Decree of the Minister of Agriculture No. 466/Kpts/TN.206/V/99 RE Manual for Prime Method of animal drugs manufacturing

6 ====~=:::===== AGRtCULTURE :=::::==::::==::::::::=:= DEPARTMENT OF AGRICULTURE DECReE OF THE MINISTER OF AGRICULTURE NO. 466/Kpts/TN.2061V/99 ; DATED MAY 7, 1999 RE MANUAL FOR PRIME METHOD Of ANIMAL DRUGS MANUFACTURING THE MINISTER OF AGRICULTURE, Considering a. that in order to guarantee the quality of animal drugs, it is necessary to apply the prime method of animal drugs manufacturing in af aspects in the series of operational activities; b. that for the application of the appropriate method of animal drugs manufacturing in a more accurate manner and at the same time the implementation of Article 8 of Government Regulation No. 78 of 1992 on Animal Drugs, it is necessary to lay down a Manual for the Prime Method of Animal Drugs Manufacturing (CPOHBL Bearing in mind 1. 2. 3. 4. 5. 6. Act No.6 of 1967; Government Regulation No. 78 of 1992; Presidential Decree No. 44 of 1974; Presidential Decree No. 61 of 1998; Presidential Decree No. 122/M; The Decree of the Minister of Agriculture No. 1016/Kpts/OT.210/12/1998. HAS DECIDED To stipulate THE DECREE OF THE MINISTER OF AGRICULTURE CONCERNING THE MANUAL FOR PRIME METHOD OF ANIMAL DRUGS MANUFACTURING. Article 1 The manual for the Prime Method of Animal Drugs Manufactucing (CPOHBl shall be as contained in the attachment to this decree as a guideline for all parties involved in the manufacture of animal drugs. Article 2 Producers of animal drugs that have fuifilled the requirements for the Prime method of Animal Drugs Manufacturing <CPOHEll as meant in Article 1 shall be granted certlficates of CPOH8 by the Director General of Animal Husbandry, which are effective tor 5 (five) year. CAFJ 06/JANUARY 21,2000 7 Article 3 Producers alreadv obtaining certificates shall be entitled to put marks of the Prime Method of Animal Drugs Manufacturing (CPOHBI on labels of their products of animal drugs. Article 4 In order to obtain the certificates of the prime method of Animal Drugs manufacturing \CPOHB) as meant in Article 2, producers of animal drugs shall submit applications to the Director General of Animal Husbandry. Article 5 AU producers of animal drugs shall refer to the Prime method of Animal Drugs Manufacturing (CPOHB) as meant in Article 1 in the processing of raw materials. bulk products and or finished products not later than 5 (five) years as from the date of stipulation of this decree. Article 6 For the implementation of Manual for the prime method of Animal Drugs rnanufacturinq /CPOHBI, the Director general of Animal Husbandry shall stipulate further directives. Article 7 This decree shall come into force as from the date of stipulation. Stipulated at J A K ART A On May 7, 1999 THE MINISTER OF AGRICULTURE, signed Prof. Dr. Ir. SQLEH SQlAHUQDIN MSc. (Editor's Note; The attachment to this decree is not published). OOOOOODOO CAFf 06/JA NUARY 2 1,200'0