a. that to protect public health from risk from not right distribution and using of drugs that is caused by over promotion of drugs, not right or misdirection, it is necessary provision concerning drugs promotion;
b. that based on consideration as intended in paragraph a, it is necessary to stipulate provision concerning drugs promotion by decree of Head of Drug and food supervisory Agency;
1. Law No. 23/1992 concerning Health (Statute Book No. 100/1992, Supplement to Statute Book No. 3495);
2. Law No. 8/1999 concerning Consumer Protection (Statute Book No. 42/1999, Supplement to Statute Book No. 3821);
3. Government Regulation No. 72/1998 concerning Safety of Pharmaceutical Supply and Health Equipment (Statute Book No. 138/1998, Supplement to Statute Book No. 3778);
4. Presidential Decree No. 103/2001 concerning Position, Task, Function, Authority, Organizational Structure and Working Arrangement of Non Ministerial Government Agency as amended by the Presidential Decree No. 46/2002;
5. Presidential Decree No. 110/2001 concerning Unit of Organization and the Task of First Echelon State employees of Non Ministerial Government Agency as amended by Presidential Decree No. 5/2002;
6. Regulation of the Minister of Health No. 949/Menkes/Per/VI/2000 concerning Registration of Pharmaceutical Drugs;
7. Decree of the Minister of Health No. 386/Menkes/SK/IV/1994 concerning Advertisement Guideline of Free Drugs, Traditional Drugs, Healthy Equipment, Cosmetics, Healthy House Hold Products and Foods - Beverages;
8. Decree of the Head of Drug and food supervisory Agency No. 02001/SK/KBPOM dated February 26, 2001 concerning Organization and Work Flow of Drug and food supervisory Agency;
DECREE OF THE HEAD OF DRUG AND FOOD SUPERVISORY AGENCY CONCERNING DRUGS PROMOTION
In this Decree:
1. Pharmaceutical drugs is supply or combination of substances, including biological products and contraception that are ready to be used to influence or check physiological system or pathology condition in the framework to decide diagnose, prevent, treatment, recovery and health improvement.
2. Drugs promotion is all activities of giving information and suggestion of pharmaceutical drugs that has distribution permit that are done by Pharmaceutical Industry and Pharmaceutical Groceries, with objection to increase prescription, distribution, selling and or using of drugs.
3. Pharmaceutical industry is Industry of Pharmaceutical Drugs including Industry of Raw Material of Drugs.
4. Pharmaceutical Groceries is Limited Company Entity or Cooperation that has license to supply, store, distribute of pharmaceutical supply in a lot of quantity according to effective laws and regulations.
5. Head of Agency is Head of Drug and food supervisory Agency.
Provision of drugs promotion arranges promotion of pharmaceutical drugs (free drugs, limited free drugs, and prescription necessary drugs) that is conducted by Pharmaceutical Industry and/or Pharmaceutical Groceries with object healthy professional or public according to the valid laws and regulations.
(1) All of pharmaceutical drugs in the form of free drugs, limited free drugs and prescription necessary drugs may be promoted.
(2) Exception for provision as intended in paragraph (1) is prescription necessary drugs cannot be promoted to the public.
(3) Promotion of prescription necessary drugs as intended in paragraph (1) will be arranged further.
(4) Promotion to the healthy professional and public shall follow effective provision of laws and regulations.
Narration claim of speciality in drugs promotion should match with claim are agreed in distribution approval of Head of Agency.
Drugs promotion by using audio visual and electronic media only can be conduct for free drugs and limited free drugs.
(1) Medical representatives should has appropriate back ground education and enough trained and has medical and technical knowledge to give information of drugs accurately, balanced, ethical and with responsibility.
(2) Pharmaceutical Industry and/or Pharmaceutical Groceries have responsibility on the training of Medical representatives.
(3) Pharmaceutical Industry and/or Pharmaceutical Groceries have responsibility to all of Medical representatives’ statement and activities.
(4) Medical representatives are not allowed to give induction, present/reward, incentive, donation, financial, and other similar form to the healthy professional of Pharmaceutical Groceries, and Drug Store.
(1) Drug promotion in the form of sponsor of activities to spread drug information only is allowed as scientific activities.
(2) Sponsorship for scientific activities of Pharmacy Industry and/or Pharmaceutical Groceries should clear and stated from the beginning of scientific activities and preceding activities.
(3) Preceding activities as intended in paragraph (2) contents topics will be presented and discussed in the scientific activities.
(4) Sponsorship for scientific activities of Pharmacy Industry and/or Pharmaceutical Groceries only be allowed for drugs that has distribution license.
(1) Giving or donation is not related with prescription or suggestion to use the drugs.
(2) Giving or donation is only for board, not for the personal of healthy professional.
Pharmaceutical Industry and/or Pharmaceutical Groceries are not allowed:
Beside will be fined crime sanction according to the effective regulation, Pharmaceutical Industry and/or Pharmaceutical Groceries that do violation on the provision as intended in Article 9 will be fined administrative sanction in the form of:
(1) Control on the promotion activities conducted by Pharmaceutical Industry and/or Pharmaceutical Groceries is conducted by Drug and Food Supervisory Agency and Drug and Food Supervisory Board.
(2) To implement control as intended in paragraph (1), Head of Agency can establish independent committee with members from healthy professional organization.
(3) Independent committee as intended in paragraph (2) investigates, checks, and recommends to Head of Agency to decide sanction according to the effective regulations.
(4) Violation by healthy professional on the professional ethical code is processed by the professional organization.
This Decree shall come into force since the date of stipulation and will be amended if in the future there is founded any mistake.
For public cognizance, this Decree shall be published by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in: Jakarta
On: August 30, 2002
Drug and food supervisory Agency
Head,
signed,
H. SAMPURNO