REGULATION OF THE HEAD OF DRUGS AND FOODS CONTROL AGENCY
NO. HK.00.05.1.42.0115
CONCERNING
CONTROL ON THE ENTRY OF BASIC SUBSTANCES OF TRADITIONAL MEDICINE
BY GRACE OF THE ALMIGHTY GOD
THE HEAD OF DRUGS AND FOODS CONTROL AGENCY,
Considering:
- a. that the public must be protected from using traditional medicine containing basic substances not meeting requirements of safety, quality and restorative power that can inflict losses and/or is hazardous to health;
- b. that in order to prevent the misuse of the distribution of basic substances of traditional medicine, it is necessary to exercise control from its entry into the territory of Indonesia;
- c. that based on the considerations as described in a and b, it is necessary to stipulate a regulation of the Head of Drug and Food Control Agency concerning control on the entry of basic substances of traditional medicine;
In view of:
- 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 Securing the Supply of Pharmacy and Health Equipment (Statute Book No. 138/1998, Supplement to Statute Book No. 3781);
- 4. Government Regulation No. 17/2001 concerning Tariff of Non-Tax State Revenue applicable for Drug and Food Control Agency (Statute Book No. 35/2001, Supplement to Statute Book No. 4087);
- 5. Presidential Decision No. 103/2001 concerning Position, Mission, Functions, Authority, Organization Structure and Work Mechanism of Non-department Government Agencies that is amended several times, the latest by Presidential Regulation No. 64/2005;
- 6. Presidential Decision 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. 52/2005;
- 7. Regulation of the Minister of Health No. 246/1990 concerning Business Permit for Traditional Medicine Industries.
- 8. Regulation of the Head of Drug and Food Control Agency No. HK.00.05.41.1384/2005 concerning Criteria and Management on the Registration of Traditional Medicine, Standardized Herbal Medicine and Phyto-pharmacy.
DECIDES:
To stipulate:
REGULATION OF THE HEAD OF DRUG AND FOOD CONTROL AGENCY CONCERNING CONTROL ON THE ENTRY OF BASIC SUBSTANCES OF TRADITIONAL MEDICINE.
CHAPTER I
GENERAL PROVISIONS
Article 1
In this Regulation:
- 1. "Basic substances of traditional medicine" refers to simplicia or supply of galenicals used as substance in the production of traditional medicine and not in containers ready to be used by consumers.
- 2. "Entry of basic substances of traditional medicine" refers to the import of basic substances of traditional medicine by land, sea and/or air transportation into the territory of Indonesia.
- 3. "Head of the Agency" refers to the Head of Drug and Food Control Agency of the Republic of Indonesia.
CHAPTER II
ENTRY OF TRADITIONAL MEDICINE BASIC SUBSTANCES
Article 2
(1) Any entry of basic substances of traditional medicine must obtain an entry approval from the Head of the Agency.
(2) Besides having to meet the provision as described in paragraph (1), the entry of basic substances of traditional medicine must meet provisions on import in accordance with prevailing regulations.
(3) In order to get the approval as described in paragraph (1), an importer must submit a written request to the Head of the Agency.
(4) Kinds of basic substances of traditional medicine obligated to get the entry approval as described in paragraph (1) are set forth in the attachments to this Regulation.
Article 3
Entry of basic substances of traditional medicine may only be performed by importers, distributors, industries and/or pharmacy industries of traditional medicine possessing import permit in accordance with prevailing provisions.
Article 4
(1) Approval for the entry of the basic substances of traditional medicine as described in Article 2 paragraph (1) shall be charged with per item costs of basic substances in accordance with provisions of regulations.
(2) Each approval for the entry as described in Article 2 paragraph (1) is valid just for one entry (each shipment).
Article 5
Procedure to get an approval for the entry of the basic substances of traditional medicine as described in Article 2 paragraph (3) is regulated separately.
Article 6
Entry of basic substances of traditional medicine may be limited by taking into consideration the availability of domestic cultivation and/or production.
CHAPTER III
CONTROL
Article 7
(1) Drug and Food Control Agency controls on the entry, distribution and/or use of basic substances of traditional medicine.
(2) Importers, distributors, traditional medicine industries and/or pharmacy industries importing basic substances of traditional medicine are obligated to document each entry, distribution and/or use of basic substances of traditional medicine.
CHAPTER IV
SANCTION
Article 8
(1) Violations on provisions of this Regulation may be imposed to an administrative sanction and/or criminal sanction in accordance with regulations.
(2) The administrative sanction as described in paragraph (1) among others is in the form of:
- a. oral or written warning;
- b. temporary cessation of activities;
- c. recommendation for the revocation of import permit.
CHAPTER V
CLOSING PROVISIONS
Article 9
With the stipulation of this Regulation, all provisions of existing regulations related with the entry of basic substances of traditional medicine are still in effect, to the extent it is not contradictory to and/or not yet replaced based on this Regulation.
Article 10
This Regulation commences to come to effect from the date of stipulation.
For public cognizance, this Regulation shall be announced in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta,
On January 13, 2009
HEAD OF DRUG AND FOOD CONTROL AGENCY
signed,
Dr. Husniah Rubiana Thamrin Akib, MS.,M.Kes, Sp.FK