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Targets of this program principle are: 1
prevention and safeguarding the distribution of pharmaceuticals, foods, and health instruments that are illegal;
2 assuring quality, safety and efficacy of pharmaceuticals, foods, and health
instruments that are permitted to be marketed; and 3
increasing concerns of the society regarding risks of their usage. Programs included in Program Principle of Medicines, Foods, and Dangerous Substances
are as follow: 5.1.
Program of Safeguarding against the Danger of Misuse and Abuse of Medicines, Narcotics, Psychotropics, Other Addictives and Other Dangerous
Substances This program is aimed at to safeguard the society from abuse and misuse of Medicines,
Narcotics, Psychotropics, other Addictives NAPZA that are permitted for marketing and to prevent risks of poisoning from dangerous substances used by the society.
The target of this program is controlled production and distribution of medicines and NAPZA, and stabilization of managerial system of dangerous substances.
Main activities conducted include among others: 1
surveillance of illegal products; 2
taking samples and laboratoric testing; 3
safeguarding withdrawal from market; 4
development of follow up system according to prevailing laws with related sectors; 5
development of standards of regulation and supervision according to progress in science and technology;
6 development of PPNS education with related sectors;
7 development of standardization in managing and safeguarding dangerous substances
at work place cross-sectoraly; 8
motivating activities of coordination forum for the management and safeguarding of chemicals cross-sectoraly;
9 development of Poisoning Information System network in 27 provinces; and
10 dissemination of information on toxicity and side effect of dangerous substances.
5.2. Program of Safeguarding and Supervision of Foods and Food Additives
BTM
This program is aimed at to assure the safety and quality of food products distributed in the society and to protect the society from foods and food additives that do not meet
public health requirements. Target of this program is to consolidate the system and to implement food safeguarding so
that food products in the society, including food products of home industries, are assured in quality and safety.
Main activities to be done include among others: 1
compilation and development of evaluation criteria and registration standards;
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2 regulation and supervision according to progress in science and technology
including supervision of genetic engineering in food production; 3
evaluation of quality and safety of foods and food additives in the context of registration;
4 surveillance of the use of food additives in food products;
5 taking samples and laboratoric testing of food products marketed throughout
Indonesia; 6
safeguarding food products that do not meet requirements; 7
inspecting catering services; 8
cultivation and supervision of the application of safe and qualified food production in the home industries; and
9 development of food safety system through the ‘food inspectors’ at districts
municipalities.
5.3. Program of Drugs, Traditional Medicines, Cosmetics and Health Instruments
Supervision
This program is aimed at to assure quality, safety, efficacy of Drugs, Traditional Medicines, Cosmetics and Health Instruments that are permitted to be marketed, to
prevent dissemination of product information that are not objective and to increase the professional ability of food and drug testing laboratory in 27 provinces.
The target are that all products in the market meet the requirements according to those permitted in the context of registration, that the public is avoided from dis-information
and that t
he PPOM BPOM laboratory’s testing ability is recognized by the international accreditation system.
The main activities to be done include among others are the following: 1
compilation and development of evaluation and registration criteria standards; 2
evaluation on the efficacy, safety, quality testing and registration that is centralized; 3
periodic re-evaluation of products already being registered; 4
evaluation on the pre-marketing labeling, advertising information and promotion claim;
5 development of harmonization of regional and international registration;
6 realization of good manufacturing production method implementation;
7 certification of PBF distribution facilities;
8 development of drugs’ side effects monitoring system;
9 examination of products and distribution facilities either of private or governmental
sector; 10
taking samples and laboratoric testing of pharmaceutical products, foods and health instruments marketed in 27 provinces;
11 investigating counterfeit cases, black market and violation in production and
distribution; 12
examination of advertisement promotion materials; 13
training personnel in investigation, examination of production and distribution facilities;
14 training of testing personnel;
15 accreditation of province wide testing laboratories for drugs and foods;
16 referral service laboratories; and
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17 supply of instruments, standard raw materials and testing animals.
5.4. Rational Drug Use Program
