(4) Requirements for the Circular Drug Circulatory Permit by a fish drug distributor:
a. Administration requirements:
1. Photocopy of the own Mechanism. Revocation.
MARINE MINISTER REGULATION AND FISHERIES
REPUBLIC OF INDONESIA
NUMBER 14 /PERMEN-KP/2013
ABOUT
CHANGES TO THE MARINE MINISTER ' S REGULATIONS AND FISHERIES
THE PER.04/MEN/2012 NUMBER ABOUT THE FISH DRUG
WITH THE GRACE OF THE ALMIGHTY GOD
MINISTER OF MARINE AND FISHERIES REPUBLIC OF INDONESIA,
Weigh: a. that the provision and circulation of fish drugs should be able to provide quality assurance and security;
B. that in order to increase the control of the provision and circulation of fish drugs, it is necessary to review the Regulation of the Minister of Marine and Fisheries of PER.15// 2007 on the Requirements and Conditions of the Publishing of Fish Drug Permits and Ordinance of Ministers Marine and Fisheries Number PER.04/MEN/2012 about the Drug Fish;
c. that under consideration as intended on letter a and letter b, need to establish the Minister of the Marine and Fisheries Regulation on the Changes to the Regulation of the Minister of Marine and Fisheries of PER.04/MEN/2012 on the Drug of Fish;
Given: 1. Act Number 16 of 1992 on Quarantine Animals, Fish and Plants (State Sheet of Indonesia Year 1992 Number 56, Additional Gazette of the Republic of Indonesia Number 3482);
2. Law No. 31 Year 2004 on Fisheries (State Gazette Indonesia Year 2004 Number 118, Additional Gazette Republic of Indonesia Number 4433), as amended by Law Number 45 Year 2009 (State Sheet) Republic of Indonesia Year 2009 Number 154, Additional Gazette of the Republic of Indonesia Number 5073);
3. Law No. 32 Year 2004 on Local Government (Indonesian Republic of Indonesia 2004 Number 128, Additional Gazette Republic of Indonesia Number 4437), as amended last by Act Number 12 Year 2008 (sheet State of the Republic of Indonesia 2008 No. 59, Additional Gazette of the Republic of Indonesia Number 4844);
4. Government Regulation No. 15 Year 2002 on Quarantine Of Fish (sheet State Of The Republic Of Indonesia In 2002 Number 36, Extra State Sheet Number 4197);
5. Government Regulation Number 38 Year 2007 on the Partition of Government Affairs Between the Government, Provincial Local Government, and the District/City Local Government (Indonesian Republic of 2007) Number 82, additional State Sheet Republic of Indonesia No. 4737);
6. Presidential Regulation No. 47 of 2009 on the Establishment and Organization of the Ministry of State, as amended with the Presidential Regulation No. 91 of 2011 (State Sheet of the Republic of Indonesia 2011 No. 141);
7. Presidential Regulation No. 24 of 2010 on Occupation, Duty, and Functions of the Ministry of State and Functions of the Organization, Duty, and Functions of the Ministry of State, as amended by Presidential Regulation No. 38 of 2013 (State of the Republic of Indonesia in 2013 Number 90);
8. Presidential Decree No. 84 /P of the Year 2009, as amended by Presidential Decree Number 60 /P of 2013;
9. Regulation of the Minister of Marine and Fisheries of PER.20/MEN/2007 on the Action of Quarantine Fish For The Income Of Pest-carrier Media and Quarantine Fish From Abroad and From A Area To Other Areas Within The State Of The Republic Of Indonesia;
Ten. The Regulation of the Minister of Maritime Affairs and Fisheries of PER.15/MEN/2010 on the Organization and the Working Governance of the Ministry of Marine and Fisheries;
11. Regulation of Marine Minister and Fisheries Number PER.04/MEN/2012 on Fish Drugs (Republic of the Republic of Indonesia News 2012 Number 139);
DECIDED:
SET: THE REGULATION OF MARINE MINISTERS AND FISHERIES ON CHANGES TO THE REGULATIONS OF MARINE MINISTER AND FISHERIES NUMBER PER.04/MEN/2012 ABOUT FISH DRUGS.
Article I
Some of the provisions in the Regulation of the Minister of Oceans and Fisheries Number PER.04/MEN/2012 on Fish Drugs (the Republic of Indonesia News 2012 Number 139) were changed as follows:
1. The provisions of Article 1 are changed, so that Article 1 reads as follows:
Section 1
1. The raw materials of fish drugs are all materials or chemicals that are an active ingredient, additional materials and/or helper materials either in the form of a single component, ruahan/half so that is used to make fish drugs.
2. Fish drugs are a supply that can be used to prevent and/or treat fish disease, relieve symptoms of the disease, or modify the chemical processes in the body including biological, pharmasetic, premiiks, probiotics and natural remedies.
3. Fish is any type of organism that is all over or part of its life cycle to be in the aquatic environment.
4. Etiquette is the direct writing or the writing affiated to the container or wrap containing the fish drug tagging.
5. Brosur is a sheet made of paper or other material that contains a complete tagging of the fish drugs that are included on the container or outer wrap.
6. Kemasan is a number that indicates a volume or weight or a certain amount of a fish medication in a container either wrapped or unwrapped.
7. People are individual persons or fish drug companies.
8. Fish-drug companies are companies that do business in the field of fish medicine whether legal or legal entities are not legal entities.
9. Fish drug manufacturers are every person who produces fish drugs from raw materials until it becomes a fish drug.
10.Importir of fish drugs is any person who performs an influx of fish drugs from abroad.
11.Eksportir of fish drugs is any person who is committing to overseas drug spending.
12.Distributor fish drugs are any person who performs a fish drug dealer from a manufacturer or importer to a depo and/or a fish drug store.
13.Depo fish drugs are any person who performs a fish drug copying from a distributor.
14.A fish drug store is any person who performs a drug smuggling of fish other than hard drugs.
API-P is an importer of the manufacturer's importers published by the Director-General of Foreign Trade, the Ministry of Commerce to the importer who imports goods to the United States. used on its own and/or to support the production process and is not allowed to trade or transfer it to other parties.
16.A fish drug provision permit is a written permit that each person must have to do the provision of fish drugs.
17.A fish drug circulation permit is a written permit that each person must have to circulate a fish drug.
18.1 Fish Quarantine Officer is a specific civil servant who is given the duty to conduct quarantine measures under the law.
19.Expert Fish Health is someone who is gaining knowledge of fish health through formal education.
2. Photocopy of the company ' s founding deed, for the business entity;
3. Photocopy of NPWP owner or company;
4. SIUP photocopy;
5. Letter of appointment as a distributor of the manufacturer or importer of a fish drug;
6. List of fish drug plans that will be channeled, which contains types, sub types, forms of supplies, and sorts of supplies; and
7. Enough meted statement letter stating the truth to the data and the information delivered.
B. Technical requirements:
The affidavit is enough of the owner or the company's responsible employer, which states:
1. have storage space to guarantee the quality of fish drugs;
2. Have the storage means to guarantee the quality of the fish drugs, which are adapted to the type of distributed fish drugs, with a list of stored storage means; and
3. have a professional professional, veterinarian or apothecary as the technical responsibility of fish drugs.
(5) Requirements of Fish Drug Dealing License Terms by fish drug depo:
a. Administration requirements:
1. Photocopy of the owner 's KTP or the company' s handler;
2. Photocopy akte establishment of the company, for the enterprise entity;
3. Photocopy of NPWP owner or company;
4. SIUP photocopy;
5. List of fish drug plans that will be channeled, which contains type, sub-type, supply form, and manner of supplies; and
6. Enough meted statement letter stating the truth to the data and the information delivered.
B. Technical requirements:
The affidavit is enough of the owner or owner of the company stating:
1. has a means of storage to guarantee the quality of fish drugs, which is tailored to the type of fish drug circulated, with a list of stored storage means; and
2. have a professional professional, veterinarian or apothecary as the technical responsibility of fish drugs.
(6) Requirements of Fish Drug Circulatory Permit by fish drug store:
a. Administration requirements:
1. KTP photocopy owner;
2. SIUP photocopy;
3. List of fish drug plans that will be channeled, which contains type, sub-type, supply form, and manner of supplies; and
4. Enough meted statement letter stating the truth to the data and the information delivered.
B. Technical requirements:
The affidavit was enough from the owner or owner of the company stating that it has a storage facility, which is a closet specifically used for storing fish drugs.
Section 7C
(1) The manufacturer, importer, or exporter of fish drugs to have a Fish Drug Permit License as referred to in Article 7 of the paragraph (1) or the Letter of the Fish Drug Pass as referred to in Article 7 of the paragraph (2) must submit written in writing to the Director General with the accompanying requirements as set forth in:
a. Section 7B paragraph (1), for the fish drug manufacturer;
B. Section 7B paragraph (2), for the importer of the fish drug; or
C. Article 7B paragraph (3), for the exporter of fish drugs.
(2) Based on the request as referred to in paragraph (1), if the request requirement is complete, the judgment is done.
(3) The lapses of lapses as referred to in paragraph (2) to conduct verification of the completeness and correctness of administrative requirements and technical requirements.
(4) The lapsed assessment as referred to in paragraph (2) is poured in the News Examination Event and the results are delivered to the Director General, in case of:
a. The issuance of the Fish Drug Approval Permit or the Fish-Drug Circulatory Permit; or
B. Recommendation for the issuance of a Fish-Drug Medication Permit or a Fish-Drug License.
(5) Based on the recommendation as referred to in paragraph (4) of the letter a, the Director General publishes a Fish Drug Approval License or a Fish Drug License.
(6) Based on the recommendation as referred to in paragraph (4) of the letter b, the Director General addresses the applicant with a reason and the request file is returned to the applicant.
(7) The Form and format of the Ikan Drug-Drug Permit Permit and the Drug Trafficking License as referred to in paragraph (5) as set forth in Annex IA and Appendix IB which is an inseparable part of this Minister's Regulation.
Section 7D
(1) Manufacturer and importer of fish drugs that have a mandatory Fish Drug Consent Letter:
a. conduct the most long-time fish drug provision for the 2 years since the Fish Drug Permit License is published;
B. list the provided fish drugs; and
c. provide fish medicine according to the type of fish medication that is permitted.
(2) Exporters, distributors, depo, and fish drug stores that have the obligatory Fish Drug Drug Remedy Permit:
a. conduct the most recent fish drug circulation 2 years since the Fish Drug Circular License was published;
B. circulate a fish drug that has a Fish Drug Registration Number Letter; and
c. circulate the fish drugs according to the type of fish medication that is permitted.
Section 7E
(1) An extension of the Ikan Drug Provision Permit or a Fish Drug License License may be submitted 3 (three) months prior to the expiration of the Ikan Drug-Drug Pass or the End of the Expiration Date of the Drug Remedy.
(2) The manufacturer, importer, or exporter of fish drugs to perform an extension of the Fish Drug Disclosure License or the Fish Drug Pass, must submit a request in writing to the Director General with the following requirements:
a. Photocopy of the Fish or Drug-Drug Permit License or the Fish Drug Pass;
B. photocopy KTP owner or company handler;
c. sufficient statement of statement to be sufficient to express the truth of the data and the information that is delivered.
(3) The provisions of the issuance of the Ikan Drug-Drug Approval License of the Fish or Drug Permit License as referred to in Article 7C apply mutatis mutandis to the mechanism of extension of the Ikan Drug's Permit Permit or It's a Fish-Drug License.
Section 7F
(1) The change of the Fish Drug Medication Permit or a mandatory Fish Drug Permit License is required if there is a change:
a. company name;
B. company ' s seat;
c. owner address, for individuals;
D. attempt location; and/or
e. Kind of a fish drug.
(2) Manufacturer, importer, or exporter of fish drugs to perform a change in the Letter of the Drug Remedies or the Letter of the Circulation of the Drug Remedies submitting a request in writing to the Director General by listing the reasons for change, which accompanied the requirement:
a. fish drug manufacturer:
1. Photocopy of the Fish ' s Drug Medication Permit Mail to be changed;
2. site plan image plant and layout image (lay out) room, for the change location location;
3. Image layout (lay out) room, for changes in the type of fish drug supply; and
4. The letter of the statement is sufficient for the truth of data and the information delivered.
(1) administrative sanction of the means of freezing of a Fish Drug Medication Permit or a Fish Drug Pass, as referred to in Section 42 of the paragraph (4) letter b provided to the manufacturer, importer, exporter, distributor, depo, or fish drug store Until the end of the third term, as referred to in Article 43 of the paragraph (2) does not perform its obligations.
(2) Freezing Of A Fish Drug Provision Permit or a Fish Drug License as referred to in paragraph (1) is imposed within 30 (thirty) days.
11. The provisions of Article 44 are amended, so that Article 44 reads as follows:
Section 44
(1) administrative sanction of the breach of the Fish Drug Registration Number as referred to in Section 42 of the paragraph (4) of the letter c given to the manufacturer or importer of a fish drug that commits a breach to the provision as contemplated in Section 26.
(2) The freezing of the Fish Drug Registration Number as referred to in paragraph (1) is imposed within 30 (thirty) days.
Twelve. The provisions of Section 45 are amended, so that Article 45 reads as follows:
Section 45
(1) administrative sanction of the revocation of the Ikan Drug or Drug Withdrawal License, referred to in Article 42 of the paragraph (4) of the letter d given to the manufacturer, importer, or exporter, up to the end of the term The freezing time of a Fish Drug Passes or Drug-Drug License, as referred to in Article 43A verse (2) does not carry out its obligations.
(2) The administrative sanction of the revocation of the Fish Drug Registration Number Letter as referred to in Article 42 of the paragraph (4) of the letter e is given to:
a. the manufacturer or importer that is up to the end of the term freezing of the Fish Drug Registration Number as referred to in Article 44 of the paragraph (2) does not perform its obligations; and/or
B. The manufacturer or importer is charged with the revocation of the Ikan Drug-Drug Approval Permit or the Fish Drug Pass.
Thirteen. Between Section 45 and Section 46 of each section, Article 45A which reads as follows:
Section 45A
(1) The manufacturer or importer of a fish drug that is subjected to the revocation of the Fish Drug Registration Number Letter as referred to in Article 45 of the paragraph (2), is obliged to withdraw a fish drug that has been circulated in the longest time 150 (one hundred and fifty) days.
(2) The manufacturer or importer who does not carry out the obligation as it is referred to in paragraph (1) is subject to the revocation of the Withdrawal of the Ikan Drug.
14. The provisions of Article 49 are amended, so that Article 49 reads as follows:
Section 49
(1) In the case of setting up the CPOIB as referred to in Article 12 of the paragraph (4) is not yet specified, then the manufacture of fish drugs refers to the provisions of the Way of Good Animal Drug (CPOHB).
(2) With the Ordinance of this Minister ' s Regulation:
a. the predefined principle approval before the Order of this Minister's Regulation remains in effect until the expiration of the term;
B. The Order of the Drug Remedy, which has been issued before the Order of the Minister, is in effect for 5 (five) years since the promulgations of this Minister's Rule; and
c. Change and/or replacement of the Delivered Fish Drug Permit License and stated complete prior to the Order of this Minister, processed under the Regulation of the Minister of Oceans and Fisheries Number PER.15//2007 of Requirements and Proceeding for Fish Drug Permit Licensing.
15. The provisions of Article 50 are amended, so that Article 50 reads as follows:
Section 50
At the time the Ordinance of the Minister came into effect, the Regulation of the Minister of Marine and Fisheries of PER.15/MEN/2007 on the Requirements and Conditions of the Application of the Medicinal Remedies Permit, was revoked and declared to be unapplicable.
PASAL II
The Regulation of the Minister comes into effect on the date of the promulctest.
For each person to know it, order the invitation of the Order of the Minister with its placement in the News of the Republic of Indonesia.
Specified in Jakarta
on July 1, 2013
MINISTER OF MARINE AND FISHERIES
REPUBLIC OF INDONESIA,
SHARIF C. SUTARDJO
It is promulred in Jakarta
on 5 July 2013
MINISTER OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA,
AMIR SYAMSUDIN
Attachment:
bn893-2013
