Read the untranslated law here: http://peraturan.go.id/inc/view/11e44c50b9785860bd80313233303332.html
bn16-2012 fnHeader (); The text is not in the original format.
Back NEWS of the REPUBLIC of INDONESIA No. 16, 2012 RULES the HEAD of FOOD and DRUG WATCHDOG AGENCY of the REPUBLIC of INDONESIA NUMBER HK. 03.1.3.12.11.10693 in 2011 ABOUT OVERSIGHT of INFUSION DRUG INGREDIENTS with the GRACE of GOD ALMIGHTY HEAD of FOOD and DRUG WATCHDOG AGENCY of the Republic of INDONESIA, Considering: a. that the medicinal ingredients used in the interest of the pharmaceutical industry's production is also likely be abused for the production of illegal drugs;
b. that to prevent the misuse of the drug for the purposes of illegal material was seen to do Oversight since the admission into the territory of Indonesia;
c. supervisory arrangements that drug material as already set out in the regulations of the Chief food and drug Watchdog Agency Number HK. 00.05.1.3460 in 2005 about the supervision of Drug raw materials supplies have been incompatible with the development of science and technology so that needs to be enhanced;
d. that based on considerations as referred to in letter a, letter b and c need to set rules of the head of the food and drug Watchdog Agency about oversight of Infusion Drug Ingredients;
Remember: 1. Act No. 8 of 1999 on the protection of the consumer (State Gazette Number 42 in 1999, an additional State Gazette Number 3821);
2. Act No. 36 of 2009 about health (State Gazette Number 144 in 2009, an additional State Gazette Number 5063);
3. Government Regulation Number 48 in 2010 about the type and price of the Above types of Acceptance State Tax is not applicable to the food and drug Supervisory Agency;
4. Presidential Decree Number 103 in 2001 about the position, duties, functions, authorities, Organization, Arrangement and Layout of Non Government agencies Work Department as it has several times changed the last presidential regulation Number 64 in 2005;
5. Presidential Decree Number 110 in 2001 about the Task and Organizational Unit Echelons of non government agencies I Department as it has several times changed the last presidential regulation Number 52 in 2005;
6. Regulation of the Minister of health Number 1799/Menkes/Per/XII/2010 about the pharmaceutical industry;
7. The decision of the head of the food and drug Supervisory Agency Number 02001/SK/KBPOM 2001 about the Organization of Supervisory Work Tata & medicines and Food as amended by decision of the head of the food and drug Supervisory Agency Number HK. 00.05.21.4231 2004;
8. The decision of the head of the food and drug Supervisory Agency Number HK. 00.05.3.2522 in 2003 on the implementation of the guidelines of How the distribution of Drugs;
9. The decision of the head of the food and drug Supervisory Agency Number HK. 00.05.23.4415 in 2008 about the enactment of the electronic systems in the framework of the Indonesia National Single Window Environment a drug and food Supervisory Agency;
10. The decision of the head of the food and drug Supervisory Agency Number HK. 00.05.23.4416 in 2008 about the determination of the level of service (Service Level Arrangement) in the environment a drug and food Supervisory Agency within the framework of the Indonesia National Single Window;
11. The decision of the head of the food and drug Supervisory Agency Number HK. 00.06.331.3.1655 in 2009 about the determination of the Batch/Lot Release Procedures Release Vaccines for humans;
DECIDED: setting: RULE the HEAD of FOOD and DRUG WATCHDOG AGENCY of the REPUBLIC of INDONESIA CONCERNING the SUPERVISION of REVENUE.
CHAPTER I GENERAL PROVISIONS article 1 in this rule is: 1. Infusion Drug Ingredient is Medicinal Materials importation into the territory of Indonesia.
2. the Medicinal Ingredient is a material good nutritious nutritious or not used in drug processing with standard and quality as raw Material, not including pharmaceutical Drugs in the form of narcotic drugs, psychotropic substances and precursors.
3. The pharmaceutical industry is a business entity that has a permit from the Minister of health to conduct the activities of making drugs or Drug Ingredients.
4. Large Merchant pharmacy is pharmaceutical Wholesalers have permission to transmit.
5. certificate of release the batch/lot (batch/lot release certificate) is a legal document that allows a manufacturer to issue a batch/lot specific as confirmation that the batch/lot meets specifications and requirements that apply.
6. Protocol summary batch/lot (batch summary protocol) is a document that contains a summary of the test results and the process of making a batch/lot of vaccine, which is certified and signed by the person in charge of vaccine industry.
7. The head of the Agency is the head of the agency responsible in the field of supervision of food and drug.
CHAPTER II INFUSION of MEDICINE article 2 (1) Infusion Drug Ingredients can only be done by: a. the pharmaceutical industry; and b. the pharmaceutical Wholesalers.
(2) pharmaceutical industry as referred to in paragraph (1) letter a Medicinal Ingredient can enter only for its own needs.
Article 3 (1) Income referred to in article 2 must be done in accordance with the provisions of the legislation in the field of import.
(2) in addition to must comply with the provisions referred to in subsection (1), it is also subject to approval of the head of a Drug Ingredient incorporation Agency.
(3) the approval referred to in subsection (2) in the form of an import Certificate (SKI).
CHAPTER III PROCEDURES for APPLICATION of article 4 (1) SKI as stipulated in article 3 paragraph (3) is given on the basis of the petition.
(2) the application referred to in subsection (1) is filed electronically through the website Drug and food Supervisory Agency (www.pom.go.id) or through the NSW BPOM (URe-bpom.pom.go.id).
(3) the approval of Medicinal Ingredients administered infusion the longest one (1) business day after you filled all requirements with complete and correct.
Article 5 Application as referred to in article 4, should be equipped with the following documents: a. the certificate of analysis for each batch/lot Medicinal Materials are included;
b. invoice (invoice);
c. Bill of Lading (b/l) or Air Way Bill (AWB);
d. proof of payment Acceptance Country instead of taxes (PNBP); and e. the protocols summary batch/lot (batch/lot summary protocol) issued by the manufacturer or batch/lot release certificate (batch/lot release certificate) from the Authorities in countries where the vaccine passed, specifically for the insertion of the active substances of the vaccine.
Article 6 (1) every SKIING are only valid for one (1) times income.
(2) upon application as referred to in article 4 paragraph (1) is not a Country as an acceptance of the tax in accordance with the legislation.
Article 7 (1) a document must be documented Medicinal Material income in accordance with the guidelines of How the distribution of Drugs is good, so it's easy to do the examination.
(2) against the document referred to in subsection (1) at any time can be performed by officers of the food and drug Supervisory Agency.
CHAPTER IV article 8 ADMINISTRATIVE ACTIONS (1) every pharmaceutical industry or pharmaceutical Wholesalers enter Drug Ingredients without fulfilling the conditions as referred to in article 3 and/or article 7 may be subject to administrative sanctions. (2) administrative Sanctions referred to in paragraph (1) can be either: a. a written warning;
b. temporary suspension of activities; or c. other administrative sanctions in accordance with the provisions of the legislation.
Chapter V TRANSITIONAL PROVISION article 9 at the time of this Regulation applies, petition for SKIING that is being asked and haven't gotten approval, remain unprocessed based on Regulations of the head of food and drug Watchdog Agency Number HK. 00.05.1.3460 in 2005 about the oversight of Infusion Drug raw materials.
CHAPTER VI CLOSING PROVISIONS article 10 at the time these regulations come into force, the regulation of the head of the food and drug Supervisory Agency Number HK. 00.05.1.3460 in 2005 about the raw material Drug Infusion Supervision was revoked and declared inapplicable.
Article 11 this Regulation comes into force from the date of promulgation.
In order to make everyone aware of it, ordered the enactment of this regulation with its placement in the news of the Republic of Indonesia.
Established in Jakarta on December 30, 2011 at the HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the Republic of INDONESIA, KUSTANTINAH Enacted in Jakarta on 4 January 2012 the MINISTER of LAW and HUMAN RIGHTS REPUBLIC of INDONESIA, AMIR SYAMSUDDIN fnFooter ();
Search Translated Laws of Indonesia