to Indonesian
a. that distributed medicines, include import medicines should fulfil conditions of safety, function and quality;
b. that to arrange supervision on the import medicine as stipulated by Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.1.3459 of 2005 concerning Supervision on the Entry of Import Medicines is not appropriate with development of science and technology, so it is necessary to improve it;
c. that based on consideration as intended in paragraphs a and b, it is necessary to stipulate Regulation of the Head of National Agency of Drug and Food Control concerning Supervision on the Entry of Imported Medicines;
1. Law No. 8/1999 concerning Consumer Protection (Statute Book No. 42/1999, Supplement to Statute Book No. 3621);
2. Law No. 36/2009 concerning Health (Statute Book No. 144/2008, Supplement to Statute Book No. 5063);
3. Government Regulation No. 48/2010 concerning Kinds and Tariff on the Non Tax State Revenue valid within National Agency of Drug and Food Control;
4. Presidential Decree No. 103/2001 concerning Position, Duties, Function, Right, Organization Structure and Work Flow of Non Ministries Government Agency as amended several times, the latest by Presidential Regulation No. 64/2005;
5. Presidential Decree No. 110/2001 concerning Organization Unit and Task of First Echelon of Non Ministries Government Agency as amended several times, the latest by Presidential Regulation No. 52/2005;
6. Regulation of the Minister of Health No. 1010/Menkes/Per/XI/2008 concerning Drugs Registration as amended by Regulation of the Minister of Health No. 1120/Menkes/Per/XII/2008;
7. Regulation of the Minister of Health No. 1799/Menkes/Per/XII/2010 concerning Pharmaceutical Industry;
8. Decree of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM/2001 concerning Organization & Work Flow of National Agency of Drug and Food Control as amended by Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.21.4231 of 2004;
9. Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.3.2522 of 2003 concerning Application of Guideline for Good Distribution of Drugs;
10. Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.23.4415 concerning Application of Electronic System in the Framework of Indonesia National Single Window in Drugs an Foods Control Agency Environment;
11. Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.23.4416 concerning Application of Service Level Arrangement in the National Agency of Drug and Food Control in the Framework of Indonesia National Single Window;
12. Decree of the Head of National Agency of Drug and Food Control No. HK.00.06.331.3.1655 of 2009 concerning Application of Passing Procedure of Vaccine Batch/Lot for Human;
13. Regulation of the Head of National Agency of Drug and Food Control No. HK.03.1.23.10.0.08481 of 2001 concerning Criteria and Procedures of Drugs Registration;
REGULATION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL CONCERNING SUPERVISION ON THE ENTRY OF IMPORT MEDICINES
In this Regulation:
1. Entry of Import Medicines is entry of medicines into the Indonesian territory.
2. Distribution License is a model of registration approval of medicines so that the medicines can be distributed in the Indonesian territory.
3. Imported Medicines are medicines produced by pharmaceutical industries abroad in the form of finishing products or break products in primary packaging that will be distributed in Indonesia, exclude Imported Goods in the form of narcotics, psychotropic and have precursor contents.
4. Break products are substances already processed and just need packaging activities to become medicines.
5. Pharmaceutical Industry is business entity already secure permit from Ministry of Health to conduct production of medicines or medicines substances.
6. Pharmaceutical Wholesalers are legal company already secure permit for procurement, store, distribution of medicines and/or medicines substance in the high amount in according to the regulations.
7. Batch/Lot testing is evaluation process by National Agency of Drug and Food Control on the every batch/lot of imported medicines in the form of vaccine for human before approved to be marketed.
8. Batch/lot release certificate is legal document that allow producer to release specified batch/lot as confirmation that the batch/lot fulfil valid specifications and conditions.
9. Summary batch protocol is document with content of summary of the production process and result of vaccine batch/lot test, certified and signed by vaccine industry responsibility.
10. Head of the Board is Head of the Board who has responsibility in the control fo Drugs and Foods.
(1) Entry of Imported Drugs can only be conducted by Pharmaceutical Industry who has Circulation Permit.
(2) Pharmaceutical Industry who has Circulation Permit as intended in paragraph (1) may appoint other Pharmaceutical Industry or Importer Pharmaceutical Wholesalers as implementer of drug import.
(1) The entry as intended in Article 2 shall be in accordance with the provisions of the regulation on the import field.
(2) Besides shall be in accordance with the provisions as intended in paragraph (1), also shall get an approval to enter the Imported Medicines from the Head of the Board.
(3) Approval as intended in paragraph (2) is in the form of Import Approval (SKI).
(1) SKI as intended in Article 3 paragraph (3) shall be given based on application.
(2) Procedure of application as intended in paragraph (1) shall be filed electronically through National Agency of Drug and Food Control website (www.pom.go.id) or through NSW BPOM (http://e-bpom.pom.go.id).
Application as intended in paragraph (4) should be attached with the following documents:
Entry of Imported Medicines in the form of vaccine for human besides shall be accompanied by documents as intended in Article 5, also shall be accompanied with following documents:
Entry of Import Medicine in the form of sera for human besides shall be accompanied with documents as intended in Article 5, also shall be accompanied with certificate of analysis that describes the source of active substances.
Approval for the entry of Imported Medicines is given within 1 (one) working day after all the requirements have been fulfilled completely and correctly.
Each SKI is valid only for 1 (one) time of entry.
(1) Entry Documents of Imported Medicine shall be documented in accordance with the Guideline of Good Distribution of Medicines, for the easiness of inspection.
(2) Documents as intended in paragraph (1) may be inspected at any time by officers of National Agency of Drug and Food Control.
(1) Imported Medicine in the form of vaccine for human that already obtain SKI, can only be distributed after its sample was taken, evaluated, tested and the results fulfil the requirements.
(2) Sampling, evaluation, and testing as intended in paragraph (1) shall be conducted by the National Agency of Drug and Food Control.
(3) All fees of sampling, evaluation, and testing shall become the responsibility of applicant.
(1) Imported Medicine in the form of vaccine that already obtain batch/lot release certificate from the Authority Agency in the country where vaccine is passed, shall have:
(2) Evaluation and testing results as intended in paragraph (1) is in the form of passing certificate.
(3) Passing certificate as intended in paragraph (1) shall be issued within 10 (ten) working days, after the laboratory of Centre of National Drugs and Foods Testing (PPOMN), National Agency of Drug and Food Control receive the complete documents and sample.
(1) Imported Medicine in the form of vaccine that has not obtain batch/lot release certificate from the Authority Agency in the country where vaccine is passed, shall have:
(2) Evaluation and testing results as intended in paragraph (1) is in the form of passing certificate and testing certificate.
(2) Passing certificate and testing certificate as intended in paragraph (2) shall be issued at the latest 65 (sixty five) calendar days, after the Centre of National Drugs and Foods Testing (PPOMN), National Agency of Drug and Food Control receive the complete documents and sample.
Each application as intended in Article 4 paragraph (1) and implementation of evaluation and testing as intended in Article 12 and Article 13 shall be subject to fee as Non Tax State Revenues in accordance with the regulations.
(1) Every pharmaceutical industry and pharmaceutical Wholesaler importing Imported Medicines without fulfilling the provisions as intended in Article 3 and/or Article 10 and/or Article 11 paragraph (1) is liable to administrative sanction.
(2) The administrative sanction as intended in paragraph (1) may be in the form of:
With the enforcement of this Regulation, SKI application that is still being processed and has not obtain an approval, shall still be processed based on the Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.1.3459 of 2005 concerning Supervision on the Entry of Imported Medicine;
When this Regulation comes into force, Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.1.3459 of 2005 concerning Supervision on the Entry of Import Medicine shall be revoked and declared null and void.
This Regulation shall come into force on the date of promulgation.
For public cognizance, this Regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on December 30, 2011
HEAD OF DRUGS AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA
signed,
KUSTANTINAH