to Indonesian
a. that medicines substances are used for pharmaceutical industry production may be misused to produce illegal medicines;
b. that to prevent misuse medicines substances for illegal medicines is necessary to be controlled since the entry to the Indonesian territory;
c. that control on the medicines substance as stipulated by Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.1.3460 of 2005 concerning Supervision on the Entry of Medicines Substances is not appropriate with development of science and technology, so it is necessary to improve it;
d. that based on consideration as intended in paragraphs a, b and c, it is necessary to stipulate Regulation of the Head of National Agency of Drug and Food Control concerning Supervision on the Entry of Medicines Substances;
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. 1799/Menkes/Per/XII/2010 concerning Pharmaceutical Industry.
7. Decree of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM/2001 concerning Organization and Work Flow of Drugs and Food Control Agency as amended by Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.21.4231 of 2004;
8. 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;
9. 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;
10. 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;
11. 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;
REGULATION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL CONCERNING SUPERVISION ON THE ENTRY OF MEDICINES SUBSTANCES
In this Regulation:
1. Entry of Medicines Substances is entry of medicines substance into the Indonesian territory.
2. Medicines Substance is substance with function or not, that is used in medicines processing with standard and quality as pharmaceutical substance, excluding Medicines Substance in the form of narcotics, psychotropic and precursor.
3. Pharmaceutical Industry is business entity that has license from Ministry of Health to produce medicines or Medicines Substances.
4. Pharmaceutical Wholesalers are Pharmaceutical Wholesalers who has permit to distribute Medicines Substances.
5. 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.
6. 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.
7. Head of Agency is Head of Agency who has responsibility in the control fo Drugs and Foods.
(1) Entry of Medical Substances only can be conducted by:
(2) Pharmaceutical Industry as intended in paragraph (1) a may only import Medicine substances for its own production.
(1) The entry as intended in Article 2 shall be done in accordance with the regulation in the import field.
(2) Beside in accordance with provision as intended in paragraph (1), also shall get approval to enter Medicines Substances from Head of Agency.
(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).
(3) Approval to enter Medicines Substances shall be given within 1 (one) day after all the requirements have been fulfilled completely and correctly.
Application as intended in paragraph (4) shall be completed with the following documents:
(1) Each SKI is valid only for 1 (one) time of entry.
(2) The application as intended in Article 4 paragraph (1) is subject to fees as Non Tax State Revenue in accordance with the regulation.
(1) Entry Documents of Medicine Substances shall be documented in accordance with Guideline for Good Distribution of Medicines, for the easiness of inspection.
(2) Documents as intended in paragraph (1) may be inspected at any time by the officers of National Agency of Drug and Food Control.
(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 7 is liable to administrative sanction.
(2) The administration sanction as intended in paragraph (1) can be in the form of:
With the enforcement of this Regulation, SKI application that is still being processed and has not obtain approval, shall still be processed based on Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.1.3460 of 2005 concerning Supervision on the Entry of Medicines Substances;
When this Regulation comes into force, Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.1.3460 of 2005 concerning Supervision on the Entry of Medicines Substances 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 NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA
signed,
KUSTANTINAH