STATE NEWS
REPUBLIC OF INDONESIA
THE MARINE MINISTER ' S REGULATION AND FISHERIES
REPUBLIC OF INDONESIA
NUMBER PER.04/MEN/2012
ABOUT
OBAT fish
WITH THE GRACE OF THE ALMIGHTY GOD
MINISTER OF MARINE AND FISHERIES REPUBLIC OF INDONESIA,
Weigh: a. that in order to protect the fish resources, the environment, and human health, need to review the Decree of the Minister of Oceans and Fisheries Number KEP.26/MEN/2002 on the Supplies, Circular, Use, and Oversight of Fish Drugs;
B. that for that it needs to establish the Minister ' s Regulation on Fish Drugs;
Given: 1. Law No. 16 of 1992 on Quarantine Animals, Fish and Plants (State Sheet of Indonesia Year 1992 Number 56, Additional Sheet of State of Indonesia Republic No. 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 the Act of Year 2009 Number 45 (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 the 2008 Act Number 12 (sheet of State of the Republic of Indonesia 2008 No. 59, Additional Gazette of the Republic of Indonesia Number 4844);
4. Law No. 18 Year 2009 on Animal and Animal Health (Sheets Of State Republic Indonesia Year 2009 Number 84, Additional Sheet Of State Republic Of Indonesia Number 5015);
5. Government Regulation No. 78 of 1992 on Animal Drugs (State Sheet of the Republic of Indonesia Year 1992 Number 129, Additional Gazette Republic of Indonesia Number 3509);
6. Government Regulation No. 15 Year 2002 on Fish Quarantine (State Sheet Of The Republic Of Indonesia 2002 Number 36, Additional Gazette Number 4197);
7. 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);
8. Presidential Regulation No. 47 of 2009 on the Establishment and Organization of the Ministry of State, as amended with the Presidential Regulation No. 76 of 2011;
9. 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 with the Presidential Regulation No. 92 of 2011;
10. Presidential Decree No. 84 /P of the Year 2009, as amended by Presidential Decree No. 56/P of 2010;
11. 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 Diseases From Abroad and From A Area To Other Areas Within The State Of The Republic Indonesia;
12. Regulation of the Minister of Oceans and Fisheries Number PER.15/MEN/2010 on the Organization and the Working Governance of the Ministry of Marine and Fisheries;
DECIDED:
Establish: MARINE MINISTER REGULATION AND FISHERY ABOUT FISH DRUGS.
BAB I
UMUM PROVISIONS
Section 1
In Regulation of the Minister this is referred to:
1. The preparation is the procurement activity of fish drugs or the raw materials of fish drugs made through the making in the country and/or income from abroad.
2. The circulation is an activity in the order of channing and submission of fish drugs either in order of trade or not trade.
3. Fish-drug raw materials 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.
4. Fish drugs are a treat that can be used to treat fish, relieve symptoms, or modify chemical processes in the body including biological, pharmasetic, premiiks, probiotics and natural remedies.
5. Fish is any type of organism that is all over or part of its life cycle to be in the aquatic environment.
6. Etiquette is the direct writing or the writing affiated to the container or wrap containing the fish drug tagging.
7. 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.
8. 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.
9. People are either individual or corporate persons.
10. Corporations are a collection of people and/or wealth organized by either a legal entity and not a legal entity.
11. Fish drug manufacturers are the ones who make fish drugs for commercial purposes.
12. Importir fish drugs are the ones who do the income of fish drugs from abroad.
13. The exporter of fish drugs is the one who does the spending effort of a fish drug overseas.
14. The fish drug distributor is the person who does the distribution of fish drugs from the manufacturer or the importer to a depo and/or fish drug store.
15. The producer's next importer ID (API-P) is an importer of the producer's importer issued 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. Fish-drug business permit is a written permit that people should have to do the fish drug effort.
17. The Fish Quarantine Officer is a particular civil servant who is given the duty to conduct quarantine measures under the law.
18. Fish Health experts are someone who gets knowledge of fish health through formal education.
19. The Minister is the Minister of Oceans and Fisheries.
20. Director General is the Director General of Fisheries Cultivation.
21. The Provincial or District Service/City is the service of the authorities and is responsible in the field of fisheries.
Section 2
The scope of this Ministerial Regulation includes:
a. fish-drug raw materials;
B. Fish drug business;
c. the purpose of use, supply, and classification of fish drugs;
D. provision of fish drugs;
e. fish drug registration;
f. the layout of the means of the inclusion of raw materials of fish drugs, samples of fish drugs, and fish drugs;
G. place of income and expense;
h. circulation;
i. reentry; and
J. coaching, monitoring, and surveillance.
BAB II
THE RAW MATERIALS OF THE FISH DRUG
Section 3
(1) The preparation of the raw materials of fish drugs through income from abroad can only be done by the importers who have API-P or government/private agencies.
(2) The preparation of the raw materials of fish medicine by government/private institutions as referred to in paragraph (1) is done only for the benefit of research.
(3) The raw materials of fish drugs originating from abroad can be included in the State of the Republic of Indonesia after obtaining the Letter of Income Of The Raw Materials Of The Fish Drugs.
(4) In order to obtain the Appropriate Information of the Ikan Remedy as referred to in paragraph (3), the importer or the government/private institution must submit a request in writing to the Director General of the least containing:
a. the raw material name of the fish drug;
B. name and applicant;
c. name of the raw materials manufacturer of the fish drug;
D. country of origin of the drug raw materials;
e. the raw material forms of the fish;
f. type of raw materials raw materials;
G. package size;
h. the purpose of the inclusion of the raw materials of the fish
i. the amount of raw drug raw materials;
J. Load port; and
No, Port of admission.
(5) The invocation as referred to in paragraph (4), performed by attaching it:
a. Certificate Certificate orCertificate of Analysis(CoA);
B. Origin Letter or Certificate of Origin (CoO), which is authorized by the representative of the Republic of Indonesia in the country of the raw materials of the fish drug; and
C. Certificate of Free Sale or Certificate of Free Sale.
(6) The Director General or the appointed official conduct the evaluation of the document in at least 3 (three) business days since the document is fully received.
(7) Based on the results of the evaluation of the document as referred to in paragraph (6), the Director General or the appointed official published:
a. The Raw Materials Drug ' s Inclusion Papers; or
B. The Rejection Letter of the Inclusion Of Fish Drugs, accompanied by a reason for rejection.
(8) Letter of the Ingredient Income of the Ingredient Drug as referred to in paragraph (7) the least bit of a letter:
a. the raw material name of the fish drug;
B. name and address of the importer or government/government agency/swasta;
c. name of the raw materials manufacturer of the fish drug;
D. country of origin of the drug raw materials;
e. the raw material forms of the fish;
f. type of raw materials raw materials;
G. package size;
h. the purpose of the inclusion of the raw materials of the fish
i. the amount of raw drug raw materials;
J. port load;
No, the port of the income place; and
I. The timing of the letter of the Ingredients Of The Raw Drug.
(9) Letter of Use of Fish-Drug raw materials as referred to in paragraph (7) letter a may only be used for 1 (one) time of income and apply for a term of 3 (three) months from the date of publication.
(10) The form and format of the Letter of Inclusion Of The Raw Materials Remedies as set forth in Appendix I which is an inseparable part of the Regulation of this Minister.
Section 4
(1) Exporters that will issue the raw materials of fish medicine from the State of the Republic of Indonesia should have a Letter of Maturity Of The Default Ingredient Drug Baku.
(2) To acquire a Letter of Appropriate Expenses of the Fish Drug Act as referred to in paragraph (1), the exporter must submit a request in writing to the Director General of the least loading:
a. the raw material name of the fish drug;
B. name and address of the applicant;
c. name of the raw materials manufacturer of the fish drug;
D. destination country;
e. the raw material forms of the fish;
f. type of raw materials raw materials;
G. package size;
h. order of the raw materials of the fish drug;
i. the amount of raw drug raw materials; and
J. The port of the expense
(3) The Director General or the designated officer performs the evaluation in the most time of 3 (three) business days since the application is fully received.
(4) Based on the evaluation results as referred to in paragraph (3) the Director General or the appointed official published:
a. Fish Drug Default Material Expenation Letter; or
B. The Rejection Letter of the Baku Medicinal Substances, accompanied by a cause of rejection.
(5) The Letter of Ingredient Expenditures of Fish Drugs as referred to in paragraph (4) of the letter a, at least contains:
a. the raw material name of the fish drug;
B. name and exporter address;
c. name of the raw materials manufacturer of the fish drug;
D. destination country;
e. the raw material forms of the fish;
f. type of raw materials raw materials;
G. package size;
h. order of the raw materials of the fish drug;
i. the amount of raw drug raw materials;
J. port of place of expense; and
No, A period of time has been applied to the following:
(6) The Letter of the Spending of the Default of the Fish Drug as referred to in paragraph (4) the letter may only be used for 1 (one) times the expense and apply for a term of 3 (three) months from the date of publication.
(7) The Form and format of the Letter of the Spending of Medicinal Substances of the Fish Drug as set forth in Annex II which is an inseparable part of the Regulation of this Minister.
BAB III
FISH DRUG EFFORTS
Section 5
(1) The fish drug business consists of:
a. attempt to provide fish drugs; and
B. It's a fish drug.
(2) The provision of fish medicine as referred to in verse (1) of the letter a covering the manufacture of fish drugs from raw materials until it becomes a fish drug and/or the income of fish drugs from abroad.
(3) The distribution of fish drugs as referred to in verse (1) letter b includes activities related to trade, transport, and handover of fish drugs.
Section 6
(1) Any person who does a fish drug effort, is classed over:
a. fish drug manufacturer;
B. importer of fish drugs;
c. fish drug exporter;
D. the distributor of fish drugs;
e. fish drug depo; and
f. Fish drugstore.
(2) The preparation of fish drugs may be carried out by government/private institutions for the benefit of research.
Section 7
(1) The efforts of the provision of fish drugs as referred to in Article 5 of the paragraph (1) of the letter a performed by the manufacturer or the importer.
(2) The distribution of fish drugs as referred to in Article 5 of paragraph (1) letter b is performed by exporters, distributors, depo, or fish drug stores.
(3) Any person who performs a fish drug effort as referred to in Article 5 of the paragraph (1) is required to have a Fish Drug Permit Letter.
(4) Further provisions on the authority, requirements and grammar of the issuance of the Fish Drug Permit Permit are set up with the Minister ' s Regulation.
BAB IV
USAGE PURPOSES, SUPPLIES, AND THE CLASSIFICATION OF FISH DRUGS
Section 8
The purpose of the use of the least fish drugs includes:
a. prevent, reduce, and eliminate symptoms of fish disease;
B. Diagnosing and treating fish diseases;
c. help calm and shut down the fish;
D. enhancing fish reproduction;
e. cope with the deficiency of vitamins and minerals;
f. embed the color and body of the fish;
G. maintaining and/or improving the water quality for cultivation fisheries; and/or
h. maintaining and/or improving the quality of fisheries results.
Section 9
Fish drugs according to the seditable type are classed over:
a. biologics;
B. farmasetic;
C. premix;
D. probiotic; and
e. natural medicine.
Section 10
(1) A fish drug with a type of biological treat as referred to in Article 9 of the letter a is produced by biological processes in animals or animal tissues to induce immunity, diagnose disease, or treat an illness with an immunological process, Among other vaccines, sera (antisera), antigen and biological diagnostics materials.
(2) The drug of fish with the type of pharmasetic supply as referred to in Article 9 of the letter b is produced from inorganic and organic materials and/or chemical syntesa reactions used in the basis of pharmacological work, among other hormones, the antibiotics, Antibacteria, chemotherapeutic, antiparasitic, anti-fungal, anthelmintic, and anaesthetics.
(3) The drug of the fish with the type of premixes as referred to in Article 9 of the letter c is a fish drug that is a feed imcure or a complement of feed that is given in fish feed, made up of feed imcure (feed additive) and the feed complement (feed supplement).
(4) Feed additive (feed additive) as referred to in verse (3) is an additional material for feed that naturally does not contain a nutrient or nutrient (nutrient) that the purpose of the use of which is to make the color of the fish, Feed archiving, and feed preservatives.
(5) The complete feed of feed (feed supplement) as referred to in verse (3) is a substance that is naturally already contained in the feed but the number needs to be improved by adding it in feed, among other amino acids, vitamins, And minerals.
(6) fish drugs with a type of probiotic supply as referred to in Article 9 of the d, resulting from non-pathogenic microbes that are naturally present in the environment in water and in the body of fish working with bioremediation processes, channel biocontrol cerna and as a spate of pathogenic bacteria, among other bacteria Bacillus Subtillis, Lactobacillus, Nitrosomonas, and Nitrobacter.
(7) The drug of fish with the type of natural medicine as referred to in Article 9 of the letter e, is a material or concoction of material from plants, animal-origin materials, mineral-origin materials, galenic supplies, or a mixture of such materials. without the addition of medicinal substances the drug and its efficacy are based solely on empirical data as well as no complete clinical data, among other extracts of meniran leaves and the extract of sambilas leaves.
Section 11
(1) The fish drug based on the hazard classification incurred in its use, classed over:
a. The drug, is a fish drug that if its use does not conform to the provisions may pose a danger to fish, environment and/or human beings who consume such fish;
B. Restricted free drugs, a hard remedy for fish that is enforced as a free drug for certain types of fish provided with the amount, dose rules, supply forms and manner of use and are given special warning signs; and
C. A free drug is a fish drug that can be obtained and used freely without the vet's prescription and/or the recommendation of a fish health expert.
(2) The further provisions of the classification of fish drugs as referred to in paragraph (1) are defined by the Decree of the Minister.
BAB V
THE PROVISION OF FISH DRUGS
Section 12
(1) The preparation of fish medicine is done through the making in the country and income from abroad.
(2) The preparation of fish medicine is done by preferring the making in the country.
(3) Fish drug supplies through the making in the country are done in accordance with the Way of Making Good Fish Drugs (CPOIB).
(4) The further provisions concerning the CPOIB as referred to in paragraph (3) are specified with the Regulation of the Minister.
Section 13
(1) Fish drug preparation with a type of biologic, probiotic, and natural medicine should meet the provisions as follows:
a. fish drugs with a type of biologic supply can be performed for the type of fish disease already present in Indonesia;
B. Fish drugs with a type of probiotic supply in one supply most contain 5 microbial species with the density of each species at least 106 cfu/ml; and/or
c. fish medicine with a type of natural drug supply in one of the most content contains a simplified type 5 (five) type of simplisia.
(2) A fish drug treatment with a type of biological treatment for the diagnosis of a disease whose type of disease is not present in Indonesia, it can be done if it does not contain living microbes and/or parts that carry pathogenic elements.
BAB VI
FISH DRUG REGISTRATION
The Kesatu section
Common
Section 14
(1) The fish drugs provided by the manufacturer or the mandatory importer have a Fish Drug Registration Number Letter.
(2) The obligation to have a Fish Drug Registration Number Letter as referred to in paragraph (1) is excluded for:
a. the fish drugs provided by the government/government agencies /swasta; or
B. The natural drug that is being treated simply, does not contain any hard drugs, and is used for its own sake.
The Second Part
Mechanism
Section 15
(1) To acquire the Fish Drug Registration Number Letter as referred to in Article 14 of the paragraph (1), the manufacturer or importer must submit a request in writing to the Director General by attaching it:
a. Quality test results report;
B. field test results report, for fish drugs that require field testing; and
c. Technical data of fish drugs.
(2) The Application Of A Fish Drug Registration Number for a fish drug originating from income from abroad, in addition to attaching the requirements as referred to in paragraph (1), is required to be supplemented by:
a. photocopy of the Origin Letter of Origin (Certificate of Origin ), by showing the original;
B. Certificate of Free Sale (Certificate of Free Sale), by showing the original;
c. Photocopy Certificate of the Way of Good Manufacturing Practice (Certificate of Good Manufacturing Practice) of the institution authorized in the home country, by showing its original;
D. photocopy Certificate Not a Genetic Engineering Product (Certificate Non Genetically Modified Organism), for a biologic fish drug that is not a genetically engineered product, by showing the original;
e. photocopy of the Agenant or Distributor (Letter of Appointment) from overseas producers to the importer company in Indonesia, by showing the originals; and
f. A photocopy of the letter from the source of the sample of the fish.
(3) The Certificate of Good Manufacturing Practice (Certificate of Good Manufacturing Practice) as referred to in paragraph (2) the letter c, is at least equivalent to the CPOIB.
Section 16
(1) Quality testing and testing of lapses as referred to in Section 15 paragraph (1) letter a and letter b performed against sample fish drugs.
(2) Samples of fish drugs originating from abroad can be included in the State of the Republic of Indonesia after obtaining the Certificate Of Admission Of A Fish Drug Sample.
(3) To obtain a Letter of Acceptance Of A Fish Drug Sample as referred to in paragraph (2), the importer must submit a request in writing to the Director General of the least loading:
a. trade name/brand of fish drug sample;
B. name and address of the applicant;
c. name of the fish drug sample manufacturer;
D. country of origin of the fish drug sample;
e. the composition of the fish drug sample;
f. fish drug sample form;
G. types of fish drug samples;
h. package size;
i. Income intent;
J. sample number of fish drugs;
No, Load port; and
I. Port of admission.
(4) The invocation as referred to in paragraph (3), performed by attaching it:
a. Certificate Certificate (Certificate of Analysis);
B. Origin Letter (Certificate of Origin), authorized by representative of the Republic of Indonesia in the country of origin of a fish drug sample;
C. Certificate of Free Sale (Certificate of Free Sale); and
D. A certificate or a letter is not a genetic engineering product (Certificate Non Genetically Modified Organism), for a sample of biologic fish drugs that are not genetically engineered products.
(5) The Director General or the designated officer performs a document evaluation in at least 3 (three) business days since the document is fully received.
(6) Based on the results of the evaluation of the document as referred to in paragraph (5), the Director General or the appointed official publishes:
a. Sample of Fish Drug Sampled Income; or
B. The Rejection Letter Of The Fish Drug Samples, accompanied by a reason for rejection.
(7) The following are the following:
a. trade name/brand of fish drug sample;
B. name and importer address;
c. name of the fish drug sample manufacturer;
D. country of origin of the fish drug sample;
e. the composition of the fish drug sample;
f. fish drug sample form;
G. type of sample of fish drugs;
h. package size;
i. Income intent;
J. sample number of fish drugs;
No, port load;
I. the port of the income place; and
M. There is a sample of the Tissue Sample.
(8) Letter of Use of Fish Samples as referred to in paragraph (6) letter a may only be used for 1 (1) time of income and apply for a term of 1 (one) months from the date of publication.
(9) The Form and format of the Letter of Inclusion Of Fish Drugs samples as set forth in Annex III which is an inseparable part of this Minister's Regulation.
Section 17
(1) Quality Testing as referred to in Article 15 paragraph (1) letter a performed by an accredited domestic laboratory in accordance with the provisions of testing in the book pharmacopoeia of Indonesian animals, Indonesian pharmacopoeia, other farmakope, and/or other drug-analysis standard books.
(2) Test usage as defined in Section 15 of the paragraph (1) of the letter b performed by a competent instance covering the efficacy or efficacy test and/or security test according to the indication of the fish drug by referring to the lapsed test guidelines.
(3) Test lapses as referred to in paragraph (2) are performed against:
a. a fish drug that contains an active substance that has not been present or has no homologues in Indonesia; dan/or
B. Fish drugs are indicative and their use has not been published and has not been proven with official scientific references.
(4) The competent Instancy as referred to in paragraph (2) is set forth by the Director General after meeting the technical requirements, consisting of:
a. means and infrastructure;
B. human resources; and
c. test method.
(5) The further provisions of the lapsed test guidelines as referred to in paragraph (2) and the technical requirements as referred to in paragraph (4) are specified with the Decision of the Director General.
Section 18
(1) The technical data of the fish drug as referred to in Article 15 of the paragraph (1) the letter c is poured in the form consisting of:
a. trade brands and the composition of fish drugs;
B. fish drug-making process;
c. The examination of fish drugs and raw materials used;
D. Stability check;
e. daya farmakology;
f. publication of clinical trial in the field;
G. description of container, wrap, lid; and
h. The description of the marking, the writing and/or the image listed on the container wrapper or etiquette and the brochure.
(2) The technical data form of the fish drug for the examination of stability as referred to in paragraph (1) letter d, does not apply to fish medicine:
a. a powder-shaped mineral type (powder) that expires at under 1 (one) year;
B. disinfectant; and/or
c. natural materials.
(3) The further provisions of the order of charging the technical data form of the fish drug as referred to in paragraph (1) are specified with the Decision of the Director General.
Section 19
(1) The Director General performs the completion of the document in at least two (two) business days since receiving the request as referred to in Article 15 of the paragraph (1).
(2) Based on the results of the completion of the document as referred to in paragraph (1), the Director General:
a. forwarded the completed document to the Fish Drug Assessor Team for technical evaluation performed; or
B. published a rejection letter accompanied by a reason for rejection, if the document is not complete.
(3) The Fish Drug Assessor Team as referred to in paragraph (2) the letter of a technical evaluation in the most prolonged period of 7 (7) business days.
(4) The technical evaluation as referred to in paragraph (3) includes:
a. Scientific verification and analysis of the technical data set forth in the request document;
B. verification of quality testing results with technical data; and
c. verification of the results of the field test with the technical data.
(5) The results of the technical evaluation as referred to in paragraph (3) are recommended and delivered to the Director General.
(6) The Director General in the most prolonged period 3 (three) of the working day since receiving the recommendation as referred to in paragraph (5) must publish:
a. Fish Drug Registration Number Letters, for fish drugs that meet the requirements; or
B. The Letter of Drug Registration Rejection, which is accompanied by reason of rejection of a fish drug that does not meet the requirements.
(7) The Fish Drug Registration Number Letter as referred to in paragraph (6) of the letter a load:
a. fish drug registration number;
B. name manufacturer/importer of fish medicine;
c. Complete address of the manufacturer/importer of the fish drug;
D. the address of the fish drug production place;
e. the name of the fish drug manufacturer abroad;
f. Licensor's name;
G. trade name/fish drug brand;
h. fish drug classification;
i. fish drug form;
J. type of fish drug supply;
No, the composition of fish drugs;
I. package size; and
M. The term of a Fish-Drug Registration Number.
(8) The Form and format of the Letter of the Fish Drug Registration Number as set forth in Annex IV which is an inseparable part of the Regulation of this Minister.
(9) Further provisions regarding the composition of the membership and task of the Fish Drug Assessor as referred to in paragraph (2) of the letter a specified by the Decision of the Director General.
Section 20
(1) The drug of fish with the same trademark and composition arrangement is given the same Fish Drug Registration Number Letter, although the size of the packaging is different.
(2) Drug fish with a different trademark and/or composition arrangement, given a different Letter of Drug Registration Number Letter.
Section 21
(1) Against the rejected request as referred to in Section 19 of the paragraph (2) letter b or paragraph (6) of the letter b, then the applicant must take back the application of the application in the most prolonged period of 15 (fifteen) working days.
(2) If in the term of 15 (fifteen) the working day of the petitioner does not take the invocation document, then the plea document belongs to the Directorate General of Fisheries of Cultivation, The Ministry Of Marine and Fisheries.
The Third Part
The Applicable, Extension, Change, and Reimbursed
Section 22
The Fish Drug Registration Number is valid for a term of 5 (five) years counting since the date of publication.
Section 23
(1) The Term of the Fish Drug Registration Number Letter as referred to in Section 22 may be extended for the same time frame.
(2) The extension of the Fish Drug Registration Number Letter as referred to in paragraph (1) may be performed at least 3 (three) months prior to the expiration date of the Fish Drug Registration Number.
(3) To obtain an extension of the Fish Drug Registration Number Letter as referred to in paragraph (1), the manufacturer or importer must submit a request in writing to the Director General by attaching it:
a. photocopy of the Fish Drug Registration Letter Letter which will be extended;
B. the latest quality test results report;
c. technical data, including:
1) the trademark and the composition of the fish drugs;
2) fish drug-making process;
3) examination of the drug supply, which includes the description, test methods and results of qualitative and quantitative test, dilampiri certificate analyzer;
4) The description of the container, wrap, lid;
5) the description of the tagging, which is written and/or the image listed on the container wrapper or etiquette and brochure; and
6) The letter of the statement berates from the applicant that there is no change of composition and indication as well as the means of the use of fish drugs.
(4) Mechanism extension of the Mutatis Mutandis Mutatis Drug Registration Letter guidelines on the provisions of Article 19.
Section 24
(1) The Fish Drug Registration Number Letter may be changed in the event of a change in administration data, which includes:
a. manufacturer name/importir;
B. manufacturer's address/importir;
c. production place address;
D. Licensor's name; and/or
e. Trade name/brand name of fish.
(2) To obtain a change in the Letter of the Drug Registration Number as referred to in paragraph (1), the manufacturer or importer must submit to the Director General at least 1 (one) month since the change in administration data with attach:
a. photocopy of the Fish Drug Registration Letter that will be made changes; and
B. An explanation for the reasons for the change
(3) The Director General within three (three) business days of receiving the administrative data change request as referred to in paragraph (1) of the verification of the document.
(4) Based on the verification of the document as referred to in paragraph (3), the Director General publishes:
a. New Fish Drug Registration Number Letter; or
B. The letter of rejection, accompanied by reason of rejection.
(5) If the new Fish Drug Registration Number has been issued, then in the same time the applicant must return the Fish Drug Registration Number Letter to the change.
Section 25
(1) The Fish Drug Registration Number Letter may be reimbursed if the original Fish Drug Registration Letter is broken or missing.
(2) To obtain the replacement of the Fish Drug Registration Number Letter as referred to in paragraph (1), the manufacturer or importer must apply to the Director General by attaching the original Fish Drug Registration Number Letter in case of Mail Fish Drug Registration number is broken, or a missing letter from the police force in case of the Missing Fish Drug Registration Number.
(3) The Director General publishes the Letter of the Drug Registration Number of the most lasting 3 (three) business days since the acceptance of the request as referred to in paragraph (2) in complete.
Section 26
Manufacturers or importers who have had a Letter of Fish Drug Registration Number are required to maintain the consistency of the quality of the fish drugs in accordance with the captions listed in the Letter of the Fish Drug Registration Number.
Section 27
(1) Foreign-derived fish drugs may be included in the State of the Republic of Indonesia after obtaining the Admission Letter Of The Fish Drug.
(2) In order to obtain the Ikan Remedy of Inclusion as referred to in paragraph (1), the importer or the government/private institution must submit a request in writing to the Director General, the least of which is to be a member of the Ap.
a. trade name/fish drug brand;
B. name and address of the applicant;
c. The name of the fish drug manufacturer;
D. country of origin of the fish drug;
e. fish drug classification;
f. fish drug form;
G. type of fish drug supply;
h. package size;
i. fish drug inclusion;
J. number of fish drugs;
No, Load port; and
I. Port of admission.
(3) The application submitted by the importer as referred to in paragraph (2), carried out by attaching it:
a. photocopy of the Fish Drug Registration Letter;
B. list of packaging (packing list) that contains type, amount (quantity), and unit volume/weight.
(4) The application submitted by the government/private institution (s) as referred to in paragraph (2), performed by attaching:
a. photocopy of the Origin Letter of Origin (Certificate of Origin), by showing the original;
B. Certificate of Free Sale (Certificate of Free Sale), by showing the original;
c. Photocopy Certificate of the Way of Good Manufacturing Practice (Certificate of Good Manufacturing Practice) of the institution authorized in the country of origin, by showing the original;
D. photocopy Certificate Not a Genetic Engineering Product (Certificate Non Genetically Modified Organism), for a biologic fish drug that is not genetically engineered, by showing the original;
e. Technical data as referred to in Section 15 of the paragraph (1) of the letter c; and
f. list of packaging (packing list) containing the type, amount (quantity), and unit volume/weight.
(5) The Director General or the appointed official conduct the evaluation of the document in at least 3 (three) business days since receiving a full request.
(6) Based on the results of the evaluation of the document as referred to in paragraph (5) the Director General or the appointed official publishes:
a. Fish Drug Income Description; or
B. The Rejection Letter Of The Fish Drug, accompanied by a reason for rejection.
(7) The (7) letter of the Ikan Remedy as referred to in paragraph (6) of the letter a, least of which it contains:
a. trade name/fish drug brand;
B. importer name;
c. importer address;
D. fish drug registration number;
e. fish drug manufacturer name;
f. country of origin of the fish drug;
G. fish drug classification;
h. fish drug form;
i. type of fish drug supply;
J. package size;
No, fish drug inclusion;
I. number of fish drugs;
M. port load;
N. the port of the income place; and
O. A Letter of Medicinal Letters.
(8) Letter of Use of the Fish Medication as referred to in paragraph (6) the letter may only be used for 1 (one) times the income and apply for a term of 3 (three) months from the date of publication.
(9) The Form and format of the Letter of Admission Of The Drug of Fish as set forth in Annex V which is an inseparable part of this Minister's Regulation.
BAB VII
SET THE WAY OF THE INTRODUCTION OF FISH MEDICINE RAW MATERIALS, FISH DRUG SAMPLES, AND FISH REMEDIES
Section 28
(1) Importers or government/private institutions that will include the raw materials of fish drugs, sample fish drugs, and/or fish drugs into the State of the Republic of Indonesia are required to report the slowest 1 (one) days prior to arrival and Handing out the Letter of Ingredient Influx Of Fish Drugs, Letter of Income Samples of the Fish, and/or Letter of Income Of The Fish Drug to Quarantine Officer at the time of arrival at the income.
(2) the Quarantine Officer performing a Warrant Examination of the Ingredients Of The Raw Materials of the Fish, the Letter of the Income Of The Fish Drugs Sample, and/or the Letter of the Inclusion Of The Drug as referred to in verse (1) to know the validity and the The truth of the letter of the inclusion of fish drugs, the letter of the income of the fish drug samples, and/or the Letter of the Income Of The Fish Drugs.
(3) Letter of Inclusion Of Raw Materials of Fish Drugs, Letter of Income Sampling Of Fish Drugs, and/or Letter of Income Of Fish Drugs, declared valid if published by the Director General or an appointed official.
(4) Letter of the Importation Of Raw Materials of Fish Drugs, Letter of Income Of Fish Drugs, and/or A Letter of Income Of Fish Medication, stated true if there is a match between the Letter of Income Of The Raw Materials Drug, The Letter The description of the inclusion of a fish drug sample, and/or the Letter of Income Of Fish Drugs with the physical goods included in the State of the Republic of Indonesia.
(5) In order to check the correctness of the Ikan Needed of the Fish, the Letter of the Admission Of The Fish Drugs, and/or the Letter of the Income Of The Fish Drug as referred to in verse (4), the Officer of Quarantine did Physical examination in the customs area.
(6) Examination of the inclusion of the income of the raw materials for fish drugs, the letter of the inclusion of a fish drug sample, and/or the Letter of the Remedy of the Drug as referred to in the paragraph (2) are performed within a term of at least 3 (3) business days.
(7) Based on the results of the Inclusion Letter of the Fish, Fish, and/or Explanation Of The Fish Drug, as referred to in verse (2) and physical examination as contemplated. on paragraph (5), the Officer of Quarantine publishes:
a. Fish Pill/Fish Drug/Fish Drug Sample Letter from the Penal Place, in the case of the Inclusion Letter Of The Fish Drug's Ingredient, The Letter Of Admission Of The Fish Drugs Sample, and/or the Valid Fish Drug's Letter of Letters And true, with stews to the Director General Oversight of Marine Resources and Fisheries; or
B. Cash Fish/Fish Drug/Fish Drug Sample Letters from the Penal Place, in the case of the Introduction Letter of the Ingredient Raw Materials, the Letter of Admission Of The Fish Drugs, and/or The Letter of the Ingredient Of The Fish Drugs are not lawful and/or not true.
Section 29
(1) If the raw materials of fish drugs, sample of fish drugs, and/or fish drugs are subject to a rejection act as referred to in Article 28 paragraph (7) letter b, then the importer or government/private institution is required to send back the raw materials of the fish drugs, sample of fish drugs, and/or fish drugs to the country of origin in the most prolonged period of 3 (three) days since the rejection is performed.
(2) If in the term of 3 (3) days no delivery is returned to the country of origin, then against the raw materials of fish drugs, samples of fish drugs, and/or fish drugs as referred to in paragraph (1) are committed extermination in accordance with the terms of the applicable law. Valid.
Section 30
The terms of the raw materials of the raw materials of fish drugs, samples of fish drugs, and/or fish drugs of the type of biologics are excluded from the provisions as referred to in Article 28 and Section 29, and are governed by the Regulation of the Minister.
BAB VIII
INCOME AND EXPENSE PLACES
Section 31
Any raw materials of fish drugs, samples of fish drugs, or fish drugs that will be incorporated into the State of the Republic of Indonesia or expelled from within the State of the Republic of Indonesia can only be done through a place of income or place of income. expenses as follows:
a. sea port: Belawan di Medan, Tanjung Priok in Jakarta, Tanjung Gold in Semarang, Tanjung Perak in Surabaya, Sukarno Hatta in Makassar, and Long in Lampung;
B. all international air ports; and/or
c. Entikong border checkpoint.
BAB IX
FISH DRUG CIRCULATION
Section 32
(1) The medicine of the fish circulated in the State of the Republic of Indonesia is required to be packaged in a watertight container and/or a specific wrap and is inscribed on the Indonesian fish medicine that is easy to see and read as well as not easy was removed.
(1) The interest of the fish drug as referred to in paragraph (1) is the least of which it contains:
a. fish drug registration number;
B. name and address of the manufacturer/importer of the fish drug;
c. trade name/fish drug brand;
D. fish drug classification;
e. fish drug form;
f. type of fish drug supply;
G. the composition of fish drugs;
h. net weight;
i. Target/indication and target fish;
J. the way of use and storage;
No, production code;
I. date expiry; and
M. fish drug stop time (withdrawl time), specifically for the hard drug classification.
Section 33
(1) Exporters that will distribute fish drugs to outside the State of the Republic of Indonesia must have a Letter of Interest in Fish Drug Spending.
(2) To acquire a Fish Drug Spending Letter as referred to in paragraph (1), the exporter must submit a request in writing to the Director General of the least loading:
a. trade name/fish drug brand;
B. name and address of the applicant;
c. The name of the fish drug manufacturer;
D. destination country;
e. fish drug classification;
f. fish drug form;
G. type of fish drug supply;
h. package size;
i. Fish drug expense intent;
J. number of fish drugs; and
No, The port of the expense
(3) The application submitted by the exporter as referred to in paragraph (2), carried out by attaching it:
a. photocopy of the Fish Drug Registration Letter; and
B. list of packaging (packing list) containing the type, amount (quantity), and unit volume/weight.
(4) The Director General or the appointed official conduct the evaluation of the document in at least 3 (three) business days since the application is fully received.
(5) Based on the results of the evaluation of the document as referred to in paragraph (4) the Director General or the appointed official publishes:
a. Fish Drug Spending Description; or
B. The Rejection Letter of the Fish Drug Spending, accompanied by a reason for rejection.
(6) The Letter of the Fish Drug Spending as referred to in paragraph (5) the letter a, at least contains:
a. trade name/fish drug brand;
B. name and exporter address;
c. fish drug registration number;
D. fish drug manufacturer name;
e. destination country;
f. fish drug classification;
G. fish drug form;
h. type of fish drug supply;
i. package size;
J. Fish drug expense intent;
No, number of fish drugs;
I. port of place of expense; and
M. The term of a Fish's Drug Spending Time.
(7) The Letter of the Fish Drug Spending as referred to in paragraph (5) the letter may only be used for 1 (one) times the expense and apply for a term of 3 (three) months from the date of publication.
(8) The Form and format of the Letter of the Fish Drug Spending as set forth in Appendix VI which is an inseparable part of this Minister ' s Regulation.
Section 34
(1) Each person is forbidden to circulate an edar-non-laic fish drug.
(2) The non-laic fish drug edar as referred to in verse (1) includes the fish drug which is:
a. does not have a Fish Drug Registration Number Letter;
B. experiencing physical changes, which include textures, colors, and/or odour;
c. have expired; and/or
D. The packaging, the container, the wrap and/or the lid is broken.
Section 35
Any person who does a fish drug effort should do a recording of any of the fish drugs circulated.
BAB X
RETURN INCOME
Section 36
(1) Any person who will make reincome of the raw materials of fish drugs or fish drugs originating from Indonesia as it is rejected by the importing country/country the mandatory destination reports the slowest 1 (one) days prior to arrival to the Officer Quarantine and submit the document:
a. Fish Drug-Drug Spending Letter or Fish Drug Spending Letter; and
B. Export Items
(2) The Quarantine Officer performs a document check as referred to in paragraph (1) in the most hours of 2 (two) days of work to find out the validity and truth of the document.
(3) The Letter of Ingredient Issuer of Fish Drugs or the Letter of Fish Drug Spending and Export Notice of Goods is declared valid if published by the authorized instance.
(4) The Letter of Interest in the Spending of Fish Drugs or the Letter of Fish Drug Spending and the Export Notice of Goods is stated to be true if there is a suitability between the Letter of the Raw Materials of the Ingredient Drug or the Letter of Adorage Fish Drug Spending and Export Notice of Export of Goods with the physical items reincorporated into the State of the Republic of Indonesia.
(5) In order to check the correctness of the Letter of the Spending of Fish Drugs or Fish Drug Spending and Export Notice of Goods, Officer Quarantine conducts a physical examination in the customs area.
(6) Based on the results of a document check as referred to in paragraph (2) and physical examination as referred to in paragraph (5), the Officer of Quarantine publishes:
a. Fish Pill/Fish Drug Spending Agreement from the Place of Instalation, if the full, legal, and correct document is correct, with busan to the Director General Oversight of Marine and Fisheries Resources; or
B. The Fish Pill/Fish Drug Spending Rejection Letter from the Place of Instalation, if the document is incomplete, invalid and/or not correct.
(7) If the raw materials of fish drugs or fish drugs are subject to a rejection act because the document is declared incomplete as in paragraph (6) the letter b, then the owner of the raw materials the fish or fish drug is obliged to supplement the lack of documents in the For a period of time, three (three) days from the acceptance of the letter of rejection.
(8) If only three (3) days since the receipt of the letter of rejection, as referred to in paragraph (6) the letter b of the owner of a fish or fish drug may be able to supplement the lack of a document, then mutatively mutandis applies to the provisions of the letter. as in verse (2), verse (3), paragraph (4), and paragraph (5).
(9) If in the term of 3 (3) days since the receipt of the receipt of the owner of the raw materials, fish or fish drugs may not complete the lack of a document or the raw materials of the fish or fish drugs are subject to a rejection of the document. Invalid and/or untrue as referred to in verse (6) letter b then the raw material of the fish or fish drugs is done extermination.
(10) The extermination as referred to in paragraph (9) is carried out by the Officer of Quarantine.
Section 37
The reentry of the raw materials of fish drugs or fish drugs must go through the designated income place as referred to in Article 31.
BAB XI
COACHING, MONITORING, AND SUPERVISING
Section 38
(1) The Director General and the Head of the Service undertake the coaching and monitoring of the provision and circulation of fish drugs according to its authority.
(2) Coaching and monitoring as referred to in paragraph (1) at least include:
a. the process of providing and circulatory of fish drugs;
B. the means and the storage of the fish drug storage; and
C. Quality, efficacy, and safety of fish drugs.
(3) In conducting coaching and monitoring as referred to in paragraph (1), the Director General or the Head of the Service establishes the Coaching Team and the Monitoring of the Fish Drug.
(4) The terms for which the Program may be installed as a member of the Coaching and Drug Monitoring Team as referred to in paragraph (3) must have a competency in the field of fish medicine.
Section 39
(1) In order of the coaching and monitoring of the fish drugs as referred to in Article 38 of the paragraph (1), the fish drug manufacturer is required to make a report every 6 (six) months to the Director General regarding:
a. the number, type, and origin of the raw material;
B. the number and type of fish drugs that have been produced; and
c. The amount of drugs that have been circulated and the area of circulation.
(2) In the course of the coaching and monitoring of the fish drugs as referred to in Article 38 of the paragraph (1), the importer of the fish drug is required to make a report every 6 (six) months to the Director General regarding:
a. the number and type of fish drugs that have been incorporated into the State of the Republic of Indonesia; and
B. the amount of fish drugs that have been circulated and the area of circulation.
(3) In the course of the coaching and monitoring of the fish drugs as referred to in Article 38 of the paragraph (1), the exporter is obliged to make a report every 6 (six) months to the Director General regarding:
a. the number and type of fish drugs that have been removed from the State of the Republic of Indonesia; and
B. Destination country.
(4) In order of the coaching and monitoring of the fish drugs as referred to in Article 38 of the paragraph (1), the distributor of the fish drug is required to make a report every 6 (six) months to the Head of the Provincial Service concerning:
a. the number and type of fish drugs circulated; and
B. The circulatory area of fish drugs.
(5) In order of the coaching and monitoring of the fish drugs as referred to in Article 38 of the paragraph (1), depo and fish drug stores are required to make a report every 6 (six) months to the Head of the County/City Service regarding:
a. the number and type of fish drugs circulated;
B. the doctor ' s name veterinarian;
c. The circulatory region of fish drugs; and
D. fish drug users name for fish drugs with a classification of hard drugs and restricted free drugs.
Section 40
(1) The Head of the Regency/City Service delivers a report of the results of the coaching and monitoring of the fish drugs to the Head of the Provincial Service most slowly every other 10 months.
(2) The Head of the Provincial Service delivers the report of the results of the coaching and monitoring of the fish drugs to the Director General of the slowest each of the 20th, which contains the results of the coaching and monitoring that it does and the recapitulation of the coaching results and County/city drug monitoring.
(3) The results of coaching and monitoring as referred to in paragraph (2) are used Director General as policy-making materials.
Section 41
Surveillance on the circulatory of fish drugs is carried out by the Fisheries Supervisor.
BAB XII
THE SANCTION
Section 42
(1) The manufacturer or importer of a fish drug that commits a violation of Article 26, Article 35, and/or Article 39 is subject to administrative sanction.
(2) Administrative sanctions as referred to in paragraph (1) may be:
a. written warning;
B. freezing of the Fish Drug Registration Number; or
c. revocation of the Fish Drug Registration Number Letter.
(3) Administrative sanctions as referred to in paragraph (2) are provided by the Director General.
Section 43
(1) The written warning as referred to in Article 42 of the paragraph (2) of the letter a given to the manufacturer or importer of a fish drug that violates the provisions is referred to in Article 35 and/or Article 39.
(2) The written warning as referred to in paragraph (1) is given to the manufacturer or importer of a fish drug that does not meet its obligations at most 3 (three) times in the most prolonged period of 15 (fifteen) days for each A warning.
Section 44
(1) administrative sanction of the freezing of the Fish Drug Registration Number Letter as referred to in Article 42 of the paragraph (2) letter b is given to:
a. the manufacturer or importer of a fish drug as referred to in Article 44 of the paragraph (1) that up to the end of the third term of the warning does not carry out its obligations;
B. the manufacturer or the importer of a fish drug that commits a violation of the provisions as referred to in Article 26.
(2) The freezing of the Letter of Fish Drug registration number as referred to in paragraph (1) is carried out for 30 (thirty) days since the sanctions were granted.
Section 45
Administrative sanction is the revocation of the Fish Drug Registration Number Letter as referred to in Article 42 of the paragraph (2) of the letter c given to the manufacturer or importer who is up to the end of the term of the freezing of the Fish Drug Registration Number does not perform its obligations.
BAB XIII
THE EXPIRATION OF THE FISH DRUG REGISTRATION NUMBER.
Section 46
(1) The Letter of the Fish Drug Registration Number as referred to in Article 19 of the paragraph (6) letter a expires due to:
a. revoked because the manufacturer or importer of the fish drug up to the end of the term freezing of the Fish Drug Registration Letter does not carry out its obligations;
B. revoked due to the request of the owner of the Fish Drug Registry Number;
c. revoked for proven scientifically or based on other references that the fish drug is harmful to fish health, human and environmental;
D. The term of the Fish Drug Registration Number is expired and is not extended.
(2) The revocation of the Fish Drug Registration Number letter as referred to in paragraph (1) letter a, letter b, and the letter c is carried out by the Director General.
BAB XIV
LAIN PROVISIONS
Section 47
(1) In conditions of emergency and/or plague prescribed by the Minister and no fish drugs have Fish Drug Registration Number to address the emergency and/or plague conditions, then the fish drug that meets the requirements can be It was given a temporary fish drug registration letter.
(2) To obtain a Temporary Fish Drug Registration Number Letter as referred to in paragraph (1), the manufacturer or impotent must submit a written request to the Director General with an explanation of the technical data as referred to in Article 15 of the paragraph (1) of the letter c and the requirements as referred to in Article 15 of the paragraph (2) for the drug of fish originating from abroad.
(3) The Director General performs the examination of the completion of the document in at least one (one) day of work since receiving the request as referred to in paragraph (2).
(4) Based on the results of the document completeness as referred to in paragraph (3), the Director General forwarded the complete document to the Fish Drug Assessor Team to perform the technical evaluation.
(5) Based on the results of the technical evaluation as referred to in paragraph (4), in the most prolonged period 2 (two) business days, the Fish Drug Assessor Team provides a recommendation to the Director General of the agreement or refusal.
(6) The Director General in the most prolonged 2 (two) business days since receiving the recommendation as referred to in paragraph (5) must publish:
a. Temporary Fish Drug Registration Number Letter, for fish drugs that meet the requirements; or
B. The letter of rejection, accompanied by the grounds of rejection of a fish drug that did not meet the requirements.
Section 48
The Temporary Fish Drug Registration Number letter as referred to in Article 47 of the paragraph (6) of the letter a valid for 1 year.
BAB XV
THE TRANSITION PROVISION
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) The Letter of the Drug Registration Number of the Fish which has been published before the enactment of this Minister ' s Regulation, is stated to remain in effect until the expiration date.
(3) The Application Of The Fish Drug Registration Number which has been delivered and is declared complete, processed under the Decree of the Minister of Marine and Fisheries Number KEP.26/MEN/2002 on the Supplies, Circular, Use, and Oversight of Fish Drugs.
BAB XVI
CLOSING PROVISIONS
Section 50
With the Ordinance of this Minister's Regulation, the Decree of the Minister of Marine and Fisheries of Number KEP.26/MEN/2002 on the Supplies, Circular, Use, and Oversight of the Fish Drugs were revoked and declared to be not applicable.
Section 51
The Minister ' s rules are beginning to apply to the date of the undrased.
In order for everyone to know it, order the invitational of the Minister's Regulation with its placement in the News of the Republic of Indonesia.
Set in Jakarta
on January 31, 2012
MINISTER OF MARINE AND FISHERIES
REPUBLIC OF INDONESIA,
SHARIF C. SUTARDJO
Promulgated in Jakarta
on February 1, 2012
MINISTER OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA,
AMIR SYAMSUDIN
* not yet in the form of loose sheets
