REGULATION OF THE HEAD OF FOOD AND DRUG SUPERVISORY BOARD OF REPUBLIC OF INDONESIA
NO. HK.00.05.1.3459
CONCERNING
SUPERVISION OVER THE IMPORT OF IMPORTED MEDICINES
THE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD OF REPUBLIC OF INDONESIA,
Attachment
Considering:
- a. that only imported medicines which had already secured the license to distribute can be imported;
- b. that in order to monitor the distribution and prevent deviation in the distribution of the imported medicines, supervision needs to be applied as from the import into the territory of the Republic of Indonesia;
- c. that based on the considerations as intended in letters a and b, it is necessary to stipulate a regulation of the head of the food and drug supervisory board on supervision over the Import of Imported medicines;
In view of:
- 1. Law No. 23/1992 on health (statute book No. 1992 No. 100, supplement to statute book No. 3495);
- 2. Law No. 8/1000 on consumer Protection (statute book of 1999 No. 42, supplement to statute book No. 3812);
- 3. Presidential decree No. 103/2001 on status , tasks, functions, authority, organizational structures and working arrangements on non-ministerial government institutions as has already been amended several times an the latest by presidential regulation No. 11/2005;
- 4. Presidential decree No. 110/2001 on first – echelon organizational units and tasks of non-ministerial government institutions as has already been amended by presidential regulation No. 12/2005;
- 5. Decision of the head of the food and drug supervisory board No. 02001/SK/KBPOM/2001 on the Organization and working arrangement of the food and drug supervisory boards as has already been amended by decision of the head of the food and Drug supervisory Board No. HK.00.05.21.4231/2004;
- 6. Decision of the head of the food and Drug supervisory Board No. HK.00.05.3.1950/2003 on criteria and procedures for registration of medicines;
- 7. Decision of the HEAD OF THE Food and Drug Supervisory board No. HK.00.05.3.2522/2003 on application of proper distribution method of medicines;
HAS DECIDED:
To stipulate:
REGULATION OF THE HEAD OF FOOD AND DRUG SUPERVISORY BOARD ON SUPERVISION OVER THE IMPORT OF IMPORTED MEDICINES
Article 1
Referred to in this regulation as:
- 1. distribution license is a model of registration approval of medicines so that the medicines can be distributed in the Indonesian territory;
- 2. imported medicines are medicines produced by pharmaceutical industries abroad;
- 3. import of imported medicines is importation of imported medicines into the Indonesian territory through both seaports and airports;
- 4. registrants are pharmaceutical industries or wholesalers securing business license in accordance with the provisions of legislation in force.
Article 2
The parties righteous to supply imported medicines into the Indonesian territory are pharmaceutical industries and wholesalers as registrants who had obtained the license to distribute the imported medicines from the head of the Food and Drug Supervisory Board.
Article 3
The import of imported medicines by pharmaceutical industries and wholesalers are also must secure approval of the imported medicines from the Head of the Food and Drug Supervisory Board, besides abiding by the provisions of import legislation in force.
Article 4
(1) approval of the import of imported medicines is granted on the basis Of application.
(2) Every application only applies to once import.
(3) the application is submitted in writing to the head of the Food and drug supervisory Board.
(4) the approval of the import of imported medicines is issued in not later than one working day.
Article 5
(1) the application as intended in article 4 must be accompanied by:
- a. application signed by pharmacist in responsible for pharmaceutical industries or assistant to pharmacist in responsible for pharmaceutical wholesalers;
- b.Photo copy of license to distribute imported medicine;
- c. Certificate of analysis of every batch of imported medicine;
- d. Cetificate of Pharmaceutical Product from producing country.
(2) Beside fulfilling the requirements as intended in paragraph (1), the import of imported medicines n the form of vaccines must be also accompanied by bets attainment certificate from the head of the Food and Drug Supervisory Board or the authorized official of the country of foreign of the imported medicines.
(3) the application as intended in paragraph (1) a is in accordance wit specimen mentioned in attachment I.
Article 6
the import of imported goods must be documented properly so as to facilitate the examination and re-tracking as well as can be examined at anytime by officers of the Food and Drug Supervisory Board and/or Food and Drug Supervisory Main Center/ Centers in accordance with Proper Distribution Method of Medicines on the basis of Decision of the Head of the Food and Drug Supervisory Board No. HK.00.05.3.2522/2003.
Article 7
(1) Every pharmaceutical industry or pharmaceutical wholesaler importing imported medicines into the Indonesian territory without the approval as intended in Article 3 is liable to administrative measure.
(2) the administrative measure as intended in paragraph (1) can be in the form of:
- a. written warning;
- b. suspension of activity;
- c. freezing and/or revocation of license to distribute imported medicines; or
- d. other administrative measures and/or penalty in accordance wit the provisions of legislation in force.
Article 8
With the enforcement of this regulation, all provisions of legislation related to the import of existied imported medicines remain effective as long as they do not contravene and/or have not been replaced on the basis of this regulation.
Article 9
The regulation comes into force as from the date of stipulation.
For public cognizance, the regulation shall be promulgated in state gazette of the republic of Indonesia.
Stipulated in Jakarta
On July 10, 2005
THE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD
Sgd
H. SAMPURNO
Attachment to REGULATION OF THE HEAD OF FOOD AND DRUG SUPERVISORY BOARD OF REPUBLIC OF INDONESIA
NO. HK.00.05.1.3459