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REGULATION OF THE MINISTER OF

AGRICULTURE NUMBER 18/Permentan/OT.140/4/2009

ABOUT

CONDITIONS AND PROCEDURES FOR GRANTING ANIMAL MEDICINE BUSINESS LICENSES

BY THE GRACE OF GOD ALMIGHTY

MINISTER OF AGRICULTURE,

Considering: a. that by Decree of the Minister of Agriculture Number 324/Kpts/

TN.120/4/1994 the Requirements and Procedures for Granting
Animal Medicine Business Licenses have been stipulated;

b. that with the changes in the organization of the Department of

Agriculture and with the enactment of Government Regulation
Number 38 of 2007 concerning the Division of Government Affairs
between the Government, Provincial Regional Governments and
Regency/City Regional Governments, it is necessary to review the
regulations regarding the Conditions and Procedures for Granting
Veterinary Medicine Business Licenses, with the Minister of
Agriculture Regulation;

Remember : 1. Law Number 6 of 1967 concerning Basic Provisions on Animal

Husbandry and Animal Health (State Gazette of 1967 Number 10,
Supplement to State Gazette Number 2824);

2. Law Number 8 of 1999 concerning Consumer Protection (State

Gazette of 1999 Number 42, Supplement to State Gazette Number
3821);
3. Law Number 32 of 2004 concerning Regional Government (State
Gazette of 2004 Number 125, Supplement to State Gazette Number
4437);
4. Government Regulation Number 78 of 1992 concerning Veterinary
Medicines (State Gazette of 1992 Number 129, Supplement to
State Gazette Number 3509);
5. Government Regulation Number 38 of 2007 concerning the Division
of Government Affairs between the Government, Provincial Regional
Governments and Regency/City Regional Governments (State
Gazette of 2007 Number 82, Supplement to State Gazette Number
4737);
6. Presidential Decree Number 187/M of 2004 concerning
Formation of the United Indonesia Cabinet;

7. Presidential Regulation Number 9 of 2005 concerning Position,

Duties, Functions, Organizational Structure and Work Procedures
of the Ministries of the Republic of Indonesia, in conjunction with
Presidential Regulation Number 62 of 2005;
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8. Presidential Regulation Number 10 of 2005 concerning Organizational Units

and Duties of Echelon I of the State Ministries of the Republic of Indonesia;

9. Regulation of the Minister of Agriculture Number 299/Kpts/OT.140/7/ 2005

concerning the Organization and Work Procedures of the Department of
Agriculture, in the form of Regulation of the Minister of Agriculture Number
11/Permentan/OT. 140/2/2007, and Minister of Agriculture Regulation
Number 22/Permentan/OT.140/4/2008;

10. Regulation of the Minister of Agriculture Number 341/Kpts/OT.140/9/ 2005

concerning Organizational Completeness and Work Procedures of the
Department of Agriculture, in conjunction with Regulation of the Minister of
Agriculture Number 12/Permentan/OT.140/2/2007;

DECIDE:

To stipulate: REGULATION OF THE MINISTER OF AGRICULTURE CONCERNING TERMS AND

PROCEDURES FOR GRANTING ANIMAL MEDICINE BUSINESS LICENSES.

PIG
GENERAL REQUIREMENTS

article 1

In this Regulation what is meant by: 1. Veterinary

medicine is medicine that is specifically used for animals.
2. A veterinary medicine business permit is a written statement given by an authorized official
to an individual Indonesian citizen or business entity to carry out business in the field of
manufacturing, supplying, distributing, importing and/or dispensing veterinary medicines.

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.

7. Releasing veterinary medicines, hereinafter referred to as exports, is a series of activities to

export veterinary medicines from the territory of the Republic of Indonesia to foreign countries.

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.

14. Biological diagnostic materials are biological preparations used for

diagnose a disease in animals.
15. Head of Center is Head of Licensing and Investment Center, Department
Agriculture.

16. Department is an agency in charge of provincial or district/city animal husbandry and/or

animal health functions.

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.

(2) This regulation aims to:

a. protect consumers from veterinary drugs that do not meet quality, efficacy and safety
requirements;
b. provide business certainty for individual Indonesian citizens or business entities in
carrying out activities in the veterinary medicine business sector;

c. prevent the entry and spread of infectious animal diseases.

CHAPTER II

GRANTING ANIMAL MEDICINE BUSINESS LICENSES

Article 3

(1) Animal medicine business includes activities:

a. manufacture/production of veterinary
medicines; b. provision of
veterinary medicine; c.
distribution of veterinary drugs; d. import of veterinary
medicines from abroad; and/or e. export of veterinary medicines abroad.

(2) The veterinary medicine business as intended in paragraph (1) can be carried out by
individual Indonesian citizens or business entities.

Article 4

(1) A veterinary medicine business permit is granted by an authorized official to an individual

Indonesian citizen or business entity to carry out business in the field of animal medicine.

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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.

(3) Granting of veterinary medicine business permits as intended in paragraph (1)

for distributors given by the Governor.

(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

REQUIREMENTS FOR ANIMAL MEDICINE BUSINESS LICENSES

Article 5

(1) To obtain a veterinary medicine business permit, individual Indonesian citizens or business entities must
fulfill administrative requirements and technical requirements.

(2) Administrative requirements as intended in paragraph (1), as

following:

1. Manufacturers of biological, pharmaceutical, premium and/or veterinary medicines

Natural preparations must have:

a. taxpayer identification number (NPWP); b.

building use rights (HGB); c. business
location permit/business location permit (SITU); d. interference
permit (HO); e. company
registration certificate (TDP); f. trading
business license (SIUP); g identity card/identification
card of company management; h. letter of approval for environmental management
and monitoring efforts
(UKL/UPL);
i. recommendations from the Head of provincial and district/city Departments; and J.
recommendations from the local Regional Management of the Indonesian Veterinary Medicine
Association and/or the Central Indonesian Veterinary Medicine Association.

2. Importers must have:

a. taxpayer identification number (NPWP); b.

building use rights (HGB); c. business
location permit/business location permit (SITU); d. interference
permit (HO); e. company
registration certificate (TDP); f. trading
business license (SIUP); g. resident card/company
management identification card; h. import identification number (API); i.
recommendation from the Head of
provincial and district/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; j. recommendations from the
Head of provincial and district/city Departments for Importers
who use warehouses outside the head office location; and K. recommendations from the local
Regional Management of the Indonesian Veterinary Medicine Association and/or the
Central Indonesian Veterinary Medicine Association.

3. Exporters must have:

a. facilities/equipment to carry out business activities; b. taxpayer

identification number (NPWP); c. building use
rights (HGB);

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d. business location permit/business location permit (SITU);

e. interference permit (HO);
f. company registration certificate
(TDP); g. trading business license (SIUP); h.
resident card/company management identification card; i. recommendation
from the Head of Service in the province and district/city at the location of the
company's head office in question if the location of the warehouse and office are
in the same province; j. recommendations from the Head of
provincial and district/city Departments for exporters who use warehouses outside the
head office location; and K. recommendations from the local Regional
Management of the Indonesian Veterinary Medicine Association and/or the Central
Indonesian Veterinary Medicine Association.
4. Distributors must have:

a. facilities/equipment to carry out business activities; b. taxpayer

identification number (NPWP); c. building
use rights (HGB); d. business
location permit/business location permit (SITU); e.
Disturbance Permit (HO); f.
company registration certificate (TDP);
g. trading business license (SIUP); h.
recommendations from the Head of provincial and district/city Departments;
i. recommendation from the Indonesian Veterinary Medicine Association Regional Management
local;
j. recommendation from the Central Indonesian Veterinary Medicine Association, if
there is no Indonesian Veterinary Medicine Association in that area; And
k. letter of appointment from the producer or importer.
5. Animal Medicine Depot or Petshop must have:
a. facilities/equipment to carry out business activities; b. taxpayer
identification number (NPWP); c. business
location permit/business location permit (SITU); d. Certificate
of Company Registration; e.
trading business license (SIUP); and f.
recommendation from the local Regional Management of the Indonesian Veterinary
Medicine Association, if a regional Veterinary Medicine Association does not yet
exist, then a recommendation is issued by the Central Indonesian Veterinary Medicine Association.
6. Veterinary Medicine Stores must have:

a. facilities/equipment to carry out business activities; b. taxpayer

identification number (NPWP); c. business
location permit/business location permit (SITU); and D. trading
business license (SIUP).

Article 6

Technical requirements as intended in Article 5 paragraph (1) for: 1. Producers of

veterinary medicines with biological preparations, pharmaceuticals, premixes and/or natural
medicines, have:

a. veterinary medicine factory, facilities and equipment to carry out activities

his business;
b. quality testing laboratory and veterinary medicine storage area; c. veterinarians
and pharmacists who work permanently as guarantors
technical responsibility;

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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a. facilities/equipment to carry out business activities; b. storage place

for veterinary medicines that can guarantee quality maintenance;
And
c. veterinarian or pharmacist who works permanently as
technical person in charge.
3. Veterinary medicine exporters have:
a. facilities/equipment to carry out business activities; b. storage place
for veterinary medicines that can guarantee quality maintenance; c. veterinarian or
pharmacist who works permanently as
technical person in charge.
4. Animal medicine distributors have
a. storage place for veterinary medicines that can guarantee quality maintenance; b.
veterinarian or pharmacist who works permanently as
technical person in charge.
5. Veterinary medicine depot or petshop has
a. storage place for veterinary medicines that can guarantee quality maintenance; b.
veterinarians or pharmacists who work on a temporary basis, or pharmacist assistants who
work permanently as technical responsibilities.
6. Veterinary drug stores have storage areas to maintain
quality, efficacy and safety of veterinary medicines.

CHAPTER IV

PROCEDURES FOR GRANTING ANIMAL MEDICINE BUSINESS LICENSES

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

Applications that have fulfilled the administrative requirements as intended in Article 8

paragraph (1) by the Head of the Center are submitted to the Director General of Animal
Husbandry for a review of the fulfillment of technical requirements.

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

Business expansion as intended in Article 13 includes:

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

REVOCATION OF ANIMAL MEDICINE BUSINESS LICENSE

Article 18

A business license is revoked if:

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

This regulation comes into force on the date it is stipulated.

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

MINISTER OF LAW AND HUMAN RIGHTS

REPUBLIC OF INDONESIA,

ANDI MATTALATTA

STATE NEWS OF THE REPUBLIC OF INDONESIA YEAR NUMBER

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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

The undersigned below :

Company name :
Company's address :
Principle Approval Number:

For consideration, we attach the following requirements:

*) I. Animal Medicine Manufacturer Business License

1. Information about company investment a. Fixed

capital........................... b. Working
Capital per year..................................
2. Photocopy of Company Establishment Deed and its amendments 3.
Photocopy of Taxpayer Identification Number (NPWP); 4.
Photocopy of Building Use Rights (HGB); 5. Photocopy
of business location permit/business location permit (SITU);; 6. Photocopy of
Disturbance Permit (HO); 7. Photocopy of
Company Registration Certificate; 8. Photocopy of
Trading Business License (SIUP); 9. Photocopy of Resident
Identification Card/Leader Identification Card
Company;
10. Recommendations from the Head of the Animal Husbandry Service or those in charge of animal
husbandry and animal health functions, Regency/City and Province; 11.
Recommendations from the Indonesian Veterinary Medicine Association Regional Management
Local and/or Central Indonesian Veterinary Medicine Association 12.
Letter of Approval of environmental management and monitoring efforts (UKL/UPL)
required.

II. Veterinary Medicine Importer Business License

1. Photocopy of Taxpayer Identification Number (NPWP); 2.

Photocopy of Building Use Rights (HGB)
3. Photocopy of business location permit/Business Location Permit (SITU); 4.
Photocopy of disturbance permit (HO); 5.
Photocopy of Company Registration Certificate; 6.
Photocopy of trade permit (SIUP); 7. Photocopy of
Resident Identification Card/Leader Identification Card
Company; 8.
Photocopy of General/Limited import identification numbers; 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 imports
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.

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III. Veterinary Medicine Exporter Business License

1. Photocopy of Taxpayer Identification Number (NPWP); 2.

Photocopy of Building Use Rights (HGB); 3. Photocopy
of business location permit/Business Location Permit (SITU); 4. Photocopy of
Disturbance Permit (HO); 5. Photocopy of
Company Registration Certificate; 6. Photocopy of
trade permit (SIUP); 7. Resident Identity Card/Company
Leadership Identification Card; 8. Information regarding facilities and equipment for
export of veterinary medicines (attached);

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........

Head of Company Stamp

Rp. 6000

(........................................)

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

In connection with your letter Number............dated...........regarding the application for an importer/

exporter veterinary medicine business permit*) you are hereby notified of the postponement of your
application for the reasons:

a................................................................ ................................................................ ..;

b................................................. ................................................................ ..;
c................................................. ................................................................ ..;
d................................................. ................................................................ ..;

Suggestions/Directions:
................................................................ ................................................................ ................................
.....
................................................................ ................................................................ ................................
.....

Thus conveyed, so that it is understandable.

Head of Licensing and Investment Center

(……………………………..)

Copy:

1. Minister of Agriculture; 2.
Secretary General of the Department of Agriculture;

Notes: *) Cross out what is not necessary

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Model form- 3

Number :
Attachment :
Regarding : Refusal of Animal Medicine Business License

Dear Dear: The

applicant
in-
................................................

In connection with your letter Number............dated...........regarding the application for an

importer/exporter veterinary medicine business permit*) you are hereby informed that your application
has been rejected for the reasons:
a ................................................................ ................................................................ .;
b................................................. ................................................................ ..;
c................................................. ................................................................ ..;
d................................................. ................................................................ ..;

Suggestions/Directions:
................................................................ ................................................................ ................................
.....
................................................................ ................................................................ ................................
.....

Thus conveyed, so that it is understandable.

Head of Licensing and Investment Center

(……………………………..)

Copy:

1. Minister of Agriculture;
2. Secretary General of the Department of Agriculture; 3.
Director General of Animal Husbandry.

Notes: *) Cross out what is not necessary

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Model form- 4

Blue Garuda
MINISTER OF AGRICULTURE
REPUBLIC OF INDONESIA

DECREE OF THE MINISTER OF AGRICULTURE

NUMBER

ABOUT

GRANTING ANIMAL MEDICINE BUSINESS LICENSES

BY THE GRACE OF GOD ALMIGHTY

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;

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

Formation of the United Indonesia Cabinet;

4. Regulation of the President of the Republic of Indonesia Number 9 of
2005 concerning the Position, Duties, Functions, Organizational
Structure and Work Procedures of the Ministries of the Republic of
Indonesia;
5. Presidential Regulation of the Republic of Indonesia Number 10 of 2005
concerning Organizational Units and Duties of Echelon I of the State
Ministries of the Republic of Indonesia, as amended by Presidential
Regulation of the Republic of Indonesia Number 15 of 2005; 6.
Regulation of the Minister
of Agriculture Number 299/Kpts/OT.140/7/2005 concerning the Organization
and Work Procedures of the Department of Agriculture; 7. Regulation
of the Minister of Agriculture Number 341/Kpts/OT.140/9/2005 concerning
Organizational Completeness and Work Procedures of the Department
of Agriculture; 8. Regulation
of the Minister of Agriculture Number ... concerning Requirements and
Procedures for Granting Animal Medicine Business Licenses;

Pay attention to: 1. Letter from the Head of the Licensing and Investment Center

Number... ...dated...; 2. Application Letter ............. Number ...........

date .........; 3. Letter of Recommendation from the Head of the Animal Husbandry Service Num
Date ............; 4.
Inspection Minutes Number ....... Date ...........;

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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) :

3. Type of Expansion: Addition of production units on site/production

equipment
export/distributed * ) or import/ type drug

SECOND : Holders of Animal Medicine Business Licenses as intended in the

FIRST dictum are obliged to actually and seriously carry out their
business in accordance with the provisions of the applicable laws and
regulations.

THIRD : Holders of Business Permits granted to companies as intended in the

first paragraph are valid as long as the Veterinary Medicine Company
in question carries out activities and are required to submit progress
reports on the implementation of the readiness of technical requirements
to the Director General of Animal Husbandry once every 1 (one) year
with a copy to the Head of the Licensing and Investment Center.

FOURTH : This decision begins on the date of enactment.

Stipulated in Jakarta
on date

AN MINISTER OF AGRICULTURE,
DIRECTOR OF GENERAL
ANIMAL LIVESTOCK,

(................................................)
NIP.:

A COPY of this decision was submitted to the Honorable. :

1. Secretariat General of the Department of
Agriculture; 2. Director General of Drug and Food Control;
3. Director General of Domestic Trade; 4. Head of the
Provincial Livestock Service, Regional Level
I ....................... ; 5. Head
of Level II Regency/Municipal Animal Husbandry
Service .....................

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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

DECREE OF THE MINISTER OF AGRICULTURE

NUMBER
ABOUT

REVOCATION OF ANIMAL MEDICINE BUSINESS LICENSES

BY THE GRACE OF GOD ALMIGHTY

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;

b. that as a follow-up to Article ........... Regulation of the Minister of Agriculture

Number.............................. ...., regarding the Requirements and Procedures
for Granting Animal Medicine Business Licenses, it is deemed necessary to
revoke the Decision on Animal Medicine Business Licenses.

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

Formation of the United Indonesia Cabinet;

4. Regulation of the President of the Republic of Indonesia Number 9 of 2005
concerning the Position, Duties, Functions, Organizational Structure and
Work Procedures of the Ministries of the Republic of Indonesia;

5. Presidential Regulation of the Republic of Indonesia Number 10 of 2005

concerning Organizational Units and Duties of Echelon I of the State Ministries
of the Republic of Indonesia, as amended by Presidential Regulation of the
Republic of Indonesia Number 15 of 2005; 6. Regulation of the Minister of
Agriculture Number 299/Kpts/
OT.140/7/-
2005 concerning the Organization and Work Procedures of the Department
of Agriculture;
7. Regulation of the Minister of Agriculture Number 341/Kpts/OT.140/9/-
2005 concerning Organizational Completeness and Work Procedures of the
Department of Agriculture; 8.
Regulation of the Minister of Agriculture Number ... concerning Requirements and
Procedures for Granting Animal Medicine Business Licenses;

Pay attention to: Letter from the Head of the Licensing and Investment Center Number... dated...;

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Machine Translated by Google

DECIDE:

Set :
FIRST : Revocation of decision on veterinary medicine business license To
Company:

aa Name of Business Entity b. :

Type of Business c. :
Office Address d. :
Company's address :

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.:

A COPY of this decision was submitted to the

Honorable. : 1. Secretariat General of the
Department of Agriculture; 2. Director General of Customs and
Excise, Ministry of Finance; 3. Director General of Drug
and Food Control; 4. Director General of Domestic Trade.
5. Head of Level I Provincial Animal Husbandry
Service ....................... ;
6. Head of Level II Regency/Municipal Animal Husbandry
Service .....................

Notes: *) Cross out what is not necessary 18

Machine Translated by Google

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