to Indonesian
a. that Decree of the Minister of Agriculture No. 324/Kpts/TN.120/4/1994, has stipulate terms and procedures for the issuance of Animal Medicine Business Permit;
b. that due to reorganization of the Ministry of Agriculture, and with the stipulation of Government Regulation No. 38/2007 concerning Division of Government Affairs between the Government, Provincial Government, and Regency/Municipality Government, it is necessary to review arrangements on terms and procedures on the issuance of Animal Medicine Business Permit with a regulation of the Minister of Agriculture;
1. Law No. 6/1967 concerning Basic Provisions on the Animal Husbandry and Health (Statute Book No. 10/1967, Supplement to Statute Book No. 2824);
2. Law No. 8/1999 concerning Consumer Protection (Statute Book No. 42/1999, Supplement to Statute Book No. 3821);
3. Law No. 32/2004 concerning Regional Government (Statute Book No. 125/2004, Supplement to Statute Book No. 4437);
4. Presidential Regulation No. 78/1982 concerning Animal Medicine (Statute Book No. 129/1992, Supplement to Statute Book No. 3509);
5. Government Regulation No. 38/2007 concerning Division of Government Affairs between the Government, Province Government, and Regency/Municipality Government (Statute Book No. 82/2007, Supplement to Statute Book No. 4737);
6. Presidential Decree No. 187/M/2004 concerning Establishment of United Indonesia Cabinet;
7. Presidential Regulation No. 9/2005 concerning Position, Duties, Functions, Organizational Structure, and Work Procedure of State Ministries of the Republic of Indonesia, in conjunction with Presidential Regulation No. 62/2005;
8. Presidential Regulation No. 10/2005 concerning Organization Units and Duties of First Echelon of State Ministries of the Republic of Indonesia;
9. Regulation of the Agriculture Minister No. 299/Kpts/OT.140/7/2005 concerning Organization and Work Procedure of the Ministry of Agriculture, in connection with Regulation of the Minister of Agriculture No. 11/Permentan/OT.140/2/2007, and Regulation of the Minister of Agriculture No. 22/Permentan/OT.140/4/2008;
10. Regulation of the Minister of Agriculture No. 341/Kpts/OT.140/9/2005 concerning Organization Complement and Work Procedure of the Ministry of Agriculture, in conjunction with Regulation of the Minister of Agriculture No. 12/Permentan/OT.140/2/2007;
REGULATION OF THE MINISTER OF AGRICULTURE CONCERNING TERMS AND PROCEDURES FOR THE ISSUANCE OF ANIMAL MEDICINE BUSINESS PERMIT
In this Regulation:
1. Animal medicines are medicines particularly used for animals.
2. Animal Medicine Business Permit is a writing statement issued by the official having the authority to Indonesian citizens or business entities to carry out business in the field of production, supply, circulation, import, and/or export of animal medicines.
3. Production is an activity process in the processing, mixing and/or changing of animal medicine raw materials to become animal medicines.
4. Supply is an activity process in the procurement, ownership, control, and/or storage of animal medicines in a place or room with the purpose to be circulated.
5. Circulation is an activity process related with trade, transportation, and/or delivery of animal medicines.
6. Import of animal medicines, hereinafter called as import, is a series of activities to import animal medicines from overseas into the territory of the Republic of Indonesia.
7. Export of animal medicines, hereinafter called as export, is a series of activities to export animal medicines from the territory of the Republic of Indonesia.
8. Producers of animal medicines are Indonesian citizens or business entities performing business on the production, supply, and/or circulation of animal medicines.
9. Importers of animal medicines are Indonesian citizens or business entities performing business on the import of animal medicines from overseas into the territory of the Republic of Indonesia.
10. Exporters of animal medicines are Indonesian citizens or business entities performing business on the export of animal medicines from the territory of the Republic of Indonesia.
11. Distributors are Indonesian citizens or business entities carrying out the supply and/or circulation of animal medicines from producers or importers.
12. Animal medicine depot or pet shop, hereinafter called as depot, is a business unit performing business on the supply and/or circulation of animal medicines from distributors.
13. Animal medicine stores, hereinafter called as stores, are business units performing business on the supply and/or circulation of animal medicines other than strong drugs.
14. Biological diagnostic substances are biological preparations used to diagnose diseases on animals.
15. Head of the Center is the Head of Permits and Investment Center of the Ministry of Agriculture.
16. Service is the agency in charge of functions on the animal husbandry and/or animal in a province or regency/municipality.
(1) This regulation is purposed as a legal basis for the provision of permits and the performance of animal medicine business activities for government officials and business performers.
(2) This regulation has the following objectives:
(1) Animal medicine business covers the following activities:
(2) The animal medicine business as intended in paragraph (1) may be performed by Indonesian citizens or business entities.
(1) Animal medicine business permits are issued by the authorized official to Indonesian citizens or business entities to perform business in the field of animal medicines.
(2) Issuance of Animal Medicine Business Permit as intended in paragraph (1) for producers, importers, and/or exporters is by the Director General of Husbandry on behalf of the Minister of Agriculture.
(3) Issuance of Animal Medicine Business Permit as intended in paragraph (1) for distributors is by the Governor.
(4) Issuance of Animal Medicine Business Permit as intended in paragraph (1) for depots and/or stores is by the Regent/Mayor.
(1) In order to obtain Animal Medicine Business Permit, Indonesian citizens or business entities must meet administrative requirements and technical requirements.
(2) The administrative requirements as intended in paragraph (1) are as follows:
The technical requirements as intended in Article 5 paragraph (1) are:
(1) Application for Animal Medicine Business Permit as intended in Article 4 paragraph (2) shall be submitted to the Minister through the Head of Center with copies to the Director General of Husbandry, by using Model-1 form.
(2) After receiving the application as intended in paragraph (1), Head of the Center shall within a period of no later then 3 (three) work days since received application, immediately gives an answer whether it is accepted, postponed, or rejected.
(1) An application shall be accepted as intended in Article 7 paragraph (2) if it meets the administrative requirements as intended in Article 5.
(2) An application shall be postponed as intended in Article 7 paragraph (2) if there are still some shortages of the administrative requirements as intended in paragraph (1), which must be equipped and notified to the applicant by the Head of the Center in writing by using Model-2 form.
(3) Within a period of no later than 5 (five) work days since received notification as intended in paragraph (2), the applicant must have completed the shortages of requirements.
(4) If within the period as intended in paragraph (3) the applicant did not complete the shortage of the administrative requirements, the application will be deemed as being withdrawn.
(5) An application shall be rejected as intended in Article 7 paragraph (2) if the administrative requirements as intended in paragraph (1) are not correct.
(6) Rejection of the application as intended in paragraph (5) shall be notified to the applicant by the Head of the Center accompanied with reasons for the rejection in writing, by using Model-3 form.
An application having met the administrative requirements as intended in Article 8 paragraph (1) shall be submitted to the Director General of Husbandry by the Head of the Center to be studied as of the fulfillment of its technical requirements.
(1) After receiving the application from the Head of the Center as intended in Article 9 the Director General of Husbandry shall perform a study on the technical requirements.
(2) In the performance of the technical study, the Director General of Husbandry, within a period of no later than 20 (twenty) work days, must have provided an answer: accepted, or rejected.
(1) An application shall be accepted as intended in Article 10 paragraph (2), if it meets the technical requirements as intended in Article 6.
(2) For an application that is accepted as intended in paragraph (1), a business permit will be issued in the form of a Decree of the Minister of Agriculture signed by the Director General of Husbandry on behalf of the Minister of Agriculture stated in Model-4 form.
(3) The Decree as intended in paragraph (2) shall be delivered to the applicant through the Head of the Center.
(4) The business permit as intended in paragraph (2) remains in force for the duration the permit holder still carry on activities.
(1) An application shall be rejected as intended in Article 10 paragraph (2) if the technical requirements as intended in Article 6 are not met.
(2) Rejection of an application as intended in paragraph (1) will be given by the Director General of Husbandry to the applicant accompanied with reasons in writing through the Head of the Center.
(1) Individuals or business entities intending to expand business activities must have an expansion permit.
(2) The expansion permit as intended in paragraph (1) can be obtained in accordance with the terms and procedure as intended in this Regulation.
The expansion of business as intended in Article 13 covers:
Holders of Animal Medicine Business Permit as intended in Article 11 paragraph (2) are obliged to submit reports periodically once in every 3 (three) months on its business activities to the Director General of Husbandry through the Head of the Center.
A permit holder intending to move its location must notify in writing to the party issuing the permit.
(1) The business permit as intended in Article 11 paragraph (2) may be transferred after receiving an approval of the party issuing the permit.
(2) The transfer as intended in paragraph (1) shall be performed in accordance with applicable legislations.
A business permit will be revoked if:
(1) Revocation of Animal Medicine Business Permit as intended in Article 18 paragraphs a, b and/or g shall be made after giving a warning in writing three (3) times in succession with an interval of 50 (fifty) work days respectively, were not heeded by the permit holder.
(2) Revocation of Animal Medicine Business Permit as intended in paragraph (1) shall be made in the form of a Decree of the Minister of Agriculture signed by the Director General on behalf of the Minister as stated in Model-5 form.
For the purpose of protecting the national interest, and to assist the tackling of animal diseases in other countries, the production of biological preparations wherein its isolate parent species are not available in Indonesia, it can be produced under separate requirements and must meet a high biological safety level.
(1) Application for Animal Medicine Business Permit under process before the stipulation of this regulation shall be performed in accordance with provisions of Decree of the Minister of Agriculture No. 324/Kpts/TN.120/4/94 concerning Terms and Procedures for the Issuance of Animal Medicine Business Permit.
(2) Animal Medicine Business Permits already issued before the stipulation of this regulation is declared as still applicable however must be conformed to this regulation.
With the stipulation of this Regulation, Decree of the Minister of Agriculture No. 324/Kpts/IN.120/4/94 concerning Terms and Procedures on the Issuance of Animal Medicine Business Permit, is revoked and declared null and void.
This Regulation shall come to force on the date of stipulation.
For public cognizance, this Regulation of the Minister of Agriculture shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on April 8, 2009
MINISTER OF AGRICULTURE,
signed,
ANTON APRIYANTONO