulations on pre-marketing clinical trials. If the new drugs are to be imported from overseas meaning that they are already marketed and distributed overseas but not in Indonesia , the development and testing may be conducted overseas. The BPOM will accept result of clinical and non-clinical trials conducted overseas as part of the MA application as below. The application of an MA is divided into 2 steps, namely: i pre-registration and ii registration phase. The timeline for registration phase is ranging from 5 days up to days, subject to the condition of the registration and the type of drugs being regis- tered. Similar to drugs, development and testing of medical devices prior to distribution shall adhere to the regulations on pre-marketing clinical trials. In general, medical devices in Indonesia are divided into 4 classifications based on the risk of use against patients:. In general, the following are the steps for obtaining an MA:. The timeline for new registration of MA is ranging from 10 days up to 45 days, subject to the type of medical devices being registered. The applicable fees vary for each authorization, as stipulated under Government Regulation No. As an illustration, a pre-registration costs up to IDR 1 million per item, and a registration of drug with new active substance, biologicals, and combination costs up to IDR 30 million per item. The applicable fees vary depending on the classification of the medical devices and the type of application new or renewal , as stipulated under Decree of the Director General of Pharmaceutical and Medical Devices No. MA for drugs and biologicals are valid for 5 years, to the extent that they comply with the prevailing laws. The timeline to submit re-registration application for renewal of MA depends on whether or not there is an alteration to the product. In the event of any alteration to the MAs e. If there is no alteration, the application may be submitted within 1 month prior to the expiration of the MAs. Should a holder of a MA fail to re-register within the required time period, a new registration application not re-registration must be submitted. MA for medical devices are valid for maximum 5 years. Application for renewal of the MA shall be submitted at the earliest 9 months prior to the expiration thereof. Should a holder of a MA fail to apply for renewal after the expiration, a new registration application not a renewal must be submitted. Drugs regulations do not differentiate the authorization process between brand-name products and generic products. The regulation however differentiates between registration of: i domestically produced drugs; ii imported drugs; iii licensed drugs; iv patent-protected drugs; v new development drugs; vi generic drugs; and vii orphan drugs. Subsequently, different details will be required for each option. Medical device regulations also do not differentiate the authorization process between brand-name products and generic products. If the medical devices are branded, the brand certificates shall be provided during the registration. Similar to drugs, the authorization process also differs between locally-made medical devices and imported medical devices. There is no specific regulation on combination products, as such, the applicant must adhere to each regulation relating to the products combined. For example, for drug and medical devices, the applicant must take into account the prevailing regulations on drugs and medical devices. However, during the application for MA for drugs, the applicant should be able to select the type of the products to be registered, as follows:. In general, the requirements of U. Food and Drug Administration or the European Drugs Agency are informally used as benchmark by the Indonesian authorities, thus certain aspects are comparable. Nevertheless, Indonesia has a set of unique regulations that govern drugs and medical devices sectors. Under Presidential Regulation No. The regulation also stipulates the establishment of a specific Investigation Deputy under BPOM, which is tasked to carry out the formulation and implementation of investigation policies against violations in the drugs and foods sector. The object of monitoring includes the public and each organizer of activities related to health resources including medical devices and health efforts e. A Health Supervisor is authorized to, among others, examine licensing related to the health resources and health efforts. In , Law No. Following the enactment of Law No. Any person, regardless of whether they already have another health insurance policy, is obligated to become a participant in the health security program managed by the Health BPJS. The Indonesian Government will provide contribution aid to the Health BPJS as an additional source of funding for the purpose of sponsoring the poor and less fortunate so that they can be covered by the health security program. The Health BPJS will cover health services expenses of its participants in accordance with the health security program regulations. The cooperation shall be carried out by a cooperation agreement between the Health BPJS and each health facility. The agreement must be valid for a minimum of 1 year. The regulation stipulates that each hospital whether public or private must fulfil certain obligations, including, to provide facilities and services for the less fortunate and poor. The information may be provided in the form of a nominal value in IDR or formula as relevant. The price information differs in accordance with the type of the drugs:. Price information based on the formula must be provided for generic drugs listed in e-catalogue. Specifically, for generic drugs not listed in the e-catalogue, the highest drug retail price must comply with the price determined by the MOH based on its decree. Patients pay for drugs and devices out-of-pocket or financed by private insurance or the Health BPJS. Some also enjoy the benefit of medical allowances provided by their employers. Although currently the majority of Indonesians have been registered as participants of Health BPJS, due to the limitation of coverage provided by the Health BPJS, a good portion of the participants either elect to pay for drugs and devices entirely out-of-pocket or pay for the excess not covered by the Health BPJS. Drugs dispensing and services based on prescription must be carried out by licensed pharmacists. In remote areas where no pharmacist is available, the MOH may assign licensed pharmacy technical personnel to primary health services facilities to compound and dispense drugs to patients. Furthermore, in more remote areas where no pharmacy is available, licensed doctors or dentists may compound and dispense drugs to patients. Drugs dispensers i. There is no general regulation on medical device dispensing. Main responsibilities of pharmacists in dispensing drugs consist of 3 stages, namely, preparation, delivery and providing information on the drugs. In general, the main duties of the pharmacists include:. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices? Pricing There is no specific regulation on the pricing of medical devices. What are the steps to obtain authorization to develop, test, and market a product? Pre-registration phase The timeline for pre-registration phase is 40 days. Registration phase The timeline for registration phase is ranging from 5 days up to days, subject to the condition of the registration and the type of drugs being regis- tered. Medical devices Similar to drugs, development and testing of medical devices prior to distribution shall adhere to the regulations on pre-marketing clinical trials. In general, medical devices in Indonesia are divided into 4 classifications based on the risk of use against patients: Class A: low risk; Class B: low to medium risk; Class C: medium to high risk; Class D : high risk. What are the approximate fees for each authorization? Drugs and Biologicals The applicable fees vary for each authorization, as stipulated under Government Regulation No. Medical devices The applicable fees vary depending on the classification of the medical devices and the type of application new or renewal , as stipulated under Decree of the Director General of Pharmaceutical and Medical Devices No. Drugs and Biologicals MA for drugs and biologicals are valid for 5 years, to the extent that they comply with the prevailing laws. Re-Registration The timeline to submit re-registration application for renewal of MA depends on whether or not there is an alteration to the product. Medical devices MA for medical devices are valid for maximum 5 years. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers? Drugs and Biologicals Drugs regulations do not differentiate the authorization process between brand-name products and generic products. Medical devices Medical device regulations also do not differentiate the authorization process between brand-name products and generic products. However, during the application for MA for drugs, the applicant should be able to select the type of the products to be registered, as follows: Single Product, if the product only consists of drug; Combination Product, if the product consists of drug and solvents or drug use aids e. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U. Drugs Under Presidential Regulation No. What is the potential range of penalties for noncompliance? Is there a national healthcare system? If so, how is it administered and funded? How does the government or public healthcare system function with private sector healthcare? Are prices of drugs and devices regulated and, if so, how? The price information differs in accordance with the type of the drugs: non-generic drugs, generic drugs listed in the e-catalogue for government procurement; and generic drugs that are not listed in the e-catalogue. Medical devices There is no specific regulation on pricing for medical devices. How are drugs and devices used by patients paid for? What roles do public and private payers play? Who dispenses drugs and devices to patients and how are those dispensers compensated? Drugs Drugs dispensing and services based on prescription must be carried out by licensed pharmacists. Medical devices There is no general regulation on medical device dispensing. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety? In general, the main duties of the pharmacists include: Dispensing drugs in accordance with the prescription, including compounding if necessary; Ensure correct labelling and packaging of the drugs; Ensure that the drugs are given to the correct patients or their families; Providing information to the patients on the use and dosage of the drugs, as well as its side effects and list of consumables that must be avoided during consuming the drugs; Maintaining records of dispensed drugs; and Educating patients who require OTC drugs for mild disease.