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Regulation of The Minister of AGRICULTURE NUMBER 18/Permentan/OT.140/4/2009
Regulation of The Minister of AGRICULTURE NUMBER 18/Permentan/OT.140/4/2009
ABOUT
MINISTER OF AGRICULTURE,
DECIDE:
PIG
GENERAL REQUIREMENTS
article 1
3. Manufacturing is the process of processing, mixing and/or changing the form of animal medicine
raw materials into animal medicine.
4. Provision is the process of procurement, ownership, control and/or storage of veterinary
medicines in a place or room with the intention of distribution.
5. Circulation is the process of activities related to trade, transportation and/or delivery of veterinary
medicines.
6. Importation of animal medicines, hereinafter referred to as imports, is a series of activities to
import animal medicines from abroad into the territory of the Republic of Indonesia.
8. Animal medicine producers are individual Indonesian citizens or business entities that carry out
the business of manufacturing, supplying and/or distributing animal medicines.
9. Veterinary medicine importers are individual Indonesian citizens or business entities that
carry out the business of importing veterinary medicines from abroad into the territory of the
Republic of Indonesia.
10. Veterinary medicine exporters are individual Indonesian citizens or business entities that carry
out the business of dispensing animal medicines from the territory of the Republic of
Indonesia abroad.
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11. Distributors are individual Indonesian citizens or business entities that provide and/or
distribute veterinary medicines from producers or importers.
12. Animal medicine depot or pet shop, hereinafter referred to as depot, is a business unit that
carries out the business of providing and/or distributing animal medicine from distributors.
13. Veterinary medicine shop, hereinafter referred to as shop, is a business unit that carries out
the business of providing and/or distributing animal medicines other than hard medicines.
Section 2
(1) This regulation is intended as a legal basis for providing licensing services and implementing
veterinary medicine business activities for officials and business actors.
CHAPTER II
Article 3
(2) The veterinary medicine business as intended in paragraph (1) can be carried out by
individual Indonesian citizens or business entities.
Article 4
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(2) The granting of veterinary medicine business permits as intended in paragraph (1) to producers, importers
and/or exporters is granted by the Director General of Animal Husbandry on behalf of the Minister of
Agriculture.
(4) The granting of veterinary medicine business permits as intended in paragraph (1) for depots and/or
shops is granted by the Regent/Mayor.
CHAPTER III
Article 5
(1) To obtain a veterinary medicine business permit, individual Indonesian citizens or business entities must
fulfill administrative requirements and technical requirements.
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Article 6
d. For producers who do not yet have a veterinary medicine factory, they can use the
services of another party who has a certificate on how to make good veterinary medicine
(CPOHB), and/or an accredited veterinary medicine quality testing laboratory owned by
another party.
2. Animal medicine importers have:
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CHAPTER IV
Article 7
(1) The application for a veterinary medicine business permit as intended in Article 4 paragraph (2)
is submitted to the Minister through the Head of the Center with a copy to the Director General
of Animal Husbandry, using the model-1 form.
(2) The Head of the Center, after receiving the application as intended in paragraph (1), within a
maximum period of 3 (three) working days from the receipt of the application letter, must
immediately provide an answer whether it is accepted, postponed or rejected.
Article 8
(1) Applications are accepted as intended in Article 7 paragraph (2) if they have fulfilled the
administrative requirements as intended in Article 5.
(2) The application is postponed as intended in Article 7 paragraph (2) if there are still deficiencies
in the administrative requirements as intended in paragraph (1) which must be completed and
notified to the applicant by the Head of the Center in writing using the model-2 form.
(3) Applicants within a period of no later than 5 (five) working days from receiving the notification as
intended in paragraph (2) must have completed the remaining requirements.
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(4) If within the time period as intended in paragraph (3) the applicant has not completed the
administrative requirements, the application is deemed to be withdrawn.
(5) The application is rejected as intended in Article 7 paragraph (2) if the administrative
requirements as intended in paragraph (1) are not correct.
(6) The rejection of the application as intended in paragraph (5) is conveyed to the applicant
by the Head of the Center accompanied by the reasons for the rejection in writing,
using the model-3 form.
Article 9
Article 10
(1) The Director General of Animal Husbandry after receiving the request from the Head of
the Center as intended in Article 9 shall conduct a review of the technical requirements.
(2) The Director General of Animal Husbandry, in carrying out a technical study within a
maximum period of 20 (twenty) working days, must provide an accepted or rejected
answer.
Article 11
(1) Applications are accepted as intended in Article 10 paragraph (2) if the technical
requirements as intended in Article 6 have been fulfilled.
(2) The application received as intended in paragraph (1) is issued a business permit in the
form of a Decree of the Minister of Agriculture signed by the Director General of Animal
Husbandry on behalf of the Minister of Agriculture as in the Model-4 form.
(3) The decision as intended in paragraph (2) is conveyed to the applicant through the Head
of the Center.
(4) The business permit as intended in paragraph (2) is valid as long as the permit holder is
still carrying out activities.
Article 12
(1) The application is rejected as intended in Article 10 paragraph (2) if the technical
requirements as intended in Article 6 cannot be fulfilled.
(2) Rejection of the application as intended in paragraph (1) is given by the Director General
of Animal Husbandry to the applicant accompanied by written reasons through the
Head of the Center.
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Article 13
(1) Individuals or business entities that wish to expand their business activities are required to have an
expansion permit.
(2) The expansion permit as intended in paragraph (1) is obtained in accordance with the requirements
and procedures as intended in this Regulation.
Article 14
a. expansion of the veterinary medicine business as a producer in the form of additional units
production in other stalls or locations; and/or
b. expansion of the veterinary medicine business as a producer in the form of increasing the number of
production equipment, increasing the types of animal medicines produced.
Article 15
Holders of animal medicine business permits as intended in Article 11 paragraph (2) are required to
submit periodic reports every 3 (three) months regarding their business activities to the Director General
of Animal Husbandry through the Head of the Center.
Article 16
Permit holders who wish to move locations are required to notify the permit provider in writing.
Article 17
(1) The business license as intended in Article 11 paragraph (2) can be transferred after obtaining
approval from the license giver.
(2) The transfer as intended in paragraph (1) is carried out in accordance with statutory regulations.
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CHAPTER V
Article 18
a. proven not to have technical responsibility; b. within a period of 1 (one) year after
being granted a veterinary medicine business license
not carrying out activities;
c. proven to manufacture, provide, and/or distribute illegal animal medicines; d. moving the location of a
veterinary medicine business without the approval of the permit provider; e. transfer a business license
without written approval from the license giver; f. does not fulfill the conditions stated in the
business permit; g. not reporting consecutive activities within a period of 1 (one)
year.
Article 19
(1) Revocation of a veterinary medicine business license as intended in Article 18 letters a, b, and/or g is carried
out after being given written warning 3 (three) times in a row with an interval of 50 (fifty) each. working days
are not respected by the permit holder.
(2) Revocation of the animal medicine business permit as intended in paragraph (1) is carried out in the form of a
Decree of the Minister of Agriculture signed
Director General of Animal Husbandry on behalf of the Minister, such as Model-5 form
CHAPTER VI
MISCELLANEOUS PROVISIONS
Article 20
In order to protect national interests and help control animal diseases in other countries, the manufacture of
biological preparations whose source isolates do not exist in Indonesia can be produced with separate provisions
and must meet the requirements for a high level of biosafety.
CHAPTER VII
TRANSITIONAL PROVISIONS
Article 21
(1) Applications for animal medicine business permits that are in process before the stipulation of this Regulation
are carried out in accordance with the provisions of Decree of the Minister of Agriculture Number: 324/Kpts/
TN.120/4/94 concerning Conditions and Procedures for Granting Animal Medicine Business Permits.
(2) The Veterinary Medicine Business License that was granted before this Regulation was stipulated is declared to
still be valid and shall be subject to conformity with this Regulation.
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CHAPTER VIII
CLOSING
Article 22
With the stipulation of this Regulation, the Decree of the Minister of Agriculture Number: 324/Kpts/TN.120/4/94
concerning Requirements and Procedures for Granting Animal Medicine Business Licenses, is revoked and
declared invalid.
Article 23
So that everyone is aware, this Minister of Agriculture Regulation is ordered to be promulgated by placing it in
the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta on
April 8 2009
MINISTER OF AGRICULTURE,
ANTON APRIYANTONO
Promulgated in Jakarta on
ANDI MATTALATTA
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Model Form- 1
Number :
Attachment :
Regarding : Business License Application
Manufacturer/Importer/Exporter*)
Dear. : Head of
Licensing and Investment Center, Department
of Agriculture Jl. Harsono
RM. No.3 Ragunan Pasar Minggu,
South Jakarta
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9. Recommendations from the Head of Provincial and Regency/City Services at the location of the
company's head office in question if the location of the warehouse and office are in the same
province;
10. Recommendations from the Head of Provincial and Regency/City Services for exports
who use warehouses outside the head office location;
11. Recommendations from the Indonesian Veterinary Medicine Association Regional Management
Local and/or Central Indonesian Veterinary Medicine Association.
Thus we make this request sincerely, thank you for your attention and assistance.
................................20........
(........................................)
Copies: 1.
Secretary General of Agriculture; 2.
Director General of Animal Husbandry.
Notes: *) I, II, III, IV, V, VI, VII requirements for each application
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Number :
Model Form- 2
Attachment :
Regarding : Postponement of Animal Medicine Business License
Dear: Applicant
in Jakarta
Suggestions/Directions:
................................................................ ................................................................ ................................
.....
................................................................ ................................................................ ................................
.....
(……………………………..)
Copy:
1. Minister of Agriculture; 2.
Secretary General of the Department of Agriculture;
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Model form- 3
Number :
Attachment :
Regarding : Refusal of Animal Medicine Business License
Suggestions/Directions:
................................................................ ................................................................ ................................
.....
................................................................ ................................................................ ................................
.....
(……………………………..)
Copy:
1. Minister of Agriculture;
2. Secretary General of the Department of Agriculture; 3.
Director General of Animal Husbandry.
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Model form- 4
Blue Garuda
MINISTER OF AGRICULTURE
REPUBLIC OF INDONESIA
ABOUT
MINISTER OF AGRICULTURE,
Weigh : that the application for a business permit ... has fulfilled the conditions set
out, therefore it is necessary to issue a business permit ... for animal
medicines;
Pay attention to: 1. Letter from the Head of the Licensing and Investment Center
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DECIDE:
Set :
FIRST : Providing Producer/Importer/Exporter Business Licenses
To Company:
1. a. Name of Business Entity b. :
Type of Business c. :
Office Address c. :
Company's address :
2. a. Facilities/Equipment used :
b. Dosage form produced/distributed * ) c. Types of :
preparations produced/distributed * ) d. Number of :
Production Units (Especially for Producers): e. Number of
Production/Circulation Equipment *) f. :
Number of Factories (one Province) :
Stipulated in Jakarta
on date
AN MINISTER OF AGRICULTURE,
DIRECTOR OF GENERAL
ANIMAL LIVESTOCK,
(................................................)
NIP.:
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Notes: *) Cross out what is not necessary
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Model form -5
Blue Garuda
MINISTER OF AGRICULTURE
REPUBLIC OF INDONESIA
MINISTER OF AGRICULTURE,
Weigh : a. that by Regulation of the Minister of Agriculture Number the Terms and
.................., Procedures have been stipulated
Granting a Veterinary Medicine Business License;
Remember : 1. Law Number 6 of 1967 concerning Basic Provisions on Animal Husbandry and
Animal Health (State Gazette of the Republic of Indonesia of 1967 Number
10, Supplement to State Gazette Number 2824); 2. Government Regulation
Number 78 of 1992 concerning Veterinary Medicines (State
Gazette of the Republic of Indonesia of 1992 Number 129, Supplement to State
Gazette Number 3509); 3. Presidential Decree Number 187/M of 2004
concerning
Pay attention to: Letter from the Head of the Licensing and Investment Center Number... dated...;
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DECIDE:
Set :
FIRST : Revocation of decision on veterinary medicine business license To
Company:
ba Facilities/Equipment used :
b. Dosage form produced/distributed * ) c. Types of :
preparations produced/distributed * ) : d. Number of
Production Units (Especially for Producers): e. Number
of Production/Circulation Equipment *) :
f. Number of Factories (one Province) :
As: Producer/Importer/Exporter/Distributor c. Type
of Expansion: Addition of production units on site/production
equipment
export/distributed *) or import/ type drug
SECOND: The permit as intended in the FIRST dictum is revoked if: h. proven not to
have technical responsibility; i. within a period of 1 (one) year after
being granted a veterinary medicine business license, do not carry
out any activities; j. proven to manufacture,
provide, and/or distribute illegal animal medicines; k. moving the
location of a
veterinary medicine business without the approval of the permit
provider; l.
transfer a business license without written approval from the license
giver; m.
does not fulfill the conditions stated in the business permit; n. not
reporting activities consecutively within a period of 1 (one) year; :
This decision begins on the
FOURTH date of enactment.
Stipulated in Jakarta on
the date of the
MINISTER OF AGRICULTURE,
DIRECTOR GENERAL OF LIVESTOCK,
(................................................)
NIP.:
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