to Indonesian
1. that to improve livestock health and production, it is necessary an adequate availability of veterinary medicines in terms of both quantity and quality in manufacture, supply, and circulation;
2. that by technological advances in veterinary medicine, nowadays, a common type of a new veterinary medicines that have not been accommodated in the Government Regulation No. 17/1973 concerning Production, Distribution, Inventory, Use of Vaccines, Serum, and Diagnostic Substances for Animals;
3. that in relation with above matter, it is necessary to re-stipulate provisions on veterinary medicines by Government Regulation;
1. Article 5 paragraph (2) of the 1945 Constitution;
2. Law No. 6/1967;
3. Government Regulation No. 15/1977;
4. Government Regulation No. 22/1983;
5. Government Regulation No. 17/1986
GOVERNMENT REGULATION OF THE REPUBLIC OF INDONESIA CONCERNING VETERINARY MEDICINES
In this Government Regulation:
1. Veterinary medicines is a specified medicines to be used for animals.
2. Production is the process of making, mixing and changing the form of raw substances of veterinary medicine into veterinary medicines.
3. Preparation is the process of procurement activities and/or ownership and/or control and/or storage of veterinary medicines in one place or room with the purpose to be circulated.
4. Circulation is the process of activities related with trade, transportation, and delivery of veterinary medicine.
5. Business Entity is a State owned or regional owned business entity, private or cooperative.
6. Minister is the Minister responsible in the field of Animal Health.
1. Government conducts research and development activities of veterinary medicines and raw substances of veterinary medicines.
2. Governments support and foster the private sector to conduct research and development activities of veterinary medicines and their raw substances.
Based on the purpose of using of veterinary medicines are used to:
1. Veterinary medicines classified in the preparation of biological, pharmaceutical and premix.
2. In addition to veterinary medicines classification as intended in paragraph (1) there is also a natural medicines class.
3. Further provisions on natural medicines as intended in paragraph (2) regulated by the Minister.
1. Biological preparations as intended in Article 4 paragraph (1) are produced through biological processes in animals or animal net to make immunity, diagnose a disease, or cure the disease with immunologic processes.
2. Pharmaceutical preparations as intended in Article 4 paragraph (1) include vitamins, hormones, antibiotics and other chemotherapeutical, medicine antihistaminic, antipyretic, anesthetic used based on the work of pharmacology.
3. Premix preparations as intended in Article 4 paragraph (1) include addition of animal food and animal food supplement that are mixed in animal food or animal drinks.
1. Based on the classification of the danger result in its use, veterinary medicines are divided into:
2. Further provisions on the classification of veterinary medicines as intended in paragraph (1) stipulated by the Minister.
1. Use of strong medicine should be done by a veterinarian or other person with the instructions of and under the supervision of a veterinarian.
2. Use limited free medicine or free medicine by any person by following stated usage direction.
1. Manufacture of veterinary medicines includes the activities of process raw substances, semi finished substances, and/or finished substances into veterinary medicines that are ready to be used.
2. Manufacture of veterinary medicines as intended in paragraph (1) shall meet the requirements of raw materials, location, building, room arrangement, equipment, experts, and the manufacturing process.
3. Further provisions on the requirements as intended in paragraph (2) stipulated by the Minister.
1. Veterinary medicines that can be prepared and/or distributed only veterinary medicines that has been registered.
2. Further provisions on the registration as intended in paragraph (1) stipulated by the Minister.
1. Veterinary medicines that are in stock and/or circulation must be packed in containers and/or certain packs are equipped with etiquette and marking and included the word "medicines only for the animals" that can be read clearly.
2. Providing marking as intended in paragraph (1) also must be included in the inclusion of a brochure.
3. Further provisions on the marking requirements on packaging, containers, wrappers, labels and brochures as intended in paragraph (1) and paragraph (2) stipulated by the Minister.
1. Business entities and individuals are prohibited from providing or distribute veterinary medicines that are not suitable to be used.
2. Veterinary medicines that are not suitable to be used as intended in paragraph (1) include:
1. In the framework to quality control, veterinary medicines that will be circulated must have passed the quality tests are performed in the framework of registration.
2. Veterinary medicines that have been registered can be re-examined their quality every time.
3. Further provisions of the requirements and procedures for medicine testing in the framework of registration of animals as intended in paragraph (1) stipulated by the Minister.
1. Testing the quality of veterinary medicines as intended in Article 12 is based on the quality standards set by the Government.
2. Quality testing as intended in paragraph (1) conducted by an agency appointed by the Minister.
1. The cost required for registration and quality testing of veterinary medicines as intended in Article 9 and Article 12 is charged to the owner of an veterinary medicines that fee determined by the Minister.
2. Procedure for collecting and registration fee is determined by the Minister after obtaining approval of the Minister of Finance.
3. The registration fee as intended in paragraph (1) is the State's revenue and must be deposited into the State Treasury.
1. Manufacture and/or the preparation and/or circulation of veterinary medicines by the Business Entities or individuals shall be made based on business license from by the Minister.
2. Further provisions on the requirements and procedures for granting business licenses as intended in paragraph (1) stipulated by the Minister.
1. Research institutes or higher education institution that conducts research and development of veterinary medicine for the purpose of science, and government agencies in the implementation of technical duties related to veterinary medicines, can perform their activities without permission.
2. Further provisions on the manufacture and/or the preparation and/or distribution of veterinary medicines conducted by research institutes, higher education institution and government agencies as intended in paragraph (1) stipulated by the Minister.
1. Business entities or individuals as license holders to make and/or prepare and/or distribute of veterinary medicines can conduct their business expansion.
2. Expansion of the business of making veterinary medicines as intended in paragraph (1) in the form of:
3. Business expansion of preparation and/or distribution of veterinary medicine in the form of:
Business license has been granted to business entities or individuals as intended in Article 15 will be ended in case of:
1. Minister supervise the manufacture, supply, distribution and use of veterinary medicines.
2. In the framework of supervision as intended in paragraph (1) the Minister may appoint veterinary medicine inspector to carry out the supervision of veterinary medicine.
3. Veterinary medicines inspector officials as intended in paragraph (2) shall be appointed and dismissed by the Minister.
1. In carrying out supervision of veterinary medicines as intended in Article 19 veterinary medicines inspector official has authorities to:
2. If the examination as intended in paragraph (1) found violation, the Minister or veterinary medicines inspector official has authorities to:
3. Further provisions on the terms and procedures for supervision as intended in paragraph (1) and paragraph (2) regulated by the Minister.
With the enactment of this Government Regulation, all statutory as the implementation of Government Regulation No. 17/1973 remain valid, as long as not contrary to this Government Regulation or has not been amended or revoked based on this Government Regulation.
From the date of enactment of this Government Regulation, Government Regulation No. 17/1973 concerning Making, Preparation, Distribution and Use of Vaccines, Serum and Biological Diagnostic Substances For Animals shall be declared null and void.
This Government Regulation comes into force on the date of promulgation.
For public cognizance, this Government Regulation shall be promulgated by placing it in the Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on December 24, 1992
PRESIDENT OF THE REPUBLIC OF INDONESIA
signed,
SOEHARTO