STATE NEWS
REPUBLIC OF INDONESIA
REGULATION OF THE HEAD OF THE REPUBLIC OF INDONESIA ' S MEDICINE AND FOOD WATCHDOG
NUMBER HK.03.1.3.12.11.10693 IN 2011
ABOUT
THE SUPERVISION OF THE INCOME OF THE DRUG
WITH THE GRACE OF THE ALMIGHTY GOD
HEAD OF THE REPUBLIC OF INDONESIA ' S MEDICINE AND MEDICINE SUPERVISORS,
Weigh: a. that the drug material used for the benefit of pharmaceutical industry production is also likely to be misused for drug production illegally;
B. that to prevent the misuse of drug material for illegal interests is seen as necessary oversight since its installer into the Indonesian territory;
c. that the supervision arrangement of the drug materials as it has been specified in the Regulation of the Head of the Drug and Drug Administration HK.00.05.1.3460 in 2005 on the Oversight of the Revenue of the Drug Baku has not been compatible with the development of the science knowledge and technology so it needs to be refined;
D. that based on the consideration as referred to in the letter a, the letter b and the letter c need to establish the Chief Regulation of the Drug and Drug Administration on the Oversight of the Drug Materials;
Given: 1. Act No. 8 of 1999 on Consumer Protection (State Sheet 1999 No. 42, Additional Gazette State Number 3821);
2. Law Number 36 Year 2009 on Health (State Sheet 2009 Number 144, Additional Gazette State Number 5063);
3. Government Regulation No. 48 of 2010 on Types and Tarif Over Types of State Reception Not the Applicable Tax on the Board of Trusts of Drug and Food;
4. The Presidential Decree Number 103 of 2001 on the Position, Duties, Functions, Authority, Organizational Arrangement, and the Working Governance of the Non-Department Government as it has been several times amended by the Presidential Regulation No. 64 of 2005;
5. Presidential Decree Number 110 of 2001 on Unit of Organization and Duty of Eselon I Institute of non-Department Governments as it has been several times amended last with Presidential Regulation No. 52 of 2005;
6. Health Minister Regulation Number 1799 /Menkes/Per/XII/2010 about Pharmaceutical Industry;
7. Decision of the Head of the Board of Trusts of the Drug and Food Number 02001 /SK/KBPOM 2001 on the Organization & Working Agency of the Food and Drug Administration as amended by Decision of Head of the Board of Trusts of Drug and Food Number HK.00.05.21.4231 2004;
8. Decision Head of the Board of Trusts of Drug and Food Number HK.00.05.3.2522 Year 2003 on the Application of the Good Drug Distribution Way Guidelines;
9. Decree Head of the Board of Trusts of Drug and Food Number HK.00.00.05.23.4415 Year 2008 on the Treatment of Electronic Systems in the Indonesian Framework National Single Window in the Environment of the Drug and Drug Administration;
10. Decision Head of the Board of Trusts of Drug and Food Number HK.00.00.05.23.4416 Year 2008 on Service Level Arrangement (Service Level Arrangement) in the Environmental Monitoring Agency and Food in Indonesia Framework National Single Window;
11. Decision Head of the Board of Trusts of Drug and Food Number HK.00.06.331.3.1655 Year 2009 on Redemption of Surgical Procedure Bets/Lot Release Vaccine For Humans;
DECIDED:
" REGULATION OF THE HEAD OF THE SUPERVISORS OF THE DRUG AND FOOD REPUBLIC OF INDONESIA ON THE SUPERVISION OF THE INCOME OF THE DRUG.
BAB I
UMUM PROVISIONS
Section 1
In this Regulation referred to:
1. Drug Material is the importation of Drug Materials into the Indonesian region.
2. Drug material is a well-chomated and unchicable material used in drug processing by standards and quality as a pharmaceutical raw material, excluding drug-based drugs, psychotropic and precursors.
3. The Pharmaceutical Industry is a business entity that has the permission of the Minister of Health to conduct drug-making or Drug-making activities.
4. The Great Merchant of Pharmacy is the Great Merchant of Pharmacy who has the permission to channel the Drug Materials.
5. The graduation certificate of bets/lot (batch/lot release certificate) is the official document that allows the manufacturer to issue certain bets/lot as confirmation that the bets/lot meet the specifications and requirements that Valid.
6. The summary of the bets/lot summary (summary batch protocol) is a document that contains a summary of the process of creating and the results of a test of a test/lot vaccine, which is certified and signed by the industry's responsible for the vaccine industry.
7. The Head of the Agency is the Head of the Agency responsible in the area of the supervision of medicine and food.
BAB II
THE INCLUSION OF THE MEDICINAL MATERIAL
Section 2
(1) The Penitter of the Drug Materials may only be performed by:
a. Pharmaceutical industry; and
B. The Great Merchant of Pharmacy.
(2) The Pharmaceutical Industry as referred to in paragraph (1) of the letter a can only include the Drug Materials for its own production needs.
Section 3
(1) The warranties as referred to in Section 2 must be performed in accordance with the provisions of the laws in the field of import.
(2) In addition to having to be in accordance with the provisions as referred to in paragraph (1), it must also receive the approval of the income of the Drug Material from the Chief.
(3) Approval as referred to in paragraph (2) of the Import Letter of Import (SKI).
BAB III
ORDER THE APPLICATION
Section 4
(1) SKI as referred to in Section 3 of the paragraph (3) is provided on the basis of a request.
(2) The order of the application as referred to in paragraph (1) is submitted electronically via the website of the Food and Drug Administration (www.pom.go.id) or through the NSW BPOM (e-bpom.pom.go.id).
(3) The Cloud Service may be used for the following:
Section 5
The request as referred to in Article 4, must be supplemented with the following document:
a. the analysis certificate for each bets/lot of the Drug Material entered;
B. invoice (
invoice);
C.
Bill of Lading (B/L) or
Air Way Bill (AWB);
D. proof of State Reception payment Not Taxes (PNBP); and
e. The bets/lot summary protocol (summary batch/lot protocol) published by the manufacturer or revocation certificate of the bets/lot (batch/lot release certificate) from the Authority Board in the state of the vaccine Graduated, specifically for the income of the active substance of the vaccine.
Section 6
(1) Each SKI only applies to 1 (one) times of income.
(2) On the request as referred to in Section 4 of the paragraph (1) is subject to the Acceptance of State Not Taxes under the provisions of the laws.
Section 7
(1) The admission documents of the Drug Materials must be documented in accordance with the Good Drug Distribution Way Guidelines, so that it is easy to check.
(2) Against the document as referred to in paragraph (1) any time can be conducted an examination by the officers of the Food and Drug Administration.
BAB IV
ADMINISTRATIVE ACTIONS
Section 8
(1) Any Pharmaceutical Industry or Large Traders of Pharmacy that includes the Drug Materials without fulfilling the provisions as referred to in Article 3 and/or Section 7 may be subject to administrative sanction.
(2) Administrative sanctions as referred to in paragraph (1) may be:
a. written warning;
B. temporary termination of activities; or
c. Other administrative sanctions in accordance with the provisions of the laws.
BAB V
THE TRANSITION PROVISION
Section 9
At the time this Regulation is in effect, the SKI request that is being filed and has not yet received approval, remains processed under the Regulation of the Head of the Drug and Drug Administration HK.00.05.1.3460 Year 2005 on the Monitoring of the Baku Ingredient Installation The drug.
BAB VI
CLOSING PROVISIONS
Section 10
By the time this Regulation came into effect, the Regulation of the Head of the Food and Drug Administration Number HK.00.00.05.1.3460 Year 2005 on the Monitoring of Drug Default Materials was revoked and declared not valid.
Section 11
This rule comes into effect from the date of the invitation.
In order for everyone to know it, order the invitational of this Regulation with its placement in the News of the Republic of Indonesia.
Set in Jakarta
on December 30, 2011
THE HEAD OF THE DRUG AND FOOD SUPERVISORS
REPUBLIC OF INDONESIA,
I ' M CHALLENGING
Promulgated in Jakarta
on January 4, 2012
MINISTER OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA,
AMIR SYAMSUDIN
