to Indonesian
a. that basic substances of medicine are used by pharmacy industry production also can be misused by illegal production of medicine;
b. that in order to prevent the misuse of basic substances of medicine for illegal production, it is necessary to exercise control from the entry into the territory of Indonesia;
c. that based on the considerations as intended in a and b, it is necessary to stipulate a regulation of the Head of Drug and Food Supervisory Agency concerning control on the entry of basic substances of medicine;
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. 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;
4. 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;
5. Decree of Head of Drug and Food Supervisory Agency No. 02001/SK/KBPOM/2001 concerning Organization and Working Management of Drug and Food Supervisory Agency, as amended by Decree of Head of Drug and Food Supervisory Agency No. HK.00.05.21.4231/2004;
6. Decree of head of Drug and Food Supervisory Agency No. HK.00.05.3.2522/2003 concerning Application of Proper Distribution Method of Drug;
REGULATION OF THE HEAD OF DRUG AND FOOD SUPERVISORY AGENCY CONCERNING CONTROL ON THE ENTRY OF BASIC SUBSTANCES OF MEDICINE.
In this Regulation:
1. Import of basic substances of medicine is the entry of basic substance of medicine into territory of Indonesia through seaport or airport.
2. Wholesalers of Pharmacy Basic Substances is Wholesalers of Pharmacy as intended in Decree of the Director General of Drug and Food Supervisory No. PO.01.01.2.02569 concerning Technical Conditions of Wholesale of Pharmacy Basic Substances.
Only pharmaceutical Industry or Pharmaceutical Basic Substances Wholesalers that has license according to effective regulations may import basic substances of medicine.
Entry of basic substances of medicine by Pharmaceutical Industry or Pharmaceutical Basic Substance Wholesalers not only fulfil provisions in effective regulations, but also should get approval to import basic substance os medicine from Head of Drugs and Foods Supervisory Agency.
(1) Approval to import basic substances of medicine is given based on application.
(2) Every application only for once import.
(3) Application is filed in written by Pharmaceutical Industry of Pharmaceutical Basic Substance of Medicine Wholesaler to Head of Drugs and Foods Supervisory Agency.
(4) Approval to import basic substance of medicine will be processed within 1 (one) working day.
(1) Application as intended in Article 4 shall be enclosed by:
(2) Application as intended in paragraph (1) a according to sample as stated in attachment.
Every import of basic substance of medicine shall be documented well to make easy in checking and inquiry as well as can be checked every time by official of Drugs and Foods Supervisory Agency and/or Drugs and Foods Controller Board according to the format of Good Medicines Distribution Ways based on Decree of the Head of Drugs and Foods Supervisory Agency No. HK.00.05.3.2522/2003.
(1) Every Pharmaceutical Industry or Pharmaceutical Basic Substance of medicine Wholesaler that import basic substances of medicine to the territory of the Republic of Indonesia without approval as intended in Article 3 may be imposed administrative actions.
(2) The administrative actions as intended in paragraph (1) are in the form of:
By effective this Regulation of the Head of Drug and Food Supervisory Agency, all provisions of existing regulations related with the entry of basic substances of medicine are still in effect, to the extent it is not contradictory to and/or not yet replaced based on this Regulation.
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 July 10, 2005
HEAD OF DRUG AND FOOD SUPERVISORY AGENCY
signed,
H. Sampurno