Regulation Of The Minister Of Marine And Fisheries The Number Per. 04/men/2012 Year 2012

Original Language Title: Peraturan Menteri Kelautan dan Perikanan Nomor PER.04/MEN/2012 Tahun 2012

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Back NEWS REPUBLIC of INDONESIA No. 139, 2011 REGULATIONS the MINISTER of MARINE and FISHERIES of the REPUBLIC of INDONESIA NUMBER PER. 04/MEN/2012 ABOUT the DRUG the FISH with the GRACE of GOD ALMIGHTY the MINISTER of MARINE and FISHERIES of the REPUBLIC of INDONESIA, Considering: a. that in order to protect fish resources, the environment, and human health, the need to review the decision of the Minister of marine and Fisheries the number KEP. 26/DOWNLOAD/2002 concerning the provision of , Circulation, use, and Drug fish;
b. that the need to establish Regulations to Ministers about Drugs fish;
Remember: 1. Act No. 16 of 1992 about the Quarantine of animals, fish and plants (State Gazette of the Republic of Indonesia Number 56 of 1992, an additional Sheet of the Republic of Indonesia Number 1111);
2. Act No. 31 of 2004 concerning Fisheries (Gazette of the Republic of Indonesia Number 118 in 2004, an additional Sheet of the Republic of Indonesia Number 4433), as amended by law Number 45 in 2009 (State Gazette of the Republic of Indonesia year 2009 Number 154, additional sheets of the Republic of Indonesia Number 5073);
3. Law Number 32 of 2004 concerning Regional Government (State Gazette of the Republic of Indonesia Number 128 in 2004, an additional Sheet of the Republic of Indonesia Number 4437), as last amended by law No. 12 of 2008 (State Gazette of the Republic of Indonesia Number 59 in 2008, an additional Sheet of the Republic of Indonesia Number 4844);
4. Act No. 18 of 2009 about animal husbandry and animal health (State Gazette of the Republic of Indonesia Number 84 in 2009, an additional Sheet of the Republic of Indonesia Number 5015);
5. Government Regulation Number 78 in 1992 about the Animal Drug (Gazette of the Republic of Indonesia Number 129 in 1992, an additional Sheet of the Republic of Indonesia Number 2782);
6. Government Regulation No. 15 of 2002 about a fish Quarantine (State Gazette of the Republic of Indonesia in 2002, an additional 36 Sheet Number country number 4197);
7. Government Regulation Number 38 in 2007 about Government Affairs Divisions between the Government, local governance and local governance of the province, Kabupaten/Kota (State Gazette of the Republic of Indonesia Number 82 in 2007, an additional Sheet of the Republic of Indonesia Number 4737);
8. Presidential regulation Number 47 in 2009 about the formation and organization of the Ministries, as amended by regulation of the President Number 76 in 2011;
9. Presidential regulation Number 24 of 2010 about the position, duties, and functions of the Ministries as well as the Organization, duties, and functions of the Echelon I Ministries, as amended later presidential regulation Number 92 in 2011;
10. Presidential Decree Number 83/P in 2009, as amended by Presidential Decree Number 56/P in 2010;
11. Regulation of the Minister of marine and fisheries the number PER 20/DOWNLOAD/2007 about the Quarantine Action fish for Infusion Media Carrier Fish Quarantine pests and diseases from overseas and from One Area to Another Area within the territory of the Republic of Indonesia;
12. Regulation of the Minister of marine and fisheries the number PER 15/DOWNLOAD/2010 about the Organization and the Work of the Ministry of marine and Fisheries;
Decide: define: REGULATION of the MINISTER of MARINE and FISHERIES of FISH MEDICINE.
CHAPTER I GENERAL PROVISIONS article 1 In this ministerial regulation is: 1. The provision of drug procurement activity is fish or fish medicine raw materials is done through the creation within the country and/or income from abroad.
2. Circulation is an activity in the framework of the distribution and delivery of drugs good fish in order to trade or not to trade.
3. Medicinal raw material fish are all materials or chemical substances that form the active ingredients, additives and/or materials good helper in the form of a single component, ruahan/half so used to make fish medicine.
4. Drug preparations are Fish that can be used to treat symptoms, freeing fish, or modify chemical processes in the body which include preparations, farmasetik, biologik premiks, probiotics, and natural remedies.
5. Fish is any kind of organism that all or part of a cycle of his life in the aquatic environment.
6. Etiquette is a direct writing or writings affixed on the containers or packs that contain tagging fish medicine.
7. Brochure is made of sheets of paper or other material that contains a complete tagging of fish supplied on container or wrap the outside.
8. Packaging is a number which indicates the volume or weight or number of medicinal preparations a certain fish in containers either wrapped or wrapped. 9. People are those individuals or corporations.
10. The Corporation is a group of people and/or wealth that is well organized legal entities or not a legal entity.
11. fish drug manufacturers are the ones who make the remedy of fish for commercial purposes.
12. fish drug Importers are people who do fish medication infusion business from abroad.
13. The exporter of fish medicine is people who do drugs fish spending efforts abroad.
14. fish Medicine Distributors are the ones who do venture circulation of medicinal fishes from the manufacturer or importer to the depo and/or drug store fish.
15. the Manufacturer Importer Identification Number subsequently abbreviated to P-API is a numeric identifier importers manufacturers, published by the Director General of foreign trade, the Ministry of Trade to importers who import goods for their own use and/or to support the production process and are not allowed to trade or memindahtangankan to the other party.
16. Business license fish medication is a must-have written permission of the person who will be doing the drug business of fish.
17. Fish Quarantine Officers are certain civil servants who are tasked to perform actions based on the quarantine law.
18. Fish health expert is someone who gain knowledge about the health of the fish through formal education. 19. the Minister is the Minister of marine and fisheries.

20. The Director-General is the Director General of the Fishery.
21. Office of the province or district/city is the authorized agency and responsible in the field of fisheries.
Article 2 scope this regulation of the Minister include: a. drug raw material fish;

b. drug effort fish;

c. the purpose of use, dosage, drug classification and fish;

d. provision of medicinal fishes;

e. registration of medicinal fishes;

f. procedures for infusion drug raw material drug samples of fish, fish, fish and medicinal;

g. place of income and expenses;

h. circulation;

i. income again; and j. the construction, monitoring, and surveillance.

CHAPTER II the DRUG RAW MATERIAL FISH Section 3 (1) the provision of medicinal raw material fish through income from abroad can only be done by importers who have FIRE-P or institutions/government agencies/private.
(2) the provision of medicinal raw material fish by agencies/government/private agencies as referred to in subsection (1) is done only for the benefit of research.
(3) Medicinal raw material fish originating from abroad can be incorporated into the territory of the Republic of Indonesia after obtaining Affidavits Infusion Drug raw material fish.
(4) to obtain Affidavits Infusion Drug raw material Fish as referred to in paragraph (3), importers or agencies/government/private agencies must apply in writing to the Director General at least contain: a. name of medicinal raw material fish;

b. the name and the applicant;

c. the name of the manufacturer of the drug raw material fish;

d. country of origin of the raw material medicine fish;

e. Forms of medicinal raw material fish;

f. types of preparations medicinal raw material fish;

g. packaging size;

h. income mean drug raw material fish;

i. the amount of medicinal ingredient in fish;

j. port of unloading; and k. port income place.
(5) the Application referred to in subsection (4), performed by attaching: a. atauCertificate Analysis Certificate of Analysis (CoA);
b. Certificate of origin or Certificate of Origin (CoO), passed by the representatives of the Republic of Indonesia in the country of origin of the raw material medicine fish; and c. the certificate Already Supplied or Certificate of Free Sale.
(6) the Director General or the designated officer to evaluate the document in writing within three (3) working days since the document is received in full.
(7) based on the results of the evaluation of the documents referred to in subsection (6), the Director General of the designated officials or issuing Certificate: a. Infusion Drug raw material fish; or b. Certificate of rejection of the drug raw material Intake of fish, accompanied with the reason for denial.
(8) Certificate of income of drug raw material Fish as referred to in paragraph (7) letters a least contain: a. name of medicinal raw material fish;

b. the name and address of the importer or the agencies/government/private agencies;

c. the name of the manufacturer of the drug raw material fish;

d. country of origin of the raw material medicine fish;

e. Forms of medicinal raw material fish;

f. types of preparations medicinal raw material fish;

g. packaging size;

h. income mean drug raw material fish;

i. the amount of medicinal ingredient in fish;

j. port of unloading;

k. port place infusion; and b. valid Certificate Medicinal raw material Intake of fish.
(9) Income Certificate Medicinal raw material Fish as referred to in paragraph (2) letter a can only be used for one (1) times revenue and apply for a period of three (3) months from the date of publication.
(10) the shape and format of Income Certificate Medicinal raw material Fish as listed in Annex I which is part an integral part of the regulation of the Minister.
Article 4 (1) an exporter who will produce the drug raw material fish from the territory of the Republic of Indonesia must have a Certificate Dispensing Medicinal raw material fish.

(2) to obtain the certificate of fish Medicine raw materials Expenses referred to in subsection (1), the exporter must apply in writing to the Director General at least contain: a. name of medicinal raw material fish;

b. the name and address of the applicant;

c. the name of the manufacturer of the drug raw material fish;

d. country of destination;

e. Forms of medicinal raw material fish;

f. types of preparations medicinal raw material fish;

g. packaging size;

h. Medicinal raw materials expenses mean fish;

i. the amount of medicinal ingredient in fish; and j. the harbour venue expenses.
(3) the Director General or officials appointed to evaluate in writing within three (3) working days since the application was received in full.
(4) based on the results of the evaluation as referred to in paragraph (3) the Director General or the designated officials publish: a. Certificate of drug raw materials Expenses fish; or b. the Rejection of fish Medicine raw material Expenses, accompanied with the reason for denial.
(5) Certificate of fish Medicine raw materials Expenditure as referred to in paragraph (2) letter a, at least contain: a. name of medicinal raw material fish;

b. the name and address of the exporter;

c. the name of the manufacturer of the drug raw material fish;

d. country of destination;

e. Forms of medicinal raw material fish;

f. types of preparations medicinal raw material fish;

g. packaging size;

h. Medicinal raw materials expenses mean fish;

i. the amount of medicinal ingredient in fish;

j. place the port expenses; and k. Certificate valid Expenditures Drug raw material fish.
(6) Certificate of fish Medicine raw materials Expenditure as referred to in paragraph (2) letter a can only be used for one (1) one-time expenses and apply for a period of three (3) months from the date of publication.
(7) the shape and format of Certificate of fish Medicine raw materials Expenses as listed in annex II which are part an integral part of the regulation of the Minister.
CHAPTER III article 5 FISH MEDICINE VENTURE (1) medicinal fish Business consists of: a. the provision of fish medicine; and b. the drug circulation effort of fish.
(2) the provision of the drugs Business of fish referred to in paragraph (1) letter a drug making activities include fish from the raw material to be medicated fish and/or fish drugs income from abroad.
(3) Efforts of drug circulation of fish referred to in paragraph (1) letter b include activities related to trade, transport, and delivery of drug on fish.
Article 6 (1) every person who commits a drug business of fish, ranked above: a. drug manufacturers of fish;

b. drug importers of fish;

c. drug exporter of fish;

d. drug distributors fish;

e. drug depo fish; and f. drug store fish.
(2) the provision of fish medicine can be done by agencies/government/private agencies for the benefit of research.
Article 7 (1) the Business of providing drugs to the fish referred to in article 5 paragraph (1) letter a is done by the manufacturer or importer.
(2) Efforts of drug circulation fish as referred to in article 5 paragraph (1) letter b done by the exporter, distributor, depositions, or drug store fish.
(3) every person who commits a drug business of fish referred to in article 5 paragraph (1) required to have Drug Businesses Permit fish.
(4) further Provisions regarding the authority, the requirements and procedures for the issuance of Business License Fish Medication is controlled by a regulation of the Minister.
CHAPTER IV the PURPOSE of use, PREPARATIONS, and MEDICATED FISH CLASSIFICATION article 8 the purpose of the use of fish at least include the following: a. to prevent, reduce, and eliminate the symptoms of the disease of fish;

2. diagnose and treat fish diseases;

c. help soothe and mematirasakan fish;

d. increase the reproduction of fish;

e. address the deficiency of vitamins and minerals;

f. color and embellish the body of fish;
g. maintain and/or improve the water quality for aquaculture; and/or h. maintain and/or improve the quality of the results of the fishery.

Article 9 the drug sediaannya is classified by the type of fish over: a. biologik;

b. farmasetik;

c. premiks;

d. probiotics; and e. a natural remedy.

Article 10 (1) fish with this type of Drug preparations biologik referred to in article 9 of the letter a is generated through biological processes in animals or animal tissues to induce immunity, diagnose disease, or treat diseases with imunologik processes, among other vaccines, sera (antisera), antigen and diagnostika biologik.
(2) Medicinal preparations with the kind of fish farmasetik as referred to in article 9 letter b produced from inorganic or organic materials and/or chemical synthesis reactions used based on pharmacological work resources, such as hormones, antibiotics, antibakteria, kemoterapetika, anti fungal, anti parasite, anthelmintik, and anestetika.
(3) the type of fish stocks to Remedy premiks as referred to in article 9 of the letter c is a drug made by fish that feed or supplementary feed that his deed was mingled in feed fish, consisting of the prefix feed (feed additive) and complementary feeding (feed supplement).
(4) Affix the feed (feed additive) as referred to in paragraph (3) is additional material to feed that naturally contain no nutrients or nutrients (nutrient) that the purpose of its use among other embellish color fish, pengaroma feed, and feed preservative.
(5) Supplementary feed (feed supplement) as referred to in paragraph (3) is a substance that is naturally already contained in the feed but the amount needs to be increased by adding them in the feed, such as amino acids, vitamins, and minerals.
(6) the type of fish Medicine preparations probiotics as referred to in article 9 of the letter d, resulting from the non pathogenic Microbe that is naturally present in the environment in the water and in fish's body that works with the process of bioremediation, biokontrol cerna and channels as contender pathogenic bacteria, such as Bacillus Subtillis bacteria, Lactobacillus, Nitrosomonas and Nitrobacter,.
(7) the type of fish stocks to Remedy natural remedies as referred to in article 9 of the letter e, is the material or materials in the form of herb material the origin of plants, animal origin materials, materials of mineral origin, galenik preparations, or a blend of these materials without the addition of chemical substances and drugs work-power which worked only on the basis of empirical data and there has not been a complete clinical data, among other meniran leaf extract and extract of sambiloto leaves.
Article 11 (1) fish Medication based on the classification of the danger posed in its use, are classified for: a. Drug hard drugs, it is the fish that if their use does not comply with the provisions may pose danger to fish, environmental and/or humans who consume the fish;
b. drug-free is limited, is a hard drug to fish that are imposed as a remedy for specific types of fish-free with the provisions provided by the number, dosage, dosage form and condition of use of a specific and given a special warning signs; and c. a drug free, is a fish of the drug can be obtained and used freely without the prescription of a veterinarian and/or recommendations from health experts the fish.
(2) Provisions on the classification of fish medicine referred to in subsection (1) is designated by a decision of the Minister.
Chapter V SUPPLYING DRUGS FISH article 12 (1) the provision of fish medicine is done through the creation of income in the country and from abroad.
(2) the provision of fish medicine is conducted with emphasis on manufacturing in the country.
(3) Peyediaan fish medications through the creation within the country is carried out according to the way of making good fish Medication (CPOIB).
(4) further Provisions regarding CPOIB as referred to in paragraph (3) are defined by regulation of the Minister.
Article 13 (1) the provision of drugs with other types of fish preparations biologik, probiotics, and natural medicine must meet the following conditions: a. the fish with the kind of drug preparations biologik enforceable for these types of fish diseases that already existed in Indonesia;
b. drug fish with different types of probiotic preparations in one of most preparations contain 5 species of microbes with a density of each species at least 106 cfu/ml; and/or c. fish medication with the kind of preparations of natural medicine in one preparation containing at most 5 (five) different types of simplicia.
(2) the provision of medicinal preparations by the type of fish to a disease diagnosis biologik kind of disease does not exist in Indonesia, can be done if it does not contain microbial life and/or any portion thereof that brings elements of pathogens.
CHAPTER VI REGISTRATION of FISH MEDICINE is considered part of the General clause 14 (1) fish Medication provided by the manufacturer or importer required to have a letter of registration number of fish Medicine.
(2) the obligation to have a letter of registration number Drug Fish as referred to in paragraph (1) excluded for: a. fish medication provided by agencies/government/private agencies; or b. a natural remedy that is processed in a simple, containing no hard drugs, and used for the benefit of its own.
The second part of the mechanism of article 15 (1) to obtain registration number Drug Fish as referred to in article 14 paragraph (1), the manufacturer or importer must apply in writing to the Director-General with the attach: a. quality test results reports;
b. report of the test results, for fish that require drug testing, airy; and c. the technical data of the drug the fish.
(2) the petition Letter registration number Drug drugs fish for fish which comes from revenue from abroad, in addition to attaching the requirements referred to in subsection (1), compulsory equipped with: a. a photocopy of the certificate of origin (Certificate of Origin), with original shows;
b. photocopy of Certificates or Affidavits Already Sold (Certificate of Free Sale), with original shows;
c. photocopy of Certificates Making good fish Medication (Certificate of Good Manufacturing Practice) from the authorized institution of the country of origin, with the original shows;

d. photocopies of Certificates is not a product of genetic engineering (Certificate of Non Genetically Modified Organism) for the fish stocks to drugs that are not product biologik genetic engineering, by showing the original;
e. photocopies of the letter designation of Agents or distributors (Letter of Appointment) of overseas manufacturers to importers in Indonesia, with the original shows; and f. photocopying Affidavits Infusion Drug Samples of fish.
(3) a certificate Making good fish Medication (Certificate of Good Manufacturing Practice) as referred to in paragraph (2) Letter c, at least on a par with the CPOIB.
Article 16 (1) quality Testing and testing of airy as stipulated in article 15 paragraph (1) letter a and letter b made against drug samples of fish.
(2) Drug Samples of fish originating from abroad can be incorporated into the territory of the Republic of Indonesia after acquiring a Drug Sample Fish Intake Information.
(3) to obtain a Certificate of income of drug Samples of fish referred to in paragraph (2), the importer must apply in writing to the Director General at least contain: a. name of the trademark/brand drug samples of fish;

b. the name and address of the applicant;

c. the name of the manufacturer of the drug samples of fish;

d. State the origin of the drug samples of fish;

e. composition of the sample of the medicine fish;

f. form of drug samples of fish;

g. type of drug samples of fish stocks;

h. packaging size;

i. the meaning of income;

j. number of drug samples of fish;

k. port of unloading; and b. the harbour place infusion.
(4) the Application referred to in subsection (3), performed by attaching: a. certificate of Analysis (Certificate of Analysis);
b. Certificate of origin (Certificate of Origin), which is endorsed by the representative of the Republic of Indonesia in the country of origin of the samples of fish medicine;
c. Certificates or Affidavits Already Sold (Certificate of Free Sale); and d. the certificate or the certificate is not a product of genetic engineering (Certificate of Non Genetically Modified Organism), drug samples for fish stocks to a product not biologik genetic engineering.
(5) the Director General or the designated officer to evaluate the document in writing within three (3) working days since the document is received in full.
(6) based on the results of the evaluation of the documents referred to in subsection (5), the Director General of the designated officials or publish: a. Certificate of income of drug Samples of fish; or b. the rejection Letter Sample Fish Medication Infusion, accompanied with the reason for denial.
(7) Certificate of income of drug Samples of fish referred to in paragraph (2) letter a contains information on: a. trade names/brands medication samples of fish;

b. the name and address of the importer;

c. the name of the manufacturer of the drug samples of fish;

d. State the origin of the drug samples of fish;

e. composition of the sample of the medicine fish;

f. form of drug samples of fish;

g. type of drug samples of fish stocks;

h. packaging size;

i. the meaning of income;

j. number of drug samples of fish;

k. port of unloading;

b. place port income; and m. Certificate validity period of drug Samples of fish Intake.
(8) Certificate of income of drug Samples of fish referred to in paragraph (2) letter a can only be used for one (1) times revenue and apply for a period of 1 (one) month from the date of publication.
(9) the shape and format of Income Certificate Sample Fish Medication as listed in Annex III which is an integral part of part of the regulation of the Minister.
Article 17 (1) quality Testing as referred to in article 15 paragraph (1) letter a is performed by an accredited laboratory within the country in accordance with the conditions of testing in animal medicine Pharmacopoeia Indonesia, Pharmacopoeia Indonesia, other Pharmacopoeia, and/or other drug analysis standards.
(2) Testing airy as stipulated in article 15 paragraph (1) letter b are performed by competent agencies that includes a test of efficacy or efficacy and/or safety test in accordance with indications of medicinal fishes with reference to the guidelines for testing. (3) testing of airy as mentioned on paragraph (2) made against: a. fish medication containing active substances that have never existed or no homolognya in Indonesia; and/or b. a fish medicine indication and its use has not been made public and the haven't been substantiated by an official scientific references.
(4) the competent Agency referred to in subsection (2) are assigned by the Director General after fulfilling technical requirements, comprising: a. facilities and infrastructure;

b. human resources; and c. the method of testing.
(5) the provisions of the guidelines further testing fields as mentioned on paragraph (2) and the technical requirements referred to in paragraph (4) was set by a decision of the Director General.
Article 18 (1) Technical Data remedy fish as referred to in article 15 paragraph (1) Letter c is poured in the form of: a. drug composition and trademark fish;

b. the process of manufacture of medicinal preparations of fish;

c. examination of fish drugs and raw materials used;

d. examination of stability;

e. power Pharmacology;

f. publication of clinical trials in the field;

g. Description of the containers, wrap, cover; and h. Description of tagging, in the form of text and/or images are imprinted on the container or wrapper and etiquette brochure.
(2) technical data form fish medication for the examination of stability referred to in subsection (1) does not apply, the letter d for fish medicine: a. type of minerals in the form of powder (powder) that time kadaluarsanya under one (1) year;

b. disinfectant; and/or c. natural ingredients.
(3) further Provisions regarding the procedures for filling out the form of technical data remedy fish as referred to in paragraph (1) established by decision of the Director General.
Article 19 (1) General Director checks the completeness of the documents in writing within 2 (two) working days from receiving the petition as stipulated in article 15 paragraph (1).
(2) based on the results of the examination of the completeness of the documents referred to in subsection (1), the Director-General: a. forward a document that stated the drug Evaluator to a team full of fish to do technical evaluation; or b. published a letter of denial accompanied by the reason of rejection, if the document is not complete.
(3) a drug Evaluator Team Fish as referred to in paragraph (2) letter a technical evaluation in writing within 7 (seven) working days. (4) Technical Evaluation as referred to in subsection (3) includes the following: a. scientific analysis and verification over the technical data contained in the documents of the petition; b. verification of quality testing results with technical data; and c. a verification test results with the technical data.
(5) the results of the technical evaluation as mentioned in paragraph (3) in the form of recommendations and submitted to the Director-General.
(6) the Director-General for a period of not longer than three (3) working days from receiving the recommendation referred to in subsection (5) must publish: a. letter of registration number of fish Medicine, for drugs that meet the requirements of the fish; or b. the Rejection of drug Registration of fish, accompanied by reason of the rejection of the drug the fish that do not meet the requirements.
(7) the Registration Number of the fish Medication Letter as referred to in paragraph (2) letter a contains: a. the registration number drug fish;

b. the name of the manufacturer/importer of fish medicine;

c. the full address of the manufacturer/importer of fish medicine;

d. the address of the place of production of the medicine fish;

e. name of drug manufacturers of fish abroad;

f. name of the licensor;

g. trade names/brands medication fish;

h. drug classification of fish;

i. form of the medicine fish;

j. types of medicinal preparations of fish;

k. composition of fish medicine;

b. size of the packaging; and d. the expiration of letter of registration number of fish Medicine.
(8) the form and format of letters of registration number Drug Fish as listed in Annex IV that is part an integral part of the regulation of the Minister.
(9) the provisions on the arrangement of Team tasks and membership Assessors Fish Medicine as mentioned on paragraph (2) letter a set with the decision of the Director General.
Article 20 (1) Medicated fish with trademark and the arrangement of the same composition is given a letter of registration number Drug of the same Fish, although the size of the packaging is different.
(2) Medicated fish with trademark and/or order a different composition, given a letter of registration number of fish of different Drugs.
Article 21 (1) of the rejected application referred to in article 19 paragraph (2) letter b or subsection (6) the letter b, then the applicant must take back the plea documents within a period of not longer than 15 (fifteen) working days.
(2) if within a period of 15 (fifteen) working days the applicant did not take the plea document, then the document application belongs to the Directorate General of Aquaculture, the Ministry of marine and fisheries.
The third part of the validity period, Extension, alteration, and replacement of section 22 Fish Drug registration number Letter valid for a period of 5 (five) years counted from the date of publication.

Article 23 (1) the expiration of letter of registration number Drug Fish as referred to in article 22 can be extended to the same time period.
(2) the application for an extension of the letter of registration number Drug of fish referred to in subsection (1) may be made at least 3 (three) months before the expiration date of the Drug registration number Letter fish.
(3) to obtain an extension letter of registration number Drug Fish as referred to in paragraph (1), the manufacturer or importer must apply in writing to the Director General by attaching a photocopy of a letter: a. Drug registration number of fish that will be extended;

b. report of the results of the latest quality testing;

c. technical data, which includes: 1) trademark and medicinal composition of fish;

2) the process of making preparations of fish medicine;

3) examination preparations fish medications, which include physical characteristics, methods of test and test results qualitative and quantitative, attached with a certificate of analysis; 4) description of containers, wrap, cover;
5) description of tagging, in the form of text and/or images are imprinted on the container or wrapper etiquette and brochures; and 6) legal affidavit of the applicant that there is no change in the composition and indication of drug use and how to fish.
(4) letter of extension Mechanism of drug Registration Numbers of the fish are mutatis mutandis provisions based on article 19.
Article 24 (1) a letter of registration number of fish Medicine can be done if there is a change in administrative data changes, which include: a. the name of the manufacturer/importer;

b. address of the manufacturer/importer;

c. the address of the place of production;

d. name of the licensor; and/or e. drug trade names/brands of fish.
(2) to obtain the drug registration number Letter changes to the fish referred to in paragraph (1), the manufacturer or importer must apply to the Director General at the latest 1 (one) month since changes administration data by attaching a photocopy of: a. a letter of registration number Drug Fish would do change; and b. explanation of the reason for the change of data administration.
(3) the Director General in writing within three (3) working days from receiving the petition for change of administrative data as referred to in paragraph (1) verifying documents.
(4) based on the results of the verification of the documents referred to in subsection (3), the Director General publish: a. letter of registration number of new fish Medication; or b. the refusal Letter, accompanied by the reason for rejection.
(5) if the letter of registration number Drug of the new Fish have been published, then at the same time the applicant must return the letter of registration number Drug fish that do change.
Article 25 (1) a letter of registration number of fish Medicine can do the replacement if the letter of registration number original Fish Medicine is broken or missing.
(2) to obtain a replacement letter of registration number Drug Fish as referred to in paragraph (1), the manufacturer or importer must apply to the Director General by attaching a letter of registration number original Fish Medication in terms of Drug registration number Fish Letter damaged, or missing from police affidavits in the case of drug Registration Numbers Letters missing Fish.
(3) the Director General publish registration number Drug substitute Fish the longest 3 (three) working days since the receipt of the application referred to in subsection (2).
Article 26 the manufacturer or importer that has possess Fish Drug registration number Letters to safeguarding the consistency of quality fish medications in accordance with the information contained in the letter of registration number of fish Medicine.

Article 27 (1) Medicated fish originating from abroad can be incorporated into the territory of the Republic of Indonesia after acquiring a Description of drug Infusion of fish.
(2) to obtain the certificate of drug Infusion of fish referred to in paragraph (1), the importer or the agencies/government/private agencies must apply in writing to the Director-General, at least contain: a. trade names/brands medication fish;

b. the name and address of the applicant;

c. the name of the manufacturer of the medicine fish;

d. State the origin of the fish medication;

e. classification of medicinal fishes;

f. form of medicine fish;

g. type of medicinal preparations of fish;

h. packaging size;

i. the meaning of drug infusion of fish;

j. number of fish medicine;

k. port of unloading; and b. the harbour place infusion.
(3) the petition filed by the importer as referred to in paragraph (2), is done by attaching a photocopy of: a. a letter of registration number Drug fish;

b. packing list (packing list) that contains the types, quantity (quantity), and the unit of volume/weight.
(4) the petition filed by agencies/government/private agencies as referred to in paragraph (2), is done by attaching a photocopy of: a. the certificate of origin (Certificate of Origin), with original shows;
b. photocopy of Certificates or Affidavits Already Sold (Certificate of Free Sale), with original shows;
c. photocopy of Certificates Making good fish Medication (Certificate of Good Manufacturing Practice) from the authorized institution of the country of origin, with the original shows;
d. photocopies of Certificates is not a product of genetic engineering (Certificate of Non Genetically Modified Organism) for the fish stocks to drugs which are not the result of biologik genetic engineering, by showing the original; e. technical data as stipulated in article 15 paragraph (1) the letter c; and f. packing list (packing list) that contains the types, quantity (quantity), and the unit of volume/weight.
(5) the Director General or the designated officer to evaluate the document in writing within three (3) working days from receiving a complete application.
(6) based on the results of the evaluation of the documents referred to in subsection (5) the Director General or the designated officials publish: a. Certificate of drug Infusion of fish; or b. the Rejection of drug Infusion of fish, accompanied with the reason for denial.
(7) Certificate of drug Infusion of fish referred to in paragraph (2) letter a, at least contain: a. trade names/brands medication fish;

b. name of importer;

c. address of the importer;

d. registration number drug fish;

e. name of drug manufacturers of fish;

f. origin fish medication;

g. classification of medicinal fishes;

h. form of medicine fish;

i. types of medicinal preparations of fish;

j. the packaging size;

k. drug infusion mean fish;

b. the amount of drug the fish;

m. port of unloading;

n. place port income; and o. Certificate validity period of drug Infusion of fish.
(8) Certificate of drug Infusion of fish referred to in paragraph (2) letter a can only be used for one (1) times revenue and apply for a period of three (3) months from the date of publication.
(9) the shape and format of Income Certificate Fish Medication as listed in Annex V which are part an integral part of the regulation of the Minister.
CHAPTER VII the INFUSION of DRUG RAW MATERIALS of DRUG SAMPLES of fish, fish, FISH MEDICINE and of article 28 (1) the importer or institutions/government agencies/private who will enter a drug raw material drug samples of fish, fish, fish and/or drugs into the territory of the Republic of Indonesia is obliged to report at least one (1) day prior to arrival and submit Income Certificate Medicinal raw material Fish Certificate of income, Drug Samples, Fish and/or Fish Drugs Infusion Affidavits to the Quarantine Officer upon arrival at the place of incorporation.
(2) the quarantine Officer conducting the examination Certificate Medicinal raw material Fish Intake, Cure Sample Income Letter, Fish and/or Fish Drugs Income Certificate referred to in subsection (1) to find out the truth and validity of Certificate Medicinal raw material Fish Intake, Cure Sample Income Letter, Fish and/or Fish Drugs Infusion Affidavits.
(3) Income Certificate Medicinal raw material fish, Sample Drug Infusion Affidavits, Fish and/or Fish Drugs Infusion Affidavits, declared valid if published by the Director General or a designated official.
(4) Affidavits Infusion of raw Fish, Drug Infusion Drug Sample Affidavits, Fish and/or Fish Drugs Infusion Affidavits, was correct when there is conformity between the Affidavits Infusion of raw Fish, Drug Infusion Drug Sample Affidavits, Fish and/or Fish Drugs Infusion Affidavits with physical goods that are incorporated into the territory of the Republic of Indonesia.
(5) in the framework of the Inspection Certificate truth Infusion of raw Fish, Drug Infusion Drug Sample Affidavits, Fish and/or Fish Drugs Incorporation Certificate as referred to in paragraph (4), Quarantine Officers perform physical examinations in the area of customs.
(6) the Inspection Certificate Medicinal raw material Fish Intake, Cure Sample Income Letter, Fish and/or Fish Drugs Incorporation Certificate as referred to in paragraph (2) was performed for a period of not longer than three (3) working days.
(7) based on the results of the Inspection Certificate Medicinal raw material Fish Intake, Cure Sample Income Letter, Fish and/or Fish Drugs Incorporation Certificate as referred to in paragraph (2) and physical examination as referred to in paragraph (5), Quarantine Officers published a Letter of approval: a. Expenditures Drug raw material fish/Fish Medication/Drug Samples of fish in place of Income, Income Certificate if the raw material Fish Medications Certificate of income, Drug Samples, Fish and/or Fish Drugs Incorporation Certificate is valid and true, with copy to the Director General of Marine Resources and fisheries; or b. the Rejection of drug raw materials Expenses fish/Fish Medication/Drug Samples of fish in place of Income, Income Certificate if the raw material Fish Medication, Drug Infusion Sample Affidavits, Fish and/or Fish Drugs Incorporation Certificate is invalid and/or incorrect.
Article 29 (1) if the drug raw material drug samples of fish, fish, fish and/or drug punishable by rejection as stipulated in article 28 paragraph (7) letter b, then the importer or agencies/government/private agencies are obliged to send back the drug raw material drug samples of fish, fish, fish medication and/or to the country of origin within a period of not longer than three (3) days from the denial was done.
(2) if within a period of three (3) days of delivery do not return to the country of origin, then against the drug raw material drug samples of fish, fish, fish and/or drug referred to in subsection (1) is carried out in accordance with the destruction.
Article 30 of the Ordinances of the ingestion of raw fish medication, fish drug samples, drug and/or fish preparation type biologik excluded from the provisions referred to in Article 28 and article 29, and is controlled by a regulation of the Minister.

CHAPTER VIII


The PLACE of INCOME and EXPENDITURE article 31 Every raw material drug drug samples of fish, fish, fish or drug that will be incorporated into the territory of the Republic of Indonesia or issued from within the territory of the Republic of Indonesia can only be done through the incorporation of the place or places of expenditure as follows: a. seaports: Belawan in Medan, Tanjung Priok in Jakarta, Tanjung Emas in Semarang, Tanjung Perak in Surabaya Soekarno Hatta in Makassar, and length in Lampung; b. the entire international airport; and/or c. cross border Entikong checkpoint.

CHAPTER IX the CIRCULATION of FISH MEDICINE Article 32 (1) Medicated fish released in the territory of the Republic of Indonesia is obliged to be packed in a waterproof container and/or a specific wrap and imprinted information on drugs fish in Indonesian Language which is easy to see and read and not easily removed.
(1) a description of the medicine fish as referred to in paragraph (1) contains at least: a. drug registration number fish;

b. the name and address of the manufacturer/importer of fish medicine;

c. trade names/brands medication fish;

d. classification of medicinal fishes;

e. drug form of fish;

f. types of medicinal preparations of fish;

g. composition of fish medicine;

h. net weight;

i. designation/indication and target fish;

j. how to use and storage;

k. production code;

b. the expiration date; and m. fish medication downtime (withdrawl time), specifically for the classification of drugs.
Article 33 (1) an exporter who will distribute the medication to fish outside the territory of the Republic of Indonesia must have a Certificate Dispensing Drugs fish.
(2) to obtain the certificate of drug Expenditures Fish as mentioned on paragraph (1), the exporter must apply in writing to the Director General at least contain: a. trade names/brands medication fish;

b. the name and address of the applicant;

c. the name of the manufacturer of the medicine fish;

d. country of destination;

e. classification of medicinal fishes;

f. form of medicine fish;

g. type of medicinal preparations of fish;

h. packaging size;

i. drug spending mean fish;

j. number of fish medicine; and k. place port expenses.
(3) the petition submitted by the exporter referred to in subsection (2), is done by attaching a photocopy of: a. a letter of registration number Drug fish; and b. packing list (packing list) that contains the types, quantity (quantity), and the unit of volume/weight.
(4) the Director General or the designated officer to evaluate the document in writing within three (3) working days since the application was received in full.
(5) based on the results of the evaluation of the documents referred to in subsection (4) the Director General or the designated officials publish: a. Drug Spending Affidavits fish; or b. the Rejection of drug Expenditures of fish, accompanied with the reason for denial.
(6) Certificate of fish Medicine Expenditure as referred to in paragraph (2) letter a, at least contain: a. trade names/brands medication fish;

b. the name and address of the exporter;

c. registration number drug fish;

d. name of the drug manufacturers of fish;

e. the country of destination;

f. classification of medicinal fishes;

g. fish form of medicine;

h. type of medicinal preparations of fish;

i. the size of the packaging;

j. drug spending mean fish;

k. number of fish medicine;

b. place the port expenses; and m. valid Drug Expenses Affidavits fish.
(7) Certificate of fish Medicine Expenditure referred to in subsection (5) the letter a can only be used for one (1) one-time expenses and apply for a period of three (3) months from the date of publication.
(8) the form and format of Certificate of expenditure as contained in Fish Medicine Annex VI which is part an integral part of the regulation of the Minister.
Article 34 (1) any person is prohibited to circulate the fish medication not be eligible to order.
(2) Medicated fish that are not be eligible to order referred to in subsection (1) include a fish remedy: a. do not have a registration number Drug fish;

b. experience physical changes, which include texture, color, and/or the bau;

c. has expired; and/or d. packaging, containers, packs and/or lid are damaged.
Article 35 Any people who do fish have to do drug business registration against any drug the fish released.

CHAPTER X INCOME BACK to article 36 (1) every person who will do the infusion of drug raw materials back to the fish or fish medicine originating from Indonesia because it was rejected by importing countries/country obliged to report at least one (1) day prior to arrival to the Quarantine Officer and submit: a. Certificate of drug raw materials Expenses fish or Fish Medicine Expenditure Certificate; and b. the notice of Export goods.
(2) the quarantine Officer conducting the examination of the documents referred to in subsection (1) in writing within 2 (two) working days to find out the truth and validity of the documents.
(3) the Affidavits of drug raw materials Expenses fish or Fish Medicine Expenditure Affidavits and notice of Export Goods were declared valid if published by the authorized agency.
(4) Affidavits of drug raw materials Expenses fish or Fish Medicine Expenditure Affidavits and notice of Export Goods is stated is correct when there is conformity between the certificate of expenditure the drug raw material fish or Fish Medicine Expenditure Affidavits and notice of Export goods with physical goods are put back into the territory of the Republic of Indonesia.
(5) in the framework of the Inspection Certificate truth Spending Drug raw material fish or Fish Medicine Expenditure Affidavits and notice of Export goods, the quarantine Officers perform physical examinations in the area of customs.
(6) based on the results of the examination of the documents referred to in subsection (2) and physical examination as referred to in paragraph (5), Quarantine Officers published a Letter of approval: a. Expenditures Drug raw material fish/Fish Medication from the place of Incorporation, if complete, valid, and true, with copy to the Director General of Marine Resources and fisheries; or b. the Rejection of drug raw materials Expenses fish/Fish from where Drug Infusion, if the documents are incomplete, invalid and/or incorrect.
(7) if the raw material fish medication or drug punishable by rejection of fish because the document was declared incomplete as referred to in paragraph (6) letter b, then the owner of raw fish or fish medicine drug mandatory complete lack of documents within a period of not longer than three (3) working days since the receipt of the Letter of denial.
(8) if within a period of 3 (three) days from receipt of the letter of Rejection as referred to in paragraph (6) letter b owner of raw fish or fish medicine medicine can complement the lack of documents, the mutatis mutandis apply the provisions referred to in subsection (2), subsection (3), subsection (4), and subsection (5).
(9) if within a period of 3 (three) days from receipt of the letter of Rejection the owner of raw fish or fish medicine remedy can not complement the lack of documents or raw material fish medication or drug punishable by rejection of fish because the document was declared invalid and/or not properly as intended in paragraph (1) letter b then drug raw material fish or fish medicine the destruction.
(10) the destruction as referred to in paragraph (9) was conducted by officers of the quarantine.
Article 37 the infusion of drug raw materials back to the fish or fish medicine have to go through the place assigned revenue referred to in article 31.

CHAPTER XI of the CONSTRUCTION, monitoring, and SUPERVISION of article 38 (1) the Director General and head of Department doing coaching and monitoring the provision and release of the drug in accordance with its fish.
(2) guidance and monitoring as referred to in subsection (1) at least include the following: a. the provision of drug circulation and process fish;

b. drug storage facilities and infrastructure of the fish; and c. the quality, efficacy, and safety of fish medicine.
(3) in conducting coaching and monitoring as referred to in paragraph (1), the Director-General or head of Department sets the Team coaching and monitoring of Fish Medicine.
(4) the terms to be appointed member of the construction Team and monitoring Drug Fish as referred to in paragraph (3) should have competence in the field of fish medicine.
Article 39 (1) in the framework of coaching and monitoring drug fish as referred to in article 38 paragraph (1), the manufacturer of the drug mandatory fish make a report every 6 (six) months to the Director-General concerning: a. the amount, type, and origin of raw materials;

b. the amount and type of fish medicine have been produced; and c. the number of drugs that have been circulated and region releases.
(2) in the framework of coaching and monitoring drug fish as referred to in article 38 paragraph (1), the importer is obligated to make a report of fish medicine every 6 (six) months to the Director-General concerning: a. the amount and type of medication the fish that have been incorporated into the territory of the Republic of Indonesia; and b. the amount of the drug has circulated the fish and its release.
(3) in order to fish medication and monitoring construction as stipulated in article 38 paragraph (1), the exporter is obligated to make a report every 6 (six) months to the Director-General concerning: a. the amount and type of medication the fish has been removed from the territory of the Republic of Indonesia; and b. the country of destination.
(4) in the framework of coaching and monitoring drug fish as referred to in article 38 paragraph (1), the distributor of the drug mandatory fish make a report every 6 (six) months to the Head Office of the province as to: a. the amount and type of fish released drugs; and b. the drug circulation area of the fish.
(5) in the framework of coaching and monitoring drug fish as referred to in article 38 paragraph (1), depo and drug store mandatory fish make a report every 6 (six) months to the Head Office of Kabupaten/Kota about: a. the amount and type of fish released drugs;

b. the name of the giver of the veterinary prescription;

c. drug circulation area fish; and

d. drug user name fish for fish medicine with the classification of drugs and drug-free.
Article 40 (1) the Head Office of district/city report results coaching and monitoring drug fish to head of Department of the province at least every 10th of the next month.
(2) the Head Office of the province delivered a report on the results of the coaching and monitoring Fish medication to the Director General at least every 20, containing the results of the monitoring and coaching that he did, and the recapitulation report results coaching and monitoring drug fish kabupaten/kota.
(3) the result of coaching and monitoring as referred to in paragraph (2) is used as the Director General of policy making.
Article 41 the supervision against the circulation of fish medicine is performed by the supervisor of fisheries.

CHAPTER XII PENALTIES Article 42 (1) the manufacturer or importer of the drug the fish doing in violation of Article 26, article 35, Article and/or administrative penalties 39. (2) administrative Sanctions referred to in paragraph (1) can be either: a. a written warning;

b. Drug registration number Letter freezing fish; or c. the revocation Letter registration number Drug fish.
(3) administrative Sanctions referred to in paragraph (2) is given by the Director General.
Article 43 (1) a written Warning as stipulated in article 42 paragraph (2) letter a is given to the manufacturer or importer of the drug the fish breaking conditions as referred to in article 35 and Article 39.
(2) a written Warning as referred to in subsection (1) is given to the manufacturer or importer of a drug that does not meet its fish at most three (3) times in a sequence within a period of not longer than 15 (fifteen) days for every time a warning.
Article 44 (1) of the administrative Sanction in the form of freezing Fish Drug registration number Letter as referred to in article 42 paragraph (2) letter b given to: a. the manufacturer or importer of the drug the fish as stipulated in article 44 paragraph (1) that up to the end of the period of the third warning do not carry out their obligations;
b. the manufacturer or importer of the drug the fish breach the provisions as referred to in article 26.
(2) the freezing of Fish Medicine registration number Letter referred to in subsection (1) done during 30 (thirty) days since the sanctions given.
Article 45 of the administrative Sanction in the form of a letter of revocation of registration number Drug Fish as referred to in article 42 paragraph (2) Letter c is given to a manufacturer or importer who is up to the expiry of a period of freezing Fish Drug registration number Letter did not carry out its obligations.

CHAPTER XIII the EXPIRY of VALIDITY PERIOD of FISH MEDICINE REGISTRATION NUMBER LETTER of article 46 (1) a letter of registration number of fish Medicine referred to in article 19 paragraph (2) letter a expired because: a. was revoked because the manufacturer or importer of the drug the fish up to the expiry of a period of freezing Fish Drug registration number Letter did not carry out his obligations; b. was revoked because the owners request registration number Drug fish;
c. revoked because of scientifically proven or based on other references that the drugs that are harmful to fish health fish, humans and the environment;
d. Mail registration number valid Fish Medication expires and is not renewed.
(2) Revocation Letter Fish Drug registration number referred to in paragraph (1) letter a, letter b, letter c, and done by the Director General.
CHAPTER XIV OTHER PROVISIONS Article 47 (1) of the emergency conditions and/or the plague that has been designated by the Minister and no drugs fish Drug registration number have a Fish to cope with emergency conditions and/or the plague, then drugs that meet the requirements of the fish can be given the letter of registration number of fish Medication temporarily.
(2) to obtain a temporary registration number of fish Medicine referred to in subsection (1), the manufacturer or impotir must apply in writing to the Director-General with explanations of the technical data as stipulated in article 15 paragraph (1) the letter c and the requirements as stipulated in article 15 paragraph (2) to cure the fish came from abroad.
(3) the Director General of the checks the completeness of the documents in writing within one (1) working day since receiving the application referred to in subsection (2).
(4) based on the results of the examination of the completeness of the documents referred to in subsection (3), the Director General continued the document expressed complete to the team Evaluator of drug technical evaluation conducted for the Fish.
(5) based on the results of the technical evaluation as mentioned in paragraph (4), for a period of not longer than 2 (two) working days, the team of Assessors Fish Medications give recommendations to the Director-General containing the approval or rejection.
(6) the Director-General for a period of not longer than 2 (two) working days from receiving the recommendation referred to in subsection (5) must publish: a. letter of registration number Drug Fish While the fish medication, for those who meet the requirements; or b. the refusal Letter, accompanied by the reason of the rejection of the drug the fish that do not meet the requirements.
Article 48 letter of registration number of fish Drugs While as stipulated in article 47 paragraph (6) letter a is valid for 1 year.

CHAPTER XV TRANSITIONAL PROVISIONS Article 49 (1) in terms of the arrangements concerning the CPOIB referred to in article 12 paragraph (4) has not been established, then the creation of fish medicine refers to a provision Making it a good Animal Drug (CPOHB).
(2) a letter of registration number of fish Medicine have been published prior to the establishment of this Ministerial Regulation, otherwise remains valid until it expires.
(3) the petition Letter registration number Drug fish that was submitted and expressed complete, processed based on the decision of the Minister of marine and Fisheries the number KEP. 26/DOWNLOAD/2002 about the provision, Circulation, use, and Drug the fish.
CHAPTER XVI CLOSING PROVISIONS article 50 With the establishment of this Ministerial Regulation, then the decision of the Minister of marine and Fisheries the number KEP. 26/DOWNLOAD/2002 about the provision, Circulation, use, and Fish Drug was revoked and declared inapplicable.

Article 51 this Ministerial Regulation comes into force on the date of promulgation.

In order to make everyone aware of it, ordered the enactment of this Ministerial Regulation with its placement in the news of the Republic of Indonesia.

Established in Jakarta on January 31, 2012, MINISTER of MARINE and FISHERIES of the REPUBLIC of INDONESIA, SHARIF c. SUTARDJO Enacted in Jakarta on February 1, 2012 the MINISTER of LAW and HUMAN RIGHTS REPUBLIC of INDONESIA, AMIR SYAMSUDDIN * not yet in the form of loose sheets fnFooter ();