a. traditional medicines that will enter the territory of Indonesia to be circulated should be equipped with circulation permit;
b. that to prevent the circulation of imported traditional medicines that are not equipped with circulation permit, it is necessary to supervise them since they enter to territory of Indonesia;
c. that based on consideration as intended in paragraph a and paragraph b, it is necessary to stipulate Regulation of the Head of Drugs and Foods Supervisory Agency concerning Control on the Entry of Entry of Traditional Medicines;
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 (R.I. Statute Book of 1999 No. 42, Supplement to Statute Book No. 3821);
3. Government Regulation No. 72/1998 concerning the Control of Pharmaceutical Preparations and Health Instruments (Statute Book No. 138/1998, Supplement to Statute Book No. 3781);
4. Government Regulation No. 17/2001 concerning the Upper Tariff of Non Tax State Revenue Applicable to the Drug and Food Supervisory Agency (Statute Book No. 35/2001, Supplement to Statute Book No. 408;
5. Presidential Decree No. 103/2001 concerning Position, Mission, Functions, Authority, Organization Structure and Work Mechanism of Non Ministerial Government Agencies that is amended several times, the latest by Presidential Regulation No. 11/2005;
6. Presidential Decree No. 110/2001 concerning Organization Units and Mission of First Echelon Non Ministry Government Agencies that is amended several times, the latest by Presidential Regulation No. 12/2005;
7. Regulation of the Minister of Health No. 246/1998 concerning Business Permit of Traditional Medicine Industry;
8. Regulation of the Minister of Health No. 1297/1998 concerning Distribution over Imported Traditional Medicines;
9. Decree of the Head of Drugs and Foods Supervisory Agency No. HK.00.05.41.1384 of 2005 concerning Criteria and Procedures of Traditional Medicine, Standard Herbal Medicine and Fitofarmaka Registration.
REGULATION OF THE HEAD OF DRUGS AND FOODS SUPERVISORY AGENCY CONCERNING CONTROL ON THE ENTRY OF TRADITIONAL MEDICINES
In this Regulation:
1. Circulation permit is an approval of the traditional medicines, standard herbal medicines and fitofarmaka registration, issued by Head of Agency to distribute them in Indonesian territory.
2. Imported traditional medicines are traditional medicines made by foreign industry, that are imported and distributed in the Indonesian territory.
3. Importation of traditional medicines is importation of traditional medicines by land, sea and or air into Indonesian territory.
4. Head of Agency is Head of Drugs and Foods Supervisory Agency of the Republic of Indonesia.
(1) Only importer, distributor, industry of traditional medicines and or pharmaceutical industry which has import permit in accordance with laws and regulations and are given power of attorney by producers in the origin country can import traditional medicines into Indonesian territory,
(2) Traditional medicines that can be taken into the Indonesian territory for circulation shall be traditional medicines equipped with circulation permit.
(3) Excepted from provisions as intended in paragraph (2) are traditional medicines used for laboratory tests, registration samples, researches, exhibitions and personal use in limited amount according to the required need.
(4) The procedures to import traditional medicines as intended in paragraph (3) is to be laid down in a separate regulation.
(1) Every importation of traditional medicines shall meet the laws and regulations.
(2) In addition to fulfilling the provisions as intended in paragraph (1), importation of traditional medicines shall secure approval to entry form Head of Agency.
(3) Applications for importation of traditional medicines as intended in paragraph (2) shall be filled to the Head of Agency.
Applications for importation of traditional medicines shall be subject to fees on each item of product in accordance with laws and regulations.
Approval of the import as intended in Article 3 paragraph (2) shall be valid for only one shipment.
The procedures to secure approval to import traditional medicines as intended in Article 3 paragraph (2) is to be laid down in separate regulation.
Within the framework of supervisory of importer, distributor, traditional medicines industry and or pharmaceutical industry that import traditional medicines shall has documentation of traditional medicines distribution.
(1) Violators of this regulations can be subject to administrative sanctions or criminal sanction in accordance with the laws and regulations.
(2) Administrative sanction as intended in paragraph (1) are:
By the issuance of this Regulation, all the existing regulations related to the importation of traditional medicines shall remain valid, provided they do not contradict this regulation and/or have not been replaced under this regulation.
This Regulation shall come into force as from the date of stipulation.
For public cognizance, this regulation shall be announced by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
On June 10, 2008
Head of Drugs and Foods Supervisory Agency of the Republic of Indonesia
signed,
Dr. Husniah Rubiana Thamrin Akib, MS, Mkes, SpFK