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௧࿴㸲ᖺᗘᾏእὶ⾜⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗ㻌ື≀⏝་⸆ရ
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㸦ࣇ࢕ࣜࣆࣥඹ࿴ᅜࠊ࢖ࣥࢻࢿࢩ࢔ඹ࿴ᅜ⦅㸧
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௧࿴㸳ᖺ㸱᭶ᗎ  ゝ බ┈♫ᅋἲே᪥ᮏື≀⏝་⸆ရ༠఍ࡣࠊᖹᡂ㸰㸶ᖺᗘ࠿ࡽ⊂❧⾜ᨻἲே㎰␆⏘ᴗ᣺⯆ᶵᵓࡀ⤒㈝ࢆ⿵ຓࡍࡿᅜ⏘␆⏘≀Ᏻᚰ☜ಖ➼ᨭ᥼஦ᴗ㸦ᾏእὶ⾜ᛶ⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗ㸧ࢆᐇ᪋ࡋ࡚ࡁࡲࡋࡓࠋ ᖹᡂ㸱㸮ᖺᗘࡲ࡛ࡢ㸱ᖺ㛫ࡣ࢔ࢪ࢔ㅖᅜࡢὶ⾜⑌⑓࡟ᑐࡍࡿᡃࡀᅜࡢື≀⏝་⸆ရࡢ᭷ຠᛶࡸ⑌⑓ࡢⓎ⏕≧ἣࢆㄪᰝࡋࡲࡋࡓࠋ௧࿴ඖᖺᗘࡣᐙ␆㜵␿࡟ᚲ㡲࡞ື≀⏝་⸆ရࡢᏳᐃ౪⤥࡟㈨ࡍࡿࡓࡵ࡟ࠊᾏእ࡟࠾ࡅࡿື≀⏝་⸆ရࡢཎ⸆ཬࡧ〇ရࡢ౪⤥≧ἣ࡟ࡘ࠸࡚ㄪᰝࡋࡲࡋࡓࠋࡲࡓࠊ௧࿴㸰ᖺᗘࡣࠊື≀⏝་⸆ရ㸦ཎ⸆ࢆྵࡴ㸧ࡢ㍺ධᡭ⥆ࡁࡢ㎿㏿໬ࠊ෇⁥໬ࡢ୍ຓ࡜࡞ࡿࡼ࠺ࠊయ⣔ⓗ࡞㍺ධᡭᘬ
᭩ࡢ᪥ᮏㄒ∧ཬࡧⱥㄒ∧ࢆసᡂࡋࡲࡋࡓࠋ ᫖ᖺᗘ࠿ࡽࡣࠊ࢔ࢪ࢔ㅖᅜ࡟࠾ࡅࡿᐙ␆⑌⑓ࡢⓎ⏕ࣜࢫࢡࢆ㍍ῶࡍࡿࡇ࡜࡟ࡼ
ࡾࠊᡃࡀᅜ࡬ࡢ⑌⑓ࡢ౵ධࣜࢫࢡࡢపῶࢆᅗࡿほⅬ࠿ࡽࠊᡃࡀᅜࡢඃ⚽࡞ື≀⏝་⸆ရ➼ࡢ࢔ࢪ࢔ㅖᅜ࡬ࡢ㍺ฟಁ㐍࡟㈨ࡍࡿࡓࡵ࡟ࠊヱᙜᅜࡢ㍺ධไᗘࡢ⌧≧࠾ࡼࡧ௒ᚋࡢᒎᮃ࡟ࡘ࠸࡚ㄪᰝࡋ࡚࠸ࡲࡍࠋ௧࿴㸱ᖺᗘࠊࢱ࢖⋤ᅜཬࡧ࣋ࢺࢼ࣒♫఍୺⩏ඹ࿴ᅜ࡟࠾ࡅࡿไᗘࢆㄪᰝࡋࡓࡢ࡟⥆ࡁࠊ௒ᖺᗘࡣࣇ࢕ࣜࣆࣥඹ࿴ᅜཬࡧ
࢖ࣥࢻࢿࢩ࢔ඹ࿴ᅜ࡟࠾ࡅࡿไᗘࢆㄪᰝࡋࡲࡋࡓࡢ࡛ࠊ〇㐀㈍኎ᴗ⪅ࡢⓙᵝ࡟㓄ᕸ࠸ࡓࡋࡲࡍࠋ ࡞࠾ࠊㄪᰝࡣᙜヱᅜ࡟ㄪᰝ⥙ࢆᣢࡘእ㒊ᶵ㛵㸦ᰴᘧ఍♫࢔ࢵࢺࢢ࣮ࣟࣂࣝ㸧࡟ጤクࡋ࡚⾜࠸ࡲࡋࡓࠋ
௧࿴㸳ᖺ㸱᭶
㸦බ♫㸧᪥ᮏື≀⏝་⸆ရ༠఍௧࿴㸲ᖺᗘᾏእὶ⾜⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗࡢ⤒㐣㸯㸬௧࿴㸲ᖺᗘ➨㸯ᅇᾏእὶ⾜⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗ᥎㐍ጤဨ఍  㛤ദ᪥㸸௧࿴㸲ᖺ㸴᭶㸰㸯᪥ ⅆ㸧᪉ ἲ㸸0LFURVRIW7HDPV ࡟ࡼࡿ :HE ఍㆟㆟ 㢟㸸㸯㸬௧࿴㸲ᖺᗘᾏእὶ⾜⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗᐇ᪋ィ⏬࡟ࡘ࠸࡚     㸰㸬㍺ฟᑐ㇟ᅜࡢື≀⏝་⸆ရ㍺ධไᗘㄪᰝࡢෆᐜ࡟ࡘ࠸࡚
㸰㸬ᰴᘧ఍♫࢔ࢵࢺࢢ࣮ࣟࣂࣝ࡜ㄪᰝጤクዎ⣙⥾⤖ࠋ㸱㸬➨㸰ᅇᾏእὶ⾜ᛶ⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗ᥎㐍ጤဨ఍㛤ദ᪥㸸௧࿴㸲ᖺ㸯㸯᭶㸯᪥ ⅆ㸧᪉ ἲ㸸0LFURVRIW7HDPV ࡟ࡼࡿ :HE ఍㆟㆟ 㢟㸸㍺ฟᑐ㇟ᅜࡢື≀⏝་⸆ရ㍺ධไᗘㄪᰝ㸦୰㛫ሗ࿌㸧࡟ࡘ࠸࡚
㸲㸬➨㸱ᅇᾏእὶ⾜ᛶ⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗ᥎㐍ጤဨ఍㛤ദ᪥㸸௧࿴㸳ᖺ㸰᭶㸷᪥㸦ᮌ㸧ሙ ᡤ㸸0LFURVRIW7HDPV ࡟ࡼࡿ :HE ఍㆟㆟ 㢟㸸㍺ฟᑐ㇟ᅜࡢື≀⏝་⸆ရ㍺ධไᗘㄪᰝ㸦᭱⤊ሗ࿌㸧࡟ࡘ࠸࡚
௧࿴䠐ᖺᗘ➨䠏ᅇᾏእὶ⾜⑌⑓౵ධ᫬ᑐᛂᙉ໬஦ᴗ᥎㐍ጤဨ఍ጤဨ㻌ጤဨẶྡ㻌఍ဨᡤ♫ྡ㻌ᡤᒓ㒊⨫㻌ụ⃝㻌 㔛ዉ㻌䠄ᮡᒣ䝘䝟䝑䝖䠅㻌ዟᮧ㻌 ᩔྖ㻌᫂἞䜰䝙䝬䝹䝦䝹䝇ᰴᘧ఍♫㻌䠄㻾㻠㻚㻡㻚㻞㻢䡚㻥㻚㻟㻜䠅㻌ᰴᘧ఍♫ᚤ⏕≀໬Ꮫ◊✲ᡤ㻌 㻌◊✲㛤Ⓨ㒊஦ᴗ㛤Ⓨㄢ㻌⤒Ⴀ⤫ᣓᐊ㻌

㮵ෆ㻌 ಙᏕ㻌䝣䝆䝍〇⸆ᰴᘧ఍♫㻌 㻌㉎㈙㒊㻌 ㉎㈙ㄢ㻌 㻌ⓑᮌ㻌 ඞᑦ㻌䝽䜽䝏䝜䞊䝞ᰴᘧ఍♫㻌ရ㉁⟶⌮㒊㻌

⏣୰㻌 ㈗ᙇ㻌᪥⏕◊ᰴᘧ఍♫㻌ᾏእ஦ᴗ㒊㻌

๓ᅧ⸨㻌 ᘯ㐨㻌ඹ❧〇⸆ᰴᘧ఍♫㻌ᅜ㝿஦ᴗ㒊㻌ᯇᒸ㻌 ◊ྖ㻌䠄ᏱἙ㻌 ႐ႛ䠅㻌᳃ᮧ㻌 ᚭ㻌

ᯇ◊⸆ရᕤᴗᰴᘧ఍♫㻌┦ㄯᙺ㻌䠄㻾㻠㻚㻡㻚㻞㻢䡚㻝㻝㻚㻟㻜䠅㻌䠄㢳ၥ䠅㻌ఫ཭䝣䜯䞊䝬䜰䝙䝬䝹䝦䝹䝇ᰴᘧ఍ ⸆஦ಙ㢗ᛶಖド㒊㻌♫㻌 㻌௧࿴ 4 ᖺᗘ␆⏘᣺⯆஦ᴗື≀⏝་⸆ရ
㍺ධไᗘ䛻㛵䛩䜛ㄪᰝ䠄䝣䜱䝸䝢䞁ඹ࿴ᅜ䚸䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ⦅䠅ㄪᰝሗ࿌᭩

௧࿴ 5 ᖺ 1 ᭶ᰴᘧ఍♫䜰䝑䝖䜾䝻䞊䝞䝹┠ḟ
1. ஦ᴗ䛾ᴫせ .............................................................................................................................. 5
1.1 ㄪᰝ䛾┠ⓗ ........................................................................................................................ 5
1.2 ㄪᰝ䛾ᐇ᪋ෆᐜ ................................................................................................................. 5
1.2.1 ㄪᰝᑐ㇟ᅜ .................................................................................................................. 5
1.2.2 ㄪᰝෆᐜ ..................................................................................................................... 5
1.2.3 ㄪᰝ᪉ἲ ..................................................................................................................... 6
2. 䝣䜱䝸䝢䞁ඹ࿴ᅜ ....................................................................................................................... 7
1. ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ䞉㛵ಀἲ௧ ..................................................................................... 7
1.1 ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ ............................................................................................... 7
1.1.1 CDRR 䛾ᡤᤸ஦ົ ................................................................................................... 7
1.1.1.1 CDRR ചୗ䛾⤌⧊䛾ᡤᤸ஦ົ .......................................................................... 8
1.1.2 FDA ཬ䜃 BAI 䛸䛾㛵ಀ ........................................................................................... 8
1.2 ື≀⏝་⸆ရ䛾㛵ಀἲ௧ ............................................................................................... 9
1.2.1 ἲᚊ䞉኱⤫㡿௧......................................................................................................... 9
1.2.2 ⾜ᨻ࿨௧䚸㏻▱䛺䛹................................................................................................ 10
1.2.3 ᐃ⩏䞉ศ㢮 .............................................................................................................. 11
2. ື≀⏝་⸆ရ㛵ಀไᗘ ...................................................................................................... 12
2.1 ື≀⏝་⸆ရ䛾㈍኎Ⓩ㘓 ............................................................................................. 12
2.1.1 ㈍኎Ⓩ㘓⏦ㄳ ........................................................................................................ 12
2.1.1.1 ⏦ㄳ᭩㢮 ......................................................................................................... 15
2.1.1.2 CPR 䛾ྲྀᚓ .................................................................................................... 20
2.1.1.3 ㎿㏿ᑂᰝ ......................................................................................................... 22
2.2 ື≀⏝་⸆ရ䛾἞㦂䛻䛴䛔䛶 ....................................................................................... 24
2.2.1 ἞㦂䜢ᐇ᪋䛩䜛⤌⧊䛾せ௳ .................................................................................... 24
2.3 VICH 䛻ᑐ䛩䜛ືྥ ...................................................................................................... 24
2.4 つไ⦆࿴䛾ഴྥ ........................................................................................................... 25
3. ື≀⏝་⸆ရ䛾〇㐀ཬ䜃ရ㉁⟶⌮ ..................................................................................... 26
3.1 ື≀⏝་⸆ရ䛾〇㐀 .................................................................................................... 26
3.1.1 〇㐀ᴗ⪅ ............................................................................................................... 26
3.1.1.1 㟁Ꮚ䝫䞊䝍䝹䠄E-Portal䠅䜰䜹䜴䞁䝖䛾ྲྀᚓ ........................................................ 26
3.1.1.2 LTO 䛾ྲྀᚓ .................................................................................................... 27
3.2 GMP ............................................................................................................................ 30
3.2.1 ᥇⏝䛥䜜䛶䛔䜛 GMP ᇶ‽...................................................................................... 31
3.2.2 䝣䜱䝸䝢䞁ᅜෆ䛾〇㐀⪅ .......................................................................................... 31
3.2.3 䝣䜱䝸䝢䞁ᅜእ䛾〇㐀⪅ .......................................................................................... 31
3.3 ㈍኎ᴗ⪅ ...................................................................................................................... 32
3.3.1 せ௳ ....................................................................................................................... 33

1

3.3.2 ㈨᱁ド᫂᭩ ............................................................................................................ 33
3.3.2.1 㟁Ꮚ䝫䞊䝍䝹䠄eServices Portal䠅䜰䜹䜴䞁䝖䛾ྲྀᚓ .......................................... 33
3.3.2.2 LTO 䛾ྲྀᚓ .................................................................................................... 34
3.3.3 ᐉఏཬ䜃㈍኎ಁ㐍䛾䛯䜑䛾チྍ ............................................................................ 37
3.4 ㍺ධᴗ⪅ ...................................................................................................................... 37
3.4.1 せ௳ ....................................................................................................................... 38
3.4.2 ㈨᱁ド᫂ ............................................................................................................... 39
3.4.2.1 㟁Ꮚ䝫䞊䝍䝹䠄eServices Portal䠅䜰䜹䜴䞁䝖䛾ྲྀᚓ .......................................... 39
3.4.2.2 LTO 䛾ྲྀᚓ .................................................................................................... 39
3.5 ື≀⏝་⸆ရ䛾㍺ධチྍ䛸㍺ධ᫬䛾᳨ᰝ ..................................................................... 39
3.5.1 ㍺ධチྍ ............................................................................................................... 39
3.5.2 ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅⏦ㄳ᭩䛸ᡭ⥆ .................................... 39
3.6 ື≀⏝་⸆ရ䝷䝧䝹 ..................................................................................................... 43
3.7 PIC/S 䛻㛵䛩䜛ືྥ ...................................................................................................... 46
3.8 ASEAN 䛾㛵୚ཬ䜃௚䛾ᅜ㝿ᇶ‽䛻ᑐ䛩䜛ືྥ ........................................................... 47
4. ὶ㏻䛾௙⤌䜏 ..................................................................................................................... 48
4.1 ື≀⏝་⸆ရ䛾ὶ㏻䛾௙⤌䜏 ...................................................................................... 48
4.2 ୺䛺ᅜෆὶ㏻ᴗ⪅ ........................................................................................................ 49
4.3 ᅜෆື≀⏝་⸆ရ䛾ᕷሙ ............................................................................................. 49
4.3.1 ᅜෆື≀⏝་⸆ရ䛾ᕷሙつᶍ ............................................................................... 49
4.3.2 ᅜෆ䝙䞊䝈............................................................................................................. 51
4.4 ㍺ධ་⸆ရ䛾ᕷሙᐇែ䛸௒ᚋ䛾ぢ㏻䛧 ......................................................................... 53
4.5 ື≀⏝་⸆ရᴗ⏺䛾ㄢ㢟 ............................................................................................. 54
4.6 ᪥ᮏ〇ရ䛻ᑐ䛩䜛ホ౯䞉ពぢ......................................................................................... 55
5. ⏝ㄒ ................................................................................................................................... 55
6. ཧ⪃㈨ᩱ ............................................................................................................................ 57
6.1 WHO 䛾᥎⸀ᇶ‽䛻䜘䜛་⸆ရ〇๣ド᫂᭩䠄CPP䠅 ........................................................ 57
6.2 ⾜ᨻ࿨௧ 2013-0022 䛾ู⣬......................................................................................... 59
3. 䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ ................................................................................................................. 69
1. ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ䞉㛵ಀἲ௧ ................................................................................... 69
1.1 ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ ............................................................................................. 69
1.1.1 ␆⏘ື≀⾨⏕⥲ᒁ䠄Ditjen PKH䠅䛾ᡤᤸ஦ົ ......................................................... 69
1.1.2 ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠅䛾ᡤᤸ஦ົ .............................. 69
1.1.3 ື≀⏝་⸆ရⓏ㘓ጤဨ఍䠄PPOH䠅 ......................................................................... 70
1.1.4 ື≀⏝་⸆ရጤဨ఍䠄KOH䠅 .................................................................................. 70
1.1.5 㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄GMO 〇ရᏳ඲ጤဨ఍䠅 ......................................... 70
1.1.6 ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊ホ౯ጤဨ఍䠄Panitia Penilai Cara Pembuatan Obat
Hwan Yang Baik䠅 ......................................................................................................... 70
1.2 ື≀⏝་⸆ရ䛾㛵ಀἲ௧ ............................................................................................. 712

1.2.1 ἲᚊ ....................................................................................................................... 71
1.2.2 ᨻ௧䞉┬௧ .............................................................................................................. 71
1.2.3 ᐃ⩏䞉ศ㢮 .............................................................................................................. 72
2. ື≀⏝་⸆ရ㛵ಀไᗘ ...................................................................................................... 74
2.1 ື≀⏝་⸆ရ䛾〇㐀䚸౪⤥ཬ䜃ὶ㏻䛻䛴䛔䛶 ............................................................... 74
2.1.1 ㈍኎Ⓩ㘓⏦ㄳ ........................................................................................................ 76
2.2 ື≀⏝་⸆ရ஦ᴗチྍ ................................................................................................. 77
2.2.1 ື≀⏝་⸆ရ஦ᴗチྍ䠄Izin usaha obat hewan䠅䛻䛴䛔䛶 ................................... 77
2.2.1.1 䛂ື≀⏝་⸆ရ஦ᴗチྍド䛃䛾ྲྀᚓ䛻ᚲせ䛺᮲௳ ............................................ 77
2.2.1.2 ⏦ㄳᡭ㡰ཬ䜃ὶ䜜........................................................................................... 83
2.2.1.3 ື≀⏝་⸆ရ஦ᴗチྍド䜢ྲྀᚓᚋ䛾⩏ົ ....................................................... 85
2.3 ື≀⏝་⸆ရⓏ㘓 ........................................................................................................ 85
2.3.1 ື≀⏝་⸆ရⓏ㘓チྍ䠄᪂つⓏ㘓ཪ䛿෌Ⓩ㘓䠅 ...................................................... 85
2.3.1.1 ῧ௜㈨ᩱ䛾グධ᪉ἲ ....................................................................................... 91
2.3.2 ෌Ⓩ㘓䠄Ⓩ㘓␒ྕ᭦᪂䠅䛻䛴䛔䛶............................................................................. 91
2.3.3 ື≀⏝་⸆ရⓏ㘓␒ྕ䛾ㆡΏ䛾せ௳ .................................................................... 93
2.3.4 ⥭ᛴ᫬䛻౑⏝䛩䜛ື≀⏝་⸆ရ䛾Ⓩ㘓せ௳........................................................... 93
2.3.5 ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕኚ᭦䛾せ௳ .................................................................... 94
2.3.6 ື≀⏝་⸆ရⓏ㘓⏦ㄳ䛾ὶ䜜 ............................................................................... 94
2.3.6.1 ஦๓᭩㢮ᑂᰝ.................................................................................................. 94
2.3.6.2 ᭩㢮ホ౯ ......................................................................................................... 95
2.3.6.3 䝃䞁䝥䝹䛾ㄪ㐩ཬ䜃ヨ㦂 ................................................................................. 96
2.3.6.4 ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ䠄Ỵᐃ᭩Ⓨ⾜䠅....................................................... 97
2.3.7 Ⓩ㘓ᚋ䛾ㅖ⯡ ........................................................................................................ 99
2.4 ື≀⏝་⸆ရ䛾〇㐀ཬ䜃ရ㉁⟶⌮ ............................................................................. 101
2.4.1 ᥇⏝䛥䜜䛶䛔䜛 GMP ᇶ‽.................................................................................... 101
2.4.1.1 CPOHB 䜢‶䛯䛩䛯䜑䛾せ௳ ........................................................................ 102
2.4.2 䜲䞁䝗䝛䝅䜰ᅜෆᴗ⪅䛾⏦ㄳ䝥䝻䝉䝇.................................................................... 103
2.4.3 ᅜእᴗ⪅䛾⏦ㄳ䝥䝻䝉䝇 ...................................................................................... 106
2.5 ື≀⏝་⸆ရ䛾㍺ධチྍ䛸㍺ධ᫬䛾᳨ᰝ ................................................................... 110
2.5.1 ㍺ධチྍ ............................................................................................................. 110
2.6 ື≀⏝་⸆ရ䝷䝧䝹 ................................................................................................... 110
2.7 ື≀⏝་⸆ရไᗘ䜢䜑䛠䜛ືྥ .................................................................................. 111
2.7.1 VICH 䛻ᑐ䛩䜛ືྥ .............................................................................................. 111
2.7.2 PIC/S 䛻㛵䛩䜛ືྥ ............................................................................................. 111
2.7.3 ASEAN 䛾㛵୚ཬ䜃௚䛾ᅜ㝿ᇶ‽䛻ᑐ䛩䜛ືྥ................................................... 111
2.7.4 䝝䝷䞊䝹ㄆドไᗘ䛻䛴䛔䛶................................................................................... 112
3. ὶ㏻䛾௙⤌䜏 ................................................................................................................... 113
3.1 ື≀⏝་⸆ရ䛾ὶ㏻䛾௙⤌䜏䠄᪥ᮏ䛸䛾ẚ㍑䠅 ............................................................ 113
3.2 ୺䛺ᅜෆ〇㐀ᴗ⪅䚸㍺ධᴗ⪅ཬ䜃ὶ㏻ᴗ⪅ ................................................................ 114
3.3 ᅜෆື≀⏝་⸆ရ䛾ᕷሙつᶍ .................................................................................... 114

3

3.3.1 ᅜෆ䝙䞊䝈........................................................................................................... 115
3.4 ㍺ධ་⸆ရ䛾ᕷሙつᶍཬ䜃ᕷሙᐇែ ......................................................................... 116
3.4.1 ㍺ධ་⸆ရ䛾௒ᚋ䛾ぢ㏻䛧 .................................................................................. 117
3.4.2 ື≀⏝་⸆ရᴗ⏺䛾ㄢ㢟 .................................................................................... 117
3.5 ᪥ᮏ〇ရ䛻ᑐ䛩䜛ホ౯䞉ពぢ....................................................................................... 117
4. ⏝ㄒ ................................................................................................................................. 118
5. ཧ⪃㈨ᩱ .......................................................................................................................... 120
5.1 ື≀⏝་⸆ရ〇㐀ᴗ⪅ཬ䜃㍺ධᴗ⪅䛜ྲྀᚓ䛩䜉䛝⏘ᴗศ㢮䝁䞊䝗 ............................. 120
5.1.1 KBLI 21013䚸ື≀⏝་⸆ရ〇㐀ᴗ䠄Industri Produk Farmasi Untuk Hewan䠅䛾஦ᴗᇶ‽ .......................................................................................................................... 120
5.1.2 KBLI 46444䚸ື≀⏝་⸆ရ኱つᶍၟᴗ䠄Perdagangan Besar Obat Farmasi Untuk
Hewan䠅䛾஦ᴗᇶ‽...................................................................................................... 123
5.2 ᐇᆅㄪᰝ⤖ᯝホ౯ᇶ‽ ............................................................................................... 126
5.3 㑇ఏᏊ⤌᥮䛘⏕≀䠄GMO䠅⏤᮶䛾ື≀⏝་⸆ရ䛻㛵䛩䜛䛂㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍
䠄KKH PRG䠅䛃䛛䜙䛾⎔ቃᏳ඲ド᫂᭩䠄Sertifikat Keamanan Lingkungan䠅 .................... 143
5.4 ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩グධせ㡿䠄GUIDANCE ON APPLICATION OF VETERINARY
DRUG䠅 ............................................................................................................................ 146
5.5 ␆⏘⾨⏕ᒁ㛗Ỵᐃ➨ 54/TN.260/Kpts/DJP/2001 ྕ .................................................. 152
5.6 CPOHB 䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 466KptsTN.260V99 ྕ ....................... 159

4

1. ஦ᴗ䛾ᴫせ1.1 ㄪᰝ䛾┠ⓗ䝣䜱䝸䝢䞁ඹ࿴ᅜཬ䜃䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䛻ື≀⏝་⸆ရ䜢㍺ฟ䛩䜛䛯䜑䛻䛿䚸ྛᅜ䛾ື≀⸆஦㛵ಀἲつ䛻ᇶ䛵䛟ᢎㄆ䞉チྍ䜢ྲྀᚓ䛧䚸GMP䠄〇㐀⟶⌮ཬ䜃ရ㉁⟶⌮䛾ᇶ‽䠅䛺䛹䛾ㅖไᗘ䛻㐺ษ䛻ᑐᛂ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹᪥ᮏᅜෆ䛾஦ᴗ⪅䛜䛣䜜䜙䛾ไᗘ䜢⌮ゎ䛩䜛䛣䛸䛜㔜せ䛷䛒䜛䛜䚸฼⏝䛷䛝
䜛㈨ᩱ䛜ᩚഛ䛥䜜䛶䛔䛺䛔䚹䛣䛾䛣䛸䛜䚸䝣䜱䝸䝢䞁ඹ࿴ᅜཬ䜃䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䜈䛾ື≀⏝་⸆ရ䛾㎿㏿䞉෇⁥䛺㍺ฟ䛾㜼ᐖせᅉ䛸䛺䛳䛶䛔䜛䚹䛭䛣䛷䚸ᮏㄪᰝ䛿䝣䜱䝸䝢䞁ඹ࿴ᅜཬ䜃䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䛾ື≀⏝་⸆ရ䛾㍺ධ䛻㛵ಀ䛩䜛ㅖไᗘ䜢య⣔ⓗ䛻ㄪᰝ䛧䚸ᡃ䛜ᅜ䛾ື≀⏝་⸆ရ䛻㛵䛩䜛
㍺ฟ䛾෇⁥໬䞉ಁ㐍䛻㈨䛩䜛ㄪᰝ⤖ᯝ䜢䜎䛸䜑䜛䛣䛸䜢┠ⓗ䛸䛧䛯䚹

1.2 ㄪᰝ䛾ᐇ᪋ෆᐜ
1.2.1 ㄪᰝᑐ㇟ᅜ
ᮏㄪᰝ䛾ㄪᰝᑐ㇟ᅜ䛿䚸䝣䜱䝸䝢䞁ඹ࿴ᅜཬ䜃䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䛷䛒䜛䚹

1.2.2 ㄪᰝෆᐜᮏㄪᰝ䛷䛿䚸௨ୗ䛾 4 䛴䛾஦㡯䜢䜎䛸䜑䛯䚹䠄1䠅ື≀⏝་⸆ရ䛾ᐃ⩏䛸ศ㢮䚸ཬ䜃㛵ಀἲ௧䛸ᡤ⟶┬ᗇ䛻䛴䛔䛶䚹䠄2䠅ື≀⏝་⸆ရ䛾㍺ධᢎㄆཬ䜃チྍ䛻㛵䛩䜛つไ䠄㍺ධ⏦ㄳ䛻ᚲせ䛺䝕䞊䝍䚸⏦ㄳ䛛䜙ᢎㄆ䜎䛷䛾ᡭ⥆䛾ὶ䜜䚸᪥ᩘ䚸ᡭᩘᩱ䛺䛹䠅䛸ᑗ᮶䛾᪉ྥᛶ䠄つไ⦆࿴䛾ഴྥ䚸ᅜ㝿‽ᣐ䛾≧ἣ䚸ACEAN䛺䛹䛾㛵୚䛺䛹䠅䛻䛴䛔䛶䚹䠄3䠅ື≀⏝་⸆ရ䛾〇㐀䞉ရ㉁⟶⌮䛻㛵䛩䜛つไ䠄GMP䠅୪䜃䛻䛭䛾ືྥ䠄PIC/S 䛸䛾㛵ಀ䜢ྵ䜐䠅䛻䛴䛔䛶䚹䠄4䠅ື≀⏝་⸆ရ䛾ὶ㏻䛾௙⤌䜏䛻䛴䛔䛶䚹5

1.2.3 ㄪᰝ᪉ἲ䛆䝕䝇䜽䝸䝃䞊䝏ㄪᰝ䛇ୖグ䠄1䠅䛛䜙䠄4䠅䛾ྛ㡯┠䛻䛴䛔䛶䚸ྛ✀㛵㐃ᶵ㛵䛺䛹䛾බ㛤᝟ሗ䞉㈨ᩱ䞉グ஦䛛䜙䝕䝇䜽䝸䝃䞊䝏䛻䜘䛳䛶᝟ሗ䜢཰㞟䛧䛯䚹䛺䛚䚸ሗ࿌᭩䛾䛸䜚䜎䛸䜑䛾㝿䛻䚸እᅜㄒ䛾ཧ⪃᝟ሗ䛾୍㒊䜢᪥ᮏㄒཬ䜃ⱥㄒ䛻⩻ヂ䛧䛯䛜䚸ᙜヱヂᩥ䛿᝟ሗබ㛤ඖ䛾ᶵ㛵䛾ᢎㄆ䜢ཷ䛡䛯䜒䛾䛷䛿䛺䛔䚹䛭䛾䛯䜑䚸ᙜヱヂᩥ䛸ཎᩥ䛾㛫䛻ゎ㔘䛾┦㐪䛜䛒䜛ሙྜ䛿䚸ཎᩥ䜢බᘧ᝟ሗ䛸䛚⪃䛘䛔䛯䛰䛝䛯䛔䚹䛆䝠䜰䝸䞁䜾ㄪᰝ䛇ୖグ䠄1䠅䛛䜙䠄4䠅䛾ྛ㡯┠䛻䛴䛔䛶䚸㛵ಀ䛩䜛᭷㆑⪅䛻䝠䜰䝸䞁䜾䜢⾜䛔䚸᝟ሗ䜢ධᡭ䛧䛯䚹䛣䛾䝠䜰䝸䞁䜾ㄪᰝ䛿䚸䝯䞊䝹䚸㟁ヰ䚸䝡䝕䜸䝭䞊䝔䜱䞁䜾䚸┤᥋ゼၥ䛺䛹䛻䜘䜚ᐇ᪋䛧䛯䚹6

2. 䝣䜱䝸䝢䞁ඹ࿴ᅜ
1. ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ䞉㛵ಀἲ௧
1.1 ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ䝣䜱䝸䝢䞁ඹ࿴ᅜ䛻䛚䛔䛶ື≀⏝་⸆ရ䜢ᡤ⟶䛧䛶䛔䜛䛾䛿ಖ೺┬䛻ᒓ䛩䜛㣗ရ་⸆ရᒁ䠄FDA䠖
Department of Health, Food and Drug Administration䠅1䛷䛒䜛䚹᰿ᣐἲ௧䛿䚸ඹ࿴ᅜἲ➨ 3720 ྕ䛂㣗ရ䚸་⸆ရཬ䜃໬⢝ရἲ䛃䠄1963 ᖺ 6 ᭶ 22 ᪥䠅2䛷䛒䜛䚹FDA 䛿䚸ᅜẸ䛾೺ᗣ䜈䛾ᶒ฼䜢Ᏺ䜚䚸ಁ㐍䛩䜛䛯䜑䚸〇ရ䛾Ᏻ඲ᛶ䚸ရ㉁䚸⣧ᗘ䚸᭷ຠᛶ䜢☜ಖ䛩䜛䛣䛸䜢䛭䛾䝭䝑䝅䝵䞁䛸䛧䛶䛔䜛䚹
FDA ചୗ䛾ᶵ㛵䛾୍䛴䛷䛒䜛䚸⸆஦つไ◊✲䝉䞁䝍䞊䠄CDRR䠖Center for Drug Regulation andResearch䠅䛜་⸆ရ䛾〇㐀䜔㍺ฟධ䚸㈍኎䛺䛹䜢つไ䛩䜛䛣䛸䜢ᐃ䜑䛶䛚䜚䚸་⸆ရ䛻䛿ື≀⏝་⸆ရ䜒ྵ䜎䜜䜛䚹

1.1.1 CDRR 䛾ᡤᤸ஦ົඹ࿴ᅜἲ➨ 9711 ྕ䛂2009 ᖺ㣗ရ་⸆ရᒁἲ䛃䠄2009 ᖺ 8 ᭶ 18 ᪥䠅3䛾ලయⓗ䛺㐠⏝䛻䛴䛔䛶つᐃ䛧䛶䛔䜛┬㏻▱ 2011-0101䛂ඹ࿴ᅜἲ➨ 9711 ྕ䛄2009 ᖺ㣗ရ་⸆ရᒁἲ䛅ᐇ᪋ἲつ๎䛃䠄2011ᖺ 3 ᭶ 22 ᪥䠅4䛾➨ 1 ⦅➨ VII ⠇➨ 8 ᮲䛿䚸CDRR 䛾ᡤᤸ஦ົ䛻䛴䛔䛶ḟ䛾䜘䛖䛻つᐃ䛧䛶䛔䜛䚹➨ 8 ᮲䠖ᡤᤸ⠊ᅖ⸆஦つไ◊✲䝉䞁䝍䞊䛿䚸་⸆ရ䛾〇㐀䚸㍺ධ䚸㍺ฟ䚸ὶ㏻䚸㈍኎䚸㈍኎䛾ᥦ♧䚸⛣㏦䚸㈍኎
ಁ㐍䚸ᐉఏ䚸䝇䝫䞁䝃䞊䝅䝑䝥䚸䜎䛯ヱᙜ䛩䜛ሙྜ䛻䛿ヨ㦂䛻䛴䛔䛶つไ䛩䜛䜒䛾䛸䛩䜛䠄ື≀⏝་⸆ရ䚸䝽䜽䝏䞁䚸⏕≀〇๣䜢ྵ䜐䠅䚹䜎䛯䚸ヱᙜ䛩䜛ሙྜ䛻䛿䚸ᢠ⏕≀㉁䛾䝞䝑䝏ཬ䜃ᢠ⏕≀㉁〇๣䜢ᢎㄆ䛩䜛䚹䜎䛯䚸ྠ䝉䞁䝍䞊䛿་⸆ရ䛾Ᏻ඲ᛶ䚸᭷ຠᛶཬ䜃ရ㉁䛻㛵䛩䜛◊✲䜢ᐇ᪋䛧䚸䛭䜜䜙䛻䛴䛔䛶䛾ᇶ‽䜢⟇ᐃ䛩䜛䜒䛾䛸䛩䜛䚹䛣䛾つᐃ䛛䜙䚸CDRR 䛜ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾つไ䜢ᡤᤸ஦ົ䛸䛧䛶䛔䜛䛣䛸䛜ศ䛛䜛䚹

1 https://www.fda.gov.ph

2 The LAWPHiL Project, “REPUBLIC ACT No. 3720”

䠄https://lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 22 ᪥䠅
3䝣䜱䝸䝢䞁ᨻᗓ䝫䞊䝍䝹 Official Gazette, “REPUBLIC ACT No. 9711”

䠄https://www.officialgazette.gov.ph/2009/08/18/republic-act-no-9711䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 22 ᪥䠅
4 䝣䜱䝸䝢䞁ඹ࿴ᅜಖ೺┬, Department Circular No. 2011-0101䠄https://www.fda.gov.ph/wpcontent/uploads/2021/04/Department-Circular-No.-2011-0101.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 22 ᪥䠅

7

1.1.1.1 CDRR ചୗ䛾⤌⧊䛾ᡤᤸ஦ົ┬㏻▱ 2011-0101䛂ඹ࿴ᅜἲ➨ 9711 ྕ䛄㣗ရ་⸆ရᒁἲ䛅ᐇ᪋ἲつ๎䛃䛾➨ 1 ⦅➨ VII ⠇➨ 3
᮲䛷䛿䚸CDRR 䜢ྵ䜐 FDA 䛾ྛ䝉䞁䝍䞊䛻䚸䛂ㄆྍⓏ㘓㒊䛃䛸䛂〇ရ◊✲䞉ᇶ‽⟇ᐃ㒊䛃䛾 2 䛴䛾㒊⨫䛜タ⨨䛥䜜䜛䛣䛸䛜ᐃ䜑䜙䜜䛶䛔䜛䚹

ㄆྍⓏ㘓㒊䛾୺䛺ᡤᤸ஦ົ䛿ḟ䛾䛸䛚䜚䛷䛒䜛䚹Ɣ ᡤᤸ⠊ᅖ䛾〇ရ䛾〇㐀䚸㍺ධ䚸㍺ฟ䚸ὶ㏻䚸㈍኎䚸㈍኎䛾ᥦ♧䚸⛣㏦䚸౑⏝䛾つไƔ ᡤᤸ⠊ᅖ䛾チㄆྍ䛾Ⓨ⾜䛻㛵㐃䛧䛯ᡤᤸ⠊ᅖ䛾〇ရ䛻㛵䛩䜛ศᯒཬ䜃᳨ᰝƔ ᡤᤸ⠊ᅖ䛾チㄆྍ䛾Ⓨ⾜䛻㛵㐃䛧䛯⏦ㄳ஦ᴗ⪅䛾ᣦᑟ䚸ほᐹ䚸᳨ᰝ䚸ホ౯Ɣ ᡤᤸ⠊ᅖ䛾Ⓩ㘓〇ရཬ䜃チㄆྍ῭஦ᴗ⪅䛾䝕䞊䝍䝧䞊䝇䛾⟶⌮Ɣ ᡤᤸ⠊ᅖ䛾チㄆྍ䛾Ⓨ⾜䛻㛵㐃䛧䛯〇ရ䛻㛵䛩䜛ヨ㦂䛾せㄳƔ ᡤᤸ⠊ᅖ䛾〇ရ䛻䜘䜛Ṛஸ஦ᨾ䛺䛹䛾䜲䞁䝅䝕䞁䝖䛻㛵㐃䛧䛯஦ᴗ⪅䜈䛾ሗ࿌䜢せㄳƔ Ṛஸ஦ᨾ䛺䛹䛾䜲䞁䝅䝕䞁䝖䜢Ⓨ⏕䛥䛫䛯〇ရ䛜༴㝤䛷䛒䜛ሙྜ䛾㈍኎⚗Ṇ䚸䝸䝁䞊䝹➼Ɣ ಖ೺〇ရ䛾䝸䝇䜽⟶⌮ィ⏬䛾ᙉไᐇ᪋Ɣ ಖ೺〇ရ䛾䝃䞁䝥䝹䛾ᅇ཰ཬ䜃ヨ㦂䛾せㄳ〇ရ◊✲䞉ᇶ‽⟇ᐃ㒊䛾୺䛺ᡤᤸ஦ົ䛿ḟ䛾䛸䛚䜚䛷䛒䜛䚹Ɣ ㄆྍⓏ㘓㒊䛸㐃ᦠ䛧䚸ಖ೺〇ရ䛾஦ᴗ⪅䛾ᇶ‽䜔つไ䜢⟇ᐃƔ ㈍኎ᚋ䛾ᕷሙㄪᰝ䝅䝇䝔䝮䜢㛤Ⓨ䞉⥔ᣢƔ ᡤᤸ⠊ᅖ䛾〇ရ䛾Ᏻ඲ᛶ䚸᭷ຠᛶཬ䜃ရ㉁䜢☜ಖ䛩䜛䛯䜑䛾┘╩䞉┘ᰝƔ ಖ೺〇ရ䛾ᇶ‽⟇ᐃ䛾᰿ᣐ䛸䛺䜛◊✲䛾ᐇ᪋䛸ศᯒ䝕䞊䝍䜢సᡂ

1.1.2 FDA ཬ䜃 BAI 䛸䛾㛵ಀ
FDA 䛿䝣䜱䝸䝢䞁ᨻᗓ䛻䛚䛔䛶ಖ೺⾨⏕䜢ᡤ⟶䛩䜛ಖ೺┬䛻ᒓ䛩䜛䛜䚸୍᪉䛷㎰␆⏘ᴗ䜢ᡤ⟶䛩䜛㎰ᴗ┬䛻䛿䚸␆⏘ᒁ䠄BAI䠖Bureau of Animal Industry䠅5䛜䛒䜚䚸䛛䛴䛶ື≀⏝་⸆ရ䛾〇ရⓏ㘓
䛺䛹䛾ᴗົ䛿 BAI 䛜ᡤ⟶䛧䛶䛔䛯䚹䜎䛯䚸ᚲせ䛻ᛂ䛨䛶ಖ೺┬䛸㎰ᴗ┬䛻䜘䜛⾜ᨻ࿨௧䛜ඹྠ䛷ฟ䛥䜜䜛䛣䛸䜒䛒䛳䛯䚹䛧䛛䛧䚸ಖ೺┬䞉㎰ᴗ┬䛻䜘䜛ඹྠ⾜ᨻ࿨௧ 2013-0026䠄2013 ᖺ 9 ᭶ 24 ᪥䠅6䛻䜘䜚䚸ື≀⏝་⸆ရ䛾ᴗົ䛜 FDA 䛻୍ᮏ໬䛥䜜䜛䛣䛸䛜ṇᘧ䛻㏻▱䛥䜜䛯䚹䛥䜙䛻䚸FDA ່࿌ 2022-0591䠄2022 ᖺ 3

5 https://www.bai.gov.ph/
6 䝣䜱䝸䝢䞁 FDA, Joint DOH and DA Administrative Order No. 2013-0026䠄https://www.fda.gov.ph/wp-

content/uploads/2021/04/JOINT-DOH-and-DA-Administrative-Order-No.-2013-0026.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022
ᖺ 9 ᭶ 22 ᪥䠅

8

᭶ 14 ᪥䠅7䛷䛿䚸ື≀⏝་⸆ရ䛻㛵㐃䛩䜛ᴗົ䛿䛩䜉䛶 CDRR 䛜ᢅ䛖䛣䛸䛜㏻▱䛥䜜䛯䚹䛸䛿䛔䛘䚸䛣䛾⛣⾜䝥䝻䝉䝇䛜䜎䛰᏶஢䛧䛶䛔䛺䛔䛯䜑䛛䚸㎰ᴗ┬䛾䜴䜵䝤䝃䜲䝖䛻ື≀⏝་⸆ရ䛻㛵㐃䛩䜛ᵝᘧ䛺䛹䛜ᥖ㍕䛥䜜䛶䛔䛯䜚䚸୍᪉䛷䚸FDA 䛾䜴䜵䝤䝃䜲䝖䛻䛿ື≀⏝་⸆ရ䛻㛵㐃䛩䜛䜺䜲䝗䝷䜲䞁䛜඘ᐇ䛧䛶䛔䛺䛛䛳䛯䜚䛸䛔䛖ᵝᏊ䛜ㄪᰝ䛾᫬Ⅼ䛷ほᐹ䛥䜜䛯䚹FDA 䛸 BAI 䛾㛵ಀ䛻䛴䛔
䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛷௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹

2021 ᖺ䛛䜙ṇᘧ䛻䚸ື≀⏝་⸆ရ䛾⾜ᨻ䛿 BAI 䛛䜙 FDA 䛻⛣⟶䛥䜜䛯䚹䛣䛾⛣⟶䛻క䛔
BAI 䛾ேဨ䛜 FDA 䛻⛣䜛䛣䛸䛿䛥䜜䛶䛔䛺䛔䚹䛧䛯䛜䛳䛶䚸FDA 䛿䛣䛾኱䛝䛺ᴗົ䜢 FDA
䛾䜏䛷ᢅ䛔ጞ䜑䛶䛔䜛䛯䜑䚸䜎䛰᫂䜙䛛䛷䛿䛺䛔䛣䛸䜒ከ䛔䚹䛯䛟䛥䜣䛾௻ᴗ䛜䝻䝡䞊άື䜢ᐇ᪋䛧䛶䛔䜛䚹

1.2 ື≀⏝་⸆ရ䛾㛵ಀἲ௧ື≀⏝་⸆ရ䛻㛵ಀ䛩䜛ἲ௧䚸኱⤫㡿௧䚸⾜ᨻ࿨௧䛺䛹䛻䛴䛔䛶௨ୗ䛻♧䛩䚹

1.2.1 ἲᚊ䞉኱⤫㡿௧䝣䜱䝸䝢䞁䛻䛚䛔䛶ື≀⏝་⸆ရ䛻᭱䜒㛵㐃䛩䜛ἲᚊ䛿䚸ඹ࿴ᅜἲ➨ 3720 ྕ䛷䛒䜛䚹䛣䛾ἲᚊ䛻
䜘䜚䚸FDA 䛾タ❧䛸ᙺ๭䛜᫂グ䛥䜜䚸་⸆ရ䛻䛴䛔䛶䜒ᐃ⩏䛥䜜䛯䚹䛭䛾ᚋ䚸ඹ࿴ᅜἲ➨ 3720 ྕ䜢ಟṇ䛧䛯኱⤫㡿௧➨ 175 ྕ䠄1987 ᖺ䠅8䛻䜘䜚ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾チㄆྍཬ䜃Ⓩ㘓䛻㛵䛩䜛䝣䜱䝸䝢䞁ᨻᗓ䛾つᐃ䛿኱ᖜ䛻ᨵゞ䛥䜜䛯䚹ᙜึ䚸ඹ࿴ᅜἲ➨3720 ྕ䛻䛿䚸➨ 21 ᮲䛛䜙ጞ䜎䜛⠇䛻䛂᪂⸆䛃䛸䛔䛖๪㢟䛜䛒䜚䚸⥆䛟➨ 21 ᮲䛻䛚䛔䛶䚸᪂⸆䛾〇㐀
䜔㈍኎䛺䛹䜢⾜䛖䛯䜑䛻䛿チྍド䛾ྲྀᚓ䛜ᚲせ䛷䛒䜛䛸ᐃ䜑䜙䜜䛶䛔䛯䚹䛧䛛䛧䚸኱⤫㡿௧➨ 175 ྕ
䠄1987 ᖺ䠅➨ 13 ᮲䛿䚸ඹ࿴ᅜἲ➨ 3720 ྕෆ䛾䛂᪂⸆䛃䛸䛔䛖๪㢟䜢䛂チㄆྍཬ䜃Ⓩ㘓䛃䛻ኚ᭦䛧䚸䛥䜙䛻ྠἲ➨ 21 ᮲䜢௨ୗ䛾䜘䛖䛻ಟṇ䛧䛯䚹䠄a䠅䛔䛪䜜䛾⪅䜒䚸ᮏ᮲䠄b䠅㡯䛻ᚑ䛳䛶ᥦฟ䛥䜜䛯⏦ㄳ䛜᭷ຠ䛷䛒䜛ሙྜ䜢㝖䛝䚸䛔䛛䛺䜛་⸆ရཪ䛿⿦⨨䜒〇㐀䚸㈍኎䚸㈍኎䛾⏦䛧ฟ䚸㍺ධ䚸㍺ฟ䚸ὶ㏻ཪ䛿ㆡΏ䛧䛶䛿䛺䜙䛺䛔䚹

7 䝣䜱䝸䝢䞁ඹ࿴ᅜ FDA, FDA Advisory No. 2022-0591䠄https://www.fda.gov.ph/wp-content/uploads/2022/03/FDA-

Advisory-No.2022-0591.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 22 ᪥䠅
8 䝣䜱䝸䝢䞁ᨻᗓ䝫䞊䝍䝹 Official Gazette, “Executive Order No. 175, s. 1987”䠄https://www.officialgazette.gov.ph/1987/05/22/executive-order-no-175-s-1987/䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 22᪥䠅9䜎䛯䚸ྠ኱⤫㡿௧➨ 15 ᮲䛿䚸ྠἲ➨ 21 ᮲䛻 A 㡯䜢㏣ຍ䛧䛯䚹ෆᐜ䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹䛔䛪䜜䛾⪅䜒䚸ᮏἲᚊ䛻ᇶ䛵䛝㛗ᐁ䛜බᕸ䛧䛯つ๎ཬ䜃つᐃ䛻ᚑ䛳䛶ᢏ⾡ⓗせ௳䜢༑ศ䛻‶䛯䛧䛯ᚋ䚸ᒁ䛛䜙஦ᴗチྍド䜢ྲྀᚓ䛧䛺䛡䜜䜀䚸་⸆ရཪ䛿⿦⨨䜢〇㐀䚸㈍኎䚸㈍኎䛾⏦ฟ䚸㍺ධ䚸㍺ฟ䚸ὶ㏻ཪ䛿⛣㌿䛩䜛䛣䛸䛿䛷䛝䛺䛔䚹䛭䛾ᚋ䚸ඹ࿴ᅜἲ➨ 9711 ྕ䛻䜘䜚䚸FDA 䛾ᙺ๭䛿䛥䜙䛻ᙉ໬䛥䜜䚸ື≀⏝་⸆ရ䛾ᡤ⟶䝉䞁䝍䞊
䛸䛧䛶 CDRR 䜢タ❧䛩䜛䛣䛸䛜᫂グ䛥䜜䛯䚹RA3720䠄ඹ࿴ᅜἲ➨ 3720 ྕ䠅䛂㣗ရ䚸་⸆ရཬ䜃໬⢝ရἲ䛃

FDA 䛾タ❧䚸ᙺ๭䛺䛹䜢つᐃ་⸆ရ䜢ᐃ⩏

EO175, s. 1987䠄኱⤫㡿௧➨ 175 ྕ䠄1987 ᖺ䠅䠅RA3720 䜢ᨵゞ䚹≉䛻་⸆ရ඲⯡䛾〇㐀䚸㈍኎䚸㍺ධ䛺䛹䛾つไ䜈䛸ᣑ኱䚹

RA9711䠄ඹ࿴ᅜἲ➨ 9711 ྕ䠅䛂FDA ἲ䛃

RA3720 䜢ᨵゞ䚹FDA 䛾ᙺ๭䜢䛥䜙䛻ᙉ໬䚹

1.2.2 ⾜ᨻ࿨௧䚸㏻▱䛺䛹ື≀⏝་⸆ရ䛾⾜ᨻ䛻㛵䛩䜛୺䛺⾜ᨻ࿨௧䚸㏻▱䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹AO2012-0008䠄⾜ᨻ࿨௧䠅

PIC/S GMP 䜢䝣䜱䝸䝢䞁䛾 GMP 䛻ᑟධ

AO2013-0022䠄⾜ᨻ࿨௧䠅ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅
䛻䛴䛔䛶

AO2013-0026䠄⾜ᨻ࿨௧䠅ື≀⏝་⸆ရ䛾ᡤ⟶䜢 BAI 䛛䜙 FDA 䛻⛣⟶

AO2014-0034䠄⾜ᨻ࿨௧䠅

LTO 䛾せ௳䛻䛴䛔䛶

AO2012-0008䠄⾜ᨻ࿨௧䠅䝠䝖⏝་⸆ရ䛾୍⯡䝷䝧䝹せ௳䛻㛵䛩䜛つ๎䛾ᨵゞ

AO2020-0045䠄⾜ᨻ࿨௧䠅䝽䜽䝏䞁ཬ䜃⏕≀〇๣䜢ྵ䜐་⸆ရ䛾㎿㏿䛺
Ⓩ㘓⤒㊰䛾☜❧

AO2022-0017䠄⾜ᨻ࿨௧䠅

LTO 䛾せ௳䛻䛴䛔䛶

Circular 2011-0101䠄㏻▱䠅ඹ࿴ᅜἲ➨ 9711 ྕ䛂2009 ᖺ㣗ရ་⸆ရᒁἲ䛃
ᐇ᪋ἲつ๎

10

Circular 2014-003䠄㏻▱䠅⤫ྜ⏦ㄳ᭩䛻䛴䛔䛶Circular 2014-016䠄㏻▱䠅ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅䛻㛵䛩䜛 AO2013-0022 䛾䜺䜲䝗䝷䜲䞁Circular 2014-025䠄㏻▱䠅LTO 䛾せ௳䛻㛵䛩䜛 AO2014-0034 䛾䜺䜲䝗䝷䜲䞁䠄⸆ᒁ䛾 LTO䠅Circular 2014-026䠄㏻▱䠅LTO 䛾せ௳䛻㛵䛩䜛 AO2014-0034 䛾䜺䜲䝗䝷䜲䞁䠄ὶ㏻ᴗ⪅䛾 LTO䠅Circular 2014-028䠄㏻▱䠅LTO 䛾せ௳䛻㛵䛩䜛 AO2014-0034 䛾䜺䜲䝗䝷䜲䞁䠄ฎ᪉⟢୙せ⸆ᒁ䛾 LTO䠅Circular 2015-003䠄㏻▱䠅LTO 䛾せ௳䛻㛵䛩䜛 AO2014-0034 䛾䜺䜲䝗䝷䜲䞁䠄ཷクヨ㦂ᶵ㛵䛾 LTO䠅Circular 2016-014䠄㏻▱䠅㟁Ꮚ⏦ㄳ䛻䛴䛔䛶

Circular 2022-004䠄㏻▱䠅⾜ᨻ࿨௧ 2020-0045䛂䝽䜽䝏䞁ཬ䜃⏕≀〇๣䜢ྵ䜐་⸆ရ䛾㎿㏿䛺Ⓩ㘓⤒㊰䛾☜❧䛃䛻‽ᣐ䛧䛯᪂⸆Ⓩ㘓⏦ㄳ䛾䛯䜑䛾せ⣙ཬ䜃᳨ド䝺䝡䝳䞊䚸䛭䜜䜙䛾ᐇ᪋䜺䜲䝗䝷䜲䞁

FDA Citizen’s charter-CDRR䠄ᕷẸ᠇❶ CDRR ∧䠅

CDRR 䛾ᴗົ䚸≉䛻 GMP 䜽䝸䜰䝷䞁䝇䜔 CPR⏦ㄳ䛻䛴䛔䛶䛾ヲ⣽䛺䜺䜲䝗䝷䜲䞁

FDA Citizen’s charter-LTO䠄ᕷẸ᠇❶ LTO ∧䠅

LTO 䛾⏦ㄳ䛻䛴䛔䛶䛾ヲ⣽䛺䜺䜲䝗䝷䜲䞁

1.2.3 ᐃ⩏䞉ศ㢮⏝ㄒ䛿ἲ௧䜔⾜ᨻ࿨௧䚸㏻▱䛺䛹䛷ᖖ䛻ᚲせ䛻ᛂ䛨䛶ᐃ⩏䛥䜜䛶䛔䜛䛜䚸་⸆ရ䛻䛴䛔䛶䛿ື≀⏝་⸆ရ䛻᭱䜒㛵㐃䛜῝䛟䚸䛛䛴᫬ᮇⓗ䛻᪂䛧䛔䚸ඹ࿴ᅜἲ➨ 9711 ྕ➨ 9 ᮲䛷ḟ䛾䜘䛖䛻ᐃ⩏䛥䜜䛶䛔䜛䚹䛂་⸆ရ䛃䠄drug䠅䛸䛿䚸䠄1䠅ᨻᗓ䛾⸆ᒁ᪉䠄ᨻᗓ䛾䝩䝯䜸䝟䝅䞊⸆ᒁ᪉䜢ྵ䜐䠅ཪ䛿䛭䜜䜙䜢⿵㊊䛩䜛ᩥ᭩䛸䛧䛶 FDA 䛜ᢎㄆ䛧᥇⏝䛧䛯䜒䛾䛻䛚䛔䛶ㄆ䜑䜙䜜䛶䛔䜛䜒䛾䚸䠄2䠅ே㛫ཪ䛿௚䛾ື≀䛾⑌ᝈ䜢デ᩿䚸἞⒵䚸⦆࿴䚸἞⒪ཪ䛿ண㜵䛻౑⏝䛩䜛䛣䛸䜢┠ⓗ䛸䛩䜛䜒䛾䚸䠄3䠅ே㛫ཪ䛿௚䛾ື≀䛾㌟యᶵ⬟䛾ᵓ㐀䛻ᙳ㡪䜢୚䛘䜛䛣䛸䜢ពᅗ䛧䛯䜒䛾䠄㣗ရ䜢㝖䛟䠅䚸䠄4䠅䠄1䠅䚸
䠄2䠅䚸䠄3䠅䛻つᐃ䛩䜛䜒䛾䛾ᵓᡂせ⣲䛸䛧䛶౑⏝䛩䜛䛣䛸䜢ពᅗ䛧䛯䜒䛾䛷䛒䜛䛜䚸ᶵჾ䚸䛭䛾ᵓᡂ㒊ရ䚸௜ᒓရ䛿ྵ䜎䛺䛔䚹
䠄2䠅ཬ䜃䠄3䠅䛻௚䛾ື≀䛜ྵ䜎䜜䛶䛔䜛䛣䛸䛛䜙䚸ື≀⏝་⸆ရ䜒་⸆ရ䛻ྵ䜎䜜䜛䛣䛸䛜ศ䛛䜛䚹11

2. ື≀⏝་⸆ရ㛵ಀไᗘ
2.1 ື≀⏝་⸆ရ䛾㈍኎Ⓩ㘓ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䜢䝣䜱䝸䝢䞁䛷㈍኎䛩䜛䛣䛸䛻䛴䛔䛶䛿䚸ඹ࿴ᅜἲ➨ 3720 ྕ䛷つᐃ䛥䜜䛶䛔䜛䚹ྠἲ䛿䚸኱⤫㡿௧➨ 175 ྕ䠄1987 ᖺ䠅䛻䜘䜚኱ᖜ䛻ಟṇ䛥䜜䚸་⸆ရ䛾㈍኎䛻䛴䛔䛶䛿ྠ኱⤫㡿௧➨ 15 ᮲䛻䜘䜚䚸ྠἲ䛻➨ 21-B ᮲䛜㏣ຍ䛥䜜䛯䚹ෆᐜ䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹➨ 21-B ᮲䠖་⸆ရཪ䛿⿦⨨䛿䚸䛭䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅ཪ䛿㈍኎ᴗ⪅䛜ᮏἲᚊ䛻ᇶ䛵䛝㛗ᐁ䛜බᕸ䛩䜛つ๎ཬ䜃つᐃ䛻ᚑ䛳䛶Ⓩ㘓䛧䛺䛔㝈䜚䚸〇㐀䚸㈍኎䚸㈍኎䛾ᥦ♧䚸㍺ධ䚸㍺
ฟ䚸ὶ㏻ཪ䛿⛣㌿䛧䛶䛿䛺䜙䛺䛔䚹➨ 21 ᮲䠄b䠅㡯䚸䠄d䠅㡯ཬ䜃䠄e䠅㡯䛾つᐃ䛿䚸㐺⏝䛥䜜䜛㝈䜚䛻䛚䛔䛶䚸ᙜヱ་⸆ရཬ䜃ᶵჾ䛾Ⓩ㘓䛻㐺⏝䛥䜜䜛䜒䛾䛸䛩䜛䚹䛣䛾䜘䛖䛻䚸䝣䜱䝸䝢䞁䛷ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾㈍኎䜢ᕼᮃ䛩䜛ሙྜ䚸㈍኎䛧䜘䛖䛸䛩䜛஦ᴗ⪅䛿䚸㛵ಀ䛩䜛ἲ௧䛾つᐃ䛻ἢ䛳䛶䛭䛾་⸆ရ䜢Ⓩ㘓䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹䜎䛯䚸ඹ࿴ᅜἲ➨ 3720 ྕ䛾➨ 21 ᮲䠄e䠅㡯䛿䚸ྠ᮲䛷ᐃ䜑䜙䜜䛶䛔䜛་⸆ရ䛾Ⓩ㘓䛜䚸ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䜛䛣䛸䜢᫂グ䛧䛶䛔䜛䚹䛺䛚䚸་⸆ရ䛾Ⓩ㘓䜢ᕼᮃ䛩䜛஦ᴗ⪅䛿䚸䜎䛪஦ᴗチྍド䠄LTO䠖License
to Operate䠅䜢ྲྀᚓ䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹LTO 䛾ྲྀᚓ䛾ヲ⣽䛻䛴䛔䛶䛿䚸䛂3.3 ㈍኎ᴗ⪅䛃䜢ཧ↷䛧䛶䛔䛯䛰䛝䛯䛔䚹

2.1.1 ㈍኎Ⓩ㘓⏦ㄳື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䜢ᙜᒁ䛻Ⓩ㘓䛩䜛ሙྜ䚸஦ᴗ⪅䛿䛭䛾་⸆ရ䛻ᑐ䛩䜛〇ရⓏ㘓ド
䠄CPR䠖Certificate of Product Registration䠅䜢⏦ㄳ䛧䚸ྲྀᚓ䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹๓㡯䛷䜒ゐ䜜䛯䜘䛖䛻䚸ᙜヱ⏦ㄳ䛻䛚䛔䛶䚸CPR 䛾⏦ㄳ䜢ᕼᮃ䛩䜛஦ᴗ⪅䛿䚸䛒䜙䛛䛨䜑 LTO 䜢ྲྀᚓ䛧䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠄LTO 䛻䛴䛔䛶䛿䛂3.3 ㈍኎ᴗ⪅䛃䜢ཧ↷䠅䚹CPR 䛿་⸆ရ䛤䛸䛻⏦ㄳ䞉ྲྀᚓ䛥䜜䛺䛡䜜䜀䛺䜙䛪䚸་⸆ရ䛤䛸䛻ᙜᒁ䜘䜚 CPR 䛜Ⓨ⾜䛥䜜䚸䝣䜱䝸䝢䞁䛻䛚䛡䜛Ⓩ㘓␒ྕ䛜௜୚䛥䜜䜛䚹
㏻ᖖ䛾 CPR 䛾⏦ㄳᡭ⥆䛻ᚲせ䛺᭩㢮䛺䛹䜔ᡭ⥆䛾㐣⛬䛻䛴䛔䛶௨ୗ䛻ヲ㏙䛩䜛䛜䚸㏻ᖖ䛾⏦ㄳᡭ⥆௨እ䛻⏦ㄳ⪅䛾ὀព䜢ᚲせ䛸䛩䜛Ⅼ䛜 2 䛴䛒䜛䚹
1 Ⅼ┠䛿䚸⏦ㄳᑐ㇟䛾ື≀⏝་⸆ရ䛜䚸ཎᩱ䛾୍㒊䛷䛒䜛䛛᏶ᡂရ䛷䛒䜛䛛䜢ၥ䜟䛪䚸㍺ධရ䛷䛒䜛䛛䛹䛖䛛䛷䛒䜛䚹ᙜヱ〇ရ䛾ཎᩱ䛾୍㒊ཪ䛿᏶ᡂရ䛜㍺ධရ䛷䛒䜛ሙྜ䚸CPR 䛾⏦ㄳ䛻ඛ❧䛱䚸ᙜヱ〇ရ䛜〇㐀ᅜ䛻䛚䛔䛶㐺ษ䛺 GMP ᇶ‽䛻‽ᣐ䛧䛶〇㐀䛥䜜䛶䛔䜛䛣䛸䜢䚸☜ㄆཬ䜃ᢎㄆ䛩䜛ᡭ⥆䛜ᚲせ䛸䛥䜜䜛䚹䛣䛾ᡭ⥆䛿 GMP 䜽䝸䜰䝷䞁䝇䛸࿧䜀䜜䛶䛔䜛䚹GMP 䜽䝸䜰䝷䞁䝇䛾ヲ⣽䛿䚸
䛂3.2.3 䝣䜱䝸䝢䞁ᅜእ䛾〇㐀⪅䛃䛻グ㍕䛧䛯䚹
2 Ⅼ┠䛿䚸CPR 䛾⏦ㄳ䛻䛚䛔䛶㎿㏿ᑂᰝ䜢ᕼᮃ䛩䜛䛛䛹䛖䛛䛷䛒䜛䚹㎿㏿ᑂᰝ䛿䚸⏦ㄳᑐ㇟䛾ື12≀⏝་⸆ရ䜢㍺ධ䛩䜛䛛䚸ཪ䛿⌧ᆅ䛷〇㐀䛩䜛䛛䛻䛛䛛䜟䜙䛪䚸ᙜヱື≀⏝་⸆ရ䛜௚ᅜ䛻䛚䛔䛶ື≀⏝་⸆ရ䛸䛧䛶᪤䛻ᢎㄆ䛥䜜䛶䛔䜛ሙྜ䚸䝣䜱䝸䝢䞁䛻䛚䛡䜛ᑂᰝᮇ㛫䛜▷⦰䛥䜜䜛䛸䛔䛖ไᗘ䛷
䛒䜛䚹㎿㏿ᑂᰝ䛾ヲ⣽䛿䚸䛂2.1.1.3 ㎿㏿ᑂᰝ䛃䛻グ㍕䛧䛯䚹

13䝣䜱䝸䝢䞁䛾ື≀⏝་⸆ရ㈍኎Ⓩ㘓䝣䝻䞊

14

2.1.1.1 ⏦ㄳ᭩㢮
CPR 䛾⏦ㄳ䛻ᚲせ䛺᭩㢮䛻䛴䛔䛶䛿䚸FDA CDRR ື≀⏝་⸆ရึᅇⓏ㘓䜺䜲䝗9䜔 FDA
Citizen’s Charter CDRR 2022 3rd edition䠄ಖ㝤┬ FDA ᕷẸ᠇❶ CDRR2022 ➨ 3 ∧䠅10䛷ᐃ䜑䜙䜜䛶䛚䜚䚸䛭䛣䛻グ㍕䛥䜜䛶䛔䜛᝟ሗ䛜ṇᘧ䛻බ㛤䛥䜜䛶䛔䜛᝟ሗ䛷䛒䜛䚹୍᪉䚸FDA 䛿බᘧ䜴䜵䝤䝃䜲䝖䛻䛚䛔䛶䛂ື≀⏝᪋タཬ䜃ື≀⏝་⸆ရ䛾ㄆྍ䚸Ⓩ㘓ཬ䜃ᕷ㈍ᚋㄪᰝ䛻㛵䛩䜛ᨵゞ䜺䜲䝗䝷䜲䞁䛃䠄௨ୗ䚸䛂ᨵゞ䜺䜲䝗䝷䜲䞁䛃䛸䛔䛖䠅䜢බ⾲䛧䚸ྠ䜺䜲䝗䝷䜲䞁䛻ᑐ䛩䜛䝟䝤䝸䝑䜽䝁䝯䞁䝖䜢 2021 ᖺ 3
᭶ 31 ᪥䜎䛷ເ㞟䛧䛶䛔䛯䚹ྠᨵゞ䜺䜲䝗䝷䜲䞁䛾᝟ሗ䛿䚸᪤Ꮡ䛾䜺䜲䝗䝷䜲䞁䜔ᕷẸ᠇❶䛸ẚ㍑䛩䜛
䛸ෆᐜ䛜⣽䛛䛟᝟ሗ㔞䜒ከ䛔䛣䛸䛛䜙䚸ཧ⪃᝟ሗ䛸䛩䜛䛣䛸䛜䛷䛝䜛䚹ྠᨵゞ䜺䜲䝗䝷䜲䞁䛻㛵䛧䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛻䛚䛔䛶௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹䛣䛾䠄ᨵゞ䠅䜺䜲䝗䝷䜲䞁䛿䜎䛰㛗ᐁ䛻䜘䜛⨫ྡཬ䜃බᕸ䛜䛺䛥䜜䛶䛔䛺䛔䚹䛧䛯䛜䛳䛶ྲྀᢅ䛔䛿౫↛䛸䛧䛶᪤Ꮡ䛾つไ䛺䛹䛻䜘䜚⾜䜟䜜䛶䛔䜛䚹FDA 䛿䚸䛣䛾䠄ᨵゞ䠅䜺䜲䝗䝷䜲䞁䛻䛴䛔䛶䛿䚸䜎䛰ఱ䜒බᕸ䛧䛶䛔䛺䛔䚹䛭䛾䜘䛖䛺⫼ᬒ䛛䜙䚸ᮏ㡯䛷䛿䚸ṇᘧ䛻බ㛤䛥䜜䛶䛔䜛᝟ሗ䛻ຍ䛘䚸ᨵゞ䜺䜲䝗䝷䜲䞁䛾᝟ሗ䜒グ㍕
䛩䜛䚹⾲ ㄪᰝ᫬Ⅼ䛷ᙜᒁ䛻䜘䜚ṇᘧ䛻බ⾲䛥䜜䛶䛔䜛⏦ㄳ᭩
1.
2.
3.
4.
5.

ṇᘧ䛺ᡭ⥆䛻䜘䛳䛶බド䛥䜜䛯䛂⤫ྜ⏦ㄳ᭩䛃䠄ᨭᡶド᫂᭩௜䛝䠅〇㐀⪅䚸㈠᫆ᴗ⪅䚸㍺ධᴗ⪅䚸㈍኎ᴗ⪅㛫䛾᭷ຠ䛺ዎ⣙᭩䠄ヱᙜ䛩䜛ሙྜ䠅༢఩ᢞ୚㔞䛸䝞䝑䝏䝣䜷䞊䝭䝳䝺䞊䝅䝵䞁඲ཎᮦᩱ䛾ᢏ⾡௙ᵝ᭷ຠཎᮦᩱ䠄Active Raw Material䠅䛾ศᯒド᫂᭩
1. ་⸆ရཎ⸆䠄API䠖Active Pharmaceutical Ingredient䠅䛾౪⤥ඖ䛛䜙䛾䜒䛾
2. ᏶ᡂရ䛾〇㐀ඖ䛛䜙䛾䜒䛾
6. ᏶ᡂရ䛾ᢏ⾡௙ᵝ7. ௦⾲䝃䞁䝥䝹䛾ྠ୍䝞䝑䝏䛛䜙సᡂ䛧䛯᭱⤊〇ရ䛾ศᯒド᫂᭩䠄CA䠖Certificate ofAnalysis䠅
8. 〇㐀᪉ἲ䚸⏕⏘䚸タഛ䚸䝃䞁䝥䝸䞁䜾䚸ᕤ⛬ෆ⟶⌮䚸䝬䝇䝍䞊ໟ⿦ᡭ㡰䠄ᐜჾ㛢㙐䝅䝇䝔䝮䛾௙ᵝ䜢ྵ䜐䠅
9. ྠ୍ᛶヨ㦂䚸⣧ᗘヨ㦂䚸䝕䞊䝍ゎᯒ䜢ྵ䜐ヨ㦂ᡭ㡰䠄ヱᙜ䛩䜛ሙྜ䠅䚹
10. Ᏻᐃᛶヨ㦂
11. 䝷䝧䝹㈨ᩱ䠄䝣䜯䜽䝅䝭䝸䝷䝧䝹䠅

9 䝣䜱䝸䝢䞁ඹ࿴ᅜ FDA, “Initial Registration of Veterinary Drugs”䠄https://www.fda.gov.ph/wp-

content/uploads/2021/05/Initial-Registration-of-Veterinary-Drugs.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 23 ᪥䠅
10 䝣䜱䝸䝢䞁ඹ࿴ᅜ FDA, “CITIZEN’S CHARTER CENTER FOR DRUG REGULATION AND RESEARCH(CDRR) 2022 (3rd Edition)”䠄https://www.fda.gov.ph/wp-content/uploads/2022/04/FDA-Citizen_s-CharterCDRR_Revised-28Mar2022.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 23 ᪥䠅

15

12. ௦⾲ⓗ䛺䝃䞁䝥䝹䠄ホ౯⪅䛻ồ䜑䜙䜜䜛ሙྜ䠅䛭䛾௚䛾せ௳
1. 䝥䝷䝇䝏䝑䜽ᐜჾ䛻ධ䛳䛯〇ရ䛾ሙྜ䠖⛣⾜ᛶ≀㉁䜔⁐ฟᛶヨ㦂䛾ศᯒド᫂᭩
2. ㍺ධရ䛾ሙྜ䠖
a. ་⸆ရ〇๣ド᫂᭩䠄CPP䠖Certificate of Pharmaceutical Product䠅䠄WHO 䛜᥎⸀䛩䜛
CPP 䛻䛴䛔䛶䛿䛂6.1 WHO 䛾᥎⸀ᇶ‽䛻䜘䜛་⸆ရ〇๣ド᫂᭩䠄CPP䠅䛃䜢ཧ↷䠅b. ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅
3. ື≀⏝་⸆ရ䛾᪂⸆䛾ሙྜ䠖
a. ๓⮫ᗋヨ㦂b. 䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇䛻㛵䛩䜛἞㦂ᐇ᪋ィ⏬᭩
4. ᅛᐃ⏝㔞㓄ྜ๣䛾ሙྜ䠖⤌ྜ䛫䛾᰿ᣐ᭷ຠ䛺 LTO䠄㍺ධᴗ⪅/〇㐀ᴗ⪅/㈍኎ᴗ⪅/䝖䝺䞊䝎䞊䠅⾲ ᨵゞ䜺䜲䝗䝷䜲䞁䛻グ㍕䛥䜜䛶䛔䜛⏦ㄳ᭩㢮11➨ I 㒊 ⟶⌮䝕䞊䝍ཬ䜃〇ရ᝟ሗ䝉䜽䝅䝵䞁 A ┠ḟ䝉䜽䝅䝵䞁 B ⟶⌮䝕䞊䝍䛻㛵䛩䜛䜺䜲䝎䞁䝇
1. ⤫ྜ⏦ㄳ᭩䚸ㄋ⣙᭩
2. ᢎㄆ᭩䠄ヱᙜ䛩䜛ሙྜ䠅
3. ド᫂᭩㢮
4. 〇㐀⪅䚸㈠᫆ᴗ⪅䞉ὶ㏻ᴗ⪅䚸㍺ධᴗ⪅䞉㍺ฟᴗ⪅㛫䛾᭷ຠ䛺ዎ⣙᭩
5. ᭷ຠ䛺 LTO
6. ᾏእ GMP ྲྀᚓ῭ド᫂᭩
7. ㍺ධရ䛾ሙྜ䠖
a. 〇⸆఍♫/㍺ධᴗ⪅/༺኎ᴗ⪅䛾チྍド䠄ᅜู䠅
b. WHO 䛾⌧⾜ᵝᘧ䛻ᇶ䛵䛝〇㐀ᅜ䛾ᡤ㎄ᐁᗇ䛜Ⓨ⾜䛧䛯་⸆ရ〇๣ド᫂᭩䠄CPP䠖Certificate of Pharmaceutical Product䠅
c. ⮬⏤㈍኎ド᫂᭩䝉䜽䝅䝵䞁 C 〇ရ䛾ヲ⣽
1. 〇ရྡ
2. ᭷ຠᡂศཬ䜃㈿ᙧ๣䛾ྡ⛠䛸ᙉ䛥
3. ๣ᙧ
4. 〇ရᴫせ5. ⸆⌮స⏝6. ⸆≀ືែ
7. ⎔ቃ≉ᛶ
8. ఇ⸆ᮇ㛫
9. ᭱኱ṧ␃ᇶ‽್䠄MRL䠅䝉䜽䝅䝵䞁 D ⿵㊊ᩥ᭩11 2021 ᖺ 3 ᭶ 31 ᪥䜎䛷䝟䝤䝸䝑䜽䝁䝯䞁䝖䜢ເ㞟䛧䛶䛔䛯䚹ྠ䜺䜲䝗䝷䜲䞁䛿 FDA 䝃䜲䝖䛷බ⾲䛥䜜䛶䛚䜚฼⏝ྍ⬟䛷䛒䜛䛜䚸䜎䛰⾜ᨻ࿨௧➼䛾බᘧ䛺ᙧ䛷䛿Ⓨ⾲䛥䜜䛶䛔䛺䛔䚹

16

1.
2.
3.
4.

䝷䝧䝹㈨ᩱ
ᝈ⪅⏝᝟ሗ䝸䞊䝣䝺䝑䝖䠄୍⯡⏝་⸆ရ䠅ཬ䜃ῧ௜ᩥ᭩䠄ฎ᪉⏝་⸆ရ䠅䝥䝷䝇䝏䝑䜽ᐜჾ䛻ධ䛳䛯〇ရ䛾ሙྜ䠖⛣⾜ᛶ≀㉁䜔⁐ฟᛶヨ㦂䛾ศᯒド᫂᭩༴㝤⸆≀䠖༴㝤⸆≀ጤဨ఍䠄DDB䠅䛛䜙䛾䜽䝸䜰䝷䞁䝇ド᫂᭩➨ II 㒊 ရ㉁A ༢఩ᢞ୚㔞䛸䝞䝑䝏〇๣
B ඲ཎᮦᩱ䛾ᢏ⾡௙ᵝC ᭷ຠཎᮦᩱ䛾ศᯒド᫂᭩
1. ་⸆ရཎ⸆䠄API䠖Active Pharmaceutical Ingredient䠅䛾౪⤥ඖ䛛䜙䛾䜒䛾
2. ᏶ᡂရ䛾〇㐀ඖ䛛䜙䛾䜒䛾D ᏶ᡂရ䛾ᢏ⾡௙ᵝ1. 㠀බᘧ䛺〇๣ཬ䜃ヨ㦂䛾䛯䜑䛾᪉ἲཬ䜃ศᯒኚ᭦E ௦⾲䝃䞁䝥䝹䛾ྠ୍䝞䝑䝏䛛䜙సᡂ䛧䛯᭱⤊〇ရ䛾ศᯒド᫂᭩䠄CA䠖Certificate ofAnalysis䠅F 〇㐀᪉ἲ䚸⏕⏘䚸タഛ䚸䝃䞁䝥䝸䞁䜾䚸ᕤ⛬ෆ⟶⌮䚸䝬䝇䝍䞊ໟ⿦ᡭ㡰䠄ᐜჾ㛢㙐䝅䝇䝔䝮䛾௙ᵝ䜢ྵ䜐䠅G ྠ୍ᛶヨ㦂䚸⣧ᗘヨ㦂䚸䝕䞊䝍ゎᯒ䜢ྵ䜐ศᯒཬ䜃ヨ㦂ᡭ㡰䠄ヱᙜ䛩䜛ሙྜ䠅
H Ᏻᐃᛶヨ㦂➨ III 㒊 Ᏻ඲ᛶཬ䜃᭷ຠᛶሗ࿌᭩
䝉䜽䝅䝵䞁 A ┠ḟ䝉䜽䝅䝵䞁 B Ᏻ඲ᛶሗ࿌᭩䛾ᴫせ䝉䜽䝅䝵䞁 C Ᏻ඲ᛶሗ࿌᭩
1. ⸆⌮స⏝2. ⸆≀ືែ
a. ྾཰
b. ศᕸ
c. ௦ㅰ䠄✀㛫ẚ㍑䠅
d. ᤼ἥ
e. 䛭䛾௚䛾⸆≀ືែヨ㦂
3. ẘᛶ
a. ༢ᅇᢞ୚ẘᛶb. ཯᚟ᢞ୚ẘᛶc. ᶆⓗື≀䛻䛚䛡䜛⪏ᛶ -ᶆⓗື≀䛾Ᏻ඲ᛶd. ⏕Ṫẘᛶe. ⏕Ṫ䛻ཬ䜌䛩ᙳ㡪䛻㛵䛩䜛ヨ㦂f. ദወᙧᛶ䚸ኚ␗ཎᛶ䜢ྵ䜐⬇ẘᛶ/⫾⏕ẘᛶ䚸Ⓨ䛜䜣ᛶ䠄ᚲせ䛺ሙྜ䠅
4. 䛭䛾௚䛾ᙳ㡪䛻㛵䛩䜛◊✲a. ≉Ṧヨ㦂䠄౛䠖⚄⤒ẘᛶ䚸ឤసᛶ䛺䛹䠅b. ᚤ⏕≀Ꮫⓗヨ㦂c. ௦ㅰ≀䚸୙⣧≀䚸䛭䛾௚䛾≀㉁䜔〇๣䛻㛵䛩䜛ヨ㦂.
5. ౑⏝⪅䛾Ᏻ඲ᛶa. ᅛ᭷䛾ẘᛶཪ䛿䛭䛾௚䛾᭷ᐖస⏝17b. ᭀ㟢⤒㊰ཬ䜃ᭀ㟢䛾⛬ᗘ
c. 䝸䝇䜽⟶⌮᱌
6. ⎔ቃ䝸䝇䜽䜰䝉䝇䝯䞁䝖䠄⎔ቃᏳ඲䠅a. 〇ရ䛾⎔ቃ䜈䛾ᭀ㟢⠊ᅖb. 㐺ᐅ䚸௨ୗ䛾ලయⓗ䛺ㄪᰝ䠖ᅵተ୰䛷䛾ືែཬ䜃ศゎ䚸Ỉ୰ཬ䜃኱Ẽ୰䛷䛾ືែཬ䜃ᣲື䚸Ỉ⏕⏕≀䜈䛾ᙳ㡪䚸䛭䛾௚䛾㠀ᶆⓗ⏕≀䜈䛾ᙳ㡪
c. ୺せᩥ⊩7. ṧ␃≀ሗ࿌᭩a. ṧ␃ᛶヨ㦂䛷౑⏝䛥䜜䜛〇๣b. ṧ␃ᛶヨ㦂
i.
⸆≀ືែ
ii.
ṧ␃≀
iii.
MRL䠄᭱኱ṧ␃ᇶ‽䠅
iv.
ఇ⸆ᮇ㛫
c. ศᯒ᪉ἲ䠄」ᩘྍ䠅i.
ศᯒ᪉ἲ䛾ㄝ᫂
ii.
᪉ἲ䛾䝞䝸䝕䞊䝅䝵䞁
iii.
≉␗ᛶ
iv.
ឤᗘ➼ṇ☜ᛶ
v.
⢭ᗘ
vi.
᳨ฟ㝈⏺
vii.
ᐃ㔞ୗ㝈್
viii.
㏻ᖖ䛾ᐇ㦂᮲௳ୗ䛷䛾ᐇ⏝ᛶཬ䜃㐺⏝ᛶ
ix.
ᖸ΅䛻ᑐ䛩䜛ឤཷᛶx.
ಖᏑᏳᐃᛶ䝉䜽䝅䝵䞁 D ᭷ຠᛶሗ࿌᭩
1. ᑐ㇟✀䛾⪏ᛶ䠄tolerance䠅
2. ⪏ᛶ䠄resistance䠅
3. ⏝㔞タᐃ䞉⏝㔞☜ㄆヨ㦂ཬ䜃⮫ᗋヨ㦂䛾⤖ᯝ䛾ᴫせ䛸ᢈุⓗホ౯
4. 䛩䜉䛶䛾⮫ᗋヨ㦂ཬ䜃◊✲䛾⾲ᙧᘧ䛷䛾ᥦ♧
5. ᭱䜒㔜せ䛷ព⩏䛒䜛ヨ㦂䛾ಶู䛾䜎䛸䜑
6. ⮫ᗋᏳ඲ᛶ䛾せ⣙ὀ䠖A ᥦฟ䛩䜛䝕䞊䝍䛿䚸ྛ⏦ㄳ䛾✀㢮䛻ᛂ䛨䛶௨ୗ䛾䛸䛚䜚䛸䛩䜛䚹
1. ฎ᪉⸆䠄Rx䠅䚸OTC ື≀⏝་⸆ရཬ䜃㠀⸆⏝ື≀⏝〇ရ䛾ሙྜ䠖➨ I 㒊ཬ䜃➨ II 㒊䛾䜏
2. MR䠄䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇䠅䛾ሙྜ䠖➨ I 㒊䛛䜙➨ III 㒊
3. MR ཪ䛿 MRE䠄䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇ᘏ㛗䠅 䛾ึᅇ⏦ㄳ
a. ➨ I 㒊䛛䜙➨ III 㒊
b. 䝸䝇䜽⟶⌮ィ⏬᭩䠄RMP䠅
c. ᐃᮇᏳ඲᝟ሗሗ࿌᭩䠄PSUR䠅B ୖグ䛾᭩㢮せ௳䛻ຍ䛘䚸䛩䜉䛶䛾ໟ⿦䝃䜲䝈䛾௦⾲䝃䞁䝥䝹ཬ䜃ᑐᛂ䛩䜛ศᯒド᫂᭩䠄CoA䠅䜢ᥦฟ䛩䜛䜒䛾䛸䛩䜛䚹

18

C FDA ㏻▱➨ 5 ྕ䠄1997 ᖺ䠅䠄BC No.5 S 1997䠖ᨵゞ∧せ௳䝏䜵䝑䜽䝸䝇䝖ཬ䜃་⸆ရⓏ㘓⏝䜺䜲䝗䝷䜲䞁 1997 ᖺ䠅䚸VICH䠄International Cooperation on Harmonisation of TechnicalRequirements for Registration of Veterinary Medicinal Products䠅ཬ䜃Ḣᕞ་⸆ရᗇ䠄EMA䠅䜢㐺⏝䛧䛯つ᱁䚹z

FDA CDRR ື≀⏝་⸆ရึᅇⓏ㘓䜺䜲䝗䜔ಖ㝤┬ FDA ᕷẸ᠇❶ CDRR 䛻䛚䛔䛶බ㛤䛥䜜䛶䛔䜛⏦ㄳ᭩㢮䛾୍ぴ䛸䚸ᨵゞ䜺䜲䝗䝷䜲䞁䛾⏦ㄳ᭩㢮䛾୍ぴ䜢ẚ㍑䛩䜛䛸䚸බ㛤᝟ሗ䛻䛒䜛㡯┠䛿䛚䛚䜐䛽ᨵゞ䜺䜲䝗䝷䜲䞁䛾➨ I 㒊ཬ䜃➨ II 㒊䛸ྠ୍䛷䛒䜛䚹䛧䛛䛧䚸ᨵゞ䜺䜲䝗䝷䜲䞁䛷䛿➨ III 㒊䛻䛚䛔䛶䚸Ᏻ඲ᛶཬ䜃᭷ຠᛶ䛾ሗ࿌᭩䛻䛴䛔䛶䜒ᐃ䜑䜙䜜䛶䛔䜛䚹䛯䛰䛧䚸➨ III 㒊䛿䚸MR䠄䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇䠅ཪ䛿 MRE䠄䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇ᘏ㛗䠅䛾ึᅇ⏦ㄳ䛾ሙྜ䛾䜏㐺⏝䛥䜜䜛䜒䛾䛷䛒䜚䚸୍⯡ⓗ䛺ື≀⏝་⸆ရ䛻䛿㐺⏝䛥䜜䛺䛔䚹䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇䚸ཪ䛿䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇ᘏ㛗䛾ไᗘ䛻䛴䛔䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛷௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹

䠄䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇ཪ䛿䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇ᘏ㛗䛸䛿䠅᪂⸆䚸་⸆ရ䛾᪂䛧䛔⤌ྜ䛫䚸ཪ䛿་⸆ရ䛾᪂䛧䛔౑⏝⏝㏵䜢᳨ウ䛧䛶䛔䜛ሙྜ䛻౑⏝䛥䜜䜛ไᗘ䛷䛒䜛䚹䜎䛪䛿䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇䜢⾜䛔䚸䛥䜙䛻ᮇ㛫䛾ᘏ㛗䛜ᚲせ䛺ሙྜ䛻䛿䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇ᘏ㛗䛻ヱᙜ䛩䜛䚹୍⯡ⓗ䛺䝰䝙䝍䝸䞁䜾䝸䝸䞊䝇䛾ᮇ㛫䛻䛴䛔䛶䚸Superiorvet ♫䛿⏦ㄳ䜢䛧䛯䛣䛸䛜䛺䛔䛾䛷▱ぢ䜢᭷䛧䛶䛔䛺䛔䚹Ɣศὀ䛾ሙྜ䛿䚸ཎ⏘ᅜ䛾ศᯒド᫂᭩䠄CoA䠅䛸 cGMP䠄Current Good Manufacturing
Practice䠖⌧⾜་⸆ရ㐺ṇ〇㐀ᇶ‽䠅䜒ྵ䜑䜛ᚲせ䛜䛒䜛䛣䛸䚸䜎䛯䝸䝟䝑䜿䞊䝆䛾ሙྜcGMP 䛜ᚲせ䛷䛒䜛䛣䛸䜢䝣䜱䝸䝢䞁䛾ື≀⏝་⸆ရ༠఍䛻☜ㄆ῭䛷䛒䜛䚹

19

2.1.1.2 CPR 䛾ྲྀᚓ
CPR 䛾⏦ㄳᡭ⥆䛾ヲ⣽䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹ᚲせ᭩㢮๓㡯䛾୍ぴ䜢ཧ↷䚹⏦ㄳᡭ㡰

1. ⤫ྜ⏦ㄳ᭩䛾ྲྀᚓ⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䜢 FDA 䛾䝃䜲䝖䛛䜙䝎䜴䞁䝻䞊䝗䛧䛶グධ䛩䜛䚹⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䛾䝎䜴䞁䝻䞊䝗䝸䞁䜽䠖https://www.fda.gov.ph/wp-content/uploads/2021/04/IntegratedApplication-Form-XLSX-Format.xlsx
2. ⤫ྜ⏦ㄳ᭩䛾సᡂ䝎䜴䞁䝻䞊䝗䛧䛯⏦ㄳ᭩䛻ᚲせ஦㡯䜢ṇ☜䛻グධ䛩䜛䚹⏦ㄳ᭩䛿䚸1䠅୍⯡᝟ሗ䚸2䠅௻ᴗ᝟ሗ䚸3䠅〇ရ᝟ሗ䚸4䠅䝃䝫䞊䝖᝟ሗ䚸5䠅౪⤥ඖཬ䜃䜽䝷䜲䜰䞁䝖䚸6䠅⏦ㄳ⪅᝟ሗ䛾 6 㒊䛷ᵓᡂ䛥䜜䛶䛔䜛䚹ᚲせ஦㡯䛜㐺ษ䛻グධ䛥䜜䜛䛸䚸⥳Ⰽ䛾䛂PROCEED䛃䝬䞊䜽䛜⾲♧䛥䜜䚸グධ䛜ᚲせ䛺䝣䜱䞊䝹䝗䛜㡰ḟ⾲♧䛥䜜䜛䚹
3. ஦๓ᑂᰝ䛾⏦ㄳ
fdac@fda.gov.ph ᐄ䛶䛻䝯䞊䝹䜢㏦ಙ䛩䜛䚹⤫ྜ⏦ㄳ᭩䛾䛂Email䛃䝅䞊䝖䛻䚸fdac@fda.gov.ph ᐄ䛶䛻㏦ಙ䛩䜛㟁Ꮚ䝯䞊䝹䛾௳ྡ䛸ᮏᩥ䜢グධ䛧䚸䛭䛾ᚋ䚸ヱᙜ䛩䜛䝣䜱䞊䝹䝗䜢䝁䝢䞊䛧䛶䝯䞊䝹䛻㈞௜䜛䚹ᚲせ䛻ᛂ䛨䛶 CC 䜒ྵ䜑䜛䛣䛸䚹⤫ྜ⏦ㄳ᭩䛾 XLS ཪ䛿 XLSX 䝣䜯䜲䝹䛿䚸䝯䞊䝹䛻ῧ௜䛧䛶䛿䛔䛡䛺䛔䛜䚸ᥦฟ᫬䛻ᚲせ䛷䛒䜛䚹ῧ௜䝣䜯䜲䝹䛜䛒䜛䛸䚸᪥⛬タᐃ䛾せㄳ䛜༷ୗ䛥䜜䜛䛾䛷ὀព䛜ᚲせ䚹1 ௳䛾䝯䞊䝹䛷 10 ௳䜎䛷䛾ᛂເ䛜ྍ⬟䚹
4. ஦๓ᑂᰝ䛾᪥⛬㏻▱
FDA 䛛䜙஦๓ᑂᰝ䛾⏦ㄳ䛾᪥⛬䛜㏻▱䛥䜜䜛䚹䛭䛾㝿䚸FDA 䛛䜙䚸஦๓ᑂᰝ䛾䛯䜑䛾ᥦฟ䛾᪥⛬䛜グ㍕䛥䜜䛯᭩㢮㏣㊧䝻䜾䠄DTL䠖
Document Tracking Log䠅䛜㏦௜䛥䜜䜛䚹
FDA 䛿䚸ྛ䝉䞁䝍䞊䛾ඃඛ㡰఩䛻ᚑ䛳䛶⏦ㄳ᪥⛬䜢ุ᩿䛩䜛䚹1 ᪥䛻᪥⛬タᐃ䛜ྍ⬟䛺⏦ㄳ᭩䛾⥲ᩘ䛻䛿㝈䜚䛜䛒䜛䛯䜑䚸1 ㏻䛾䝯䞊䝹䛷」ᩘ䛾⏦ㄳ᭩䛜㏦ಙ䛥䜜䛯ሙྜ䚸ู䚻䛾᪥䛻᪥⛬䛜タᐃ䛥䜜䜛ሙྜ䛜䛒䜛䚹᪥⛬䛾タᐃ䛻㛵䛩䜛≉ู䛺せㄳ䛿ཷ䛡௜䛡䜙䜜䛶䛔䛺䛔䚹ཷ௜䛿䚸⏦ㄳ䝯䞊䝹䛾ཷ㡿ᚋ䚸10 Ⴀᴗ᪥௨ෆ䛸䛥䜜䛶䛔䜛䚹
5. ஦๓ᑂᰝ
FDA 䛜஦๓ᑂᰝ䜢ᐇ᪋䛩䜛䚹஦๓ᑂᰝ䛻ྜ᱁䛧䛯ሙྜ䚸FDA 䛿⏦ㄳ⪅䛻䚸ᡭᩘᩱ䛾ᨭᡶ䜢⾜䛖䜘䛖㏻▱䛩䜛䚹஦๓ᑂᰝ䛻ྜ᱁䛧䛺䛛䛳䛯ሙྜ䚸FDA 䛿⏦ㄳ⪅䛻䛭䛾᪨䜢㏻▱䛩䜛䚹୙ྜ᱁䛾ሙྜ䚸⏦ㄳ⪅䛿ၥ㢟⟠ᡤ䛻ᑐᛂ䛧䛯ୖ䛷䚸෌ᗘ䚸䛂3䛃䛾ᡭ㡰䛻䜘䜚஦๓ᑂᰝ䛾⏦ㄳ䜢⾜䛖䚹
6. ᡭᩘᩱ䛾ᨭᡶ
FDA 䛾❆ཱྀཪ䛿㖟⾜䠄䝷䞁䝗䝞䞁䜽䜸䞁䝁䞊䝹䝨䜲䝯䞁䝖ཪ䛿 Bancnet䠅䛷ᣦᐃ䛥䜜䛯ᡭᩘᩱ䜢ᨭᡶ䛖䚹䛭䛾ᚋ䚸ᨭᡶド᫂᭩䜢 FDA 䛻㏦௜䛩20䜛䚹ᨭᡶド᫂᭩䜢☜ㄆᚋ䚸FDA 䛿ᮏᑂᰝ䛻ධ䜛䚹
7. ᮏᑂᰝ
FDA 䛾ᑂᰝᐁ䛻䜘䜚ᑂᰝ䛜⾜䜟䜜䜛䠄ᑂᰝᮇ㛫䛿⣙ 180 ᪥䠅䚹䛣䛾㝿䚸ᑠ䛥䛺ၥ㢟䛻䛴䛔䛶䛿䚸FDA 䛛䜙㟁Ꮚⓗ䛺ᙧᘧ䛷⏦ㄳ⪅䛸䛾䜔䜚ྲྀ䜚䛜䛺䛥䜜䜛䛣䛸䛜䛒䜛䚹䛭䜜௨እ䛾ሙྜ䛿䚸䛂㟁Ꮚ୙ഛ㏻▱᭩䛃䠄ENOD䠅䛜㏦௜䛥䜜䜛䚹⏦ㄳ⪅䛜䛣䜜䜢ཷ㡿䛧䛯ሙྜ䚸㏿䜔䛛䛻ᑐᛂ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
8. ⤖ᯝ㏻▱
ᑂᰝ䛾⤖ᯝ䚸⏦ㄳ䛜ᇶ‽䜢‶䛯䛧䛶䛔䛺䛔ሙྜ䚸୙チྍ㏻▱䠄LOD䠖
Letter of Disapproval䠅䛜⏦ㄳ⪅䛻㏦௜䛥䜜䜛䚹⏦ㄳ䛜ᇶ‽䜢‶䛯䛧䛶䛔䜛ሙྜ䚸ᑂᰝ䛾᭱⤊⤖ᯝሗ࿌᭩䛜సᡂ䛥䜜䚸䛭䜜䜢䝇䜻䝱䞁䛧䛯䜒䛾䛜 CPR 䛸䛸䜒䛻⏦ㄳ⪅䛻㏦௜䛥䜜䜛䚹㈝⏝᭷ຠᮇ㛫䛾㛗䛥ཬ䜃ၟᶆ䛾᭷↓䛻䜘䛳䛶␗䛺䜛䚹䛆ึᅇ䛇Ɣၟᶆ䛒䜚䠖3,000 䝨䝋/ᖺ+500 䝨䝋䠄ၟᶆ☜ㄆ䠅+1% LRFƔၟᶆ䛺䛧䠖2,000 䝨䝋/ᖺ+1% LRF⏦ㄳ⪅䛿䚸2 ᖺཪ䛿 5 ᖺ䛾 CPR ᭷ຠᮇ㛫䜢⏦ㄳ䛩䜛䛣䛸䛜䛷䛝䜛䚹
䛆2 ᖺ᭷ຠ䛇Ɣၟᶆ䛒䜚䠖6,000 䝨䝋/ᖺ+500 䝨䝋䠄ၟᶆ☜ㄆ䠅+1% LRFƔၟᶆ䛺䛧䠖4,000 䝨䝋/ᖺ+1% LRF
䛆5 ᖺ᭷ຠ䛇Ɣၟᶆ䛒䜚䠖15,000 䝨䝋/ᖺ+500 䝨䝋䠄ၟᶆ☜ㄆ䠅+1% LRFƔၟᶆ䛺䛧䠖10,000 䝨䝋/ᖺ+1% LRF᭷ຠᮇ㛫⏦ㄳ⪅䛾⏦ㄳෆᐜ䛻䜘䜛䚹㛵㐃䛩䜛㏻▱䜔䜺䜲䝗䝷䜲䞁䞉FDA CDRR ື≀⏝་⸆ရึᅇⓏ㘓䜺䜲䝗䞉FDA Citizen’s Charter CDRR 2022 3rd edition䠄ಖ㝤┬ FDA ᕷẸ᠇❶ CDRR2022 ➨ 3 ∧䠅䚸pp. 103-110

21

2.1.1.3 ㎿㏿ᑂᰝ㎿㏿ᑂᰝ䛸䛿䚸⏦ㄳᑐ㇟䛾ື≀⏝་⸆ရ䜢㍺ධ䛩䜛䛛ཪ䛿⌧ᆅ䛷〇㐀䛩䜛䛛䛻䛛䛛䜟䜙䛪䚸ᙜヱື≀⏝་⸆ရ䛜௚ᅜ䛻䛚䛔䛶ື≀⏝་⸆ရ䛸䛧䛶᪤䛻ᢎㄆ䛥䜜䛶䛔䜛ሙྜ䚸䝣䜱䝸䝢䞁䛻䛚䛡䜛ᑂᰝᮇ㛫䛜▷⦰䛥䜜䜛䛸䛔䛖ไᗘ䛷䛒䜛䚹⾜ᨻ࿨௧ 2020-0045䠄2020 ᖺ 9 ᭶ 22 ᪥䠅12䛷䛿䚸ᅜ㝿໬䛾㐍ᒎ䛸ᢏ⾡䛾㐍Ṍ䛻క䛔་⸆ရ䜒ᅜ㝿໬䛧䛶䛔䜛䛣䛸䛛䜙䚸ྛᅜ䛾⾜ᨻᙜᒁ䛸༠ㄪ䛩䜛䛣䛸䛻䜘䜚ᑂᰝ䛾ຠ⋡໬䜢ᅗ䜛䛯䜑䚸䝣䜱䝸䝢䞁䛻䛚䛔䛶㎿㏿䛺Ⓩ㘓䛸ホ౯䛾ᕤ⛬䜢☜❧䛩䜛䛣䛸䛜ᐃ䜑䜙䜜䛶䛔䜛䚹ලయⓗ䛻䛿䚸䛒䜛 1 䛛ᅜ䛷ᢎㄆ䛥䜜䛶䛔䜛་⸆ရ䜢㎿㏿䛻ᑂᰝ䛩䜛䛯䜑䛾䛂せ⣙䝺䝡䝳䞊䛃䠄abridged review䠅䚸䛒䜛 2 䛛ᅜཪ䛿䛭䜜௨ୖ䛾ᅜ䛷ᢎㄆ䛥䜜䛶䛔䜛་⸆ရ䜢㎿㏿䛻ᑂᰝ䛩䜛䛯䜑䛾䛂᳨ド䝺䝡䝳䞊䛃䠄verification review䠅䚸ୡ⏺ಖ೺ᶵ㛵་⸆ရ஦๓ᑂᰝ䠄WHO-PQP䠅䛺䛹䛸䛾ඹྠᑂᰝ䛻䜘䜚 FDA 䛜ᢎㄆ䛩䜛䛂ඹྠᡭ⥆䛃
䠄collaborative procedure䠅䛾 3 ✀㢮䛜䛒䜛䚹ྠ⾜ᨻ࿨௧䛿䚸ไᗘ䛾ヲ⣽䛻䛴䛔䛶䛿ู㏵㏻▱䛻䜘䜚ᐃ䜑䜛䛸䛧䛶䛔䜛䛜䚸ᮏㄪᰝ䛾᫬Ⅼ䛷䚸せ⣙䝺䝡䝳䞊䛸᳨ド䝺䝡䝳䞊䛾ヲ⣽䜢ᐃ䜑䛯 FDA ㏻▱ 2022-004䠄2022 ᖺ 6 ᭶ 16 ᪥䠅13䛜ฟ䛥䜜䛶䛔䜛䛾䜏䛷䚸ඹྠᡭ⥆䛻䛴䛔䛶ᐃ䜑䛯㏻▱䛿☜ㄆ䛥䜜䛶䛔䛺䛔䚹㎿㏿ᑂᰝ䛾ヲ⣽䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹⾲ ㎿㏿ᑂᰝ䛾せ௳ཬ䜃⏦ㄳ᭩㢮せ௳

1. FDA 䛻䜘䜚 LTO 䛜Ⓨ⾜䛥䜜䛶䛔䜛䛣䛸䚹
2. ⏦ㄳ⪅䛿䚸௨ୗ䛾᮲௳䛻㐺ྜ䛧䛶䛔䜛䛣䛸䚹a. せ⣙䝺䝡䝳䞊䛾ሙྜ䚸་⸆ရ䛜䛒䜛 1 䛛ᅜ䛾⾜ᨻᙜᒁ䛻䜘䜚ᢎㄆ䛥䜜䛶䛔䛶䚸ྠᢎㄆ䛜ฟ䛥䜜䛯᪥䛛䜙 3 ᖺ௨ෆ䛾⏦ㄳ䛷䛒䜛䛣䛸䚹b. ᳨ド䝺䝡䝳䞊䛾ሙྜ䚸་⸆ရ䛜 2 䛛ᅜ௨ୖ䛾⾜ᨻᙜᒁ䛻䜘䜚ᢎㄆ䛥䜜䛶䛔䛶䚸ྠᢎㄆ䛜ฟ䛥䜜䛯᪥䛛䜙 3 ᖺ௨ෆ䛾⏦ㄳ䛷䛒䜛䛣䛸䚹c. ⏦ㄳ⪅䛿䛔䛪䜜䛛୍䛴䛾㎿㏿ᑂᰝ䜢㑅䜆䛣䛸䛜䛷䛝䜛䚹⏦ㄳෆᐜ䛜せ௳䜢‶䛯䛧䛶䛔䛺䛔ሙྜ䚸㏻ᖖ䛾ᑂᰝ䛜⾜䜟䜜䜛䚹
3. ᑐ㇟〇ရ䛿䚸௚ᅜ䛷ᢎㄆ䛥䜜䛯〇ရ䛸ྠ〇ရ䛷䛒䜛䛣䛸䚹
4. ᙜヱ〇ရཬ䜃౑⏝⏝㏵䛜䛔䛪䜜䛾⾜ᨻᙜᒁ䛻䛚䛔䛶䜒䚸ရ㉁䚸Ᏻ඲ᛶ䚸᭷ຠᛶ䜢⌮⏤䛸䛧䛶༷ୗ䚸ྲྀୗ䛢䚸୰᩿䚸↓ຠ䛸䛥䜜䛶䛔䛺䛔䛣䛸䚹
5. ⏦ㄳ᭩㢮䛻䛒䜛ῧ௜ᩥ᭩䛻䛒䜛᝟ሗ䛿䚸௚ᅜ䛷ᢎㄆ䛥䜜䛯ῧ௜ᩥ᭩䛾᝟ሗ䛸ྠ୍䛷䛒䜚䚸䝷䝧䝹䛻㛵䛩䜛᭱᪂䛾 FDA 䛾せ௳䛻つᐃ䛥䜜䛯ᅜ⊂⮬䛾᝟ሗ䜒㏣ຍ䛥䜜䛶䛔䜛䛣䛸䚹
6. ᭩㢮䛿䛩䜉䛶ⱥㄒ䛷సᡂ䛥䜜䛶䛔䜛䛛䚸ⱥㄒ䛻⩻ヂ䛥䜜䛶䛔䜛䛣䛸䚹⏦ㄳ᭩㢮

1. ᪂つ䛾་⸆ရ䚸䝽䜽䝏䞁䚸⏕≀〇๣a. ⏦ㄳ⪅䛻䜘䜛ṇᘧ䛺᭩㠃䛻䜘䜛⏦ㄳ᭩䚹㎿㏿ᑂᰝ䛾ᕼᮃཬ䜃ᙜヱ

12 䝣䜱䝸䝢䞁ඹ࿴ᅜ FDA, Administrative Order 2020-0045䠄https://www.fda.gov.ph/wp-

content/uploads/2020/10/Administrative-Order-2020-0045.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 25 ᪥䠅
13 䝣䜱䝸䝢䞁ඹ࿴ᅜ FDA, FDA Circular 2022-004䠄https://www.fda.gov.ph/wp-content/uploads/2022/06/FDACircular-No.2022-004.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 25 ᪥䠅

22

b.
c.

d.
e.

f.

〇ရ䜢ᢎㄆ䛧䛶䛔䜛௚ᅜ䛾⾜ᨻᙜᒁ䜢᫂グ䚹ᙜヱ〇ရ䜢ᢎㄆ䛧䛶䛔䜛௚ᅜ䛾⾜ᨻᙜᒁ䛜Ⓨ⾜䛧䛯ホ౯ሗ࿌᭩WHO 䛾ㄆドไᗘཪ䛿ྠ➼䛾௚ᅜ䛾⾜ᨻᙜᒁ䛻䜘䜛᭷ຠ䛺་⸆ရ〇ရド᫂᭩䠄CPP䠅䚹ᙜヱ〇ရ䛜䚸ᢎㄆ䜢ཷ䛡䛯௚ᅜ䛾⾜ᨻᙜᒁ䛾⟶㎄ᆅᇦ䛷㈍኎䛥䜜䛶䛔䛺䛔ሙྜ䚸ู䛻ᐃ䜑䜛䝸䝇䝖䛻䛒䜛௚䛾⾜ᨻᙜᒁ䛛䜙䛾 CPP ཪ䛿ྠᵝ䛾ᩥ᭩䛷䜒ྍ⬟䚹
ICH-CTD ཪ䛿 ACTD 䛻‽ᣐ䛧䛯䝕䞊䝍୍ᘧ䚹Ẽೃ༊ศ IVB 䛷ᐇ᪋䛥䜜䛯ヨ㦂䛾Ᏻᐃᛶሗ࿌᭩䚹ᥦฟ᫬䛻䝕䞊䝍䛜‶䛯䛩䜉䛝᭱ప᫬㛫䚸᭱ᑠ䝞䝑䝏ᩘ䚸ຍ㏿ヨ㦂ཬ䜃㛗ᮇヨ㦂䛾䛯䜑䛾ಖ⟶᮲௳䛜ᥦ♧䛥䜜䛶䛔䜛䛣䛸䚹௚ᅜ䛷ᢎㄆ䛥䜜䛯ῧ௜ᩥ᭩䛾᝟ሗ䛸ྠ୍䛷䛒䜚䚸䝷䝧䝹䛻㛵䛩䜛᭱᪂䛾 FDA 䛾せ௳䛻つᐃ䛥䜜䛯ᅜ⊂⮬䛾᝟ሗ䜒㏣ຍ䛥䜜䛶䛔䜛ᥦ᱌ᩥ᭩䛾᱌

䝺䝡䝳䞊䛸ホ౯

1. せ⣙䝺䝡䝳䞊䛿䚸䝗䝅䜶䛾≉ᐃ䛾㒊ศ䛻ᑐ䛧䛶㝈ᐃⓗ䛺⊂❧ホ౯䛻䜘䜚⾜䜟䜜䜛䚹ู⣬䛩䜉䛶䚸Ᏻᐃᛶ䝕䞊䝍䜢ྵ䜐䝗䝅䜶䛺䛹䛾ホ౯ሗ࿌᭩୍ᘧ
䛜䝺䝡䝳䞊ཬ䜃ホ౯䛥䜜䜛䚹௚ᅜ䛾⾜ᨻᙜᒁ䛻䜘䜚஦๓ホ౯䜢฼⏝䛧䛴䛴䚸ᆅඖ䛾⎔ቃ䛻䛚䛔䛶౑⏝䛾Ᏻᐃᛶཬ䜃つไせ௳䛜䝺䝡䝳䞊䛥䜜䜛䚹Ⓩ㘓䛻
䛒䛯䜚䚸〇ရ䛾Ᏻᐃᛶ䚸᭷ຠᛶ䚸ရ㉁䜢☜ㄆ䛩䜛䛯䜑䚸ᚲせ䛻ᛂ䛨䛶 FDA
䛿㏣ຍ䛾㈨ᩱ䜢ồ䜑䜛䛣䛸䛷䛝䜛䚹
2. FDA 䛿䚸⏦ㄳ⪅䛻䜘䜚ᥦฟ䛥䜜䛯฼⏝ྍ⬟䛺䝕䞊䝍䛻ᇶ䛵䛝䚸䝣䜱䝸䝢䞁䛻䛚䛡䜛฼Ⅼ䛸䝸䝇䜽䜢⪃៖䛩䜛䚹
3. FDA 䛿䚸ᚲせ䛻ᛂ䛨䛶䚸἞㦂䛾ᑓ㛛ᐙ䛾ពぢ䜢ồ䜑䜛䛣䛸䛜䛷䛝䜛䚹ᑂᰝᮇ㛫せ⣙䝺䝡䝳䞊䠖45 Ⴀᴗ᪥௨ୗ᳨ド䝺䝡䝳䞊䠖30 Ⴀᴗ᪥௨ୗ

FDA ㏻▱ 2022-004
䛾ู⣬ A 䛻グ㍕䛥䜜䛶䛔䜛 FDA 䛜ᢎㄆ䛩䜛ື≀⏝་⸆ရ䛾⾜ᨻᙜᒁ䛺䛹

1. European Commission - European Union
2. European Medicines Agency (EMA) - European Union
3. International Federation for Animal Health - Europe(AnimalhealthEurope)
4. ㎰ᯘỈ⏘┬䠄᪥ᮏ䠅
5. ᪥ᮏື≀⏝་⸆ရ༠఍䠄᪥ᮏ䠅
6. US Department of Agriculture (USDA) - Center for Veterinary
Biologics (CVB) - United States of America
7. US Food and Drug Administration (USFDA) - Center for Veterinary
Medicine (CVM) - United States of America
VICH 䛾୺せ䝯䞁䝞䞊ཬ䜃ྠᅋయ䛾㐠Ⴀ䝯䞁䝞䞊䜢㑅ᐃせ௳䛸䛧䛶䛔䜛䚹23

2.2 ື≀⏝་⸆ရ䛾἞㦂䛻䛴䛔䛶୍⯡ⓗ䛻䚸་⸆ရ䛾἞㦂䛻䛴䛔䛶䛿䚸GCP䠄Good Clinical Practice䠖་⸆ရ䛾⮫ᗋヨ㦂䛾ᐇ᪋ᇶ‽䠅䛜㐺⏝䛥䜜䜛䛜䚸䝣䜱䝸䝢䞁䛷䛿䚸⾜ᨻ࿨௧ 47-a䠄2001 ᖺ䠅䛻䛚䛔䛶䚸ICH䠄་⸆ရつไㄪ࿴ᅜ㝿఍㆟䠅䛾 GCP 䜢㐺⏝䛩䜛䛣䛸䛜ᐃ䜑䜙䜜䛶䛔䜛䚹䛣䛾 GCP 䛜ື≀⏝་⸆ရ䛾἞㦂䛻䜒㐺⏝䛥䜜䜛䛣䛸䛻䛴䛔䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛷௨ୗ䛾䜘䛖䛺ᅇ⟅䜢ᚓ䛶☜ㄆ῭䛷䛒䜛䚹䠄䛂་⸆ရ䛾἞㦂䛻䛴䛔䛶䚸䝣䜱䝸䝢䞁䛷䛿⾜ᨻ࿨௧ 47-a䠄2021 ᖺ䠅䛻䜘䜚䚸ICH 䛾 GCP 䛜䝣䜱䝸䝢䞁䛾 GCP ᇶ‽䛸䛧䛶᥇⏝䛥䜜䛶䛔䜛䚹ྠᇶ‽䛿ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䛶䛔䜛䛸⌮ゎ䛧䛶䜘䛔䛛䠛䛃䛸䛔䛖㉁ၥ䛻ᑐ䛧䛶䠅ICH 䛾 GCP 䛜ື≀⏝་⸆ရ䛾 GCP 䛸䛧䛶㐺⏝䛥䜜䛶䛔䜛䚹

2.2.1 ἞㦂䜢ᐇ᪋䛩䜛⤌⧊䛾せ௳⾜ᨻ࿨௧ 2014-0034 䛻䛚䛔䛶䚸་⸆ရ䛾〇㐀䚸ὶ㏻䚸㍺ධ䚸㍺ฟ䚸㈍኎䚸⛣㏦䜢ྲྀ䜚ᢅ䛖ᆅ᪉⮬἞య䛾㒊ᒁ䚸ᨻᗓ䛜ᡤ᭷䜎䛯⟶㎄䛩䜛ἲே䚸㠀ᨻᗓ⤌⧊䚸ᨻᗓ㒊ᒁ䚸ཷク◊✲ᶵ㛵䠄CRO䠖Contract
Research Organization䠅䚸ጤクᶵ㛵䠄䝇䝫䞁䝃䞊䠅䛿䚸FDA 䜘䜚 LTO 䜢௜୚䛥䜜䜛ᚲせ䛜䛒䜛䛣䛸䛜ᐃ䜑䜙䜜䛶䛔䜛䚹䛴䜎䜚䚸἞㦂䜢ᐇ᪋䛩䜛⤌⧊䛿ᚲ䛪 LTO 䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹

2.3 VICH 䛻ᑐ䛩䜛ືྥ
VICH 䛾άື䛿䚸ື≀་⸆ရ᳨ᰝᡤ䛾䝩䞊䝮䝨䞊䝆14䛻ᗈሗ㈨ᩱ䛸䛧䛶ᖺሗ䛜ᥖ㍕䛥䜜䛶䛔䜛䚹ᖹᡂ 20 ᖺᗘ䡚௧࿴ 2 ᖺᗘ䛾ሗ࿌䛻ྵ䜎䜜䛶䛔䜛䝣䜱䝸䝢䞁䛻㛵䛩䜛グ㍕䜢☜ㄆ䛧䛯䛸䛣䜝䚸䝣䜱䝸䝢䞁䛿 2013 ᖺᗘ䛻㛤ദ䛥䜜䛯 VOF䠄VICH Outreach Forum䠅఍ྜ䛻䛾䜏 BAI 䛾௦⾲⪅䛜ฟᖍ䛧䛶䛔䜛䚹䛣䛾఍ྜ䛻䛿 ASEAN 䛾௦⾲⪅䜒ฟᖍ䛧䛶䛔䛯䚹䝉䝑䝅䝵䞁䛾⤖ㄽ䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䠖
䛂ASEAN 䛿䚸䛭䛾ຍ┕ᅜ䛻䛚䛡䜛 VICH-GL 䛾▱ྡᗘ䜢㧗䜑䜛䛸䛸䜒䛻⌮ゎ䜢῝䜑䜛άື䛜ᚲせ䛷䛒䜚䚸ASEAN 䛾ື≀⏝་⸆䛻㛵䛩䜛఍ྜ䜢฼⏝䛧䛯䛔䛸㏙䜉䛯䚹䝍䜲䛿䛣䛾䜰䝥䝻䞊䝏䜢ᨭᣢ䛧䚸
ASEAN 䛾ື≀⸆ㄪ࿴䝹䞊䝹䛜䚸VICH-GL 䛸ᩚྜᛶ䜢ᣢ䛴䛣䛸䛜㔜せ䛷䛒䜛䛸㏙䜉䛯䚹䜎䛯䚸
ASEAN 䛾୰䛷䜲䞁䝗䝛䝅䜰䚸䝣䜱䝸䝢䞁䚸䝍䜲䛿䚸⌧ᅾ䚸ື≀⏝䝽䜽䝏䞁䛾ㄪ࿴άື䜢䝸䞊䝗䛧䛶䛔䜛䛣䛸䚸ḟᅇ䛾 VOF ఍ྜ䛷䛿䝽䜽䝏䞁䛾ㄪ࿴ཬ䜃⏕≀Ꮫⓗྠ➼ᛶ䛻㛵䛩䜛ヰ㢟䜢ྲྀ䜚ୖ䛢䜛䛣䛸䜢ᕼᮃ
䛧䛯䛃15䚹

14 ື≀་⸆ရ᳨ᰝᡤ䛂ᗈሗ㈨ᩱ䛃䠄https://www.maff.go.jp/nval/kouhou/index.html䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 30᪥䠅
15 ື≀་⸆ရ᳨ᰝᡤ䛂ᖺሗ➨ 51 ྕ䠄ᖹᡂ 25 ᖺᗘ䠅䛃䠄URL 䛿ྠୖ䠅24

ୖグ௨እ䛻䝣䜱䝸䝢䞁䛸 VICH 䛸䛾䛛䛛䜟䜚䛿☜ㄆ䛷䛝䛶䛔䛺䛔䛜䚸䝣䜱䝸䝢䞁䜒 ASEAN ຍ┕ᅜ䛸䛧
䛶䚸ASEAN 䛾ື≀⏝་⸆䛾ㄪ࿴䝹䞊䝹䛜 VICH 䛾䜺䜲䝗䝷䜲䞁䛸ᩚྜᛶ䜢ᣢ䛴䛣䛸䛜㔜せ䛷䛒䜛䛸⪃䛘䛶䛔䜛䛣䛸䛜ఛ䛘䜛䚹䛧䛛䛧䚸䝣䜱䝸䝢䞁䛿䛭䛾ᚋ䛾䜰䜴䝖䝸䞊䝏䝣䜷䞊䝷䝮䛻ཧຍ䛧䛶䛔䛺䛔䚹

2.4 つไ⦆࿴䛾ഴྥಖ೺┬䜔 FDA 䛛䜙䛾⾜ᨻ࿨௧䜔㏻▱䜢ぢ䛶䜒䚸ື≀⏝་⸆ရ䛻㛵䛩䜛つไ䛜⦆࿴䛥䜜䛶䛔䜛䛸䛔䛖ഴྥ䛿☜ㄆ䛷䛝䛺䛛䛳䛯䚹䛯䛰䛧䚸ᅜ㝿ᇶ‽䛸䛾⤫୍䚸㟁Ꮚ䝅䝇䝔䝮䛾ά⏝䛻䜘䜛⏦ㄳ䝥䝻䝉䝇䛾⡆᫆໬䜔⤫୍໬䚸᫬௦䛾ኚ໬䛻క䛳䛶⾜ᨻ࿨௧䜔㏻▱䜢ᨵゞ䛩䜛ഴྥ䛿☜ㄆ䛥䜜䛯䚹25

3. ື≀⏝་⸆ရ䛾〇㐀ཬ䜃ရ㉁⟶⌮3.1 ື≀⏝་⸆ရ䛾〇㐀ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䜢䝣䜱䝸䝢䞁䛷〇㐀䛩䜛䛣䛸䛻䛴䛔䛶䛿䚸ඹ࿴ᅜἲ➨ 3720 ྕ䛻つᐃ䛥䜜䛶䛔䜛䚹ྠἲ䛿䚸኱⤫㡿௧➨ 175 ྕ䠄1987 ᖺ䠅䛻䜘䜚኱ᖜ䛻ಟṇ䛥䜜䛶䛔䜛䛜䚸་⸆ရ䛾〇㐀䛻䛴䛔䛶䛿ྠ኱⤫㡿௧➨ 15 ᮲䛻䜘䜚䚸ྠἲ䛻௨ୗ䛾➨ 21-B ᮲䛜㏣ຍ䛥䜜䛯䚹➨ 21-B ᮲䠗་⸆ရཪ䛿⿦⨨䛿䚸䛭䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅ཪ䛿㈍኎ᴗ⪅䛜ᮏἲᚊ䛻ᇶ䛵䛝㛗ᐁ䛜බᕸ䛩䜛つ๎ཬ䜃つᐃ䛻ᚑ䛳䛶Ⓩ㘓䛧䛺䛔㝈䜚䚸〇㐀䚸㈍኎䚸㈍኎䛾⏦ฟ䚸㍺ධ䚸㍺
ฟ䚸ὶ㏻ཪ䛿⛣㌿䛧䛶䛿䛺䜙䛺䛔䚹➨ 21 ᮲䠄b䠅㡯䚸䠄d䠅㡯ཬ䜃䠄e䠅㡯䛾つᐃ䛿䚸㐺⏝䛥䜜䜛㝈䜚䛻䛚䛔䛶䚸ᙜヱ་⸆ရཬ䜃ᶵჾ䛾Ⓩ㘓䛻㐺⏝䛥䜜䜛䜒䛾䛸䛩䜛䚹䛣䛾䜘䛖䛻䚸䝣䜱䝸䝢䞁䛷ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾〇㐀䜢ᕼᮃ䛩䜛ሙྜ䚸〇㐀䛧䜘䛖䛸䛩䜛஦ᴗ⪅䛿䚸㛵ಀ䛩䜛ἲ௧䛾つᐃ䛻ἢ䛳䛶チྍ䜢ྲྀᚓ䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹䜎䛯䚸ඹ࿴ᅜἲ➨3720 ྕ䛾➨ 21 ᮲䠄e䠅㡯䛿䚸ྠ᮲䛾つᐃ䛜䚸ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䜛䛣䛸䜢᫂グ䛧䛶䛔䜛䚹䜎䛯䚸〇㐀䜢ᕼᮃ䛩䜛ື≀⏝་⸆ရ䛾Ⓩ㘓䜒ᚲせ䛸䛥䜜䜛䠄ື≀⏝་⸆ရ䛾Ⓩ㘓䛻䛴䛔䛶䛿䚸䛂2.1.1 ㈍኎
Ⓩ㘓⏦ㄳ䛃䜢ཧ↷䠅䚹䛧䛯䛜䛳䛶䚸஦ᴗ⪅䛿䜎䛪〇㐀䛾䛯䜑䛾チྍド䜢ྲྀᚓ䛧䚸䛭䛾ᚋ䚸〇㐀䜢ᕼᮃ䛩
䜛〇ရ䜢Ⓩ㘓䛩䜛ᚲせ䛜䛒䜛䚹

3.1.1 〇㐀ᴗ⪅๓㡯䛾䛸䛚䜚䚸䝣䜱䝸䝢䞁ᅜෆ䛷ື≀⏝་⸆ရ䜢〇㐀䛩䜛䛯䜑䛻䛿䚸〇㐀ᴗ⪅䛿ᙜᒁ䛛䜙チྍド䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹་⸆ရ䛻㛵㐃䛧䛶஦ᴗ⪅䛻௜୚䛥䜜䜛チྍド䛿䚸஦ᴗチྍド䠄LTO䠖License
to Operate䠅䛸࿧䜀䜜䛶䛔䜛䚹་⸆ရ䛾〇㐀䛰䛡䛷䛺䛟䚸䛭䛾㈍኎䜔ὶ㏻䚸㍺ฟ䛻ᦠ䜟䜛஦ᴗ⪅䜒
LTO 䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䛜䚸ᇶᮏⓗ䛻ྠ䛨䝥䝻䝉䝇䛷⏦ㄳ䛷䛝䜛䚹

3.1.1.1 㟁Ꮚ䝫䞊䝍䝹䠄E-Portal䠅䜰䜹䜴䞁䝖䛾ྲྀᚓ⌧ᅾ䚸ື≀⏝་⸆ရ䛾チྍ⏦ㄳ䛾䛯䜑䛾ᡭ⥆䛿㟁Ꮚ໬䛥䜜䛶䛚䜚䚸LTO 䛾⏦ㄳ䛾๓䛻䜎䛪ᙜᒁ䛾㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䠄E-Portal䠅䛾䜰䜹䜴䞁䝖䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹〇㐀ᴗ⪅䛜⏦ㄳ䛩䜛䜉䛝ᡭ⥆䛾ヲ⣽䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹ᚲせ᭩㢮

FDA ㏻▱ 2016-014 ู⣬ B ᵝᘧ䛻‽ᣐ䛧䛯䝺䝍䞊⨫ྡཬ䜃බド䛜ᚲせ

26

⏦ㄳᡭ㡰

1. ⏦ㄳ⪅䛿䚸dac@fda.gov.ph ᐄ䛶䛻ୖグ䛾ᚲせ᭩㢮䜢㏦ಙ䛩䜛䚹䛒䜛䛔䛿௨ୗ䛾䝃䜲䝖䛷ᚲせ஦㡯䜢グධ䛾ୖ䚸ୖグ䛾ᚲせ᭩㢮䜢䜰䝑䝥䝻䞊䝗䛩䜛䚹
https://eportal2.fda.gov.ph/syseportal/en/neoclassic/2025723735d4
504e361dde4030330943/2656580155d4641ea8aa1d9091841768.p
hp
2. FDA 䛿䚸グ㍕஦㡯䛜༑ศ䛷䛒䜛䛛䚸䜎䛯ṇ☜䛷䛒䜛䛛☜ㄆ䛧䚸ၥ㢟䛜䛺䛡䜜䜀ḟ䛾Ⴀᴗ᪥䜎䛷䛻䝴䞊䝄䞊䝛䞊䝮䛸䝟䝇䝽䞊䝗䜢⏦ㄳ⪅䛻
Ⓨ⾜䛩䜛䚹

㈝⏝

୙せ

㛵㐃䛩䜛㏻▱䜔䜺䜲䝗䝷䜲䞁䞉FDA Circular 2016-014䠄FDA ㏻▱ 2016-014䠅䚸II-C
䞉FDA Citizen’s Charter 2021 1st edition䠄ಖ㝤┬ FDA ᕷẸ᠇❶ 2021
➨ 1 ∧䠅䚸pp. 7-8

3.1.1.2 LTO 䛾ྲྀᚓ〇㐀ᴗ⪅䛜 LTO 䜢⏦ㄳ䛩䜛䛯䜑䛾ᡭ⥆䛾ヲ⣽䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹ᚲせ᭩㢮

1. ⤫ྜ⏦ㄳ᭩
2. ஦ᴗⓏ㘓ド᫂᭩㢮
3. ཰ධド᫂᭩㢮
4. ᨭᡶド᫂᭩㢮
5. ⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹
6. 䝸䝇䜽⟶⌮ィ⏬
7. ᭷㈨᱁⪅䛾ド᫂᭩㢮
8. LTO䠄ึᅇ䠅⏦ㄳ⏝䝉䝹䝣䝏䜵䝑䜽䝅䞊䝖䠄⏦ㄳ᫬䛻ᥦฟ䛩䜛ᚲせ䛿䛺䛔䛜䚸䛣䛾䝅䞊䝖䛻ἢ䛳䛶⏦ㄳ᭩㢮䜢☜ㄆ䛩䜛䛣䛸䛜ᚲせ䛸䛥䜜䛶䛔䜛䠅⏦ㄳᡭ㡰

1. ⤫ྜ⏦ㄳ᭩䛾ྲྀᚓ⤫ྜ⏦ㄳ᭩䜢⏦ㄳ䛩䜛᪉ἲ䛿 2 ✀㢮䛒䜛䚹୍䛴䛿㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䛻䝻䜾䜲䞁䛧䚸䜸䞁䝷䜲䞁䝣䜷䞊䝮䛻グධ䛩䜛᪉ἲ䚸䜒䛖୍䛴䛿⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䜢 FDA 䛾䝃䜲䝖䛛䜙䝎䜴䞁䝻䞊䝗䛧䛶グධ䛩䜛᪉ἲ䛷䛒䜛䚹௨ୗ䛻䚸㟁Ꮚ䝣䜯䜲䝹䛾⤫ྜ⏦ㄳ᭩䛾䝎䜴䞁䝻䞊䝗䝸䞁䜽䜢グ㍕䛩䜛䛜䚸௨㝆䛿㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䛻䛚䛔䛶䜸䞁䝷䜲䞁䝣䜷䞊䝮䛻グධ䛩䜛᪉ἲ䜢⏝䛔䛯ᡭ㡰䜢ㄝ᫂䛩䜛䚹⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䛾䝎䜴䞁䝻䞊䝗䝸䞁䜽䠖https://www.fda.gov.ph/wp-content/uploads/2021/04/IntegratedApplication-Form-XLSX-Format.xlsx
2. 㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䜈䛾䝻䜾䜲䞁27

㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䛂E-Portal䛃䠄https://eportal2.fda.gov.ph䠅䛻䜰䜽䝉䝇䛧䚸஦๓䛻ྲྀᚓ䛧䛯䜰䜹䜴䞁䝖䛷䝻䜾䜲䞁䛩䜛䚹

3. LTO䠄ึᅇ䠅䛾⏦ㄳ䜢㑅ᢥ䝩䞊䝮䝍䝤䛻䛒䜛䝘䝡䝀䞊䝅䝵䞁䝨䜲䞁䛷䛂New Application䛃䠄᪂つ⏦ㄳ䠅䜢㑅ᢥ䛧䚸䛂e-License to Operate䠄Initial Application䠅䛃䠄e-LTO䠄ึᅇ⏦ㄳ䠅䠅䜢㑅ᢥ䛩䜛䚹䛭䛾ᚋ䚸ㄋ⣙᭩䛾ෆᐜ䛜⾲♧䛥䜜䜛䛾䛷䚸䛭䛾ෆᐜ䜢䜘䛟ㄞ䜏䚸⌮ゎ䛧䛯ୖ䛷ྠព䛩䜛䛾䛷䛒䜜䜀䚸䝨䞊䝆䛾᭱ᚋ䛻䛒䜛㑅ᢥ䝯䝙䝳䞊䛛䜙ྠព䜢㑅ᢥ䛩䜛䚹䠄ྠព䛧䛺䛡䜜䜀ᙜ↛⏦ㄳ䛿୙ྍ䠅
4. ⤫ྜ⏦ㄳ᭩䛾సᡂ⾲♧䛥䜜䜛䝣䜷䞊䝮䛻㐺ษ䛻グධ䛩䜛䚹〇㐀䛾ሙྜ䚸䛂Primary
Activity䛃䛷䛂Manufacturer䛃䜢㑅ᢥ䛩䜛䚹䜎䛯䚸௨ୗ䛾㡯┠䛿䚸〇㐀䛾⏦ㄳ䛾㝿䛻㏣ຍ䛷グධ䛜ồ䜑䜙䜜䜛䚹䞉タ❧ᆅ䛸 GPS ᗙᶆ䞉᭷㈨᱁⪅䛾Ặྡ䠄䛂〇㐀䛃䛾ሙྜ䚸ඹ࿴ᅜἲ➨ 10918 ᮲䛻ᇶ䛵䛟䛂⸆๣ᖌ䛃䠅䚹
5. ᚲせ᭩㢮䛾ῧ௜௨ୗ䛾ᚲせ᭩㢮䛿䚸150dpi ௨ୖ䛾ゎീᗘ䛷䝇䜻䝱䞁䛧䛯 PDF 䝣䜯䜲䝹䛸䛩䜛䚹䠄1䠅஦ᴗⓏ㘓ド᫂᭩㢮஦ᴗ⪅䛾ྡ⛠䛜Ⓩ㘓䛥䜜䛶䛔䜛䛣䛸䜢ド᫂䛩䜛䛯䜑䚸௨ୗ䛾᭩㢮䛾䛔䛪䜜䛛䜢ᥦฟ䛩䜛䚹䛺䛚䚸ド᫂᭩㢮䛾グ㍕஦㡯䛸䚸⤫ྜ⏦ㄳ᭩䛾グ㍕
஦㡯䛿ᩚྜ䛜䛸䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹Ɣ ಶே஦ᴗ୺䛾ሙྜ䛿䚸㈠᫆⏘ᴗ┬䠄DTI䠅Ⓨ⾜䛾஦ᴗⓏ㘓ド᫂᭩䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅Ɣ ἲே䚸⤌ྜ䚸䛭䛾௚䛾ἲே䛾ሙྜ䛿䚸ドๆྲྀᘬጤဨ఍䠄SEC䠅
Ⓨ⾜䛾Ⓩ㘓ド᫂᭩䛸ᐃḰ䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅Ɣ ༠ྠ⤌ྜ䛾ሙྜ䛿䚸༠ྠ⤌ྜᒁⓎ⾜䛾Ⓩ㘓ド᫂᭩ཬ䜃༠ྠ⤌28ྜᐃḰ䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅Ɣ ᨻᗓᡤ᭷ཪ䛿⟶⌮ἲே䛾ሙྜ䛿䚸タ❧ἲ䠄ᐃḰ䛾ཎᮏ䛜䛒䜛ሙྜ䠅䚸ドๆྲྀᘬጤဨ఍䠄SEC䠅Ⓨ⾜䛾Ⓩ㘓ド᫂᭩䚸ᐃḰ䠄ᐃḰ䛾ཎᮏ䛜䛺䛔ሙྜ䠅䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅஦ᴗᡤ䛾ఫᡤ䛜஦ᴗ⪅䛾ྡ⛠Ⓩ㘓䛾ఫᡤ䛸␗䛺䜛ሙྜ䛿䚸஦ᴗチྍド䛾෗䛧䠄౛䠖ᕷ㛗䛛䜙䛾チྍド䠅䜢ᥦฟ䛩䜛ᚲせ䛜䛒䜛䚹䠄2䠅཰ධド᫂᭩㢮㈚೉ᑐ↷⾲䛜௜ᒓ䛧䛯᭱᪂䛾┘ᰝ῭㈈ົㅖ⾲ཪ䛿බド῭ึᮇ㈨ᮏ㔠䛻㛵䛩䜛᭩㢮/ド᫂᭩䠄3䠅⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹ရ㉁⟶⌮䝫䝸䝅䞊䚸⌧ᆅ䛷䛾άື䚸グ㍕䛥䜜䛯ሙᡤ䛻䛚䛡䜛〇㐀䛾ᐇ᪋䜔䚸㞄᥋ཬ䜃㏆㞄䛾᪋タ䛻䛚䛡䜛῝䛟㛵ಀ䛧䛯ᴗົ䛷䛾⏕⏘⟶⌮ཬ䜃ရ㉁⟶⌮䛻㛵䛩䜛≉ᐃ䛾᝟ሗ䜢ྵ䜑䛯᭩㢮䚹PIC/S GMP 䛻‽ᣐ䛧䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹䠄4䠅䝸䝇䜽⟶⌮ィ⏬
஦ᴗ⪅䛜〇㐀䛧䛶䛔䜛〇ရ䛻㛵㐃䛧䛯䝸䝇䜽䛾Ⓨぢ䚸୺䛺≉ᚩ䛾ᢳฟ䚸ண㜵䚸᭱ᑠ໬䛩䜛᪉ἲ䛾ヲ⣽䜢ྵ䜑䛯᭩㢮䚹ᕷ㈍ᚋ䛾ㄪᰝάື䜔䝸䝇䜽䜢ไᚚ䛩䜛䛯䜑䛾ᑐ⟇䜒ྵ䜎䜜䜛䚹䠄5䠅タ❧ᆅィ⏬᭩〇㐀᪋タ䛾ᩜᆅ䛻䛚䛡䜛ᘓ≀䛺䛹䛾䝇䜿䝑䝏䚹୺せ䛺䝷䞁䝗䝬䞊䜽䜔GPS ᗙᶆ䜒ྵ䜑䜛䚹
䠄6䠅᭷㈨᱁⪅䛾ド᫂᭩㢮
6. ᡭᩘᩱᨭᡶ⚊䛾ཷ㡿䜸䞁䝷䜲䞁䝣䜷䞊䝮䜢䛩䜉䛶グධ䛧䚸ᚲせ䛺᭩㢮䜢ῧ௜䛧䛶㏦ಙ䛩䜛䛸䚸ᡭᩘᩱᨭᡶ⚊䛜⾲♧䛥䜜䜛䛾䛷䚸䛭䜜䜢䝎䜴䞁䝻䞊䝗䛧䛶༳ๅ䛩䜛䚹
7. ᡭᩘᩱ䛾ᨭᡶ
FDA 䛾❆ཱྀཪ䛿㖟⾜䠄䝷䞁䝗䝞䞁䜽䜸䞁䝁䞊䝹䝨䜲䝯䞁䝖ཪ䛿 Bancnet䠅䛷ᣦᐃ䛥䜜䛯ᡭᩘᩱ䜢ᨭᡶ䛖䚹䛺䛚䚸ᨭᡶ䛜῭䜐䛸䚸䜸䞁䝷䜲䞁䝣䜷䞊䝮䛻䛭䛾᝟ሗ䛜ᥖ㍕䛥䜜䚸⏦ㄳ᭩㢮䛾 FDA 䛻䛚䛡䜛ᡭ⥆䛜ጞ䜎䜛䚹ᨭᡶ䛛䜙㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䜈䛾ᨭᡶ᝟ሗ䛾཯ᫎ䛻せ䛩䜛᫬㛫䛿௨ୗ䛾䛸䛚䜚䛸䛥䜜䛶䛔䜛䚹
Ɣ FDA 䛾❆ཱྀ䠖2 ᪥ᚋƔ 䝷䞁䝗䝞䞁䜽䠖5 ᪥ᚋƔ Bancnet䠖2 ᪥ᚋ
8. ᆅᇦ⌧ᆅ஦ົᡤ䠄RFO䠖Regional Field Office䠅䛻䜘䜛஦๓ᑂᰝ〇㐀䛾䛯䜑䛾 LTO ⏦ㄳ䛾ሙྜ䚸RFO 䛻䜘䜛⌧ᆅ❧ධ䜚ᑂᰝ䛜ᚲ䛪ᐇ᪋䛥䜜䜛䚹
9. FDA 䛻䜘䜛ᑂᰝ29ᑂᰝᮇ㛫䛿 17 Ⴀᴗ᪥䛸䛥䜜䛶䛔䜛䚹
10. FDA 䛻䜘䜛⤖ᯝ㏻▱
FDA 䛿ᑂᰝ⤊஢ᚋ䚸3 Ⴀᴗ᪥௨ෆ䛻䛭䛾⏦ㄳ䛻ᑐ䛩䜛᭱⤊ⓗ䛺ุ᩿䜢⾜䛖䚹ᑂᰝ䛻ྜ᱁䛧䛯ሙྜ䚸㏻▱᭩䜈䛾䝸䞁䜽䛜㏦௜䛥䜜䚸⏦ㄳ⪅⮬䜙䛜༳ๅ䛷䛝䜛䚹ᑂᰝ䛻୙ྜ᱁䛷䛒䛳䛯ሙྜ䚸⏦ㄳ༷ୗ䛾ᩥ᭩䛜䝯䞊䝹䛷㏦௜䛥䜜䜛䚹㈝⏝㈨ᮏ㔠䛾㢠䛻䜘䛳䛶␗䛺䜛䚹
Ɣ 2,000 ୓䝣䜱䝸䝢䞁䝨䝋௨ୗ䠖1 ୓䝨䝋+1% LRF
Ɣ 2,000 ୓ 1 䝣䜱䝸䝢䞁䝨䝋௨ୖ 5,000 ୓ᮍ‶䠖1 ୓ 5,000 䝨䝋+1% LRFƔ 5,000 ୓䝣䜱䝸䝢䞁䝨䝋௨ୖ䠖2 ୓䝨䝋+1% LRF᭷ຠᮇ㛫ึᅇ䠖2 ᖺ
᭦᪂䠖3 ᖺ

㛵㐃䛩䜛㏻▱䜔䜺䜲䝗䝷䜲䞁䞉FDA Citizen’s Charter 2021 1st edition䠄ಖ㝤┬ FDA ᕷẸ᠇❶ 2021
➨ 1 ∧䠅䚸pp. 13-17
䞉LTO䠄ึᅇ䠅⏦ㄳ⏝䝉䝹䝣䝏䜵䝑䜽䝅䞊䝖
䞉AO2020-0017

3.2 GMP䝣䜱䝸䝢䞁䛷䛿䚸1974 ᖺ䛻 GMP䠄Good Manufacturing Practice䠖་⸆ရ䛾〇㐀⟶⌮ཬ䜃ရ㉁⟶⌮䛾ᇶ‽䠅䛜ไᐃ䛥䜜䛯䚹ྠᖺ 6 ᭶ 13 ᪥௜䛾⾜ᨻ࿨௧➨ 220 ྕ䠄1974 ᖺ䠅16䛻䛚䛔䛶䚸ୡ⏺ಖ೺ᶵᵓ䠄WHO䠅䛾 GMP 䜢䝣䜱䝸䝢䞁䛾 GMP 䛸䛩䜛䛣䛸䛜ᐃ䜑䜙䜜䛯䚹䛭䛾ᚋ䚸䝣䜱䝸䝢䞁䛾 GMP 䛿䚸1999
ᖺ䛻䚸⾜ᨻ࿨௧➨ 43 ྕ䠄1999 ᖺ䠅17䛻䜘䜚ᨵṇ䛥䜜䛯䚹୍᪉䚸䝣䜱䝸䝢䞁䜒ຍ┕ᅜ䛷䛒䜛 ASEAN䠄ᮾ༡䜰䝆䜰ㅖᅜ㐃ྜ䠅䛿䚸2004 ᖺ 11 ᭶䛻䚸PIC/S GMP
䜢 ASEAN ඹ㏻䛾 GMP 䛸䛩䜛䛣䛸䛻ྜព䛧䛯䚹䛭䛾䛯䜑䚸䝣䜱䝸䝢䞁ᨻᗓ䜒 PIC/S GMP 䜢䝣䜱䝸䝢䞁䛾 GMP 䛸䛩䜛䛣䛸䛸䛺䛳䛯䛜䚸⾜ᨻ࿨௧➨ 43 ྕ䠄1999 ᖺ䠅䛷ᐃ䜑䛶䛔䛯䝣䜱䝸䝢䞁䛾᪤Ꮡ䛾 GMP
䛸䚸PIC/S GMP 䛜ྠ䛨䛷䛿䛺䛛䛳䛯䛯䜑䚸⾜ᨻ࿨௧ 2012-000818䛻䛚䛔䛶䚸PIC/S GMP 䜢䝣䜱䝸䝢䞁䛾 GMP 䛸䛧䛶ᑟධ䛩䜛䛣䛸䜢㏻▱䛧䛯䚹

16 䝣䜱䝸䝢䞁ඹ࿴ᅜಖ೺┬, Administrative Order No. 220, s. 1974䠄https://www.fda.gov.ph/wp-

content/uploads/2021/04/Administrative-Order-No.-220-s.-1974.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 25 ᪥䠅
17 䝣䜱䝸䝢䞁ඹ࿴ᅜಖ೺┬, Administrative Order No. 43, s. 1999䠄https://wipolex.wipo.int/en/text/313972䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 25 ᪥䠅
18 䝣䜱䝸䝢䞁ඹ࿴ᅜ FDA, Administrative Order No. 2012-0008 䠄https://www.fda.gov.ph/wpcontent/uploads/2021/04/Administrative-Order-No.-2012-0008.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 25 ᪥䠅

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3.2.1 ᥇⏝䛥䜜䛶䛔䜛 GMP ᇶ‽๓㡯䛾䛸䛚䜚䚸⌧ᅾ䚸䝣䜱䝸䝢䞁䛷䛿䚸ASEAN 䛾 GMP 䛸䛧䛶᥇⏝䛥䜜䛶䛔䜛 PIC/S GMP 䜢⮬ᅜ䛾
GMP 䛸䛧䛶䛔䜛䚹䜎䛯䚸䛭䜜䜢ᐃ䜑䛯⾜ᨻ࿨௧ 2012-0008 ➨ IV ᮲➨ 1 㡯䛻䛚䛔䛶䚸་⸆ရ䛿ື≀䛻౑⏝䛥䜜䜛་⸆ရ䜒ྵ䜎䜜䜛䛣䛸䜢ᐃ⩏䛧䛶䛔䜛䛣䛸䛛䜙䚸PIC/S GMP 䛿ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䜛䚹䛥䜙䛻䚸ྠ᮲➨ 3 㡯䛻䛚䛔䛶䚸ྠ⾜ᨻ࿨௧䛷䛔䛖 PIC/S GMP 䛿䚸⌧⾜䛾 PIC/S GMP 䛾➨ 1 㒊䚸
➨ 2 㒊䚸ู⣬䛷䛒䜛䛣䛸䛜᫂グ䛥䜜䛶䛔䜛䚹

3.2.2 䝣䜱䝸䝢䞁ᅜෆ䛾〇㐀⪅⾜ᨻ࿨௧ 2012-0008 ➨ IV ᮲➨ 5 㡯䛷䛿䚸་⸆ရ஦ᴗ⪅䛸䛿䚸་⸆ရ䛾〇㐀ᴗ⪅䚸෌㈍⪅䚸་⸆ရ㍺ධᴗ⪅䚸་⸆ရὶ㏻ᴗ⪅䚸་⸆ရ༺኎ᴗ⪅䚸་⸆ရ䛾㍺ฟᴗ⪅䚸ཬ䜃ඹ࿴ᅜἲ➨ 9711 ྕ䛷ᐃ䜑䛶䛔䜛ᐃ⩏䛻ヱᙜ䛩䜛஦ᴗయ䛷䛒䜛䛸ᐃ䜑䜙䜜䛶䛔䜛䚹䛧䛯䛜䛳䛶䚸䝣䜱䝸䝢䞁ᅜෆ䛾ື≀⏝་⸆ရ䛾〇㐀⪅䛿䝣䜱䝸䝢䞁䛾་⸆ရ GMP 䛴䜎䜚䚸PIC/S GMP 䜢㡰Ᏺ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹

3.2.3 䝣䜱䝸䝢䞁ᅜእ䛾〇㐀⪅⾜ᨻ࿨௧ 2013-0022 䛻䛚䛔䛶䚸㍺ධᴗ⪅䛜䝣䜱䝸䝢䞁ᅜእ䛷〇㐀䛥䜜䛯་⸆ရ䜢䝣䜱䝸䝢䞁ᅜෆ䛻
㍺ධ䛩䜛ሙྜ䚸䛭䛾〇㐀ᴗ⪅䛜䛭䛾ᅜ䛻䛚䛔䛶 GMP 䜢ྲྀᚓ䛧䛶䛔䜛䛣䛸䜢ド᫂䛩䜛䛣䛸䛜ồ䜑䜙䜜䛶䛔䜛䚹䛣䛾ド᫂䛜ᢎㄆ䛥䜜䜛䛸䚸GMP 䜽䝸䜰䝷䞁䝇䠄GMP ྲྀᚓ῭䠅ド᫂᭩䛜 FDA 䛛䜙Ⓨ⾜䛥䜜䜛䚹ྠ⾜ᨻ࿨௧➨ VII ᮲ B.2 䛻䜘䜛䛸䚸GMP ྲྀᚓ῭䛾ド᫂䛸䛧䛶ㄆ䜑䜙䜜䜛䜒䛾䛿䚸〇㐀ᅜ䛾ᙜᒁ䛛䜙䛾 GMP ド᫂᭩䚸WHO ་⸆ရド᫂᭩䚸ཪ䛿≉ᐃ䛾་⸆ရ䞉๣ᙧ䛻ᑐ䛩䜛〇㐀チྍドཪ䛿〇㐀ᢎㄆ䛷䛒䜛䚹䝣䜱䝸䝢䞁䛾ື≀⏝་⸆ရ༠఍䛻ၥ䛔ྜ䜟䛫䛯䛸䛣䜝䚸ศὀ䛾ሙྜ䚸ཎ⏘ᅜ䛾ศᯒド᫂᭩䠄CoA䠅䛸 cGMP 䜒ᚲせ䛷䛒䜛䛣䛸䛜☜ㄆ䛷䛝䛯䚹
GMP 䜽䝸䜰䝷䞁䝇䛻䛚䛔䛶䚸PIC/S ຍ┕ᅜ䛻䜘䜛 GMP ド᫂᭩䛜ᥦฟ䛥䜜䜛ሙྜ䚸ᑂᰝᮇ㛫䛜༙ศ䛻䛺䜛䛸䛔䛖䝯䝸䝑䝖䛜䛒䜛䚹᪥ᮏ䛾ሙྜ䚸䝠䝖⏝་⸆ရ䜢⟶㎄䛩䜛ཌ⏕ປാ┬䛿 PIC/S 䛻ຍ┕䛧䛶䛔䜛䛜䚸ື≀⏝་⸆ရ䜢⟶㎄䛩䜛㎰ᯘỈ⏘┬䛿 PIC/S 䛻ຍ┕䛧䛶䛔䛺䛔䛯䜑䚸ື≀⏝་⸆ရ䛻㛵䛧䛶䛿 PIC/S ຍ┕ᅜ䛸䛿䜏䛺䛥䜜䛺䛔䚹䛭䜜䛷䚸㎰ᯘỈ⏘┬䛜Ⓨ⾜䛧䛯 GMP ド᫂᭩䜢౑⏝䛧䛶䚸䝣䜱䝸䝢䞁䛷䛾ᾏእ GMP 䜽䝸䜰䝷䞁䝇䜢⏦ㄳ䛧䚸䜎䛪᭩㢮ᑂᰝ䜢ཷ䛡䜛ᚲせ䛜䛒䜛䚹᭩㢮ᑂᰝ䛷䚸PIC/S
GMP 䛾ᇶ‽䜢‶䛯䛧䛶䛔䜛䛸䛔䛖༑ศ䛺ドᣐ䛜䛺䛔䛸ุ᩿䛥䜜䛯ሙྜ䚸〇㐀ᴗ⪅䛿 FDA 䝣䜱䝸䝢䞁䛾 GMP ᰝᐹᅋ䛻䜘䜛⌧ᆅㄪᰝ䜢ཷ䛡䜛ᚲせ䛜䛒䜚䚸䛭䛾ሙྜ䛻Ⓨ⏕䛩䜛㈝⏝䛿〇㐀ᴗ⪅䛜㈇ᢸ䛩䜛ᚲせ䛜䛒䜛䠄䛂3.5.2 ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅⏦ㄳ᭩䛸ᡭ⥆䛃䜢ཧ↷䠅䚹䛣䛾Ⅼ䛻㛵䛧䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛷௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹

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㎰ᯘỈ⏘┬䛿ຍ┕ᶵ㛵䛷䛿䛺䛔䛾䛷䚸GMP 䜽䝸䜰䝷䞁䝇䛻䛚䛔䛶䛿 PIC/S ຍ┕ᅜ௨እ䛻ồ䜑䜙䜜䜛᭩㢮䜢ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹ᾏእㄪᰝ䛜୰᩿䛥䜜䛶䛔䜛䛾䛿䛒䛟䜎䛷ᅜ㝿౽䛜฼⏝䛷䛝䛺䛛䛳䛯䛛䜙䛷䛒䜛䛯䜑䚸≧ἣ䛜ᨵၿ䛥䜜䜜䜀䚸㏆䛔ᑗ᮶䚸⌧ᆅㄪᰝ䛜෌㛤䛥䜜䜛䛸ᛮ䜟䜜䜛䚹ᾏእ⌧ᆅㄪᰝ䛜ᐇ᪋䛥䜜䛯䛸䛔䛖䜿䞊䝇䜢⪺䛔䛯䛣䛸䛿䛒䜛䛜䚸ᙜ♫䛾䝃䝥䝷䜲䝲䞊䛷ㄪᰝᑐ㇟䛸䛺䛳䛯䜿䞊䝇䛿䛺䛔䚹᪥ᮏ䛻⌧ᆅㄪᰝ䛷⾜䛳䛯䛸䛔䛖䜿䞊䝇䛿⪺䛔䛯䛣䛸䛜䛺䛔䚹䛯䛰䛧䚸㡑ᅜ䛻⾜䛳䛯䛸䛔䛖䜿䞊䝇䛿⪺䛔䛯䛣䛸䛜䛒䜛䚹

3.3 ㈍኎ᴗ⪅ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䜢䝣䜱䝸䝢䞁䛷㈍኎䛩䜛䛣䛸䛻䛴䛔䛶䛿䚸ඹ࿴ᅜἲ➨ 3720 ྕ䛻つᐃ䛥䜜䛶䛔䜛䚹ྠἲ䛿䚸኱⤫㡿௧➨ 175 ྕ䠄1987 ᖺ䠅䛻䜘䜚኱ᖜ䛻ಟṇ䛥䜜䛶䛔䜛䛜䚸་⸆ရ䛾㈍኎䛻䛴䛔䛶䛿ྠ኱⤫㡿௧➨ 15 ᮲䛻䜘䜚䚸ྠἲ䛻௨ୗ䛾➨ 21-B ᮲䛜㏣ຍ䛥䜜䛯䚹➨ 21-B ᮲䠖་⸆ရཪ䛿⿦⨨䛿䚸䛭䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅ཪ䛿㈍኎ᴗ⪅䛜ᮏἲᚊ䛻ᇶ䛵䛝㛗ᐁ䛜බᕸ䛩䜛つ๎ཬ䜃つᐃ䛻ᚑ䛳䛶Ⓩ㘓䛧䛺䛔㝈䜚䚸〇㐀䚸㈍኎䚸㈍኎䛾⏦ฟ䚸㍺ධ䚸㍺
ฟ䚸ὶ㏻ཪ䛿⛣㌿䛧䛶䛿䛺䜙䛺䛔䚹➨ 21 ᮲䠄b䠅㡯䚸䠄d䠅㡯ཬ䜃䠄e䠅㡯䛾つᐃ䛿䚸㐺⏝䛥䜜䜛㝈䜚䛻䛚䛔䛶䚸ᙜヱ་⸆ရཬ䜃ᶵჾ䛾Ⓩ㘓䛻㐺⏝䛥䜜䜛䜒䛾䛸䛩䜛䚹䛣䛾䜘䛖䛻䚸䝣䜱䝸䝢䞁䛷ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾㈍኎䜢ᕼᮃ䛩䜛ሙྜ䚸㈍኎䛧䜘䛖䛸䛩䜛஦ᴗ⪅䛿䚸㛵ಀ䛩䜛ἲ௧䛾つᐃ䛻ἢ䛳䛶チྍ䜢ྲྀᚓ䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹䜎䛯䚸ඹ࿴ᅜἲ➨3720 ྕ䛾➨ 21 ᮲䠄e䠅㡯䛿䚸ྠ᮲䛾つᐃ䛜䚸ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䜛䛣䛸䜢᫂グ䛧䛶䛔䜛䚹䜎䛯䚸㈍኎䜢ᕼᮃ䛩䜛ື≀⏝་⸆ရ䛾Ⓩ㘓䜒ᚲせ䛸䛥䜜䜛䠄ື≀⏝་⸆ရ䛾Ⓩ㘓䛻䛴䛔䛶䛿䚸䛂2.1.1 ㈍኎
Ⓩ㘓⏦ㄳ䛃䜢ཧ↷䠅䚹㈍኎ᴗ⪅䛾✀㢮䛻䛴䛔䛶䚸ಖ೺┬䛜Ⓨ⾜䛧䛶䛔䜛䛂ඹ࿴ᅜἲ➨ 9711 ྕ䠄2009
ᖺ FDA ἲ䠅ᐇ᪋ἲつไ䛃䛻䜘䜛䛸䚸௨ୗ䛾䛸䛚䜚ศ㢮䛥䜜䜛䚹➨ 1 ⦅➨ 1 ⠇➨ 5 ᮲䜘䜚䠄⏝ㄒ䛾䜰䝹䝣䜯䝧䝑䝖㡰䠅
ὶ㏻ᴗ⪅䠄㍺ධᴗ⪅䞉㍺ฟᴗ⪅䠅䠄Distributor/Importer
Exporter䠅ཎᮦᩱ䚸᭷ຠᡂศཪ䛿᏶ᡂရ䜢⮬䜙䛾౑⏝ཪ䛿௚ᴗ⪅ཪ䛿ᗑ⯒䛻༺኎㈍኎䛩䜛䛯䜑䚸㍺ධཪ䛿㍺ฟ䛩䜛஦ᴗ⪅䚹ὶ㏻ᴗ⪅䠄㍺ධᴗ⪅䞉㍺
ฟᴗ⪅䠅䛜୍⯡䛻ᑐ䛧䛶㈍኎䛩䜛ሙྜ䚸ᑠ኎ᴗ⪅䠄retailer䠅䛸䜏䛺䛥䜜䜛䚹

ὶ㏻ᴗ⪅䠄༺኎ᴗ⪅䠅
䠄Distributor/Wholesaler䠅ཎᮦᩱ䚸᭷ຠᡂศཪ䛿᏶ᡂရ䜢ᅜෆ䛷༺኎㈍኎䛩䜛䛯䜑䛻䚸ᅜෆ䛾஦ᴗ⪅䛛䜙ㄪ㐩䛩䜛஦ᴗ⪅䚹

32

ᑠ኎ᴗ⪅
䠄Retailer䠅ಖ೺⏝ရ䠄་⸆ရ䜢ྵ䜐䠅䜢୍⯡䛻┤᥋㈍኎䛩䜛஦ᴗ⪅䚹䝖䝺䞊䝎䞊
䠄Trader䠅ಖ೺⏝ရ䠄་⸆ရ䜢ྵ䜐䠅䛾Ⓩ㘓῭ᡤ᭷⪅䛷䛒䜛஦ᴗ⪅䛷䚸ཎᮦᩱ䛾ㄪ㐩䚸ᵓᡂせ⣲䛾Ვໟ䚸〇ရ䛾䝰䝜䜾䝷䝣䚸ရ㉁⟶⌮䛾ᇶ‽ཬ䜃ᡭ㡰䛾ᥦ౪䜢⾜䛖䛜䚸ᙜヱ〇ရ䛾〇㐀䛿チྍྲྀᚓ῭䛾〇㐀ᴗ⪅䛻ጤク䛩䜛஦ᴗ⪅䚹䝖䝺䞊䝎䞊䛿ᙜヱ〇ရ䛾ὶ㏻ཪ䛿㈍኎䜢ᐇ᪋䛩䜛䛣䛸䛜䛷䛝䜛䚹䠄ὀព䠅䛂〇㐀ᴗ⪅䠄manufacturer䠅䛃䛾ᐃ⩏䛻䛿䚸䝖䝺䞊䝎䞊䛿〇㐀ᴗ⪅䛸䛧䛶ศ㢮䛥䜜䜛䚸䛸ᐃ䜑䜙䜜䛶䛔䜛䚹䜎䛯䚸䝖䝺䞊䝎䞊䛾ᐃ⩏䛷䛿䚸䝖䝺䞊䝎䞊䛿⮬♫〇ရ䛾㈍኎䜒ྍ⬟䛷䛒䜛䚹LTO 䛾⏦ㄳ䛷䛿䚸䝖䝺䞊䝎䞊⏝䛾
LTO 䛾⏦ㄳᡭ⥆䛜䛒䜛䛜䚸䝖䝺䞊䝎䞊䛾 LTO 䜢ྲྀᚓ䛩䜛䛰䛡䛷䜘䛔䛾䛛䚸䛒䜛䛔䛿〇㐀ཪ䛿㈍኎䛺䛹䚸௚䛾 LTO 䛾ྲྀᚓ䜒ᚲせ䛷䛒䜛䛛䛿☜ㄆ䛷䛝䛺䛛䛳䛯䚹

3.3.1 せ௳
๓㏙䛾䛸䛚䜚䚸䝣䜱䝸䝢䞁ᅜෆ䛷ື≀⏝་⸆ရ䜢㈍኎䛩䜛䛯䜑䛻䛿䚸㈍኎ᴗ⪅䛿ᙜᒁ䛛䜙チྍド䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䛜䚸་⸆ရ䛻㛵㐃䛧䛶஦ᴗ⪅䛻௜୚䛥䜜䜛チྍド䛿䚸஦ᴗチྍド䠄LTO䠖
License to Operate䠅䛸࿧䜀䜜䛶䛔䜛䚹LTO 䛿䚸་⸆ရ䛾㈍኎䛰䛡䛷䛺䛟䚸䛭䛾〇㐀䜔ὶ㏻䚸㍺ฟ䛻ᦠ䜟䜛஦ᴗ⪅䛻䜒ྲྀᚓ䛜ồ䜑䜙䜜䛶䛔䛶䚸ᇶᮏⓗ䛺⏦ㄳ䝥䝻䝉䝇䛿ඹ㏻䛧䛶䛔䜛䚹ື≀⏝་⸆ရ䛾㈍኎䜢ᕼᮃ䛩䜛஦ᴗ⪅䛿䚸ḟ㡯䛻ヲ㏙䛩䜛ᡭ㡰䛻ᚑ䛳䛶ồ䜑䜙䜜䜛⏦ㄳ᭩䜔᭩㢮䜢ᙜᒁ䛻ᥦฟ䛧䚸ᑂᰝ䜢ཷ䛡䛺䛡䜜䜀䛺䜙䛺䛔䚹ᑂᰝ䛻ྜ᱁䛩䜛䛸䚸LTO 䛜௜୚䛥䜜䜛䛣䛸䛻䛺䜛䚹
䜎䛯䚸LTO 䛜௜୚䛥䜜䛯ᚋ䛷䜒䚸௨ୗ䛾஦㡯䛾ᐇ㊶䛜ồ䜑䜙䜜䜛䚹Ɣ་⸆ရ䛾㐺ṇὶ㏻䠄GDP䠅ཬ䜃་⸆ရ䛾㐺ษಖ⟶䠄GSP䠅䜺䜲䝗䝷䜲䞁㡰Ᏺ䛻䛴䛔䛶䛾ᐃᮇⓗ䛺᳨ᰝƔ䝞䝸䜶䞊䝅䝵䞁䠄ኚ᭦஦㡯䠅䛜Ⓨ⏕䛧䛯䛸䛝䛾ᙜᒁ䜈䛾㏿䜔䛛䛺ሗ࿌

3.3.2 ㈨᱁ド᫂᭩ື≀⏝་⸆ရ䜢㈍኎䛩䜛䛯䜑䛾 LTO 䛾ྲྀᚓᡭ⥆䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹

3.3.2.1 㟁Ꮚ䝫䞊䝍䝹䠄eServices Portal䠅䜰䜹䜴䞁䝖䛾ྲྀᚓ㈍኎ᴗ⪅䛜 LTO 䜢⏦ㄳ䛩䜛䛯䜑䛾㟁Ꮚ䝅䝇䝔䝮䠄eServices Portal䠅䛷䛿䚸䜰䜹䜴䞁䝖䛾஦๓ྲྀᚓ䛿ᚲせ䛸䛥䜜䛶䛔䛺䛔䚹33

3.3.2.2 LTO 䛾ྲྀᚓ㈍኎ᴗ⪅䛜 LTO 䜢⏦ㄳ䛩䜛䛯䜑䛾ᡭ⥆䛾ヲ⣽䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹ᚲせ᭩㢮

1. ⤫ྜ⏦ㄳ᭩
2. ஦ᴗⓏ㘓ド᫂᭩㢮
3. ཰ධド᫂᭩㢮
4. ᨭᡶド᫂᭩㢮
5. ⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹
6. 䝸䝇䜽⟶⌮ィ⏬
7. ᭷㈨᱁⪅䛾ド᫂᭩㢮
8. LTO䠄ึᅇ䠅⏦ㄳ⏝䝉䝹䝣䝏䜵䝑䜽䝅䞊䝖䠄⏦ㄳ᫬䛻ᥦฟ䛾ᚲせ䛿䛺䛔䛜䚸䛣䛾䝅䞊䝖䛻ἢ䛳䛶⏦ㄳ᭩㢮䜢☜ㄆ䛩䜛䛣䛸䛜ᚲせ䛸䛥䜜䛶䛔䜛䠅⏦ㄳᡭ㡰

1. ⤫ྜ⏦ㄳ᭩䛾ྲྀᚓ⤫ྜ⏦ㄳ᭩䜢⏦ㄳ䛩䜛᪉ἲ䛿 2 ✀㢮䛒䜛䚹୍䛴䛿㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䛻䝻䜾䜲䞁䛧䚸䜸䞁䝷䜲䞁䝣䜷䞊䝮䛻グධ䛩䜛᪉ἲ䚸䜒䛖୍䛴䛿⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䜢 FDA 䛾䝃䜲䝖䛛䜙䝎䜴䞁䝻䞊䝗䛧䛶グධ䛩䜛᪉ἲ䛷䛒䜛䚹௨ୗ䛻䚸㟁Ꮚ䝣䜯䜲䝹䛾⤫ྜ⏦ㄳ᭩䛾䝎䜴䞁䝻䞊䝗䝸䞁䜽䜢グ㍕䛩䜛䛜䚸௨㝆䛿㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䛻䛚䛔䛶䜸䞁䝷䜲䞁䝣䜷䞊䝮䛻グධ䛩䜛᪉ἲ䜢⏝䛔䛯ᡭ㡰䜢ㄝ᫂䛩䜛䚹⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䛾䝎䜴䞁䝻䞊䝗䝸䞁䜽䠖https://www.fda.gov.ph/wp-content/uploads/2021/04/IntegratedApplication-Form-XLSX-Format.xlsx
2. 㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䜈䛾䜰䜽䝉䝇㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䛂eServices Portal䛃䠄https://eservices.fda.gov.ph䠅䛻䜰䜽䝉䝇䛧䚸ྑୖ䛾䝯䝙䝳䞊䛛䜙䛂Applications䛃䠄⏦ㄳ䠅䜢㑅ᢥ䠄ὀ䠖䛣䛾⏦ㄳ䝃䜲䝖䛿䚸3.1 㡯䛷ヲ㏙䛧䛶䛔䜛〇㐀ᴗ⪅⏝ LTO 䛾⏦ㄳ⏝䝃䜲䝖䛸䛿␗䛺䜛䠅䚹

3. ⏦ㄳ䛩䜛 LTO 䜢㑅ᢥ䛂License to Operate䛃䠄LTO䠅䚸䛂Drug䛃䠄་⸆ရ䠅䛸⥆䛡䛶㑅ᢥ䛩䜛䚹⏦ㄳ䜢ᕼᮃ䛩䜛஦ᴗ䛾✀㢮䛻ྜ䜟䛫䛶㐺ษ䛺䜒䛾䜢㑅ᢥ䛧䚸⾲♧䛥䜜䜛䜸䞁䝷䜲䞁䝣䜷䞊䝮䛻ᚲせ஦㡯䜢グධ䛩䜛䚹
4. ㄋ⣙᭩䛻ྠព34ㄋ⣙᭩䛾ෆᐜ䛜⾲♧䛥䜜䜛䛾䛷䚸䛭䛾ෆᐜ䜢䜘䛟ㄞ䜏䚸⌮ゎ䛧䛯ୖ䛷ྠព䛩䜛䛾䛷䛒䜜䜀䚸䝨䞊䝆䛾᭱ᚋ䛻䛒䜛㑅ᢥ䝯䝙䝳䞊䛛䜙ྠព䜢㑅ᢥ䛩䜛䠄ྠព䛧䛺䛡䜜䜀ᙜ↛⏦ㄳ䛿୙ྍ䠅䚹
5. ᚲせ᭩㢮䛾ῧ௜௨ୗ䛾ᚲせ᭩㢮䛿䚸150dpi ௨ୖ䛾ゎീᗘ䛷䝇䜻䝱䞁䛧䛯 PDF 䝣䜯䜲䝹䛸䛩䜛䠄1 䝣䜯䜲䝹䛻䛴䛝 5MB 䜢㉸䛘䛺䛔䛣䛸䠅䚹
䠄1䠅஦ᴗⓏ㘓ド᫂᭩㢮஦ᴗ⪅䛾ྡ⛠䛜Ⓩ㘓䛥䜜䛶䛔䜛䛣䛸䜢ド᫂䛩䜛䛯䜑䚸௨ୗ䛾᭩㢮䛾䛔䛪䜜䛛䜢ᥦฟ䛩䜛䚹䛺䛚䚸ド᫂᭩㢮䛾グ㍕஦㡯䛸䚸⤫ྜ⏦ㄳ᭩䛾グ㍕
஦㡯䛿ᩚྜ䛜䛸䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹Ɣ ಶே஦ᴗ୺䛾ሙྜ䛿䚸㈠᫆⏘ᴗ┬䠄DTI䠅Ⓨ⾜䛾஦ᴗⓏ㘓ド᫂᭩䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅Ɣ ἲே䚸⤌ྜ䚸䛭䛾௚䛾ἲே䛾ሙྜ䛿䚸ドๆྲྀᘬጤဨ఍䠄SEC䠅
Ⓨ⾜䛾Ⓩ㘓ド᫂᭩䛸ᐃḰ䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅Ɣ ༠ྠ⤌ྜ䛾ሙྜ䛿䚸༠ྠ⤌ྜᒁⓎ⾜䛾Ⓩ㘓ド᫂᭩ཬ䜃༠ྠ⤌ྜᐃḰ䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅Ɣ ᨻᗓᡤ᭷ཪ䛿⟶⌮ἲே䛾ሙྜ䛿䚸タ❧ἲ䠄ᐃḰ䛾ཎᮏ䛜䛒䜛ሙྜ䠅䚸ドๆྲྀᘬጤဨ఍䠄SEC䠅Ⓨ⾜䛾Ⓩ㘓ド᫂᭩䚸ᐃḰ䠄ᐃḰ䛾ཎᮏ䛜䛺䛔ሙྜ䠅䠄䝇䜻䝱䞁῭ PDF 䝣䜯䜲䝹 1 㒊䠅஦ᴗᡤ䛾ఫᡤ䛜஦ᴗ⪅䛾ྡ⛠Ⓩ㘓䛾ఫᡤ䛸␗䛺䜛ሙྜ䛿䚸஦ᴗチྍド䛾෗䛧䠄౛䠖ᕷ㛗䛛䜙䛾チྍド䠅䜢ᥦฟ䛩䜛ᚲせ䛜䛒䜛䚹䠄2䠅཰ධド᫂᭩㢮䠄䝖䝺䞊䝎䞊䛾⏦ㄳ䠅㈚೉ᑐ↷⾲䛜௜ᒓ䛧䛯᭱᪂䛾┘ᰝ῭㈈ົㅖ⾲ཪ䛿බド῭ึᮇ㈨ᮏ㔠䛻㛵䛩䜛᭩㢮/ド᫂᭩䚹䠄3䠅⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹ရ㉁⟶⌮䝫䝸䝅䞊䚸⌧ᆅ䛷䛾άື䚸グ㍕䛥䜜䛯ሙᡤ䛻䛚䛡䜛〇㐀䛾ᐇ᪋䜔䚸㞄᥋ཬ䜃㏆㞄䛾᪋タ䛻䛚䛡䜛῝䛟㛵ಀ䛧䛯ᴗົ䛷䛾⏕⏘⟶⌮ཬ䜃ရ㉁⟶⌮䛻㛵䛩䜛≉ᐃ䛾᝟ሗ䜢ྵ䜑䛯᭩㢮䚹PIC/S GMP 䛻‽ᣐ䛧䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹䠄4䠅䝸䝇䜽⟶⌮ィ⏬
஦ᴗ⪅䛜〇㐀䛧䛶䛔䜛〇ရ䛻㛵㐃䛧䛯䝸䝇䜽䛾Ⓨぢ䚸୺䛺≉ᚩ䛾ᢳฟ䚸ண㜵䚸᭱ᑠ໬䛩䜛᪉ἲ䛾ヲ⣽䜢ྵ䜑䛯᭩㢮䚹ᕷ㈍ᚋ䛾ㄪᰝάື䜔䝸䝇䜽䜢ไᚚ䛩䜛䛯䜑䛾ᑐ⟇䜒ྵ䜎䜜䜛䚹䠄5䠅タ❧ᆅィ⏬᭩〇㐀᪋タ䛾ᩜᆅ䛻䛚䛡䜛ᘓ≀䛺䛹䛾䝇䜿䝑䝏䚹୺せ䛺䝷䞁䝗䝬䞊䜽䜔GPS ᗙᶆ䜒ྵ䜑䜛䚹
䠄6䠅᭷㈨᱁⪅䛾ド᫂᭩㢮
6. ᡭᩘᩱᨭᡶ⚊䛾ཷ㡿䜸䞁䝷䜲䞁䝣䜷䞊䝮䜢䛩䜉䛶グධ䛧䚸ᚲせ䛺᭩㢮䜢ῧ௜䛧䛶㏦ಙ䛩䜛䛸䚸

35ᡭᩘᩱᨭᡶ⚊䛜⾲♧䛥䜜䜛䛾䛷䚸䛭䜜䜢䝎䜴䞁䝻䞊䝗䛧䛶༳ๅ䛩䜛䚹
7. ᡭᩘᩱ䛾ᨭᡶ
FDA 䛾❆ཱྀཪ䛿㖟⾜䠄䝷䞁䝗䝞䞁䜽䜸䞁䝁䞊䝹䝨䜲䝯䞁䝖ཪ䛿 Bancnet䠅䛷ᣦᐃ䛥䜜䛯ᡭᩘᩱ䜢ᨭᡶ䛖䚹䛺䛚䚸ᨭᡶ䛜῭䜐䛸䚸䜸䞁䝷䜲䞁䝣䜷䞊䝮䛻䛭䛾᝟ሗ䛜ᥖ㍕䛥䜜䚸⏦ㄳ᭩㢮䛾 FDA 䛻䛚䛡䜛ᡭ⥆䛜ጞ䜎䜛䚹ᨭᡶ䛛䜙㟁Ꮚ⏦ㄳ䝅䝇䝔䝮䜈䛾ᨭᡶ᝟ሗ䛾཯ᫎ䛻せ䛩䜛᫬㛫䛿௨ୗ䛾䛸䛚䜚䛸䛥䜜䛶䛔䜛䚹
Ɣ FDA 䛾❆ཱྀ䠖2 ᪥ᚋƔ 䝷䞁䝗䝞䞁䜽䠖5 ᪥ᚋƔ Bancnet䠖2 ᪥ᚋ㻌
8. ᆅᇦ⌧ᆅ஦ົᡤ䠄RFO䠖Regional Field Office䠅䛻䜘䜛஦๓ᑂᰝ〇㐀䛾䛯䜑䛾 LTO ⏦ㄳ䛾ሙྜ䚸RFO 䛻䜘䜛⌧ᆅ❧ධ䜚ᑂᰝ䛜ᚲ䛪ᐇ᪋䛥䜜䜛䚹
9. FDA 䛻䜘䜛ᑂᰝᑂᰝᮇ㛫䛿 4 Ⴀᴗ᪥䛸䛥䜜䛶䛔䜛䚹
10. FDA 䛻䜘䜛⤖ᯝ㏻▱
FDA 䛿ᑂᰝ⤊஢ᚋ䚸3 Ⴀᴗ᪥௨ෆ䛻䛭䛾⏦ㄳ䛻ᑐ䛩䜛᭱⤊ⓗ䛺ุ᩿䜢⾜䛖䚹ᑂᰝ䛻ྜ᱁䛧䛯ሙྜ䚸㏻▱᭩䜈䛾䝸䞁䜽䛜㏦௜䛥䜜䚸⏦ㄳ⪅⮬䜙䛜༳ๅ䛷䛝䜛䚹ᑂᰝ䛻୙ྜ᱁䛷䛒䛳䛯ሙྜ䚸⏦ㄳ༷ୗ䛾ᩥ᭩䛜䝯䞊䝹䛷㏦௜䛥䜜䜛䚹㈝⏝㈍኎ᴗ⪅䛾✀㢮䠄3.3 䛾๓ᩥ䛻䛒䜛ᐃ⩏ཧ↷䠅䛸㈨ᮏ㔠䛾㢠䛻䜘䛳䛶␗䛺䜛䚹䛆䝖䝺䞊䝎䞊䛇
Ɣ 2,000 ୓䝣䜱䝸䝢䞁䝨䝋௨ୗ䠖3,000 䝨䝋
Ɣ 2,000 ୓ 1 䝣䜱䝸䝢䞁䝨䝋௨ୖ 5,000 ୓ᮍ‶䠖5,000 䝨䝋
Ɣ 5,000 ୓䝣䜱䝸䝢䞁䝨䝋௨ୖ䠖7,000 䝨䝋䛆ὶ㏻ᴗ⪅䛇
Ɣ ㍺ධᴗ⪅䚸㍺ฟᴗ⪅䚸༺኎ᴗ⪅䠖7,000 䝨䝋䛆ᗑ⯒䛇Ɣ ⸆ᒁ䠄᪋タෆ⸆ᒁ䚸₎᪉⸆ᒁ䜢ྵ䜐䠅䠖㞽኎་⸆ရ䠄ฎ᪉⟢୙せ䠅䛾ᑠ኎ᗑ⯒䛾䜏 1,000 䝨䝋᭷ຠᮇ㛫ึᅇ䠖2 ᖺ
᭦᪂䠖3 ᖺ

㛵㐃䛩䜛㏻▱䜔䜺䜲䝗䝷䜲䞁䞉FDA Citizen’s Charter 2021 1st edition䠄ಖ㝤┬ FDA ᕷẸ᠇❶ 2021
➨ 1 ∧䠅䚸pp. 13-17
䞉LTO䠄ึᅇ䠅⏦ㄳ⏝䝉䝹䝣䝏䜵䝑䜽䝅䞊䝖䞉⾜ᨻ࿨௧ 2020-0017
䞉㏻▱ 2014-025

36

3.3.3 ᐉఏཬ䜃㈍኎ಁ㐍䛾䛯䜑䛾チྍ⾜ᨻ࿨௧ 2011-0101 ➨ 1 ෉➨ VII 㒊➨ 8 ᮲䛷䛿䚸CDRR 䛜ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾㈍኎
䜔ᐉఏ䛻䛴䛔䛶つไ䛩䜛䛣䛸䛜ᐃ䜑䜙䜜䛶䛔䜛䚹ᐉఏཬ䜃㈍኎ಁ㐍チྍ⏦ㄳᡭ⥆䛾ヲ⣽䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹ᚲせ᭩㢮䛆ᐉఏチྍ䛇
1. ⏦ㄳ᭩
2. ௨๓䛾 CPR ཬ䜃஦ᚋᢎㄆኚ᭦ド᫂᭩䛾෗䛧
3. 䝷䝧䝹㈨ᩱ䠄䝣䜯䜽䝅䝭䝸䝷䝧䝹䠅
4. ᩥᏐ䛻䜘䜛ᐉఏ䛾ሙྜ䠄䝟䞁䝣䝺䝑䝖䜔䝍䞊䝫䝸䞁䠅䠖㩭᫂䛺ᐉఏᮦᩱ䛾෗䛧䠄PDF ᙧᘧ䠅
5. 㡢ኌ䛻䜘䜛ᐉఏ䛾ሙྜ䠄䝔䝺䝡䚸䝷䝆䜸䚸ᫎ⏬䛷䛾ᐉఏ䛺䛹䠅䠖᫂ᛌ䛺㡢ኌ䛾ᐉఏᮦᩱ䠄MP4 䜔 AVI 䛺䛹䛾୍⯡ⓗ䛺ື⏬㡢ኌ䝣䜯䜲䝹ᙧᘧ䠅䛸䝇䜽䝸䝥䝖
䛆㈍኎ಁ㐍チྍ䛇
1. ⏦ㄳ᭩
2. ㊃᪨ㄝ᫂᭩
3. ⤫ྜ᝟ሗ䝅䞊䝖୍ᘧཬ䜃㈍኎ಁ㐍䝣䜷䞊䝮䛾௙⤌䜏
4. ᑐ㇟〇ရ䠄ṇᘧ䛻Ⓩ㘓䛥䜜䛛䛴௨๓᭷ຠ䠅䚹᪤ᐃ䛾ᵝᘧ䠄䜶䜽䝉䝹䝣䜯䜲䝹䠅
5. CPR䚸CPN䚸㝖እド᫂᭩䛾㟁Ꮚ䝁䝢䞊
6. 䝷䝧䝹せ௳䛻‽ᣐ䛧䛯䚸฼⏝䛥䜜䜛ணᐃ䛾䝺䜲䜰䜴䝖䚸䝯䝕䜱䜰䛾䝕䝄䜲䞁䚸䝁䝷䝔䝷䝹䚸ᐉఏᮦᩱ㈝⏝䛆ᐉఏチྍ䛇
Ɣ 2,500 䝨䝋
䛆㈍኎ಁ㐍䛇
Ɣ 500 䝨䝋᭷ຠᮇ㛫᭱㛗 1 ᖺ

㛵㐃䛩䜛㏻▱䜔䜺䜲䝗䝷䜲䞁䞉䛂ື≀⏝᪋タཬ䜃ື≀⏝་⸆ရ䛾ㄆྍ䚸Ⓩ㘓ཬ䜃ᕷ㈍ᚋㄪᰝ䛻㛵䛩䜛ᨵゞ䜺䜲䝗䝷䜲䞁䛃

3.4 ㍺ධᴗ⪅ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾䝣䜱䝸䝢䞁䜈䛾㍺ධ䛿䚸ඹ࿴ᅜἲ➨ 3720 ྕ䛻つᐃ䛥䜜䛶䛔䜛䚹ྠἲ䛿䚸኱⤫㡿௧➨ 175 ྕ䠄1987 ᖺ䠅䛻䜘䜚኱ᖜ䛻ಟṇ䛥䜜䛶䛔䜛䛜䚸་⸆ရ䛾㍺ධ䛻䛴䛔䛶䛿ྠ኱⤫㡿௧➨ 15 ᮲䛻䜘䜚䚸ྠἲ䛻௨ୗ䛾➨ 21-B ᮲䛜㏣ຍ䛥䜜䛯䚹

37

➨ 21-B ᮲䠖་⸆ရཪ䛿⿦⨨䛿䚸䛭䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅ཪ䛿㈍኎ᴗ⪅䛜ᮏἲᚊ䛻ᇶ䛵䛝㛗ᐁ䛜බᕸ䛩䜛つ๎ཬ䜃つᐃ䛻ᚑ䛳䛶Ⓩ㘓䛧䛺䛔㝈䜚䚸〇㐀䚸㈍኎䚸㈍኎䛾⏦ฟ䚸㍺ධ䚸㍺
ฟ䚸ὶ㏻ཪ䛿⛣㌿䛧䛶䛿䛺䜙䛺䛔䚹➨ 21 ᮲䠄b䠅㡯䚸䠄d䠅㡯ཬ䜃䠄e䠅㡯䛾つᐃ䛿䚸㐺⏝䛥䜜䜛㝈䜚䛻䛚䛔䛶䚸ᙜヱ་⸆ရཬ䜃ᶵჾ䛾Ⓩ㘓䛻㐺⏝䛥䜜䜛䜒䛾䛸䛩䜛䚹䛣䛾䜘䛖䛻䚸䝣䜱䝸䝢䞁䜈䛾ື≀⏝་⸆ရ䜢ྵ䜐་⸆ရ䛾㍺ධ䜢ᕼᮃ䛩䜛ሙྜ䚸㍺ධ䛧䜘䛖䛸䛩䜛஦ᴗ⪅䛿䚸㛵ಀ䛩䜛ἲ௧䛾つᐃ䛻ἢ䛳䛶チྍ䜢ྲྀᚓ䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹䜎䛯䚸ඹ࿴ᅜἲ➨3720 ྕ䛾➨ 21 ᮲䠄e䠅㡯䛿䚸ྠ᮲䛾つᐃ䛜䚸ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䜛䛣䛸䜢᫂グ䛧䛶䛔䜛䚹㈍኎
ᴗ⪅䛾✀㢮䛻䛴䛔䛶䚸ಖ೺┬䛜Ⓨ⾜䛧䛶䛔䜛䛂ඹ࿴ᅜἲ➨ 9711 ྕ䠄2009 ᖺ FDA ἲ䠅ᐇ᪋ἲつไ䛃䛻䜘䜛䛸䚸௨ୗ䛾䛸䛚䜚ศ㢮䛥䜜䜛䚹➨ 1 ⦅➨ 1 ⠇➨ 5 ᮲䜘䜚䠄⏝ㄒ䛾䜰䝹䝣䜯䝧䝑䝖㡰䠅
ὶ㏻ᴗ⪅䠄㍺ධᴗ⪅䞉㍺
ฟᴗ⪅䠅䠄Distributor/Importer
Exporter䠅ཎᮦᩱ䚸᭷ຠᡂศཪ䛿᏶ᡂရ䜢⮬䜙䛾౑⏝ཪ䛿௚ᴗ⪅ཪ䛿ᗑ⯒䛻༺኎㈍኎䛩䜛䛯䜑䚸㍺ධཪ䛿㍺ฟ䛩䜛஦ᴗ⪅䚹ὶ㏻ᴗ⪅䠄㍺ධᴗ⪅䞉㍺ฟ
ᴗ⪅䠅䛜୍⯡䛻ᑐ䛧䛶㈍኎䛩䜛ሙྜ䚸ᑠ኎ᴗ⪅䠄retailer䠅䛸䜏䛺䛥䜜䜛䚹

ὶ㏻ᴗ⪅䠄༺኎ᴗ⪅䠅
䠄Distributor/Wholesaler䠅ཎᮦᩱ䚸᭷ຠᡂศཪ䛿᏶ᡂရ䜢ᅜෆ䛷༺኎㈍኎䛩䜛䛯䜑䛻䚸ᅜෆ䛾஦ᴗ⪅䛛䜙ㄪ㐩䛩䜛஦ᴗ⪅䚹ᑠ኎ᴗ⪅䠄Retailer䠅ಖ೺⏝ရ䠄་⸆ရ䜢ྵ䜐䠅䜢୍⯡䛻┤᥋㈍኎䛩䜛஦ᴗ⪅䚹䝖䝺䞊䝎䞊
䠄Trader䠅ಖ೺⏝ရ䠄་⸆ရ䜢ྵ䜐䠅䛾Ⓩ㘓῭ᡤ᭷⪅䛷䛒䜛஦ᴗ⪅䛷䚸ཎᮦᩱ䛾ㄪ㐩䚸ᵓᡂせ⣲䛾Ვໟ䚸〇ရ䛾䝰䝜䜾䝷䝣䚸ရ㉁⟶⌮䛾ᇶ‽ཬ䜃ᡭ㡰䛾ᥦ౪䜢⾜䛖䛜䚸ᙜヱ〇ရ䛾〇㐀䛿チྍྲྀᚓ῭䛾〇㐀ᴗ⪅䛻ጤク䛩䜛஦ᴗ⪅䚹䝖䝺䞊䝎䞊䛿ᙜヱ〇ရ䛾ὶ㏻ཪ䛿㈍኎䜢ᐇ᪋䛩䜛䛣䛸䛜䛷䛝䜛䚹ୖグ䛾ᐃ⩏䛻䛒䜛䛸䛚䜚䚸㍺ධᴗ⪅䛿䛂ὶ㏻ᴗ⪅䛃䛻ศ㢮䛥䜜䚸ὶ㏻ᴗ⪅䛸䛧䛶䛾 LTO 䛾ྲྀᚓ䛜ᚲせ䛸䛥䜜䜛䚹

3.4.1 せ௳
๓㏙䛾䛸䛚䜚䚸䝣䜱䝸䝢䞁䜈ື≀⏝་⸆ရ䜢㍺ධ䛩䜛䛯䜑䛻䛿䚸㈍኎ᴗ⪅䛿ᙜᒁ䛛䜙チྍド䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䛜䚸་⸆ရ䛻㛵㐃䛧䛶஦ᴗ⪅䛻௜୚䛥䜜䜛チྍド䛿䚸஦ᴗチྍド䠄LTO䠖License to
Operate䠅䛸࿧䜀䜜䛶䛔䜛䚹LTO 䛿䚸་⸆ရ䛾㍺ධ䛰䛡䛷䛺䛟䚸䛭䛾〇㐀䜔ὶ㏻䚸㍺ฟ䛻ᦠ䜟䜛஦ᴗ⪅䛻䜒ྲྀᚓ䛜ồ䜑䜙䜜䛶䛔䛶䚸ᇶᮏⓗ䛺⏦ㄳ䝥䝻䝉䝇䛿ඹ㏻䛧䛶䛔䜛䚹38ື≀⏝་⸆ရ䛾㍺ධ䜢ᕼᮃ䛩䜛஦ᴗ⪅䛿䚸ḟ㡯䛻ヲ㏙䛩䜛ᡭ㡰䛻ᚑ䛳䛶ồ䜑䜙䜜䜛⏦ㄳ᭩䜔᭩㢮䜢ᙜᒁ䛻ᥦฟ䛧䚸ᑂᰝ䜢ཷ䛡䛺䛡䜜䜀䛺䜙䛺䛔䚹ᑂᰝ䛻ྜ᱁䛩䜛䛸䚸LTO 䛜௜୚䛥䜜䜛䚹
䜎䛯䚸LTO 䛜௜୚䛥䜜䛯ᚋ䛷䜒䚸௨ୗ䛾஦㡯䛾ᐇ㊶䛜ồ䜑䜙䜜䜛䚹Ɣ་⸆ရ䛾㐺ṇὶ㏻䠄GDP䠅ཬ䜃་⸆ရ䛾㐺ษಖ⟶䠄GSP䠅䜺䜲䝗䝷䜲䞁㡰Ᏺ䛻䛴䛔䛶䛾ᐃᮇⓗ䛺᳨ᰝƔ䝞䝸䜶䞊䝅䝵䞁䠄ኚ᭦஦㡯䠅䛜Ⓨ⏕䛧䛯䛸䛝䛾ᙜᒁ䜈䛾㏿䜔䛛䛺ሗ࿌

3.4.2 ㈨᱁ド᫂
㍺ධᴗ⪅䛜ື≀⏝་⸆ရ䛾 LTO 䜢ྲྀᚓ䛩䜛䛯䜑䛾ᡭ⥆䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹

3.4.2.1 㟁Ꮚ䝫䞊䝍䝹䠄eServices Portal䠅䜰䜹䜴䞁䝖䛾ྲྀᚓ㍺ධᴗ⪅䛜 LTO 䜢⏦ㄳ䛩䜛䛯䜑䛾㟁Ꮚ䝅䝇䝔䝮䠄eServices Portal䠅䛷䛿䚸䜰䜹䜴䞁䝖䛾஦๓ྲྀᚓ䛿ᚲせ䛸䛥䜜䛶䛔䛺䛔䚹

3.4.2.2 LTO 䛾ྲྀᚓ㍺ධᴗ⪅䛿䚸䛂ὶ㏻ᴗ⪅䛃䛾 LTO 䜢ྲྀᚓ䛩䜛䛣䛸䛜ᚲせ䛷䛒䜛䛜䚸ྠ LTO 䛾⏦ㄳᡭ⥆䛿㈍኎ᴗ⪅䛾 LTO 䛾⏦ㄳ䛸ྠ䛨䛷䛒䜛䛯䜑䚸ᡭ⥆䛾ヲ⣽䛿䚸䛂3.3.2.2 LTO 䛾ྲྀᚓ䛃䛻グ㍕䛧䛯䚹

3.5 ື≀⏝་⸆ရ䛾㍺ධチྍ䛸㍺ධ᫬䛾᳨ᰝ
3.5.1 ㍺ධチྍ
๓㏙䛾䛸䛚䜚䚸ື≀⏝་⸆ရ䛾㍺ධ䛻䛒䛯䛳䛶䛿䚸㍺ධ䜢ᕼᮃ䛩䜛〇ရ䜢Ⓩ㘓䛧䚸CPR 䜢ྲྀᚓ䛧䛺䛡䜜䜀䛺䜙䛺䛔䠄䛂2.1 ື≀⏝་⸆ရ䛾㈍኎Ⓩ㘓䛃䜢ཧ↷䠅䚹䛥䜙䛻䚸ື≀⏝་⸆ရ䜢㍺ධ䛧䜘䛖䛸䛩䜛஦ᴗ⪅䛿䚸ື≀⏝་⸆ရ䛾㍺ධ䛾䛯䜑䛾 LTO 䜢ྲྀᚓ䛧䛺䛡䜜䜀䛺䜙䛺䛔䠄䛂3.4 ㍺ධᴗ⪅䛃䜢ཧ↷ 䠅䚹⾜ᨻ࿨௧ 2013-0022 䛻䜘䜜䜀䚸እᅜ䛷〇㐀䛥䜜䛯ື≀⏝་⸆ရ䜢㍺ධ䛩䜛䛯䜑䛻 CPR 䜢⏦ㄳ䛩䜛ሙྜ䚸䛭䛾⏦ㄳ᭩㢮䛻䛿ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅䜢ῧ௜䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹

3.5.2 ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅⏦ㄳ᭩䛸ᡭ⥆
ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅䛾⏦ㄳ䛻ᚲせ䛺᭩㢮䛸ᡭ⥆䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹ᚲせ᭩㢮

1. ⏦ㄳ౫㢗᭩

39

2. AO2013-0022 ู⣬ B䠄GMP ドᣐ᭩㢮ホ౯⏦ㄳᵝᘧ䠅䠄䛂6.2 ⾜ᨻ࿨௧ 2013-0022 䛾ู⣬䛃䜢ཧ↷䠅
3. AO2013-0022 ู⣬ C䠄GMP ドᣐ᭩㢮䝗䝅䜶䚹PIC/S ຍ┕ᅜ䛾ሙྜ䛿୙せ䛰䛜䚸᪥ᮏ䛾ሙྜ䛿ື≀⏝་⸆ရ䜢⟶㎄䛩䜛㎰ᯘỈ⏘┬䛜
PIC/S 䛾ຍ┕ᶵ㛵䛷䛿䛺䛔䛯䜑䚸PIC/S 㠀ຍ┕ᅜ䛸䛧䛶ᢅ䜟䜜䜛䛾䛷ᥦฟ䛜ᚲせ䛷䛒䜛䚹䜎䛯䚸ศὀ䛾ሙྜ䛿ཎ⏘ᅜ䛾ศᯒド᫂᭩䠄CoA䠅䛸cGMP 䜒ྵ䜑䜛ᚲせ䛜䛒䜛䚹䛣䛾Ⅼ䛿䝠䜰䝸䞁䜾䛻䜘䛳䛶☜ㄆ῭䛷䛒䜛䠅䠄䛂6.2 ⾜ᨻ࿨௧ 2013-0022 䛾ู⣬䛃䜢ཧ↷䠅
3. AO2013-0022 ู⣬ E䠄ㄋ⣙᭩䠅䠄䛂6.2 ⾜ᨻ࿨௧ 2013-0022 䛾ู⣬䛃䜢ཧ↷䠅
4. GMP ド᫂᭩䠄䝇䜻䝱䞁ྍ䠅
GMP ド᫂᭩䛿䚸GMP ド᫂᭩䛾䜋䛛䚸WHO ་⸆ရド᫂᭩䚸ཪ䛿≉ᐃ䛾་⸆ရ䞉๣ᙧ䛻ᑐ䛩䜛〇㐀チྍドཪ䛿〇㐀ᢎㄆ䚹⏦ㄳᡭ㡰

1. ⤫ྜ⏦ㄳ᭩䛾ྲྀᚓ⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䜢 FDA 䛾䝃䜲䝖䛛䜙䝎䜴䞁䝻䞊䝗䛧䛶グධ䛩䜛䚹⤫ྜ⏦ㄳ᭩䛾㟁Ꮚ䝣䜯䜲䝹䛾䝎䜴䞁䝻䞊䝗䝸䞁䜽䠖https://www.fda.gov.ph/wp-content/uploads/2021/04/IntegratedApplication-Form-XLSX-Format.xlsx
2. ⤫ྜ⏦ㄳ᭩䛾సᡂ䝎䜴䞁䝻䞊䝗䛧䛯⏦ㄳ᭩䛻ᚲせ஦㡯䜢ṇ☜䛻グධ䛩䜛䚹⏦ㄳ᭩䛿䚸1䠅୍⯡᝟ሗ䚸2䠅௻ᴗ᝟ሗ䚸3䠅〇ရ᝟ሗ䚸4䠅䝃䝫䞊䝖᝟ሗ䚸5䠅౪⤥ඖཬ䜃䜽䝷䜲䜰䞁䝖䚸6䠅⏦ㄳ⪅᝟ሗ䛾 6 㒊䛷ᵓᡂ䛥䜜䛶䛔䜛䚹ᚲせ஦㡯䛜㐺ษ䛻グධ䛥䜜䜛䛸䚸⥳Ⰽ䛾䛂PROCEED䛃䝬䞊䜽䛜⾲♧䛥䜜䚸グධ䛜ᚲせ䛺䝣䜱䞊䝹䝗䛜㡰ḟ⾲♧䛥䜜䜛䚹
3. ஦๓ᑂᰝ䛾⏦ㄳ
fdac.letters.cdrr@fda.gov.ph ᐄ䛶䛻⏦ㄳ᭩㢮䜢䝯䞊䝹䛷㏦ಙ䛩䜛䚹
4. ஦๓ᑂᰝ
FDA 䛜஦๓ᑂᰝ䜢ᐇ᪋䛩䜛䚹஦๓ᑂᰝ䛻ྜ᱁䛧䛯ሙྜ䚸FDA 䛿⏦ㄳ⪅䛻䚸ᡭᩘᩱ䛾ᨭᡶ䜢⾜䛖䜘䛖㏻▱䛩䜛䚹஦๓ᑂᰝ䛻ྜ᱁䛧䛺䛛䛳䛯ሙྜ䚸FDA 䛿⏦ㄳ⪅䛻䛭䛾᪨䜢㏻▱䛩䜛䚹୙ྜ᱁䛾ሙྜ䚸⏦ㄳ⪅䛿ၥ㢟⟠ᡤ䛻ᑐᛂ䛧䛯ୖ䛷䚸෌ᗘ䚸䛂3䛃䛾ᡭ㡰䛻䜘䜚஦๓ᑂᰝ䛾⏦ㄳ䜢⾜䛖䚹
5. ᡭᩘᩱ䛾ᨭᡶ
FDA 䛾❆ཱྀཪ䛿㖟⾜䠄䝷䞁䝗䝞䞁䜽䜸䞁䝁䞊䝹䝨䜲䝯䞁䝖ཪ䛿 Bancnet䠅䛷ᣦᐃ䛥䜜䛯ᡭᩘᩱ䜢ᨭᡶ䛖䚹䛭䛾ᚋ䚸ᨭᡶド᫂᭩䜢 FDA 䛻㏦௜䛩䜛䚹ᨭᡶド᫂᭩䜢☜ㄆᚋ䚸FDA 䛿ᮏᑂᰝ䛻ධ䜛䚹
6. ᮏᑂᰝ
FDA 䛾ᑂᰝᐁ䛻䜘䜚ᑂᰝ䛜⾜䜟䜜䜛䠄ᑂᰝᮇ㛫䛿䚸PIC/S ຍ┕ᅜཪ䛿᪥ᮏ䛾 GMP ᭩㢮䛾ሙྜ⣙ 60 ᪥䚸䛭䜜௨እ䛿 120 ᪥䠅䚹䛣䛾㝿䚸ᑠ䛥䛺ၥ㢟䛻䛴䛔䛶䛿䚸FDA 䛛䜙㟁Ꮚⓗ䛺ᙧᘧ䛷⏦ㄳ⪅䛸䛾䜔䜚ྲྀ䜚䛜䛺䛥40䜜䜛䛣䛸䛜䛒䜛䚹䛭䜜௨እ䛾ሙྜ䛿䚸䛂㟁Ꮚ୙ഛ㏻▱᭩䛃䠄E-NOD䠅䛜㏦௜䛥䜜䜛䚹⏦ㄳ⪅䛜䛣䜜䜢ཷ㡿䛧䛯ሙྜ䚸㏿䜔䛛䛻ᑐᛂ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹ᑂᰝ䛿䜎䛪᭩㢮ᑂᰝ䛜ᐇ᪋䛥䜜䜛䚹᭩㢮䛻୙ഛ䛜䛺䛔ሙྜ䚸䛭䛾⤖ᯝ䛜 FROO䠄ᆅᇦつไ㐠⏝஦ົᡤ䠅䛻㏻▱䛥䜜䜛䚹᭩㢮ᑂᰝ䛷䚸PIC/S
GMP 䛾ᇶ‽䜢‶䛯䛧䛶䛔䜛䛸䛔䛖༑ศ䛺ドᣐ䛜䛺䛔䛸ุ᩿䛥䜜䛯ሙྜ䚸
FROO 䛿 FDA 䝣䜱䝸䝢䞁䛾 GMP ᰝᐹᅋ䛻䜘䜛⌧ᆅㄪᰝ䜢ྲྀ䜚Ỵ䜑䜛䚹⌧ᆅㄪᰝ䛾⤖ᯝ䚸ၥ㢟䛜䛺䛡䜜䜀䚸FROO 䛿᥎⸀䛾㏻▱䜢 CDRR 䛻㏦௜䛩䜛䚹୍᪉䚸⌧ᆅㄪᰝ䛾⤖ᯝ䚸ၥ㢟䛜䛒䜛䛸ุ᩿䛥䜜䛯ሙྜ䛻䛿䚸ᣄྰ䛾᥎⸀䛜 FROO 䛛䜙 CDRR 䛻㏦௜䛥䜜䜛䚹
7. ⤖ᯝ㏻▱
ᑂᰝ䛾⤖ᯝ䚸⏦ㄳ䛜ᇶ‽䜢‶䛯䛧䛶䛔䛺䛔ሙྜ䚸୙チྍ㏻▱䠄LOD䠖
Letter of Disapproval䠅䛜⏦ㄳ⪅䛻㏦௜䛥䜜䜛䚹⏦ㄳ䛜ᇶ‽䜢‶䛯䛧䛶䛔䜛ሙྜ䚸ᑂᰝ䛾᭱⤊⤖ᯝሗ࿌᭩䛜సᡂ䛥䜜䚸䛭䜜䜢䝇䜻䝱䞁䛧䛯䜒䛾䛜ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅䛸䛸䜒䛻⏦ㄳ⪅䛻㏦௜䛥䜜䜛䚹つᐃ䛻䜘䜜䜀䚸FDA 䛿ᾏእ䛾⌧ᆅ〇㐀⌧ሙ䜢ᰝᐹ䛩䜛䛣䛸䛜䛷䛝䚸䛭䛾㝿䛾㈝⏝䛿⏦ㄳ⪅䛜㈇ᢸ䛩䜛䚹㈝⏝䛆ึᅇ䛇Ɣ 5,000 䝨䝋䠄1 ㍺ධᴗ⪅䞉1 〇㐀⌧ሙ䠅+1% LRF+5,000 䝨䝋
䠄FGC 䝴䝙䝑䝖䝺䝡䝳䞊䠅+1% LRF䛆᭦᪂䛇Ɣ 2,000 䝨䝋+1% LRF

᭷ຠᮇ㛫ᾏእ GMP ྲྀᚓ῭ド᫂᭩䠄GMP 䜽䝸䜰䝷䞁䝇䠅䛻グ㍕

㛵㐃䛩䜛㏻▱䜔䜺䜲䝗䝷䜲䞁䞉⾜ᨻ࿨௧ 2013-0022
䞉FDA ㏻▱ 2014-016
䞉FDA Citizen’s Charter CDRR 2022 3rd edition䠄ಖ㝤┬ FDA ᕷẸ᠇❶ CDRR2022 ➨ 3 ∧䠅䚸pp. 12-27

41

AO2013-0022 ูῧ C GMP ドᣐ䝗䝅䜶
ᚲせ䛺ᩥ᭩

〇㐀ẁ㝵
䝣䝹〇㐀

䝞䝹䜽〇㐀

QC 䝔䝇䝖

ໟ⿦䞉䝷䝧䝸䞁䜾ฟⲴẅ⳦

GMP ド᫂᭩䛾ཎᮏཪ䛿බド῭䛾෗
䛧

せ

せ

せ

せ

せ

せ

᭱᪂䛾᳨ᰝሗ࿌᭩
ཬ䜃グ㍕䛥䜜䛯୙ഛ䜈䛾〇㐀⪅䛾ᑐ
ᛂ䛾෗䛧

せ

せ

せ

せ

せ

せ

〇㐀⪅䛸㍺ධᴗ⪅䛾 GMP ዎ⣙䛾෗䛧䚹䝣䜱䝸䝢䞁䛷ὶ㏻
ணᐃ䛾〇ရ䛩䜉䛶
䛾䝸䝇䝖䜢ῧ௜䚹

せ

せ

せ

せ

せ

せ

⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹ཪ䛿ྠ➼䛾᭩㢮
䛾෗䛧

せ

せ

せ

䝞䝸䝕䞊䝅䝵䞁䝬䝇䝍䞊䝥䝷䞁䛾෗䛧䠄ᕤ⛬䚸ᇵᆅ඘䛶䜣䠄ヱᙜ䛩䜛ሙྜ䠅䚸Ύᤲ䚸䝁䞁䝢䝳䞊䝍䝅䝇䝔䝮䛺䛹ヱᙜ䛩䜛䜒䛾䚹䝞䝸䝕䞊䝅䝵䞁䛾ᑐ㇟䛸⠊ᅖ䜢ุ᩿䛩䜛䛾䛻౑⏝䛥䜜䛯䝸䝇䜽䜰䝉䝇䝯䞁䝖䜢ྵ䜐䠅せせせヨ㦂᪉ἲ䝞䝸䝕䞊
䝅䝵䞁䚸᪉ἲ௨㝆䛾
ᡭ⥆䛾᰿ᣐ

せ

せ

せ

㐓⬺ཪ䛿௙ᵝእ䛾ヨ㦂⤖ᯝ䛾ྲྀ䜚ᢅ䛔ᡭ㡰䛾෗䛧

せ

せ

せ

42

せ

せ

せ

せ

3.6 ື≀⏝་⸆ရ䝷䝧䝹ື≀⏝་⸆ရ㍺ධ௻ᴗ䜈䛾⪺䛝ྲྀ䜚ㄪᰝ䛷☜ㄆ䛧䛯䛸䛣䜝䚸FDA 䛿ື≀⏝་⸆ရ䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁䜢ฟ䛧䛶䛚䜙䛪䚸ື≀⏝་⸆ရ䛾䝷䝧䝹䛻䛴䛔䛶䚸௻ᴗ䛿䝠䝖⏝䛾་⸆ရ䛾䝷䝧䝹䛻㛵䛧䛶つᐃ䛧䛶䛔䜛ಖ೺┬⾜ᨻ࿨௧ 2012-0008䛂䝠䝖⏝་⸆ရ䛾୍⯡䝷䝧䝹せ௳䛻㛵䛩䜛つ๎䛾ᨵゞ䛃19䛻‽䛨䛶䛔䜛䛸䛾䛣䛸䛷䛒䛳䛯䚹ྠ⾜ᨻ࿨௧䛷䛿䚸➨ 4 ᮲䛂⏝ㄒ䛾ᐃ⩏䛃䛾➨ 13 㡯 b ྕ䛷䚸ྠ⾜ᨻ࿨௧䛻䛚䛡䜛་⸆ရ䛻䛿ື≀⏝་⸆ရ䜒ྵ䜎䜜䜛䛸䛧䛶䛔䜛䜒䛾䛾䚸➨ 6 ᮲䛂ලయⓗᣦ㔪䛃䛾➨ C 㡯䛂౛እ䛃䛻䛚䛔䛶䚸ື≀⏝་⸆ရ䛻䛿ྠ⾜ᨻ࿨௧䛾つᐃ䛜㐺⏝䛥䜜䛺䛔䛸䛧䛶䛔䜛䚹䛧䛛䛧䚸๓㡯䛾䛸䛚䜚䚸ᐇែ䛸䛧䛶䛿ྠ⾜ᨻ࿨௧䛻䛒䜛䝷䝧䝹䛾つᐃ䛜ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䛶䛔䜛䚹ලయⓗ䛺せ௳䛸䛧䛶䛿䚸➨ 5 ᮲䛻䛚䛔䛶୍⯡ⓗ䛺せ௳䛜ᐃ䜑䜙䜜䚸➨ 6 ᮲䛂ලయⓗᣦ㔪䛃䛾➨ A 㡯䛷䚸➨ 5 ᮲➨ 1 㡯䛷ᐃ䜑䜙䜜䛶䛔䜛ᚲ㡲஦㡯䛾ヲ⣽䛜ㄝ᫂䛥䜜䛶䛔䜛䚹୺䛺せ௳ᚲ㡲グ㍕஦㡯

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s.

〇ရྡ
๣ᙧཬ䜃ຠຊ
⸆⌮Ꮫⓗศ㢮
〇๣䞉⤌ᡂຠ⬟䞉ຠᯝᢞ୚㔞ཬ䜃ᢞ୚᪉ἲ
⚗ᚷ䚸౑⏝ୖ䛾ὀព䚸㆙࿌䠄ヱᙜ䛩䜛ሙྜ䠅┦஫స⏝䠄ヱᙜ䛩䜛ሙྜ䠅⸆≀᭷ᐖ཯ᛂ䠄ヱᙜ䛩䜛ሙྜ䠅㐣㔞ᢞ୚䛸ฎ⨨䠄ヱᙜ䛩䜛ሙྜ䠅ಖ⟶᮲௳ṇ࿡㔞ཪ䛿ໟ⿦䛾኱䛝䛥
MAH䠄㈍኎チྍಖᣢ⪅䠅䛾ྡ⛠䛸ఫᡤ〇㐀⪅䛾ྡ⛠䛸ఫᡤRx 䝅䞁䝪䝹ཬ䜃ὀព᭩䛝䠄ฎ᪉䜢せ䛩䜛་⸆ရ䛾ሙྜ䠅
ADR ሗ࿌᭩
Ⓩ㘓␒ྕ䝞䝑䝏␒ྕཬ䜃/ཪ䛿䝻䝑䝖␒ྕ䠄ヱᙜ䛩䜛ሙྜ䠅᭷ຠᮇ㝈ཬ䜃〇㐀ᖺ᭶᪥ゝㄒⱥㄒཪ䛿䝣䜱䝸䝢䝜ㄒཪ䛿䛭䛾ేグどㄆᛶ

㏻ᖖ䛾⎔ቃୗ䛷どㄆᛶ䛜☜ಖ䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹Ⰽ䜔✵ⓑ䛻䛴䛔䛶䛿䚸どㄆᛶ䛜☜ಖ䛥䜜䛶䛔䜛㝈䜚䚸≉ู䛺つไ䛿䛺䛔䚹

19 䝣䜱䝸䝢䞁ඹ࿴ᅜ FDA, “Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug

Products for Human Use”䠄https://www.fda.gov.ph/wp-content/uploads/2021/08/Administrative-Order-No.-20160008.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 12 ᪥䠅43ྠ⾜ᨻ࿨௧䛾௜㘓 A 䛻䛿䚸䝷䝧䝹䜢グ㍕䛩䜛Ვໟ䛾ᙧែ䛻䜘䜚䚸␗䛺䜛せ௳䛜ᐃ䜑䜙䜜䛶䛔䜛䚹ヲ⣽䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
ᙧែ

グ㍕஦㡯

ಶ⿦⟽

1. 〇ရྡ
2. ๣ᙧཬ䜃ຠຊ
3. ⸆⌮Ꮫⓗศ㢮
4. 〇๣䞉⤌ᡂ
5. ຠ⬟䞉ຠᯝ
6. ㆙࿌䠄ヱᙜ䛩䜛ሙྜ䠅
7. ಖ⟶᮲௳
8. Ვໟ䝃䜲䝈
9. MAH䠄㈍኎チྍಖᣢ⪅䠅䛾ྡ⛠䛸ఫᡤ
10. 〇㐀⪅䛾ྡ⛠䛸ఫᡤ
11. Rx 䝅䞁䝪䝹ཬ䜃ὀព᭩䛝䠄ฎ᪉䜢せ䛩䜛་⸆ရ䛾ሙྜ䠅
12. ADR ሗ࿌᭩
13. Ⓩ㘓␒ྕ
14. 䝞䝑䝏␒ྕཬ䜃/ཪ䛿䝻䝑䝖␒ྕ䠄ヱᙜ䛩䜛ሙྜ䠅15. ᭷ຠᮇ㝈ཬ䜃〇㐀ᖺ᭶᪥୺䝷䝧䝹䠄䝤䝸䝇䝍䞊䝟䝑䜽䚸䜰䝹䝭䝅䞊䝖䚸ᑠ⟽䜢㝖䛟䠅

1. 〇ရྡ
2. ๣ᙧཬ䜃ຠຊ
3. ⸆⌮Ꮫⓗศ㢮
4. 〇๣䞉⤌ᡂ
5. ຠ⬟䞉ຠᯝ
6. ㆙࿌䠄ヱᙜ䛩䜛ሙྜ䠅
7. ಖ⟶᮲௳
8. ṇ࿡㔞
9. MAH䠄㈍኎チྍಖᣢ⪅䠅䛾ྡ⛠䛸ఫᡤ
10. 〇㐀⪅䛾ྡ⛠䛸ఫᡤ
11. Rx 䝅䞁䝪䝹ཬ䜃ὀព᭩䛝䠄ฎ᪉䜢せ䛩䜛་⸆ရ䛾ሙྜ䠅
12. ADR ሗ࿌᭩䠄ಶ⿦⟽䛜䛺䛔ሙྜ䠅
13. Ⓩ㘓␒ྕ
14. 䝞䝑䝏␒ྕཬ䜃/ཪ䛿䝻䝑䝖␒ྕ䠄ヱᙜ䛩䜛ሙྜ䠅15. ᭷ຠᮇ㝈ཬ䜃〇㐀ᖺ᭶᪥䝤䝸䝇䝍䞊䝟䝑䜽ཪ䛿䜰
䝹䝭䝅䞊䝖

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〇ရྡ䜢䚸᭷ຠᡂศ䛜 1 䛴䛾ሙྜ䛿䛭䜜䛮䜜䛾ಶ⿦䛻䚸᭷ຠᡂศ䛜」ᩘ䛾ሙྜ䛿 2 ಶ⿦䛤䛸๣ᙧཬ䜃ຠຊ䜢䚸᭷ຠᡂศ䛜 1 䛴䛾ሙྜ䛿䛭䜜䛮䜜䛾ಶ⿦䛻䚸᭷ຠᡂศ䛜」ᩘ䛾ሙྜ䛿 2 ಶ⿦䛤䛸㈍኎チྍಖᣢ⪅䛾ྡ⛠ཪ䛿䝻䝂䠄ే⏝䜒ྍ䠅䜢䚸᭷ຠᡂศ䛜 1䛴䛾ሙྜ䛿䛭䜜䛮䜜䛾ಶ⿦䛻䚸᭷ຠᡂศ䛜」ᩘ䛾ሙྜ䛿 2ಶ⿦䛤䛸䠄ၟᶆ䛺䛧䛾〇ရ䛾䜏䠅

44

4.
5.

ᑠ⟽䛾୺䝷䝧䝹
䝇䝨䞊䝇䛻䜘䜚ㄪᩚ䛜⪃៖䛥䜜䜛䛣䛸䜒䛒䜛ໟ⿦ෆῧ௜ᩥ᭩
ຠຊ䛜␗䛺䜛〇ရ䛾ሙྜ䚸ඹ㏻䛾ㄝ᫂㈨ᩱ䜢౑⏝䛩䜛䛾䛷䛿䛺䛟䚸ຠຊู䛻␗䛺䜛᝟ሗ䜢ྵ䜑䜛䛣䛸䜒ྍ⬟ᝈ⪅⏝᝟ሗ䝸䞊䝣䝺䝑䝖

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Rx 䝅䞁䝪䝹䜢䚸᭷ຠᡂศ䛜 1 䛴䛾ሙྜ䛿䛭䜜䛮䜜䛾ಶ⿦䛻䚸᭷ຠᡂศ䛜」ᩘ䛾ሙྜ䛿 2 ಶ⿦䛤䛸䝤䝸䝇䝍䞊䝟䝑䜽ཪ䛿䜰䝹䝭䝅䞊䝖䛾ሙྜ䚸䝞䝑䝏␒ྕ䛸᭷ຠᮇ㝈䜢䛭䜜䛮䜜䛾ಶ⿦䛻䚸䛯䛰䛧䚸䛭䛾་⸆ရ䛜୍⯡ⓗ䛺䝤䝸䝇䝍䞊䝞䝑䜽ཪ䛿䜰䝹䝭䝅䞊䝖䛾㔞䜘䜚ᑡ䛺䛔䛣䛸䛻䛴䛔䛶䛾ไ㝈䛜䛺䛔ሙྜ䚸䝞䝑䝏␒ྕཪ䛿䝻䝑䝖␒ྕ䛸᭷ຠᮇ㝈䜢䛭䜜䛮䜜䛾ಶ⿦䛻グ㍕〇ရྡ๣ᙧཬ䜃ຠຊṇ࿡㔞㈍኎チྍಖᣢ⪅䛾ྡ⛠䛸䝻䝂Rx 䝅䞁䝪䝹䠄ヱᙜ䛩䜛ሙྜ䠅
Ⓩ㘓␒ྕ
ಖ⟶᮲௳
䝞䝑䝏␒ྕཪ䛿䝻䝑䝖␒ྕ䠄ヱᙜ䛩䜛ሙྜ䠅᭷ຠᮇ㝈ཬ䜃〇㐀᪥

1. 〇ရྡ
2. ๣ᙧཬ䜃ຠຊ
3. ⸆⌮Ꮫⓗศ㢮
4. 〇ရㄝ᫂
5. 〇๣⤌ᡂ
6. ⸆ຊᏛ䞉⸆≀ືែ䞉⎔ቃ≉ᛶ
7. ຠ⬟䞉ຠᯝ
8. ᢞ୚㔞ཬ䜃ᢞ୚᪉ἲ
9. ⚗ᚷ䚸౑⏝ୖ䛾ὀព䚸㆙࿌䠄ヱᙜ䛩䜛ሙྜ䠅
10. ዷፎཬ䜃ᤵஙᮇ㛫୰䛾౑⏝䛻㛵䛩䜛ㄝ᫂
11. ┦஫స⏝12. ⸆≀᭷ᐖ཯ᛂ
13. 㐣㔞ᢞ୚䛸ฎ⨨
14. ಖ⟶᮲௳15. ๣ᙧཬ䜃฼⏝ྍ⬟䛺ໟ⿦䠄ໟ⿦䛾኱䛝䛥䠅
16. ྲྀᢅ䛔䛸ᗫᲠ䛻㛵䛩䜛ㄝ᫂ཬ䜃≉グ஦㡯䠄ヱᙜ䛩䜛ሙྜ䠅
17. ㈍኎チྍಖᣢ⪅䛾ྡ⛠䛸ఫᡤ
18. 〇㐀⪅䛾ྡ⛠䛸ఫᡤ
19. ὀព᭩䛝
20. ADR ሗ࿌᭩
21. Ⓩ㘓␒ྕ22. ᢎㄆ䛾ึᅇᢎㄆ᪥䞉᭦᪂᪥23. ㄝ᫂ᩥ᭩䛾ᨵゞ᪥
1.
2.

〇ရྡ
〇ရㄝ᫂

45

3. ⸆䛾ᡂศ
4. ⸆䛾ຠຊ
5. ౑⏝⏝㏵
6. ື≀䛻ᢞ୚䛩䜛ᅇᩘ䛸㢖ᗘ
7. 㣧䜣䛷䛿䛔䛡䛺䛔䛸䛝
8. ື≀䛻ᢞ୚䛧䛶䛿䛔䛡䛺䛔䛸䛝
9. ⸆䛾ᮃ䜎䜜䛺䛔⤖ᯝ䞉๪స⏝
10. ື≀䛻ᢞ୚䛩䜛䛸䛝䛻㑊䛡䜛䜉䛝௚䛾⸆䜔㣗≀
11. ື≀䛻ᢞ୚䛩䜛䛾䜢ᛀ䜜䛯䛸䛝12. 㐣㔞ᢞ୚䛾඙ೃ
13. ᥎ዡᢞ୚㔞௨ୖ䛻᥋✀䛧䛯䛸䛝
14. ⸆䛾ಖ⟶᪉ἲ
15. ⋇་ᖌ䜈䛾┦ㄯ䛜ᚲせ䛺䛸䛝
16. ㈍኎チྍಖᣢ⪅䛾ྡ⛠䛸ఫᡤ
17. 〇㐀⪅䛾ྡ⛠䛸ఫᡤ
18. ADR ሗ࿌᭩
19. Ⓩ㘓␒ྕ20. ᢎㄆ䛾ึᅇᢎㄆ᪥䞉᭦᪂᪥21. ᝈ⪅⏝᝟ሗ䝸䞊䝣䝺䝑䝖䛾ᨵゞ᪥

3.7 PIC/S 䛻㛵䛩䜛ືྥ
䛂3.2 GMP䛃䛾㡯䛻䜒䛒䜛䛸䛚䜚䚸ASEAN 䛜 2004 ᖺ䛻 PIC/S䠄Pharmaceutical Inspection
Convention and Pharmaceutical Inspection Co-operation Scheme䠖་⸆ရᰝᐹ༠ᐃཬ䜃་⸆ရᰝᐹඹྠ䝇䜻䞊䝮䠅䛾 GMP 䜢 ASEAN ඹ㏻䛾 GMP 䛸䛧䛶ᑟධ䛩䜛䛣䛸䛻ྜព䛧䛯䛣䛸䛻క䛔䚸䝣䜱䝸䝢䞁ᨻᗓ䜒 2012 ᖺ 6 ᭶ 25 ᪥௜䛾⾜ᨻ࿨௧ 2012-0008 䛻䜘䜚䚸PIC/S GMP 䜢䝣䜱䝸䝢䞁䛾་⸆ရ
GMP 䛸䛩䜛䛣䛸䜢㏻▱䛧䛯䚹
PIC/S 䛾䜴䜵䝤䝃䜲䝖䛻ᥖ㍕䛥䜜䛶䛔䜛ຍ┕ᅜ䛻䝣䜱䝸䝢䞁䛾ྡ๓䛿䛺䛔䛯䜑䚸䝣䜱䝸䝢䞁䛿 PIC/S䛻ຍ┕䛧䛶䛔䛺䛔䛣䛸䛜ศ䛛䜛䛜䚸䝣䜱䝸䝢䞁⮬ᅜ䛾⾜ᨻ࿨௧䛻䜘䜚 PIC/S GMP 䜢䝣䜱䝸䝢䞁䛾་⸆ရ
GMP 䛸䛩䜛䛣䛸䜢ᐃ䜑䛶䛔䜛䚹FDA 䛾䜴䜵䝤䝃䜲䝖䛷䛿䚸་⸆ရ䛾〇㐀஦ᴗ⪅䛾⏦ㄳᡭ⥆䛻䛴䛔䛶ㄝ᫂䛧䛶䛔䜛䝨䞊䝆䛷䚸ཧ⪃㈨ᩱ䛸䛧䛶 PIC/S GMP 䛜⤂௓䛥䜜䛶䛚䜚䚸ྠ GMP 䛾඲ᩥ䛜 PDF 䛷䝎䜴䞁䝻䞊䝗䛷䛝䜛䚹
䜎䛯䚸LTO 䛾⏦ㄳ᫬䛻䚸⏦ㄳ⪅⮬䜙䛜⏦ㄳෆᐜ䜢☜ㄆ䛩䜛┠ⓗ䛷⏝ព䛥䜜䛶䛔䜛䝉䝹䝣䝏䜵䝑䜽䝅䞊䝖䜢ぢ䜛䛸䚸〇㐀䛾 LTO 䛾⏦ㄳ᫬䛻ᥦฟ䛩䜉䛝⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹䠄Site Master File䠅䛻㛵㐃䛧䛶䚸ḟ䛾 2 䛴䛾䝏䜵䝑䜽㡯┠䛜Ꮡᅾ䛩䜛䚹z㻼㻵㻯㻛㻿㻌㻳㻹㻼 䛾㛵㐃䛩䜛䝉䜽䝅䝵䞁䛜䚸ᥦฟ䛥䜜䜛⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹䛻ྵ䜎䜜䛶䛔䜛䛛䠛㻌zᥦฟ䛥䜜䜛⌧ᆅ䝬䝇䝍䞊䝣䜯䜲䝹䛿䚸㻼㻵㻯㻛㻿㻌㻳㻹㻼 䛻‽ᣐ䛧䛶䛔䜛䛛䠛㻌46

3.8 ASEAN 䛾㛵୚ཬ䜃௚䛾ᅜ㝿ᇶ‽䛻ᑐ䛩䜛ືྥ
䛂3.2 GMP䛃ཬ䜃䛂3.7 PIC/S 䛻㛵䛩䜛ືྥ䛃䛻䜒䛒䜛䛸䛚䜚䚸2004 ᖺ䛻 ASEAN 䛜 PIC/S GMP 䜢
ASEAN ඹ㏻䛾 GMP 䛸䛩䜛䛣䛸䛻ྜព䛧䛯䛣䛸䛻క䛔䚸䝣䜱䝸䝢䞁ᨻᗓ䜒 2012 ᖺ䛻 ASEAN 䛸Ṍㄪ䜢᏶඲䛻ྜ䜟䛫䚸⮬ᅜ䛾་⸆ရ GMP 䜢 PIC/S GMP 䛸䛧䛯䚹䛣䛾 GMP 䛿ື≀⏝་⸆ရ䛻䜒㐺⏝䛥䜜䛶䛔䜛䚹䛭䛾௚䛻䜒䚸་⸆ရศ㔝䛷䛾 ASEAN 䛸䛾༠ㄪ䛸䛧䛶䚸་⸆ရ䛾ศ㔝䛷䛿 ASEAN ඹ㏻ᢏ⾡䝗䝅䜶
䠄ACTD䠖ASEAN Common Technical Dossier䠅䜔 ASEAN ඹ㏻ᢏ⾡せ௳䠄ACTR䠖Common
Technical Requirements䠅䛜䝣䜱䝸䝢䞁䛷౑⏝䛥䜜䛶䛔䜛䚹䛧䛛䛧䛺䛜䜙䚸ACTD 䜒 ACTR 䜒䝠䝖⏝་⸆ရ䛻㐺⏝䛥䜜䜛䜒䛾䛷䚸ື≀⏝་⸆ရ䛻䛿㐺⏝䛥䜜䛺䛔䚹䛧䛯䛜䛳䛶䚸ື≀⏝་⸆ရ䛾ศ㔝䛻䛚䛔䛶ᮏㄪᰝ䛷☜ㄆ䛥䜜䛯 ASEAN 䛸䛾㛵୚䛿䚸GMP 䛾䜏䛷䛒䜛䚹䝣䜱䝸䝢䞁䛿 2012 ᖺ䛻 PIC/S GMP 䜢ᑟධ䛩䜛䜎䛷䛿䚸WHO 䛾 GMP 䜢⮬ᅜ䛾་⸆ရ GMP 䛸䛧䛶᥇⏝䛧䛶䛔䛯䚹⌧ᅾ䛷䜒䚸FDA 䛾䜴䜵䝤䝃䜲䝖䛻䛿䚸་⸆ရ䛾〇㐀ᴗ⪅ྥ䛡䛾ཧ↷᝟ሗ䛸䛧䛶 WHO
䛾 GMP 䛜ᥖ㍕䛥䜜䛶䛔䜛䚹PCI/S GMP 䜒䜒䛸䜒䛸䛿 WHO GMP 䛛䜙ὴ⏕䛧䛯䜒䛾䛷䛒䜛䛣䛸䛛䜙䚸䝣䜱䝸䝢䞁ᨻᗓ䛿་⸆ရ䛾ศ㔝䛻䛚䛔䛶䚸ᅜ㝿♫఍䛸Ṍㄪ䜢ྜ䜟䛫䛶䛝䛯䛸⌮ゎ䛥䜜䜛䚹

47

4. ὶ㏻䛾௙⤌䜏
4.1 ື≀⏝་⸆ရ䛾ὶ㏻䛾௙⤌䜏䝣䜱䝸䝢䞁䛷䛾ື≀⏝་⸆ရ䛾୍⯡ⓗ䛺ὶ㏻䛾ὶ䜜䛿䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹CPR 䜢ྲྀᚓ䛧䛯㍺ධ
ᴗ⪅䛜䚸ᐇ㝿䛻་⸆ရ䜢㍺ධ䛧䚸䜎䛪಴ᗜ䛻ಖ⟶䛩䜛䚹䛭䛾ᚋ䚸㍺ධᴗ⪅䛜༺኎ᴗ⪅䛻㈍኎䛧䚸༺኎ᴗ⪅䛜඲ᅜ䛾௦⌮ᗑ䛻〇ရ䜢༺䛩䚹䛣䛾Ⅼ䛻䛴䛔䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛷௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹䠄䝣䜱䝸䝢䞁䛷䛾ື≀ྥ䛡་⸆ရ䛾୍⯡ⓗ䛺ὶ㏻䛾ὶ䜜䛻㛵䛧䛶䠅䜎䛪ື≀⏝་⸆ရ䛻䛛䛛䜟䜛䛩䜉䛶䛾஦ᴗ⪅䛿ヱᙜ䛩䜛 LTO䠄License to Operate䠅䜢ྲྀᚓ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹ᙜ♫䛾䜘䛖䛺㍺ධᴗ⪅䛜㍺ධ䛩䜛ሙྜ䚸䛭䛾་⸆ရ䛾 GMP 䜽䝸䜰䝷䞁䝇䜢⤒䛶䚸CPR 䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹CPR 䛜䛺䛡䜜䜀㍺ධ䛭䛾䜒䛾䛜䛷䛝䛺䛔䚹䛭䛾ᚋ䚸ᐇ㝿䛻་⸆ရ䜢㍺ධ
䛧䚸䜎䛪಴ᗜ䛻⣡ရ䛩䜛䚹䛭䛧䛶䚸༺኎ᴗ⪅䛻㈍኎䛧䚸༺኎ᴗ⪅䛜඲ᅜ䛾௦⌮ᗑ䛻〇ရ䜢༺
䛧䛶䛔䛟䚹

48

4.2 ୺䛺ᅜෆὶ㏻ᴗ⪅2022 ᖺ 12 ᭶ 1 ᪥⌧ᅾ䚸FDA 䛾䜸䞁䝷䜲䞁↷ྜ䝫䞊䝍䝹20䛻䛿䚸1,920 ရ┠䛾ື≀⏝་⸆ရ䛜Ⓩ
㘓䛥䜜䛶䛚䜚䚸ྠ䝫䞊䝍䝹䛻Ⓩ㘓䛥䜜䛶䛔䜛ὶ㏻ᴗ⪅䛾ᩘ䛿 100 ♫䜋䛹䛷䛒䜛䚹Ⓩ㘓ᩘୖ఩䛾 10 ♫䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. Zoetis Philippines
2. Boehringer Ingelheim Animal Health Philippines
3. MSD Animal Health (Phils.)
4. Hipra Philippines
5. P & D Medivet Distribution
6. Ceva Animal Health (Philippines)
7. Vet Specialists
8. Jickstar Pharm
9. Prime Veterinary Phils
10. Asvet䛣䜜䜙䛾䛖䛱䛾ከ䛟䛿䚸ື≀་⸆ရᴗ⏺䛾኱ᡭ䜾䝻䞊䝞䝹௻ᴗ䛜䝣䜱䝸䝢䞁ᅜෆ䛷άື䛩䜛䛯䜑䛻タ❧䛧䛯఍♫䛷䛒䜛䚹䛣䛖䛧䛯఍♫䛿䚸⮬♫〇ရ䛾ື≀⏝་⸆ရ䜢ྵ䜑䛯ᾏእ〇ရ䜢㍺ධ䛧䚸ὶ㏻䛥
䛫䛶䛔䜛䚹ୖグ 10 ♫䛾䛖䛱䝣䜱䝸䝢䞁ᅜෆ䛾ື≀⏝་⸆ရ䜢୺䛻ᢅ䛳䛶䛔䜛䛾䛿䚸䜟䛪䛛 2 ♫䠄PrimeVeterinary Phils ཬ䜃 Asvet䠅䛾䜏䛷䚸䛭䜜䛮䜜≉ᐃ䛾〇㐀ᴗ⪅䛾〇ရ䜢୺䛻ᢅ䛳䛶䛔䜛䚹ୖグ䛾ὶ㏻ᴗ⪅䛾ከ䛟䛜ື≀⏝་⸆ရ༠఍䠄PVDA䠖Philippine Veterinary Drug Association䠅䛻ຍ┕䛧䛶䛔䜛䚹䜎䛯䚸㜚㭜⏝䛾〇ရ䜔䚸㣫ᩱῧຍ≀䛺䛹䚸≉ᐃ䛾ศ㔝䛻≉໬䛧䛶䛔䜛ὶ㏻ᴗ⪅䜒Ꮡᅾ䛩䜛䚹

4.3 ᅜෆື≀⏝་⸆ရ䛾ᕷሙ
4.3.1 ᅜෆື≀⏝་⸆ရ䛾ᕷሙつᶍ䝣䜱䝸䝢䞁䛾ື≀⏝་⸆ရ༠఍䛾䝕䞊䝍21䛻䜘䜛䛸䚸䝣䜱䝸䝢䞁䛻䛚䛡䜛ື≀⏝་⸆ရᴗ⏺䛾ᕷሙつᶍ䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹

20 https://verification.fda.gov.ph/veterinary_productslist.php
21 KAHPA 䝛䝑䝖䝽䞊䜻䞁䜾䝣䜷䞊䝷䝮䛾ሗ࿌᭩䠄https://www.kati.net/file/down.do?path=/animal/2021/10/&fileName=PT_Phillippines_Revised+2%281%29.pdf.
pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 16 ᪥䠅49ᅗ 䝣䜱䝸䝢䞁䛻䛚䛡䜛ື≀⏝་⸆ရᴗ⏺䛾ᖺ㛫኎ୖ䛢䛾᥎⛣* 䝣䜱䝸䝢䞁䛷䛿 1 ᭶ 1 ᪥䡚12 ᭶ 31 ᪥䜎䛷䜢 FY䠄఍ィᖺᗘ䠅䛸䛩䜛䛾䛜୍⯡ⓗ䛷䛒䜛2019 ᖺ䛾ື≀⏝་⸆ရ䛾ᖺ㛫኎ୖ䛢䛿⣙ 530 ൨䝨䝋䠄⣙ 1,300 ൨෇䠅䛷䛒䜚䚸ẖᖺቑຍ䛧䛶䛔
䜛䚹2019 ᖺ䛾ᖺ㛫኎ୖ䛢䛿 2014 ᖺ䛸ẚ㍑䛧䛶 57䠂ቑຍ䛧䛶䛔䜛䚹ື≀⏝་⸆ရ䛾ศ㔝ู䛾 5 ᖺᖹᆒᡂ㛗⋡䛸 2019 ᖺ䛾ᴗ⏺඲య䛻ᑐ䛩䜛኎ୖ䛢ẚ⋡䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹⾲ 䝣䜱䝸䝢䞁䛻䛚䛡䜛ື≀⏝་⸆ရ䛾ศ㢮ู䛾ᕷἣᴗ⏺඲య䛾኎ୖ䛢䛾䝖䝑䝥䛿䚸䝥䝺䝭䝑䜽䝇㣫ᩱ/㣫ᩱῧຍ≀䠄Feed premixes/Additives䠅䛷䛒䜚䚸඲య䛾 25䠂䜢༨䜑䛶䛔䜛䚹䛣䜜䜢㝖䛟䛸䚸ᐙ⚺⏝⏕≀〇๣䠄Poultry biologicals䠅䚸㇜➼⏝⏕≀〇๣䠄Swine and other biologicals䠅䛜኱䛝䛺኎ୖ䛢䜢༨䜑䛶䛔䜛䚹50

5 ᖺᖹᆒᡂ㛗⋡䜢ぢ䜛䛸䚸ᐙ⚺⏝⏕≀Ꮫⓗ་⸆ရ䜔䝥䝺䝭䝑䜽䝇㣫ᩱ/㣫ᩱῧຍ≀䛾ᡂ㛗⋡䛜㧗䛔䚹

4.3.2 ᅜෆ䝙䞊䝈䝣䜱䝸䝢䞁䛾⤫ィᒁ䛾䝨䞊䝆䛻ᥖ㍕䛥䜜䛶䛔䜛᝟ሗ22䛻䜘䜛䛸䚸䝣䜱䝸䝢䞁ᅜෆ䛾ᐙ␆ཬ䜃ᐙ⚺䛾⥲ᩘ䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹⾲ 䝣䜱䝸䝢䞁䛻䛚䛡䜛ᐙ␆ཬ䜃ᐙ⚺䛾✀ู⥲ᩘ

* carabao䠖䝣䜱䝸䝢䞁䛾䝇䜲䜼䝳䜴ୖグ䛾䛖䛱䚸㣫⫱ᩘ䛜᭱䜒ከ䛔ື≀䛿㭜䛷䛒䜚䚸䛣䜜䛿䝣䜱䝸䝢䞁䛷䛂㜚㭜䛃䛜ᅜẸⓗ䛺䜼䝱䞁䝤䝹䛷䛒䜛䛣䛸䜒୍ᅉ䛾䜘䛖䛷䛒䜛䚹ḟ䛔䛷㣫⫱ᩘ䛜ከ䛔ື≀䛿㇜䛷䛒䜚䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛻䛚䛔䛶䜒ື≀་⸆ရ䛾䝙䞊䝈䛻㛵䛧䛶௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹䠄䛂䝣䜱䝸䝢䞁䛷䛿䚸䛹䛾ື≀䛻ᑐ䛧䛶ື≀⏝་⸆ရ䛾䝙䞊䝈䛜䛒䜛䛛䛃䛸䛔䛖㉁ၥ䛻ᑐ䛧䛶䠅ୖ఩䛿㇜䠄swine䠅䛸㭜䠄poultry䠅䚹⥆䛔䛶䚸䝲䜼䚸䜰䝠䝹䠄duck䠅䚸䜎䛯㣴Ṫ㨶䠄ᾏỈ㨶䚸䜶䝡䚸ῐỈ㨶䠅䛾䝙䞊䝈䜒䛒䜛䚹䛯䛰䛧䚸㇜䛸㭜䛾䝙䞊䝈䜋䛹䛷䛿䛺䛔䚹䜎䛯䚸㏆ᖺ䚸䝲䜼䛸䜰䝠䝹䛾㣫⫱ᩘ䛜኱ᖜ䛻ቑ䛘䛶䛔䜛䚹䝣䜱䝸䝢䞁䛾⏣⯋䛷䛿␆⏘ᴗ䜢Ⴀ䜣䛷䛔䛺䛔ᐙᗞ䛷䜒䝲䜼䜢ᨺ䛧㣫䛔䛷㣫䛳䛶䛔䜛䛣䛸䛜䜘䛟䛒䜛䚹䜎䛯䚸䛂䝞䝻䝑䝖䛃䛸࿧䜀䜜䜛䜅໬┤๓䛾䜰䝠䝹䛾༸䜢ⲗ䛷䛯ᩱ⌮䛿䝣䜱䝸䝢䞁ྡ≀䛷䛒䜛䚹⌧ᅾ䚸䝲䜼䛸䜰䝠䝹䛻ᑐ䛩䜛ື≀་⸆ရ䛾䝙䞊䝈䛿㇜䜔㫽䛻⥆䛟఩⨨䛻䛒䜛䛜䚸ᑗ᮶䛣䜜䜙䛾䝙䞊䝈䜒኱䛝䛟䛺䜛ྍ⬟ᛶ䛜䛒䜛䚹௨ୗ䛻䝲䜼䛸䜰䝠䝹䛾⥲㣫⫱ᩘ䛸䛭䛾ᖺ㛫ᡂ㛗⋡䜢♧䛩䚹

22䝣䜱䝸䝢䞁䛾ᐙ␆䛸ᐙ⚺䛾⤫ィ䚸2016-2020䠄https://psa.gov.ph/content/livestock-and-poultry-statistics-

philippines䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 16 ᪥)51ᅗ 䝣䜱䝸䝢䞁䛻䛚䛡䜛䝲䜼䛾⥲㣫⫱ᩘ䛸䛭䛾ᖺ㛫ᡂ㛗⋡ᅗ 䝣䜱䝸䝢䞁䛻䛚䛡䜛䜰䝠䝹䛾⥲㣫⫱ᩘ䛸䛭䛾ᖺ㛫ᡂ㛗⋡52

4.4 ㍺ධ་⸆ရ䛾ᕷሙᐇែ䛸௒ᚋ䛾ぢ㏻䛧
FDA 䛻Ⓩ㘓䛥䜜䛶䛔䜛 1,900 ௨ୖ䛾ື≀⏝་⸆ရ䛾䛖䛱䚸䝣䜱䝸䝢䞁ᅜෆ䛷〇㐀䛥䜜䛶䛔䜛䜒䛾䛿䚸⣙ 1/3 䛷䛒䜛䚹㍺ධ䛻㛵䛧䛶䛿䚸䜰䝯䝸䜹䜢➹㢌䛻䚸50 䜋䛹䛾ᅜ䛛䜙㍺ධ䛥䜜䛶䛔䜛䚹䝣䜱䝸䝢䞁䛻䛚䛡䜛㏆ᖺ䛾ᅜෆ⏘་⸆ရ䛸㍺ධ་⸆ရ䛾᥎⛣䜢ẚ㍑䛩䜛䛸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹2018 ᖺ䛻䛚䛔䛶䛿䚸ᅜෆ⏘䛸ᾏእ⏘䛾Ⓩ㘓ᩘ䛿䜋䜌ྠᩘ䛰䛳䛯䛜䚸2022 ᖺ䛻䛚䛔䛶䛿ᾏእ⏘䛜ᅜෆ⏘䛾 3.5 ಸ௨ୖ䛻䛺䛳䛯䚹53䛥䜙䛻䚸䝣䜱䝸䝢䞁䛾ື≀⏝་⸆ရ䛻䛚䛔䛶㍺ධ䛾ከ䛔䝖䝑䝥 5 䛛ᅜ䠄䜰䝯䝸䜹䚸䝣䝷䞁䝇䚸䝇䝨䜲䞁䚸୰ᅜ䚸䝧䝖䝘䝮䠅䛷䛾᭱㏆ 5 ᖺ㛫䛾་⸆ရⓏ㘓ᩘ䛾᥎⛣䜢௨ୗ䛻♧䛩䚹䜰䝯䝸䜹䚸䝇䝨䜲䞁䚸䝣䝷䞁䝇䚸୰ᅜ䛾 4 䛛ᅜ䛻䛴䛔䛶䛿䚸2022 ᖺ䛾Ⓩ㘓௳ᩘ䛻䛛䛺䜚䛾ቑຍ䛜ぢ䜙䜜䜛䛜䚸䝧䝖䝘䝮䛻኱䛝䛺ኚ໬䛿䛺䛛䛳䛯䚹

௨ୖ䛾䝕䞊䝍䛛䜙䚸䜾䝻䞊䝞䝹໬䛻క䛔䚸௒ᚋ䜒䝣䜱䝸䝢䞁䛾ື≀⏝་⸆ရᕷሙ䛻䛚䛔䛶䚸㍺ධ〇ရ䛜ቑ䛘䜛䛣䛸䛜ண᝿䛥䜜䜛䛜䚸Ḣ⡿ཬ䜃୰ᅜ䛾䛥䜙䛺䜛ྎ㢌䛜ண᝿䛥䜜䜛䚹

4.5 ື≀⏝་⸆ရᴗ⏺䛾ㄢ㢟ື≀⏝་⸆ရᴗ⏺䛾ᒎᮃ䜢ண䛩䜛ୖ䛷䚸␆⏘ᴗ⏺䛭䛾䜒䛾䛾ᒎᮃ䜢ண䛩䜛䛣䛸䛿୙ྍḞ䛷䛒䜛䚹⌧ᅾ䚸䝣䜱䝸䝢䞁䛻䛚䛔䛶䚸␆⏘ᴗ⏺䛾᭱኱䛾ㄢ㢟䛿㈝⏝䛷䛒䜛䚹␆⏘ᴗ⏺䛻䛚䛔䛶䜒䚸ཎᩱ䜔㣫ᩱ䛾౯᱁䛰䛡䛷䛺䛟䛩䜉䛶䛾≀౯䛜ୖ䛜䛳䛶䛔䜛䛾䛷䚸␆⏘ᴗ⪅䛾฼┈䛜ᅽ㏕䛥䜜䛶䛔䜛䚹䛥䜙䛻䚸฼┈䜢ୖᅇ䜛ໃ䛔䛷㈝⏝䛜㧗㦐䛧䛶䛔䜛䛯䜑䚸␆⏘ᴗ⪅䛜⤒Ⴀ䜢⥆䛡䜛䛣䛸䛜㞴䛧䛟䛺䛳䛶䛔䜛䚹䛣䛾
䜘䛖䛺Ⅼ䜢⪃䛘䜛䛸䚸་⸆ရ஦ᴗ䜒㧗ရ㉁䛾䜒䛾䜢ప౯᱁䛷ᥦ౪䛩䜛ᚲせ䛜኱䛝䛟䛺䜛䛸ண᝿䛥䜜䜛䚹
䛣䛾Ⅼ䛻䛴䛔䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛻䛚䛔䛶䜒௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹␆⏘ᴗ⪅䛿ே㛫䛾㣗ᩱ䛾䛯䜑䛻⏕⏘䜢䛧䛶䛔䜛䛾䛷䚸ື≀⏝་⸆ရ஦ᴗ䜒ᣑ኱䛧䛶䛔䛟䛸ぢ䛶䛔䜛䚹ㄢ㢟䛿㈝⏝䛷䛒䜛䚹䛩䜉䛶䛾≀౯䛜ୖ䛜䛳䛶䛔䜛䛾䛷␆⏘ᴗ⏺䛻䛚䛔䛶䜒䚸ཎᩱ䛜㧗㦐䛧䛯䜚䚸㣫ᩱ䛾౯᱁䛜ୖ䛜䛳䛯䜚䛧䛶䚸␆⏘ᴗ⪅䛾฼┈䛜ᅽ㏕䛥䜜䛶䛔䜛䚹฼┈䜢ୖᅇ䜛ໃ䛔䛷㈝⏝䛜㧗㦐䛧䛶䛔䜛䛯䜑䚸␆⏘ᴗ⪅䛜⤒Ⴀ䜢⥆䛡䜛䛣䛸䛜㞴䛧䛟䛺䛳䛶䛔䜛䚹54

4.6 ᪥ᮏ〇ရ䛻ᑐ䛩䜛ホ౯䞉ពぢ୍⯡䛻䚸᪥ᮏ䛾〇ရ䛿ရ㉁䛜㧗䛟䚸ಙ㢗䛷䛝䜛䛸䛔䛖㧗䛔ホ౯䜢ᚓ䛶䛔䜛䚹䛯䛰䛧䚸䛔䛟䛴䛛䛾〇ရ䛷䛿౯᱁䛜௚ᅜ䛾〇ရ䜘䜚䜒㧗䛟䚸䛣䛾Ⅼ䛿᪥ᮏ〇ရ䛾ㄢ㢟䛸䛔䛘䜛䚹䝽䜽䝏䞁䛺䛹ಙ㢗ᛶ䛜㔜ど䛥䜜䜛་⸆ရ䛷䛿౯᱁䛜㧗䛟䛶䜒ཷ䛡ධ䜜䜙䜜䜛䛜䚸䛭䛾௚䛾〇ရ䛻䛴䛔䛶䛿䚸䝬䞊䜿䝑䝖䛻ཷ䛡ධ䜜䜙䜜䜛䛯䜑䛻䛿䚸䜒䛖ᑡ䛧Ᏻ䛔౯᱁䛷ᥦ౪䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹䛣䛾Ⅼ䛻䛴䛔䛶䛿䚸Superiorvet ♫䜈䛾䜲䞁䝍䝡䝳䞊䛻䛚䛔䛶䜒௨ୗ䛾ᅇ⟅䜢ᚓ䛯䚹᪥ᮏ䛾〇ရ䛿ရ㉁䛜㧗䛟䚸ಙ㢗䛷䛝䜛䚹䛯䛰䛧䚸䛔䛟䛴䛛䛾〇ရ䛷䛿౯᱁䛜௚ᅜ䛾〇ရ䜘䜚䜒㧗䛔䚹䝽䜽䝏䞁䛺䛹ಙ㢗ᛶ䛜㔜ど䛥䜜䜛་⸆ရ䛷䛿౯᱁䛜㧗䛟䛶䜒ཷ䛡ධ䜜䜙䜜䜛䛜䚸䛭䛾௚䛾〇ရ䛻䛴䛔䛶䛿䚸䜒䛖ᑡ䛧౯᱁䛜Ᏻ䛡䜜䜀䜒䛳䛸䝬䞊䜿䝑䝖䛷ཷ䛡ධ䜜䜙䜜䜛䛸ᛮ䛖䚹

5. ⏝ㄒ
Ɣ

ື≀⏝་⸆ရ䛸䛿䚸ື≀䛾⑌ᝈ䛾デ᩿䚸἞⒵䚸⦆࿴䚸἞⒪ཪ䛿ண㜵䛻౑⏝䛩䜛䛣䛸䜢┠ⓗ䛸䛧䚸ື≀䛾㌟యᶵ⬟䛾ᵓ㐀䛻ᙳ㡪䜢୚䛘䜛䛣䛸䜢ពᅗ䛧䛯䜒䛾䠄㣗ရ䜢㝖䛟䠅䛷䛒䜚䚸䝣䜱䝸䝢䞁䛻䛚䛔䛶䛿 FDA 䛻䜘䜛ᢎㄆ䛜ᚲせ䛷䛒䜛䚹23Ɣ་⸆ရ஦ᴗ⪅䛸䛿䚸་⸆ရ䛾〇㐀ᴗ⪅䚸෌㈍⪅䚸་⸆ရ㍺ධᴗ⪅䚸་⸆ရὶ㏻ᴗ⪅䚸་⸆ရ༺኎ᴗ⪅䚸་⸆ရ䛾㍺ฟᴗ⪅䚸ཬ䜃ඹ࿴ᅜἲ➨ 9711 ྕ䛷ᐃ䜑䛶䛔䜛ᐃ⩏䛻ヱᙜ䛩䜛஦ᴗయ䜢ᣦ䛩䚹24Ɣ㈍኎ᴗ⪅䛸䛿䚸㈍኎䛻䛛䛛䜟䜛ᴗ⪅䜢ᣦ䛧䚸ὶ㏻ᴗ⪅䚸ᑠ኎ᴗ⪅䚸䝖䝺䞊䝎䞊䜢ྵ䜐䚹25Ɣ

ὶ㏻ᴗ⪅䠄Distributor䠅䛿䚸䛥䜙䛻㍺ධᴗ⪅䠄Importer䠅䛸䚸༺኎ᴗ⪅䠄Wholesaler䠅䛻ศ㢮䛥
䜜䜛䚹㍺ධᴗ⪅䛸䛿䚸ཎᮦᩱ䚸᭷ຠᡂศཪ䛿᏶ᡂရ䜢⮬䜙䛾౑⏝ཪ䛿௚ᴗ⪅ཪ䛿ᗑ⯒䛻༺኎㈍኎䛩䜛䛯䜑䚸㍺ධ䛩䜛஦ᴗ⪅䛷䛒䜚䚸༺኎ᴗ⪅䛸䛿ཎᮦᩱ䚸᭷ຠᡂศཪ䛿᏶ᡂရ䜢ᅜෆ䛷༺኎㈍኎䛩䜛䛯䜑䛻䚸ᅜෆ䛾஦ᴗ⪅䛛䜙ㄪ㐩䛩䜛஦ᴗ⪅䜢ᣦ䛩䚹26Ɣᑠ኎ᴗ⪅䠄Retailer䠅䛿䚸ಖ೺⏝ရ䠄་⸆ရ䜢ྵ䜐䠅䜢୍⯡䛻┤᥋㈍኎䛩䜛஦ᴗ⪅䜢ᣦ䛩䚹27

23 ඹ࿴ᅜἲ➨ 9711 ྕ➨ 9 ᮲䠄https://www.officialgazette.gov.ph/2009/08/18/republic-act-no-9711䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
24 ⾜ᨻ࿨௧ 2012-0008 ➨ IV ᮲➨ 5 㡯䠄https://www.fda.gov.ph/wp-content/uploads/2021/04/AdministrativeOrder-No.-2012-0008.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
25 ඹ࿴ᅜἲ➨ 9711 ྕ䠄2009 ᖺ FDA ἲ䠅ᐇ᪋ἲつไ➨ 1 ⦅➨ 1 ⠇➨ 5 ᮲䠄https://www.officialgazette.gov.ph/2009/08/18/republic-act-no-9711䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
26 ඹ࿴ᅜἲ➨ 9711 ྕ䠄2009 ᖺ FDA ἲ䠅ᐇ᪋ἲつไ➨ 1 ⦅➨ 1 ⠇➨ 5 ᮲䠄https://www.officialgazette.gov.ph/2009/08/18/republic-act-no-9711䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
27 ඹ࿴ᅜἲ➨ 9711 ྕ䠄2009 ᖺ FDA ἲ䠅ᐇ᪋ἲつไ➨ 1 ⦅➨ 1 ⠇➨ 5 ᮲䠄https://www.officialgazette.gov.ph/2009/08/18/republic-act-no-9711䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅55Ɣ䝖䝺䞊䝎䞊䠄Trader䠅䛸䛿䚸ಖ೺⏝ရ䠄་⸆ရ䜢ྵ䜐䠅䛾Ⓩ㘓῭ᡤ᭷⪅䛷䛒䜛஦ᴗ⪅䛷䚸ཎᮦᩱ䛾ㄪ㐩䚸ᵓᡂせ⣲䛾Ვໟ䚸〇ရ䛾䝰䝜䜾䝷䝣䚸ရ㉁⟶⌮䛾ᇶ‽ཬ䜃ᡭ㡰䛾ᥦ౪䜢⾜䛖䛜䚸ᙜヱ〇ရ䛾〇㐀䛿チྍྲྀᚓ῭䛾〇㐀ᴗ⪅䛻ጤク䛩䜛஦ᴗ⪅䛷䛒䜚䚸䝖䝺䞊䝎䞊䛿ᙜヱ〇ရ䛾ὶ㏻ཪ䛿㈍኎䜢ᐇ᪋䛩䜛䛣䛸䛜䛷䛝䜛䚹28Ɣ་⸆ရ〇㐀ᴗ⪅䠄Drug Manufacturer䠅䛸䛿䚸᭱⤊ⓗ䛻་⸆ရ䜢㈍኎ཪ䛿ὶ㏻䛥䛫䜛䛸䛔䛖┠ⓗ䜢ぢᤣ䛘䛯ㄪྜ䚸ຍᕤ䚸ྜᡂ䚸〇๣໬䚸඘䛶䜣䚸ໟ⿦䚸෌ໟ⿦䚸ኚ᭦䚸⿦㣭䚸௙ୖ䛢䚸䝷䝧䝹௜䛡䜢ྵ䜐䚸་⸆ရ䛾〇㐀䛻㛵୚䛩䜛䛒䜙䜖䜛ᴗົ䛻ᚑ஦䛩䜛஦ᴗ⪅䜢ᣦ䛩䚹Ɣ㎿㏿ᑂᰝ䛸䛿䚸ᙜヱື≀⏝་⸆ရ䛜௚ᅜ䛻䛚䛔䛶ື≀⏝་⸆ရ䛸䛧䛶᪤䛻ᢎㄆ䛥䜜䛶䛔䜛ሙྜ䚸䝣䜱䝸䝢䞁䛻䛚䛡䜛ᑂᰝᮇ㛫䛜▷⦰䛥䜜䜛䛸䛔䛖ไᗘ䛷䛒䜚䚸せ⣙䝺䝡䝳䞊䚸᳨ド䝺䝡䝳䞊䚸ඹྠᡭ⥆䛾 3 ✀㢮䛜䛒䜛䚹29Ɣせ⣙䝺䝡䝳䞊䠄abridged review䠅䛸䛿䚸་⸆ရ䛜䛒䜛 1 䛛ᅜ䛾⾜ᨻᙜᒁ䛻䜘䜚ᢎㄆ䛥䜜䛶䛔䛶䚸ྠᢎㄆ䛜ฟ䛥䜜䛯᪥䛛䜙 3 ᖺ௨ෆ䛾⏦ㄳ䛷䛒䜛ሙྜ䛻⾜䛖䛣䛸䛾䛷䛝䜛㎿㏿ᑂᰝ䛾᪉ἲ䛷䛒䜚䚸䝗䝅䜶䛾≉ᐃ䛾㒊ศ䛻ᑐ䛧䛶㝈ᐃⓗ䛺⊂❧ホ౯䛜⾜䜟䜜䜛䚹30Ɣ᳨ド䝺䝡䝳䞊䠄verification review䠅䛸䛿䚸䛒䜛 2 䛛ᅜཪ䛿䛭䜜௨ୖ䛾ᅜ䛷ᢎㄆ䛥䜜䛶䛔䜛་⸆ရ䛻ᑐ䛧䛶⾜䛖䛣䛸䛾䛷䛝䜛㎿㏿ᑂᰝ䛾᪉ἲ䛷䛒䜛䚹31Ɣඹྠᡭ⥆䠄collaborative procedure䠅䛸䛿䚸㎿㏿ᑂᰝ䛾୍䛴䛾᪉ἲ䛷䛒䜚䚸ୡ⏺ಖ೺ᶵ㛵་⸆ရ஦๓ᑂᰝ䠄WHO-PQP䠅䛺䛹䛸䛾ඹྠᑂᰝ䛻䜘䜚 FDA 䛜ᢎㄆ䛩䜛ᡭ⥆䛷䛒䜛䚹32

Ɣ

GMP 䜽䝸䜰䝷䞁䝇䛸䛿䚸ᙜヱ〇ရ䛜〇㐀ᅜ䛻䛚䛔䛶㐺ษ䛺 GMP ᇶ‽䛻‽ᣐ䛧䛶〇㐀䛥䜜䛶䛔䜛䛣䛸䜢☜ㄆཬ䜃ᢎㄆ䛩䜛ᡭ⥆䛷䛒䜛䚹33Ɣ஦ᴗチྍド䠄LTO䠖License to Operate䠅䛸䛿䚸་⸆ရ䛻㛵㐃䛧䛶ᙜᒁ䜘䜚஦ᴗ⪅䛻௜୚䛥䜜䜛チྍド䛷䛒䜛䚹34

28 ඹ࿴ᅜἲ➨ 9711 ྕ䠄2009 ᖺ FDA ἲ䠅ᐇ᪋ἲつไ➨ 1 ⦅➨ 1 ⠇➨ 5 ᮲䠄https://www.officialgazette.gov.ph/2009/08/18/republic-act-no-9711䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
29 ⾜ᨻ࿨௧ 2020-0045䠄https://www.fda.gov.ph/wp-content/uploads/2020/10/Administrative-Order-20200045.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
30 FDA ㏻▱ 2022-004䠄https://www.fda.gov.ph/fda-circular-no-2022-004-implementing-guidelines-on-theabridged-and-verification-review-pathways-for-new-drug-registration-applications-in-accordance-withadministrative-order-no-2020-0045/䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
31 FDA ㏻▱ 2022-004䠄https://www.fda.gov.ph/fda-circular-no-2022-004-implementing-guidelines-on-theabridged-and-verification-review-pathways-for-new-drug-registration-applications-in-accordance-withadministrative-order-no-2020-0045/䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
32 ⾜ᨻ࿨௧ 2020-0045䠄https://www.fda.gov.ph/wp-content/uploads/2020/10/Administrative-Order-20200045.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
33 ⾜ᨻ࿨௧ 2013-0022䠄https://www.fda.gov.ph/wp-content/uploads/2021/08/Administrative-Order-No.-20130022.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅
34 ⾜ᨻ࿨௧ 2014-0034䠄https://www.fda.gov.ph/wp-content/uploads/2021/08/Administrative-Order-No.-20140034.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 23 ᪥䠅

56

6. ཧ⪃㈨ᩱ
6.1 WHO 䛾᥎⸀ᇶ‽䛻䜘䜛་⸆ရ〇๣ド᫂᭩䠄CPP䠅
WHO 䛾᥎⸀ᇶ‽䛻䜘䜛་⸆ရ〇๣ド᫂᭩䠄CPP䠖Certificate of Pharmaceutical Product䠅䛾グ㍕ෆᐜ䛻䛿䚸௨ୗ䛾஦㡯䛜ྵ䜎䜜䜛䚹
Certificate of a pharmaceutical product35
This certificate conforms to the format recommended by the World Health Organization
No. of certificate
Exporting (certifying country):
Importing (requesting country):
1. Name and dosage form of the product:
1.1. Active ingredient(s) and amount(s) per unit dose:
For complete composition including excipients, see attached:
1.2. Is this product licensed to be placed on the market for use in the exporting country?
(yes/no)1.3 Is this product actually on the market in the exporting country?
If the answer to 1.2. is yes, continue with section 2A and omit section 2B.
If the answer to 1.2 is no, omit section 2A and continue with section 2B:
2.A.1. Number of product licence and date of issue:
2.A.2. Product licence holder (name and address):
2.A.3. Status of product licence holder8: (Key in appropriate category as defined in note)
2.A.3.1. For categories b and c the name and address of the manufacturer producing thedosage form is:
2.A.4. Is a summary basis for approval appended? (yes/no)
2.A.5. Is the attached, officially approved product information complete and consonant withthe licence? (yes/no/not provided)
2.A.6. Applicant for certificate, if different from licence holder (name and address):
2.B.1. Applicant for certificate (name and address):
2.B.2. Status of applicant: (Key in appropriate category as defined in footnote 8)
2.B.2.1. For categories (b) and (c) the name and address of the manufacturer producing
the dosage form is:
2.B.3. Why is marketing authorization lacking? (not required/not requested/underconsideration/refused)
2.B.4. Remarks:
3. Does the certifying authority arrange for periodic inspection of the manufacturing plant inwhich the dosage form is produced? (yes/no/not applicable)
If not or not applicable, proceed to question.
3.1. Periodicity of routine inspections (years):
3.2. Has the manufacture of this type of dosage form been inspected? (yes/no)
35 WHO 䛜᥎⸀䛩䜛་⸆ရ〇๣ド᫂᭩䠄CPP䠖Certificate of Pharmaceutical Product)䠄https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss/certification-scheme/modelcertificate-of-a-pharmaceutical-product䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 10 ᭶ 12 ᪥䠅

57

3.3 Do the facilities and operations conform to GMP as recommended by the World HealthOrganization? (yes/no/not applicable)
4. Does the information submitted by the applicant satisfy the certifying authority on all aspectsof the manufacture of the product: (yes/no)
If no, explain:
Address of certifying authority:
Telephone:
Fax:
Name of authorized person:
Signature
Stamp and dat

58

6.2 ⾜ᨻ࿨௧ 2013-0022 䛾ู⣬䠄䝃䞁䝥䝹䠅Annex B

59

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63

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䠄䝃䞁䝥䝹䠅Annex C66䠄䝃䞁䝥䝹䠅Annex E

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3. 䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ
1. ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ䞉㛵ಀἲ௧
1.1 ື≀⏝་⸆ရ䛾ᡤ⟶┬ᗇ䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䛾ື≀⏝་⸆ရ䛿䚸䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ┬䠄Kementerian Pertanian
Republik Indonesia䠅䛾␆⏘ື≀⾨⏕⥲ᒁ䠄Ditjen PKH䠖Direktorat Jenderal Peternakan dan
Kesehatan Hewan䠅䛜ᡤ㎄䛧䛶䛔䜛䚹36䝠䝖⏝་⸆ရ䛿䚸䜲䞁䝗䝛䝅䜰ඹ࿴ᅜಖ೺┬䛾་⸆ရཬ䜃་⒪ᶵჾᒁ䛜ᡤ㎄䛧䛶䛔䜛䛯䜑䚸ື≀⏝་⸆ရ䛸䛿᫂☜䛻༊ู䚸⟶⌮䛥䜜䛶䛔䜛䚹䛧䛯䛜䛳䛶䚸ᮏㄪᰝ䛿䚸ື≀⏝་⸆ရ䛾䜏䜢ᑐ㇟䛸䛧䛯䚹
1.1.1 ␆⏘ື≀⾨⏕⥲ᒁ䠄Ditjen PKH䠅䛾ᡤᤸ஦ົ
䛂2015 ᖺ䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ኱⤫㡿௧➨ 45 ྕ䛃䛻ᇶ䛵䛝䚸኱⤫㡿䛜ᕞᨻᗓ䜢⤌⧊䛩䜛䛣䛸䜢⿵బ䛩䜛䛯䜑䛻䚸㎰ᴗ┬䛿㎰ᴗศ㔝䛾ᨻົ䜢ᐇ᪋䛩䜛䛯䜑䛻タ䛡䜙䜜䛯 16 䛾ᶵ㛵䜢ᡤᤸ䛧䛶䛔䜛䚹䛭䛾ᡤ⟶䛾୍䛴䛷䛒䜛␆⏘ື≀⾨⏕⥲ᒁ䛿䚸ື≀䛾ಶయཬ䜃㞟ᅋ䛾೺ᗣቑ㐍䛻㛵䛩䜛ᨻ⟇❧᱌䛾‽ഛཬ䜃ᐇ᪋䛾䛯䜑䛻䚸௨ୗ䛾௵ົ䜢ᢸ䛳䛶䛔䜛䚹
1. ື≀⏝་⸆ရ䛾⟶⌮➼䛻䛚䛡䜛ᨻ⟇❧᱌䛾‽ഛ
2. ື≀⏝་⸆ရ䛾⟶⌮➼䛻䛚䛡䜛ᨻ⟇䛾ᐇ᪋
3. ື≀⏝་⸆ရ䛾⟶⌮䛻䛚䛡䜛つ⠊䚸ᇶ‽䚸ᡭ㡰ཬ䜃ุ᩿ᇶ‽䛾⟇ᐃ
4. ື≀⏝་⸆ရ䛾⟶⌮➼䛻䛚䛡䜛ᢏ⾡ᣦᑟ䛸┘╩
5. ື≀⏝་⸆ရ⟶⌮䛻㛵䛩䜛ホ౯ཬ䜃ሗ࿌
1.1.2 ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠅䛾ᡤᤸ஦ົ
Ditjen PKH 䛾ᢏ⾡ᐇ᪋ᶵ㛵䛷䛒䜛ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠖Balai
Besar Pengujian Mutu dan Sertifikasi Obat Hewan䠅37䛾୺䛺ᴗົ䛿䚸ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䚸ㄆド䚸ᑂᰝཬ䜃䝰䝙䝍䝸䞁䜾䜢⾜䛖䛣䛸䛷䛒䜛䚹BBPMSOH 䛿䚸䛣䜜䜙䛾ᴗົ䜢ᐇ᪋䛩䜛䛯䜑䛻䚸௨ୗ䛾௵ົ䜢ᢸ䛳䛶䛔䜛䚹
1. ື≀⏝་⸆ရ䛻㛵䛩䜛ྛ✀䝥䝻䜾䝷䝮䚸సᴗィ⏬䚸ண⟬䛾సᡂ䚹༠ຊ㛵ಀ䛾ᵓ⠏䚹ホ౯/ሗ࿌᭩䛾సᡂ
2. ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䛾ᐇ᪋
3. ື≀⏝་⸆ရ䛾ㄆド
4. ື≀⏝་⸆ရ䛾ᑂᰝ
5. ື≀⏝་⸆ရ䛾ὶ㏻᫬䛾䝰䝙䝍䝸䞁䜾
6. ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䛻㛵䛩䜛ᢏ⾡ཬ䜃᪉ἲ䛾㛤Ⓨ
36 ␆⏘ື≀⾨⏕⥲ᒁ䠄https://ditjenpkh.pertanian.go.id/pages/15-direktorat-kesehatan-hewan䚸᭱⤊䜰䜽䝉䝇᪥䠖

2022 ᖺ 7 ᭶ 8 ᪥䠅
37 ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄https://bbpmsoh.ditjenpkh.pertanian.go.id/profil/tugas-fungsi/䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶ 24 ᪥䠅

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7. ᐇ㦂⏝ື≀㣫ᩱ䛾〇๣໬/ㄪ〇8. ᐇ㦂ື≀䛾⟶⌮
9. ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䛻䛚䛡䜛ᗫᲠ≀䛾⟶⌮
10. ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂⤖ᯝ䛾ಖド
11. ရ㉁ヨ㦂ཬ䜃ື≀⏝་⸆ရ〇๣䛻㛵䛩䜛ᢏ⾡ᣦᑟ䛾ᐇ᪋12. 䝞䜲䜸䝔䜽䝜䝻䝆䞊〇ရ䛾䝞䜲䜸䝉䞊䝣䝔䜱䛾ホ౯ཬ䜃ᑂᰝ
13. 㣫ᩱ䛻ྵ䜎䜜䜛ື≀⏝་⸆ရ䛾᭷ຠᛶཬ䜃Ᏻ඲ᛶ䛾ヨ㦂
14. ື≀⏝་⸆ရ䛾ṧ␃ヨ㦂ཬ䜃䝰䝙䝍䝸䞁䜾15. ື≀⏝་⸆ရ䛾๪స⏝䛻㛵䛩䜛䝰䝙䝍䝸䞁䜾
16. ື≀⏝་⸆ရ䛾᭱኱ṧ␃ᇶ‽್䛾ホ౯
17. ື≀⏝་⸆ရ䛾᝟ሗ䛻㛵䛩䜛䝅䝇䝔䝮㛤Ⓨཬ䜃ᬑཬάື
18. ື≀⏝་⸆ရ䛾䝸䝣䜯䝺䞁䝇䝷䝪䝷䝖䝸䞊䝃䞊䝡䝇ཬ䜃䝸䝣䜯䝺䞁䝇䝔䝇䝖䛾ᐇ᪋19. ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䚸ㄆド䚸ホ౯ཬ䜃䝰䝙䝍䝸䞁䜾䜢ᐇ᪋䛩䜛䛯䜑䛾ᢏ⾡䝃䞊䝡䝇䛾ᥦ౪20. ᐇ㦂ື≀䛾⟶⌮ཬ䜃ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䛻䛚䛡䜛ᗫᲠ≀䛾⟶⌮21. ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂⤖ᯝ䛾ㄆド䚸┘どཬ䜃ಖㆤ
22. BBPMSOH 䛾஦ົ⟶⌮
1.1.3 ື≀⏝་⸆ရⓏ㘓ጤဨ఍䠄PPOH䠅ື≀⏝་⸆ရⓏ㘓ጤဨ఍䠄PPOH䠖Panitia Pendaftaran Obat Hewan䠅䛿䚸␆⏘⥲ᒁ䛾⤌⧊ᶵᵓ䛾୍䛴䛷䛒䜚䚸␆⏘⥲ᒁ㛗䜢㏻䛧䛶㎰ᴗ኱⮧䛻ຓゝ䜔ᥦ᱌䜢⾜䛖䚹䛥䜙䛻䚸ྠጤဨ఍䛿ື≀⏝་⸆ရ䛾ᑓ㛛ᐙ䛷ᵓᡂ䛥䜜䛶䛚䜚䚸ື≀⏝་⸆ရ䛾ရ㉁䚸᭷ຠᛶ䚸Ᏻ඲ᛶ䛻䛴䛔䛶䚸Ⓩ㘓᭩㢮䛾ᑂᰝ䜢⾜䛖䚹䛭䛾ᚋ䚸䜲䞁䝗䝛䝅䜰ᅜෆ䛷〇㐀䞉౪⤥䞉ὶ㏻䛜ྍ⬟䛛䛹䛖䛛䜢ุ᩿䛩䜛䚹
1.1.4 ື≀⏝་⸆ရጤဨ఍䠄KOH䠅ື≀⏝་⸆ရጤဨ఍䠄KOH䠖Komisi Obat Hewan䠅䜒 PPOH 䛸ྠᵝ䚸␆⏘⥲ᒁ䛾⤌⧊ᶵᵓ䛾୍䛴䛷䛒䜚䚸␆⏘⥲ᒁ㛗䜢㏻䛧䛶ᨻᗓつᐃ➨ 78 ྕ䛻ᇶ䛵䛝ື≀⏝་⸆ရ䛻㛵䛩䜛ᨻ⟇Ỵᐃ䛻㛵䛧䛶㎰ᴗ኱⮧䛻ຓゝ䜔ᥦ᱌䜢⾜䛖䚹ྠጤဨ఍䜒䚸ື≀⏝་⸆ရ䛾ᑓ㛛ᐙ䛷ᵓᡂ䛥䜜䛶䛚䜚䚸ື≀⏝་⸆ရ䛾᪂つⓏ㘓᭩㢮䛾ᑂᰝ䜢⾜䛖䚹
1.1.5 㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄GMO 〇ရᏳ඲ጤဨ఍䠅㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄KKH PRG䠖Komisi Keamanan Hayati Produk Rekayasa
Genetik䠅䛿䚸⎔ቃᯘᴗ┬ചୗ䛾ᶵ㛵䛷䛒䜚䚸㑇ఏᏊ⤌᥮䛘〇ရ䛾Ᏻ඲䛻㛵䛩䜛ᨻ⟇䛾❧᱌䚸☜❧ཬ䜃ド᫂᭩䛾Ⓨ⾜䛻㛵䛧䛶䚸䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䛾኱⮧ཬ䜃ᶒ㝈䜢᭷䛩䜛㠀ᨻᗓᶵ㛵䠄LPND䠖
Lembaga Pemerintah Non Departemen䠅䛾㛗䛻່࿌䜢⾜䛖䚹
1.1.6 ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊ホ౯ጤဨ఍䠄Panitia Penilai Cara Pembuatan Obat Hwan
Yang Baik䠅
1992 ᖺ䛻䚸㎰ᴗ኱⮧Ỵᐃ䛻䜘䜚䛂ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊ホ౯ጤဨ఍䠄CPOHB ホ౯ጤဨ఍䠅䛃䛜タ⨨䛥䜜䛯䚹38CPOHB ホ౯ጤဨ఍䛿䚸ḟ䛾௵ົ䜢ᢸ䛖䛣䛸䛻䜘䛳䛶␆⏘㛤Ⓨᒁ㛗䜢⿵బ䛧䛶䛔䜛䚹38 ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊䠄CPOHB䠅ホ౯ጤဨ఍タ⨨䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 302/Kpts/KP.150/6/2003 ྕ䠄https://jdihn.go.id/files/609/SK-302-03.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 16 ᪥䠅

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1. ᅜෆ〇㐀ᴗ⪅䛛䜙ᥦฟ䛥䜜䜛 CPOHB ド᫂᭩䛾⏦ㄳ᭩㢮䛜䛩䜉䛶䛭䜝䛳䛶䛔䜛䛛䛹䛖䛛☜ㄆ䛩䜛䚹
2. ᅜෆ〇㐀ᴗ⪅䛻ᑐ䛧䛶 CPOHB 䛾㐺⏝≧ἣ䜢ホ౯䛩䜛䚹ᅜእ〇㐀ᴗ⪅䛻ᑐ䛧䛶 CPOHB 䛾㐺⏝≧ἣ䜢᳨ᰝ䛩䜛䚹
3. ᅜෆ〇㐀ᴗ⪅䜈䛾 CPOHB ド᫂᭩䛾Ⓨ⾜䛻㛵䛧䛶䚸CPOHB 䛾㐺⏝䛻㛵䛩䜛ホ౯⤖ᯝ䜢☜ㄆ䛩䜛䚹
4. ᅜእ〇㐀ᴗ⪅䛻ᑐ䛩䜛᥎⸀≧䛾Ⓨ⾜䛻㛵䛧䛶䚸CPOHB 䛾㐺⏝䛻㛵䛩䜛᳨ᰝ⤖ᯝ䜢☜ㄆ䛩䜛䚹

1.2 ື≀⏝་⸆ရ䛾㛵ಀἲ௧䜲䞁䝗䝛䝅䜰䛷䛿䚸2020 ᖺ䛻䛂㞠⏝๰ฟ䛻㛵䛩䜛ἲᚊ 2020 ᖺ 11 ྕ䠄䜸䝮䝙䝞䝇ἲ䠅䛃䛜᪋⾜䛥䜜䛯䚹ྠἲ䛾ไᐃ䜢ཷ䛡䛶ᨻᗓ䛿䚸2021 ᖺ䛻䛂䝸䝇䜽䝧䞊䝇䛾஦ᴗチྍᑟධ䛻㛵䛩䜛ᨻᗓつ๎ 2021
ᖺ➨ 5 ྕ䛃䜢Ⓨ௧䛧䚸᪂䛧䛔஦ᴗチྍไᗘ䜢㛤ጞ䛧䛯䚹ᮏつ๎䛷䛿䚸4 ẁ㝵䛾䝸䝇䜽䝺䝧䝹䛜つᐃ䛥䜜䛶䛚䜚䚸䝺䝧䝹䛤䛸䛻␗䛺䜛஦ᴗチྍ䛾ྲྀᚓせ௳䛜ᐃ䜑䜙䜜䛶䛔䜛䚹஦ᴗチྍ⏦ㄳ䛾䛯䜑䛾せ௳䜔᮲௳䛿䚸஦ᴗつᶍ䛸㛵㐃䛩䜛஦ᴗศ㔝䛾䝸䝇䜽ᗘྜ䛔䛻䜘䜚␗䛺䜛䚹ື≀⏝་⸆ရ஦ᴗ䛿䚸㧗䝸䝇䜽䛻ศ㢮䛥䜜䜛䚹
㧗䝸䝇䜽䛻ศ㢮䛥䜜䛯஦ᴗ䛿䚸䝸䝇䜽䝧䞊䝇䛾䜸䞁䝷䜲䞁༢୍ᥦฟ䝅䝇䝔䝮䠄OSS䠖Online Single
Submission System䠅䜢㏻䛧䛶஦ᴗ⪅㆑ู␒ྕ䠄NIB䠖Nomor Induk Berusaha䠅䜢ྲྀᚓ䛩䜛䛣䛸䛻ຍ䛘䚸஦ᴗ㛤ጞ๓䛻䚸஦ᴗチྍ䛻ἢ䛳䛯せ௳䜢‶䛯䛩ᚲせ䛜䛒䜛䚹䛥䜙䛻䚸䜲䞁䝗䝛䝅䜰ᶆ‽⏘ᴗศ㢮䠄KBLI䠖Klasifikasi Baku Lapangan Usaha Indonesia䠅䛜ᑟධ䛥䜜䛶䛚䜚䚸௻ᴗ䛿ヱᙜ䛩䜛 KBLI 䝁䞊䝗䛻ᑐᛂ䛩䜛஦ᴗ䝁䞊䝗䜢ᡤ᭷䛩䜛ᚲせ䛜䛒䜛䚹KBLI 䛿䚸䜲䞁䝗䝛䝅䜰䛷ㄆ䜑䜙䜜䛶䛔䜛ᶆ‽ⓗ䛺஦ᴗศ㔝䜢ศ㢮䛧䛯䜒䛾䛷䛒䜚䚸5 ᱆䛾ᴗ✀ศ㢮䝁䞊䝗䛷⾲䛥䜜䜛䚹᭱᪂∧䛾 2020 ᖺ䜲䞁䝗䝛䝅䜰ᶆ‽⏘ᴗศ㢮䛿䛂KBLI 2020䛃䛷䛒䜛䚹䜲䞁䝗䝛䝅䜰䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅䛿䛂KBLI 21013䚸ື≀⏝་⸆ရ〇㐀ᴗ䠄Industri Produk Farmasi Untuk Hewan䠅䛃䚸䜲䞁䝗䝛䝅䜰䛷ື≀⏝་⸆ရ䛾㍺ฟධཬ䜃ὶ㏻䜢⾜䛖ᴗ⪅䛿䛂KBLI 46444䚸ື≀⏝་⸆ရ኱つᶍၟᴗ䠄Perdagangan Besar Obat Farmasi Untuk Hewan䠅䛃䛸䛔䛖䝁䞊䝗䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹䛣䜜䜙䛾䝁䞊䝗䛾ྲྀᚓ䛻䛛䛛䜟䜛せồ஦㡯䛻䛴䛔䛶䛿䚸䛂㎰ᴗศ㔝䛻䛚䛡䜛䝸䝇䜽䝧䞊䝇䛾஦ᴗㄆྍᐇ᪋䛻䛚䛡䜛஦ᴗάືᇶ‽ཬ䜃〇ရᇶ‽䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨
15 ྕ䛃䛻♧䛥䜜䛶䛚䜚䚸ᮏሗ࿌᭩䛷䛿䚸䛂5. ཧ⪃㈨ᩱ䛃䛾䛂5.1 ື≀⏝་⸆ရ〇㐀ᴗ⪅ཬ䜃㍺ධᴗ⪅䛜ྲྀᚓ䛩䜉䛝⏘ᴗศ㢮䝁䞊䝗䛃䛷ヲ㏙䛧䛯䚹
1.2.1 ἲᚊ䜲䞁䝗䝛䝅䜰䛻䛚䛔䛶ື≀⏝་⸆ရ䛻᭱䜒㛵㐃䛩䜛ἲᚊ䛿௨ୗ䛾 2 䛴䛷䛒䜛䚹ƔƔ␆⏘ཬ䜃ື≀⾨⏕䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜἲ 2009 ᖺ➨ 18 ྕ␆⏘ཬ䜃ື≀⾨⏕ᇶᮏつᐃ䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜἲ 1967 ᖺ➨ 6 ྕ

1.2.2 ᨻ௧䞉┬௧ື≀⏝་⸆ရ䛻㛵ಀ䛩䜛୺䛺ᨻ௧䞉┬௧䜢௨ୗ䛻♧䛩䚹ƔƔƔᨻᗓ䛾ᶒ㝈ཬ䜃ᆅ᪉⮬἞య䛸䛧䛶䛾ᕞ䛾ᶒ㝈䛻㛵䛩䜛 2000 ᖺᨻᗓつไ➨ 25 ྕື≀⏝་⸆ရ䛾ศ㢮䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ➨
14/PERMENTAN/PK.350/5/2017 ྕື≀⏝་⸆ရ஦ᴗチྍ䛾せ௳ཬ䜃⏦ㄳᡭ㡰䛻㛵䛩䜛㎰ᴗ኱⮧つᐃ➨71

8PermentanOT.14042009 ྕື≀⏝་⸆ရ䛾ᐇᆅㄪᰝཬ䜃┘╩䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 16 ྕ
CPOHB 䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 466KptsTN.260V99 ྕື≀⏝་⸆ရⓏ㘓⏦ㄳᡭ⥆䛻㛵䛩䜛␆⏘ᒁ㛗つᐃ➨ 02/Kpts/LB.450/F/03/06 ྕື≀⏝་⸆ရ䛾Ⓩ㘓ཬ䜃ရ㉁ヨ㦂䛻㛵䛩䜛せ௳ཬ䜃ᡭ㡰䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨695/Kpts/TN.260/8/96 ྕື≀⏝་⸆ရ䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつᐃ 1992 ᖺ➨ 78 ྕ㎰ᴗศ㔝䛻䛚䛡䜛䝸䝇䜽䝧䞊䝇䛾஦ᴗㄆྍᐇ᪋䛻䛚䛡䜛஦ᴗάືᇶ‽ཬ䜃〇ရᇶ‽䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 15 ྕ㑇ఏᏊ⤌᥮䛘〇ရ䛾Ᏻ඲䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつᐃ 2005 ᖺ➨ 21 ྕ䝸䝇䜽䝧䞊䝇䛾஦ᴗチྍᐇ᪋䛻㛵䛩䜛ᨻᗓつᐃ 2021 ᖺ➨ 5 ྕ

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1.2.3 ᐃ⩏䞉ศ㢮䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䛾つᐃ 39, 40, 41䛻䜘䜛䛸䚸ື≀⏝་⸆ရ䠄Obat Hewan䠅䛸䛿䚸⏕≀Ꮫⓗ〇๣
䠄Sediaan Biologik䠅䚸་⸆ရ䠄Farmasetik䠅䚸䝥䝺䝭䝑䜽䝇〇๣䠄Sediaan Premiks䠅ཬ䜃⏕⸆䠄Obat
Alami䠅䜢ྵ䜏䚸ື≀䛾἞⒪䚸⑕≧䛾⦆࿴ཪ䛿యෆ䛾໬Ꮫⓗ䝥䝻䝉䝇䜢ኚ᭦䛩䜛䛯䜑䛻౑⏝䛩䜛〇๣䛾䛣䛸䛷䛒䜛䚹
ື≀⏝་⸆ရ䛾౑⏝䛸䛿䚸ື≀䛾ච␿ຊ䛾ྥୖ䚸⑌⑓䛾ண㜵ཬ䜃἞⒪䚸ື≀䛾೺ᗣቑ㐍䚸೺ᗣᅇ᚟䛾䛯䜑䛾་⒪⾜Ⅽ䜢⾲䛧䛶䛔䜛䚹䛥䜙䛻䚸ື≀䛾೺ᗣཬ䜃ᡂ㛗䜢ಁ㐍䛩䜛䛯䜑䛻䚸ື≀⏝་⸆ရ䜢〇๣䛾✀㢮ཬ䜃ศ㢮䛻ᚑ䛳䛶㣫ᩱ䚸㣧ᩱỈ䛻ῧຍ䛧䚸Ⅼ⁲䛸䛧䛶ཪ䛿እ⏝䚸㠀⤒ཱྀⓗ䛻ฎ᪉䛩䜛⾜Ⅽ䛾䛣䛸䛷䛒䜛䚹
ື≀⏝་⸆ရ䛿䚸ື≀⏝་⸆ရ䜢౑⏝䛩䜛㝿䛾༴㝤ᗘ䛻ᇶ䛵䛔䛶ศ㢮䛥䜜䛶䛚䜚䚸ḟ䛾䛸䛚䜚 4䛴䛻ศ㢮䛥䜜䜛䚹
1.
2.
3.
4.

⏕≀Ꮫⓗ〇๣
་⸆ရ䝥䝺䝭䝑䜽䝇〇๣⏕⸆
1. ⏕≀Ꮫⓗ〇๣䛸䛿䚸ච␿Ꮫⓗ〇ἲ䛻䜘䜚⑌⑓䛾デ᩿䜔἞⒵䜢┠ⓗ䛸䛧䛶䚸ື≀䜔ື≀⤌⧊䜢⏝䛔䛶〇㐀䛥䜜䛯ື≀⏝་⸆ရ䛾䛣䛸䛷䛒䜛䚹䝽䜽䝏䞁䚸⾑Ύ䠄ᢠ⾑Ύ䠅䚸㑇ఏᏊ⤌᥮䛘〇ရ䚸⏕≀Ꮫⓗデ᩿ᮦᩱ䛺䛹䛜ྵ䜎䜜䜛䚹
2. ་⸆ရ䛸䛿䚸㠀⏕≀Ꮫⓗ〇ἲ䛻䜘䜚〇㐀䛥䜜䛯ື≀⏝་⸆ရ䛾䛣䛸䛷䛒䜛䚹䝡䝍䝭䞁䚸䝩䝹䝰䞁䚸㓝⣲䚸ᢠ⏕≀㉁䛺䛹䛾໬Ꮫ⒪ἲ๣䚸ᢠ䝠䝇䝍䝭䞁๣䚸ゎ⇕๣䚸㯞㓉๣䛺䛹䚸䛭䛾⸆⌮స⏝䛻ᇶ䛵䛔䛶౑⏝䛥䜜䜛〇๣䛺䛹䛜ྵ䜎䜜䜛䚹

39 ື≀⏝་⸆ရ䛾ศ㢮䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ➨ 14/PERMENTAN / PK.350 /5/2017 ྕ䠄https://simrek.ditjenpkh.pertanian.go.id/fileinfo/Regulasi-3-Permentan142017.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶
4 ᪥䠅
40 ␆⏘ཬ䜃ື≀⾨⏕䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜἲ 2009 ᖺ➨ 18 ྕ䠄https://peraturan.bpk.go.id/Home/Details/38634/uu-no-18-tahun-2009䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 4 ᪥䠅
41 ㎰ᴗศ㔝䛾ᐇ᪋䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつ๎ 2021 ᖺ➨ 26 ྕ䠄https://peraturan.go.id/common/dokumen/ln/2021/pp26-2021bt.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 10 ᪥䠅

72

3. 䝥䝺䝭䝑䜽䝇〇๣䛸䛿䚸ື≀⏝་⸆ရ䛾ᡂศ䜢㣫ᩱῧຍ≀䠄Feed Additive䠅䜔ື≀⏝䝃䝥䝸䝯䞁䝖䠄Feed Supplement䠅䛻ຍᕤ䛧䛯〇๣䛾䛣䛸䛷䛒䜛䚹ື≀䛾㣫ᩱ䜔㣧ᩱỈ䛻ΰ䛬䛶౑⏝䛩䜛䜒䛾䛷䛒䜚䚸䛭䛾⏝ἲ/⏝㔞䛿㧗ရ㉁䛷Ᏻ඲䛛䛴᭷ຠ䛷䛒䜛䛣䛸䛜ồ䜑䜙䜜䛶䛔䜛䚹
4. ⏕⸆䛸䛿䚸ື≀⏝་⸆ရ䛸䛧䛶౑⏝䛥䜜䜛᳜≀ᡂศ䚸ື≀ᡂศ䚸㖔≀ᡂศ䚸ཪ䛿䛣䜜䜙ᡂศ䛾ΰྜ≀䛾ᙧ䜢䛧䛯ኳ↛≀㉁ཪ䛿ㄪྜ≀䛾䛣䛸䛷䛒䜛䚹
ୖ㏙䛾ศ㢮䛛䜙䚸ᮏㄪᰝ䛷䛿䚸⏕≀Ꮫⓗ〇๣ཬ䜃་⸆ရ䛾䜏䜢ㄪᰝᑐ㇟䛸䛩䜛䚹䛥䜙䛻䚸ື≀⏝་⸆ရ䛿䚸౑⏝ୖ䛾༴㝤ᛶ䛸䛭䛾ᙳ㡪䛾ᗘྜ䛔䛻䜘䜚䚸ḟ䛾䛸䛚䜚ศ㢮䛥䜜䜛䚹a. ๻⸆䠄Obat Keras䠅b. ไ㝈௜䛝་⸆ရ䠄Obat Bebas Terbatas䠅
c. ᕷ㈍⸆䠄Obat Bebas䠅
a. ๻⸆䛸䛿䚸つᐃ䛻ᚑ䜟䛪䛻ᢞ୚䛥䜜䛯ሙྜ䚸䛣䜜䜙䛾ື≀〇ရ䜢ᦤྲྀ䛧䛯ື≀ཬ䜃/ཪ䛿ே㛫䛻ᐖ䜢䜒䛯䜙䛩ྍ⬟ᛶ䛾䛒䜛ື≀⏝་⸆ရ䛾䛣䛸䛷䛒䜛䚹ͤ๻⸆䛿䚸ື≀䛾⑌⑓ண㜵ཬ䜃/ཪ䛿἞⒪䜢┠ⓗ䛸䛧䛶౑⏝䛩䜛䛣䛸䛜䛷䛝䜛䚹⋇་ᖌ䛾ฎ᪉⟢䛜䛺䛡䜜䜀ධᡭ䛷䛝䛺䛔䚹๻⸆䛾౑⏝䛿䚸ᚲ䛪⋇་ᖌཪ䛿⋇་ᖌ䛾┘ど䛾䜒䛸ື≀་⒪ᚑ
஦⪅䛜⾜䛖䚹㠀⤒ཱྀⓗ䛻ᢞ୚䛥䜜䜛ື≀⏝་⸆ရ䛿๻⸆䛻ศ㢮䛥䜜䜛䚹b. ไ㝈௜䛝་⸆ရ䛸䛿䚸⏝㔞䚸᭹⏝つᐃ䚸๣ᙧ䚸ᢞ୚᪉ἲ䛜ㄝ᫂䛥䜜䚸≉ู䛺ὀព᭩䛝䛜䛒䜛๻⸆䛾䛣䛸䛷䛒䜛䚹ͤไ㝈௜䛝་⸆ရ䛿䚸⋇་ᖌ䛾ฎ᪉⟢䛜䛺䛡䜜䜀ධᡭ䛷䛝䛺䛔䚹ไ㝈௜䛝་⸆ရ䛾౑⏝䛿䚸ᚲ䛪⋇་ᖌཪ䛿⋇་ᖌ䛾┘ど䛾䜒䛸ື≀་⒪ᚑ஦⪅䛜⾜䛖䚹ͤ ๻⸆ཬ䜃ไ㝈௜䛝་⸆ရ䛿䚸ື≀⏝་⸆ရ䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅䚸㈍኎௦⌮ᗑ䚸ື≀⏝་⸆ရ䛾ಖ⟶ᗜᴗ⪅䛛䜙ᥦ౪䛥䜜䜛䚹ୖ㏙䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅䚸㈍኎௦⌮ᗑ䚸ື≀⏝་⸆ရ䛾ಖ⟶ᗜᴗ⪅䛿䚸ື≀⏝་⸆ရ஦ᴗチྍド䠄Izin usaha obat hewan䠅䜢ྲྀᚓ䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹c. ᕷ㈍⸆䛸䛿䚸ື≀䛻䛛䛛䜟䜛䛩䜉䛶䛾ே䛜⮬⏤䛻౑⏝䛷䛝䜛ື≀⏝་⸆ရ䛾䛣䛸䛷䛒䜛䚹ͤ䛯䛰䛧䚸ே䛾೺ᗣ䛻ᐖ䜢ཬ䜌䛩ྍ⬟ᛶ䛾䛒䜛ື≀⏝་⸆ရ䛿䚸㣗⏝䛾ᐙ␆䜈䛾౑⏝䛜⚗Ṇ䛥䜜䛶䛔䜛䚹
ͤື≀⏝ᕷ㈍⸆䛿䚸ື≀⏝་⸆ရ䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅䚸㈍኎௦⌮ᗑ䚸ື≀⏝་⸆ရ䛾ಖ⟶ᗜᴗ⪅䚸㈍኎ᗑ䛛䜙ᥦ౪䛥䜜䜛䚹ୖ㏙䛾〇㐀ᴗ⪅䚸㍺ධᴗ⪅䚸㈍኎௦⌮ᗑ䚸ື≀⏝་⸆ရ䛾ಖ⟶ᗜᴗ⪅䚸㈍኎ᗑ䛿䚸ື≀⏝་⸆ရ஦ᴗチྍド䠄Izin usaha obat hewan䠅䜢ྲྀᚓ䛩䜛䛣䛸䛜⩏ົ௜䛡䜙䜜䛶䛔䜛䚹73

2. ື≀⏝་⸆ရ㛵ಀไᗘ
2.1 ື≀⏝་⸆ရ䛾〇㐀䚸౪⤥ཬ䜃ὶ㏻䛻䛴䛔䛶䛂ື≀⏝་⸆ရ䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつᐃ 1992 ᖺ➨ 78 ྕ䛃42ཬ䜃䚸䛂ື≀⏝་⸆ရ䛾ᐇᆅㄪᰝཬ䜃┘╩䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 16 ྕ䛃43䛷䛿䚸ື≀⏝་⸆ရ䛾〇㐀䚸౪⤥ཬ䜃ὶ㏻䛻㛵䛧䛶䚸௨ୗ䛾䛣䛸䛜ᐃ䜑䜙䜜䛶䛔䜛䚹
1. ື≀⏝་⸆ရ䛾〇㐀䛻䛿䚸ཎᮦᩱ䚸༙᏶ᡂရཬ䜃/ཪ䛿᏶ᡂရ䜢䛩䛠䛻౑⏝䛷䛝䜛ື≀⏝་⸆ရ䛻ຍᕤ䛩䜛ᕤ⛬䛜ྵ䜎䜜䜛䚹
2. ➨ 1 㡯䛾ື≀⏝་⸆ရ䛾〇㐀䛿䚸ཎᮦᩱ䚸ሙᡤ䚸ᘓ≀䚸ᐊෆつᐃ䚸タഛ䚸ᢏ⾡⪅ཬ䜃〇㐀ᕤ⛬䛻㛵䛩䜛せ௳䜢‶䛯䛩䜒䛾䛷䛺䛡䜜䜀䛺䜙䛺䛔䚹
3. ౪⤥ཬ䜃/ཪ䛿ὶ㏻䛜ྍ⬟䛺ື≀⏝་⸆ရ䛿䚸Ⓩ㘓῭䛾ື≀⏝་⸆ရ䛻㝈䜙䜜䜛䚹䛧䛯䛜䛳䛶䚸ື≀⏝་⸆ရ䜢ὶ㏻䚸㈍኎䛩䜛┠ⓗ䛷〇㐀䚸౪⤥䛩䜛ሙྜ䚸Ⓩ㘓␒ྕ䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹
4. Ⓩ㘓␒ྕ䜢ྲྀᚓ䛩䜛䛯䜑䛻䚸䛩䜉䛶䛾ື≀⏝་⸆ရ䛿䚸Ⓩ㘓䚸ᑂᰝ䚸ヨ㦂䜢ཷ䛡䛺䛡䜜䜀䛺䜙䛪䚸ᑂᰝ䚸ヨ㦂䛻ྜ᱁ᚋ䚸ရ㉁ド᫂᭩䛜ᤵ୚䛥䜜䜛䚹
5. ౪⤥ཬ䜃/ཪ䛿ὶ㏻୰䛾ື≀⏝་⸆ရ䛿䚸䝷䝧䝹䜢ഛ䛘䛯≉ᐃ䛾ᐜჾཬ䜃/ཪ䛿⟽䛻ධ䜜䚸䛂ື≀ᑓ⏝䛾་⸆ရ䠄obat hanya untuk hewan䠅䛃䛸᫂☜䛻ㄞ䜑䜛䜘䛖⾲♧䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
6. ➨ 5 㡯䛾⾲♧䛿䚸䛭䜜䛻௜㝶䛩䜛䝟䞁䝣䝺䝑䝖䛻䜒グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
7. ஦ᴗ⪅ཬ䜃ಶே䛿䚸౑⏝䛻㐺䛥䛺䛔ື≀⏝་⸆ရ䜢ᥦ౪ཪ䛿ὶ㏻䛥䛫䛶䛿䛺䜙䛺䛔䚹
8. ➨ 7 㡯䛾౑⏝䛻㐺䛥䛺䛔ື≀⏝་⸆ရ䛻䛿䚸௨ୗ䛾䜒䛾䛜䛒䜛䚹a. Ⓩ㘓᫬ཪ䛿ὶ㏻๓䚸ὶ㏻୰䛾䛔䛪䜜䛻䛚䛔䛶䜒䚸ᨻᗓ䛜ᐃ䜑䛯ရ㉁ᇶ‽䛻ᇶ䛵䛟ရ㉁ヨ㦂䛻ྜ᱁䛧䛶䛔䛺䛔䚹b. つᐃ䛻ᇶ䛵䛔䛶ᐇ᪋䛩䜛䜉䛝ရ㉁ヨ㦂䜢⾜䛳䛶䛔䛺䛔䚹c. ≀⌮ⓗ䛺ኚ໬䜢ཷ䛡䛶䛔䜛䚹d. ᭷ຠᮇ㝈䛜ษ䜜䛶䛔䜛䚹
9. 䛩䜉䛶䛾⪅䛿௨ୗ䛾ື≀⏝་⸆ရ䛾〇㐀䚸౪⤥ཬ䜃/ཪ䛿ὶ㏻䜢⾜䛖䛣䛸䛜⚗Ṇ䛥䜜䜛䚹a. 䜲䞁䝗䝛䝅䜰䛷⑌ᝈ䛾䛺䛔⏕≀Ꮫⓗ〇๣䚹b. Ⓩ㘓␒ྕ䛾䛺䛔䜒䛾䚹c. 䝷䝧䝹ཬ䜃⾲♧䛜㈞䜙䜜䛶䛔䛺䛔䜒䛾䚹d. ရ㉁つ᱁䜢‶䛯䛧䛶䛔䛺䛔䜒䛾䚹10. ື≀⏝་⸆ရ䛾౪⤥䛿䚸௨ୗ䛾〇ရ䛻ᑐ䛧䛶⾜䜟䜜䜛䚹a. ᅜෆ⏕⏘䛾ື≀⏝་⸆ရb. ㍺ධ䛾ື≀⏝་⸆ရ
11. ➨ 10 㡯䛾ື≀⏝་⸆ရ䛿ḟ䛾㡯┠䜢ྵ䜐䚹a. ཎᩱb. ༙᏶ᡂရ
c. ὀᑕჾ䛺䛹䛾ື≀⏝་⒪ᶵჾ䠄peralatan kesehatan hewan䠅䜢ྵ䜐᏶ᡂရཪ䛿ྵ䜎䛺䛔᏶ᡂရ

42 ື≀⏝་⸆ရ䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつᐃ 1992 ᖺ➨ 78 ྕ䠄https://peraturan.bpk.go.id/Home/Details/57944/pp-no-78-tahun-1992䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 27 ᪥䠅
43 ື≀⏝་⸆ရ䛾ᐇᆅㄪᰝཬ䜃┘╩䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 16 ྕ(https://www.regulasip.id/book/18615/read䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶ 8 ᪥)74

d. ື≀⏝་⒪ᶵჾ
䛺䛚䚸䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 16 ྕ䛻䜘䜛䛸䚸ື≀⏝་⸆ရ䛾౪⤥䛿䚸ᅜෆ⏕⏘䛜ඃඛ䛥䜜䜛䚹ྠつᐃ䛻䛿䚸ᅜෆ⏘䛾〇ရ䛜⏕⏘䛥䜜䛺䛔䚸ཪ䛿ᅜෆ䛾ᚲせ䜢‶䛯䛩䛯䜑䛻༑ศ䛺㔞䛜⏕⏘䛥䜜䛺䛔ሙྜ䛾䜏䚸እᅜ〇ရ䛻䜘䜚ᚲせ䜢‶䛯䛩䛣䛸䛜䛷䛝䜛䛸䛔䛖䛣䛸䛜♧䛥䜜䛶䛔䜛䚹┘ど䛻䛴䛔䛶䠖
1. ㎰ᴗ኱⮧䛿䚸ື≀⏝་⸆ရ䛾〇㐀䚸౪⤥䚸ὶ㏻ཬ䜃౑⏝䜢┘ど䛩䜛䚹
2. ㎰ᴗ኱⮧䛿䚸➨ 1 㡯䛾ື≀⏝་⸆ရ䛾┘ど䜢䛩䜛䛯䜑䛻䚸ື≀⏝་⸆ရ䛾┘どᐁ䠄pejabat
pengawas obat hewan䠅䜢ᣦྡ䛷䛝䜛䚹
3. ➨ 2 㡯䛾ື≀⏝་⸆ရ䛾┘どᐁ䛿䚸㎰ᴗ኱⮧䛜㑅௵ཬ䜃ゎ௵䜢⾜䛖䚹
4. ື≀⏝་⸆ရ䛾┘ど䜢䛩䜛㝿䛻䚸ື≀⏝་⸆ရ䛾┘どᐁ䛿䚸௨ୗ䛾ᶒ㝈䜢᭷䛩䜛䚹a. ື≀⏝་⸆ရ䛾〇㐀䚸౪⤥䚸ὶ㏻䛾䛯䜑䛾஦ᴗචチ䛾つᐃᒚ⾜䛻㛵䛩䜛ヨ㦂䜢ᐇ᪋䛩䜛䚹b. ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊䛻䛴䛔䛶᳨ウ䛩䜛䚹
c. ㍺㏦ᡭẁ䜔᪉ἲ䜢ྵ䜑䚸౪⤥ཬ䜃ὶ㏻䛥䛫䜛ື≀⏝་⸆ရ䚸䛭䛾᪋タ䚸ಖ⟶ሙᡤ䜢᳨ᰝ䛩䜛䚹d. ື≀⏝་⸆ရ䛾౑⏝䛻㛵䛩䜛᳨ᰝ䜢䛩䜛䚹e. ᭷ຠᛶཬ䜃Ᏻ඲ᛶ䛾ヨ㦂䛾䛯䜑䛻䚸ཎᮦᩱཬ䜃ື≀⏝་⸆ရ䛾䝃䞁䝥䝹䜢᥇ྲྀ䛩䜛䚹
5. ➨ 4 㡯䛾ᐇ᪋୰䛻୙ṇ䛜䛒䛳䛯ሙྜ䚸␆⏘኱⮧ཪ䛿ື≀⏝་⸆ရ䛾┘どᐁ䛿ḟ䛾䛣䛸䜢࿨௧䛷䛝䜛䚹
a. ື≀⏝་⸆ရ䛾〇㐀䜢୍᫬ⓗ䛻೵Ṇ䛩䜛䚹b. ື≀⏝་⸆ရ䛾ὶ㏻䜢⚗Ṇ䛩䜛䚹c. ὶ㏻୰䛾ື≀⏝་⸆ရ䜢ᅇ཰䛥䛫䜛䚹d. つᐃ䛻ᚑ䜟䛺䛔ື≀⏝་⸆ရ䛾౑⏝䜢୰Ṇ䛥䛫䜛䚹

75

2.1.1 ㈍኎Ⓩ㘓⏦ㄳ᪥ᮏ䛛䜙ື≀⏝་⸆ရ䜢䜲䞁䝗䝛䝅䜰䛻㍺ฟ䛧䚸㈍኎䛩䜛㝿䛾Ⓩ㘓⏦ㄳ䛾䝣䝻䞊䜢௨ୗ䛻♧䛩䚹

76

2.2 ື≀⏝་⸆ရ஦ᴗチྍ
2.2.1 ື≀⏝་⸆ရ஦ᴗチྍ䠄Izin usaha obat hewan䠅䛻䛴䛔䛶䜲䞁䝗䝛䝅䜰䛷ື≀⏝་⸆ရ䛻㛵ಀ䛩䜛஦ᴗ⪅䛿䚸ື≀⏝་⸆ရ஦ᴗチྍ䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹チྍ䜢ᚲせ䛸䛩䜛஦ᴗ⪅䜔チྍド䛾௜୚⪅➼䛻㛵䛩䜛᝟ሗ䜢௨ୗ䛻䜎䛸䜑䜛䚹
1. ື≀⏝་⸆ရ஦ᴗ䛻䛿䚸௨ୗ䛾஦㡯䛜ྵ䜎䜜䜛䚹a. ື≀⏝་⸆ရ䛾〇㐀/⏕⏘b. ື≀⏝་⸆ရ䛾౪⤥c. ື≀⏝་⸆ရ䛾ὶ㏻
d. እᅜ䛛䜙䛾ື≀⏝་⸆ရ䛾㍺ධ
e. እᅜ䜈䛾ື≀⏝་⸆ရ䛾㍺ฟ
2. ➨ 1 㡯䛾ື≀⏝་⸆ရ䛾〇㐀䚸౪⤥ཬ䜃/ཪ䛿ὶ㏻䛻㛵ಀ䛩䜛஦ᴗ䜢⾜䛖䛩䜉䛶䛾⪅䛿䚸ἲつᐃ䛻ᚑ䛔䚸ື≀⏝་⸆ရ஦ᴗチྍド䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹44, 45
3. ື≀⏝་⸆ရ஦ᴗチྍド䛾⏦ㄳ䛿䚸௨ୗ䛾⪅䛜⾜䛖䚹a. ஦ᴗయ
b. ἲே
4. ື≀⏝་⸆ရ஦ᴗチྍド䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛஦ᴗ⪅䛿䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹a. ື≀⏝་⸆ရ䛾㍺ධᴗ⪅b. ື≀⏝་⸆ရ䛾㍺ฟᴗ⪅c. ື≀⏝་⸆ရ䛾〇㐀ᴗ⪅d. ື≀⏝་⸆ရ䛾ὶ㏻ᴗ⪅e. 䠄ື≀⑓㝔ෆ䛾䠅ື≀⏝་⸆ရ⸆ᒁ䠄apotek veteriner䠅f. ື≀⏝་⸆ရ䛾ಖ⟶/㈓ⶶᗜᴗ⪅g. 䝨䝑䝖䝅䝵䝑䝥h. ᐙ⚺ᗑ
i. ື≀⏝་⸆ရ㈍኎ᗑ䠄toko obat hewan䠅
5. 〇㐀ᴗ⪅䚸㍺ධᴗ⪅䚸㍺ฟᴗ⪅䜈䛾ື≀⏝་⸆ရ஦ᴗチྍド䛾௜୚䛿䚸㎰ᴗ኱⮧䛾ྡ䛾䜒䛸䛻␆⏘ᒁ㛗䛜⾜䛖䚹
6. ὶ㏻ᴗ⪅䜈䛾ື≀⏝་⸆ရ஦ᴗチྍド䛾௜୚䛿䚸ᕞ▱஦䛜⾜䛖䚹
7. ಖ⟶ᗜᴗ⪅䚸㈍኎ᗑ䜈䛾ື≀⏝་⸆ရ஦ᴗチྍド䛾௜୚䛿䚸ᆅ᪉ᨻᗓ䠄┴/ᕷ䠅䛜⾜䛖䚹

2.2.1.1 䛂ື≀⏝་⸆ရ஦ᴗチྍド䛃䛾ྲྀᚓ䛻ᚲせ䛺᮲௳ື≀⏝་⸆ရ஦ᴗチྍド䠄㍺ධᴗ⪅䛾ሙྜ䛿䛂ື≀⏝་⸆ရ㍺ධ஦ᴗチྍド䛃䠅䜢⏦ㄳ䛩䜛䛯䜑䛻䚸௨ୗ䛾⟶⌮せ௳ཬ䜃ᢏ⾡せ௳䜢‶䛯䛩ᚲせ䛜䛒䜛䚹44 ␆⏘ཬ䜃ື≀⾨⏕䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜἲ 2009 ᖺ➨ 18 ྕ䠄https://peraturan.bpk.go.id/Home/Download/27909/UU%20Nomor%2018%20Tahun%202009.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 5 ᪥䠅
45 ㎰ᴗศ㔝䛻䛚䛡䜛஦ᴗチྍ䛾ᡭ⥆䛝䛻㛵䛩䜛 2019 ᖺ䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ┬つ๎➨ 5 ྕ䠄http://www.bpdp.or.id/wp-content/uploads/2019/05/2019pmtani005.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 5 ᪥䠅77

⟶⌮せ௳䠖
1. ື≀⏝་⸆ရ䛾〇㐀ᴗ⪅䛿䚸௨ୗ䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹a. ஦ᴗ⪅㆑ู␒ྕ䠄NIB䠖Nomor Induk Berusaha䠅b. ⣡⛯⪅ᇶᮏ␒ྕ䠄NPWP䠖Nomor Pokok Wajib Pajak䠅
c. ᘓ≀౑⏝ᶒ䠄HGB䠖Hak Guna Bangunan䠅
d. ㏞ᝨ⾜Ⅽチྍド䠄H.O䠅
e. ၟྲྀᘬ஦ᴗチྍド䠄SIUP䠖Surat Izin Usaha Perdagangan䠅f. ఍♫௦⾲⪅䛾㌟ศド᫂᭩䠄KTP䠅
g. ⎔ቃ⟶⌮ཬ䜃䝰䝙䝍䝸䞁䜾䛾ྲྀ䜚⤌䜏䛻㛵䛩䜛⎔ቃチྍ᭩䠄UKL-UPL䠅h. ᕞཬ䜃┴/ᕷ䛾䝃䞊䝡䝇஦ົᡤ㛗䛛䜙䛾᥎⸀≧i. 䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䛛䜙䛾᥎⸀≧
2. ㍺ධᴗ⪅䛿䚸௨ୗ䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹a. ஦ᴗ⪅㆑ู␒ྕ䠄NIB䠖Nomor Induk Berusaha䠅b. ⣡⛯⪅␒ྕ䠄NPWP䠅
c. ᘓ≀౑⏝ᶒ䠄HGB䠅
d. ㏞ᝨ⾜Ⅽチྍド䠄H.O䠅
e. ၟྲྀᘬチྍド䠄SIUP䠅
f. ఍♫䛾௦⾲⪅䛾㌟ศド᫂᭩
g. ᮏ♫ᡤᅾᆅእ䛾಴ᗜ䜢฼⏝䛩䜛㍺ධᴗ⪅䛻ᑐ䛧䛶䛿䚸ᕞཬ䜃┴/ᕷ䛾䝃䞊䝡䝇஦ົᡤ㛗䛛䜙䛾᥎⸀≧h. 䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䛛䜙䛾᥎⸀≧
ୖ㏙䛾ᚲせ᭩㢮䛾⏦ㄳ᪉ἲƔ OSS 䛾䜰䜹䜴䞁䝖సᡂ䠖
1. 2021 ᖺ 8 ᭶ 9 ᪥䛻䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ኱⤫㡿䛻䜘䜚䚸䛂㞠⏝๰ฟἲཬ䜃䝸䝇䜽䝧䞊䝇䛾஦ᴗㄆྍᐇ᪋䛻㛵䛩䜛 2021 ᖺᨻᗓつ๎➨ 5 ྕ䛃䛾ᐇ᪋䛸䛧䛶䝸䝇䜽䝧䞊䝇䛾䜸䞁䝷䜲䞁༢୍ᥦฟ䠄OSS䠅䝅䝇䝔䝮䛜Ⓨ㊊䛧䛯䛣䛸䛻క䛔䚸ྛ✀஦ᴗチྍド䛿䚸
https://oss.go.id/䜢㏻䛧䛶⏦ㄳ䛩䜛䚹Ɣ஦ᴗ⪅㆑ู␒ྕ䠄NIB䠖Nomor Induk Berusaha䠅䠖
1. ື≀⏝་⸆ရ஦ᴗチྍド䜢⏦ㄳ䛩䜛๓䛻䚸OSS 䛛䜙䚸ᡭ㡰䛻ᚑ䛔䛂NIB䛃䜢ྲྀᚓ䛩䜛䚹NIB 䛿㟁Ꮚ⨫ྡ䜢క䛖Ᏻ඲䛺 13 ᱆䛾␒ྕ䛷䚸஦ᴗ⪅䛸⛯ົ᝟ሗ䜢 OSS 䛾䝕䞊䝍䝧䞊䝇䛻Ⓩ㘓䛩䜛䛣䛸䛷ྲྀᚓ䛷䛝䜛䚹NIB 䛿䜎䛯䚸௨๓Ⓨ⾜䛥䜜䛶䛔䛯௻ᴗⓏ
㘓ド᫂᭩䠄TDP䠖Tanda Daftar Perusahaan䠅䚸㍺ධ⪅␒ྕ䠄API䠖Angka Pengenal
Importir䠅䛻௦䜟䜛ド᫂᭩䛸䛧䛶㐺⏝䛥䜜䚸㍺ධᴗ⪅䛻⛯㛵䜰䜽䝉䝇ᶒ䜢௜୚䛩䜛䚹ヲ䛧䛔ᡭ㡰䛻䛴䛔䛶䛿䚸OSS 䝅䝇䝔䝮฼⏝䜺䜲䝗 https://oss.go.id/panduan 䜢ཧ↷䛧䛶䛔䛯䛰䛝䛯䛔䚹46Ɣἲே⏝⣡⛯⪅␒ྕ䠄NPWP䠅䠖
1. ᚲせ᭩㢮䠖a. 䜲䞁䝗䝛䝅䜰ᅜ⡠⪅䛾ሙྜ䠖఍♫௦⾲⪅䛾㌟ศド᫂᭩䠄KTP䠅ཬ䜃ಶே䛾
NPWP

46 OSS 䝅䝇䝔䝮฼⏝䜺䜲䝗䠄https://oss.go.id/panduan䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶ 29 ᪥䠅

78

b. እᅜ⡠䛾ሙྜ䠖䝟䝇䝫䞊䝖ཬ䜃䛒䜜䜀⣡⛯⪅␒ྕ䠄NPWP䠅
c. ఍♫䛾බㄆ㛵ಀ⪅䛷䛒䜛୍ே䛾䚸༳⣬௜䛝䛾⾲᫂᭩d. ၟᴗ஦ᴗάື䜢⾜䛖ሙᡤ䛷䛾άືෆᐜ䜢グ㍕䛧䛯⾲᫂᭩
2. ⏦ㄳᡭ㡰䠖
1. DJP Online e-Reg 䛾䜴䜵䝤䝃䜲䝖䛛䜙䝻䜾䜲䞁ཪ䛿䜰䜹䜴䞁䝖䜢సᡂ䛩䜛䚹⛯ົ⥲ᒁ䠄DGT䠅䜸䞁䝷䜲䞁䝨䞊䝆䠄http://ereg.pajak.go.id/daftar䠅䜈䜰䜽䝉䝇䛩䜛䚹᭷ຠ䛺㟁Ꮚ䝯䞊䝹䜰䝗䝺䝇䛷Ⓩ㘓䛩䜛䚹䝉䜻䝳䝸䝔䜱䝁䞊䝗/䜻䝱䝥䝏䝱䞊䜢ධຊ䛩䜛䚹
2. Ⓩ㘓ᡭ⥆䛜᏶஢䛩䜛䛸䚸⣡⛯⪅䛾䜰䜹䜴䞁䝖䝨䞊䝆䛻㏻▱䛜⾲♧䛥䜜䚸⣡⛯⪅䛜⛯ົ⥲ᒁ䛷䛾䝅䝇䝔䝮䜰䜹䜴䞁䝖Ⓩ㘓䛾➨୍ẁ㝵䜢↓஦㏻㐣䛧䛯䛣䛸䜢♧䛩ᩥゝ䛜⾲♧䛥䜜䜛䚹
3. ᭱ึ䛾䝇䝔䝑䝥䛾ᚋ䚸⣡⛯⪅䛻䛿䜰䜹䜴䞁䝖䜢᭷ຠ໬䛩䜛䛯䜑䛾㏻▱䝯䞊䝹䛜ᒆ䛟䚹
4. 䜰䜹䜴䞁䝖సᡂᚋ䚸⣡⛯⪅䛿 Tax e-Reg 䛾䝣䜷䞊䝮䛷᝟ሗ䜢ධຊ䛩䜛䚹ἲே⏝ NPWP 䜢㑅ᢥ䛧䚸Ặྡ䚸㌟ศド᫂᭩䚸䝯䞊䝹䜰䝗䝺䝇䚸䝟䝇䝽䞊䝗䚸㟁ヰ␒ྕ䛺䛹䛾䝕䞊䝍䜢ᡤᐃ䛾ḍ䛻ධຊ䛩䜛䚹䝕䞊䝍ධຊᚋ䚸䝉䜻䝳䝸䝔䜱䝁䞊䝗/䜻䝱䝥䝏䝱䞊䜢ධຊ䛩䜛䚹ḟ䛻䚸䛂Ⓩ㘓䛃䝪䝍䞁䜢䜽䝸䝑䜽䛩䜛䚹
5. Ⓩ㘓᏶஢ᚋ䚸⣡⛯⪅䛻ἲே⏝ NPWP సᡂᡂຌ䛾㏻▱䛜ᒆ䛟䚹ᡂຌ䛧䛯Ⓩ
㘓᭩䛿䚸⣡⛯⪅䛾ᡤ㎄⛯ົ⨫䛻⮬ືⓗ䛻㏦ಙ䛥䜜䜛䚹⣡⛯⪅䛿ᣦ♧䛻ᚑ䛳䛶Ⓩ㘓䝨䞊䝆䜢༳ๅ䛧䚸⨫ྡ䛩䜛䚹ᚲせ᭩㢮䛾䝁䝢䞊䜢䛭䜝䛘䛶䚸Ⓩ㘓䛛䜙
14 ᪥௨ෆ䛻䚸ᡤ㎄䛾⛯ົ⨫䛻㒑㏦䛩䜛䚹䛭䛾ᚋ䚸༳ๅ䛥䜜䛯ἲே⏝ NPWP䜹䞊䝗䛿 3䡚14 Ⴀᴗ᪥௨ෆ䛻㒑㏦䛷ᒆ䛟䚹
6. Ⓩ㘓䛛䜙䜹䞊䝗ཷྲྀ䜎䛷䛾᪥ᩘ䠖᭱኱ 20 Ⴀᴗ᪥
7. ᩱ㔠䠖↓ᩱƔᕞཬ䜃┴/ᕷ䛾䝃䞊䝡䝇஦ົᡤ㛗䛛䜙䛾᥎⸀≧䠄䝎䜴䞁䝻䞊䝗ྍ⬟䠅䠖
1. ྲྀᚓ᪉ἲ䠖䝏䜵䝑䜽䝸䝇䝖䠄䝎䜴䞁䝻䞊䝗ྍ⬟䠅䛸ඹ䛻ື≀⏝་⸆ရ஦ᴗチྍド⏦ㄳ䛻ᚲせ䛺᭩㢮ཬ䜃෗䛧䜢䛩䜉䛶䛭䜝䛘䛶ᥦฟ䛩䜛䚹୙ഛ䛜䛺䛡䜜䜀᥎⸀≧䛜௜୚䛥䜜䜛䚹
2. ᡤせ᫬㛫䠖7 Ⴀᴗ᪥
3. ᩱ㔠䠖↓ᩱƔ䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䛛䜙䛾᥎⸀≧47䠄䝎䜴䞁䝻䞊䝗ྍ⬟䠅䠖
1. 䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䛻᥎⸀≧䜢Ⓨ⾜䛧䛶䜒䜙䛖䛯䜑䛻䛿䚸஦๓䛻఍ဨ䛻䛺䜛ᚲせ䛜䛒䜛䚹䠄ึᖺᗘ䛾఍ဨⓏ㘓㈝ཬ䜃ᖺ఍㈝䛜ᚲせ䠅
2. ᚲせ᭩㢮䠖
1. ఍♫௦⾲⪅䛾㌟ศド᫂᭩䠄KTP䠅
2. ἲே⏝ NPWP
3. ஦ᴗ⪅㆑ู␒ྕ䠄NIB䠖Nomor Induk Berusaha䠅
4. ᭷ຠ䛺ᮏᣐᆅド᫂᭩
5. タ❧ド᭩
6. ኚ᭦ཬ䜃ᢎㄆ䛻㛵䛩䜛ド᭩
7. 〇㐀ᴗ⪅/䝃䝥䝷䜲䝲䞊䛛䜙௦⌮ᗑ䜈䛾௵࿨≧47 ື≀⏝་⸆ရ༠఍䠄http://www.asohi.org/䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 8 ᪥䠅79

8. ⮬ᕫᡤ᭷䛾಴ᗜ⾲᫂᭩䠄ᡤ᭷ᶒド᫂᭩䜢ῧ௜䠅/಴ᗜ㈤㈚ዎ⣙᭩
9. ᕤሙ/಴ᗜ䛾䝺䜲䜰䜴䝖10. ᕤሙ/಴ᗜ䛾ṇ㠃ཬ䜃ෆ㒊䛾෗┿
11. ㍺ධ/ὶ㏻/㍺ฟ/⏕⏘䛥䜜䜛〇ရ䛾䝸䝇䝖12. ᢏ⾡㈐௵⪅䛾㌟ศド᫂᭩ཬ䜃⫋ົ⤒Ṕ᭩
13. ᢏ⾡㈐௵⪅䛾༞ᴗド᭩
14. ᢏ⾡㈐௵⪅䛜఍♫䛾ṇつᚑᴗဨ䛷䛒䜛䛣䛸䜢♧䛩ᐉㄋ᭩䠄༳⣬௜䛝䠅
3. ᡤせ᫬㛫䠖᭱኱ 7 Ⴀᴗ᪥
4. ᩱ㔠䠖↓ᩱƔၟྲྀᘬ஦ᴗチྍド䠄SIUP䠖Surat Izin Usaha Perdagangan䠅䠖48
1. ⏦ㄳ᪉ἲ䠖OSS 䝅䝇䝔䝮䛷⏦ㄳ᭩䜢ᥦฟ䛩䜛䚹
2. ᚲせ᭩㢮䠖
1. ⏦ㄳ⏝⣬䠄䝎䜴䞁䝻䞊䝗ྍ⬟䠅
2. ఍♫௦⾲⪅䛾 KTP
3. タ❧ド᭩ཬ䜃䛩䜉䛶䛾ኚ᭦ド᭩
4. ἲே⏝ NPWP
5. ᅜෆᢞ㈨䛻㛵䛩䜛௬ㄆྍ⏦ㄳ᭩䠄䝎䜴䞁䝻䞊䝗ྍ⬟䠅
6. ᐉㄋ᭩䠄䝎䜴䞁䝻䞊䝗ྍ⬟䠅
7. ఍♫௦⾲⪅䛾෗┿䠄⫼ᬒ㉥䚸䝃䜲䝈 3×4䠅
3. ᡤせ᫬㛫䠖1 Ⴀᴗ᪥
4. ᩱ㔠䠖↓ᩱᢏ⾡せ௳䠖
1. ື≀⏝་⸆ရ䛾〇㐀ᴗ⪅䛿䚸௨ୗ䜢ᡤ᭷䛧䛶䛔䜛ᚲせ䛜䛒䜛䚹a. ஦ᴗάື䜢⾜䛖䛯䜑䛾ື≀⏝་⸆ရᕤሙ䚸᪋タཬ䜃タഛb. ရ㉁ヨ㦂ᡤཬ䜃ື≀⏝་⸆ရ䛾ಖ⟶ሙᡤc. ື≀⏝་⸆ရᢏ⾡㈐௵⪅䠄PJTOH䠖penanggung jawab teknis obat hewan䠅䛸䛧䛶ᖖ໅䛩䜛⋇་ᖌཬ䜃⸆๣ᖌͤ䜎䛰ື≀⏝་⸆ရᕤሙ䜢ᡤ᭷䛧䛶䛔䛺䛔〇㐀ᴗ⪅䛿䚸CPOHB ド᫂᭩䜢ᡤᣢ䛩䜛➨୕⪅䝃䞊䝡䝇ཬ䜃/ཪ䛿ṇᘧ䛻ㄆྍ䜢ཷ䛡䛯➨୕⪅䛜ᡤᣢ䛩䜛ື≀⏝་⸆ရရ㉁ヨ㦂ᡤ䜢฼⏝䛷䛝䜛䚹
2. ື≀⏝་⸆ရ䛾㍺ධᴗ⪅䛿䚸௨ୗ䜢ᡤ᭷䛧䛶䛔䜛ᚲせ䛜䛒䜛䚹a. ஦ᴗάື䜢⾜䛖䛯䜑䛾᪋タཬ䜃タഛb. ရ㉁䜢⥔ᣢ䛷䛝䜛ື≀⏝་⸆ရ䛾ಖ⟶ሙᡤ
c. PJTOH 䛸䛧䛶ᖖ໅䛩䜛⋇་ᖌཪ䛿⸆๣ᖌd. ⤌⧊ᵓ㐀ᅗe. ◊ಟ㟂せ䛾ᢕᥱཬ䜃ᐇ᪋ィ⏬⾲䜢ྵ䜐䚸ேᮦ⫱ᡂ䝥䝻䜾䝷䝮f. ᾘ㈝⪅┦ㄯ❆ཱྀ
g. タഛ
48 䝆䝱䜹䝹䝍㤳㒔≉ูᕞ䝽䞁䝇䝖䝑䝥䝃䞊䝡䝇䠄https://pelayanan.jakarta.go.id/site/detailperizinan/590䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 8 ᪥䠅80̺ ⾨⏕タഛ̺ ᐖ⹸㥑㝖タഛ̺ ᳨␿䜶䝸䜰䚸୙ྜ᱁䠄rejected䠅䜶䝸䜰䚸ྜ᱁䠄released䠅䜶䝸䜰̺ 㘽䛾䛛䛛䜛୙ྜ᱁䜶䝸䜰̺ ༑ศ䛺᥮Ẽཬ䜃↷̺᫂ ་⸆ရಖ⟶ᇶ‽䛻ἢ䛳䛯༑ศ䛺ಖ⟶䝇䝨䞊䝇̺ ௚䛾ၟရ䛸ศ䛡䛶ಖ⟶䛷䛝䜛ື≀⏝་⸆ရಖ⟶ᗜ̺ ື≀⏝་⸆ရ䜢ಖ⟶䛩䜛䛯䜑䛾䝟䝺䝑䝖/䝷䝑䜽
̺ ᾘⅆჾ
̺
ᗘ┘ど⿦⨨
h. ᡭ㡰
̺ 㒊ᒇ䛾⾨⏕⟶⌮ᡭ㡰̺ ື≀⏝་⸆ရ䛾ㄪ㐩/㉎ධ䛾ᡭ㡰̺ ᭩㢮ᩚ⌮䛾ᡭ㡰̺ ື≀⏝་⸆ရ䛾ධⲴᡭ㡰̺ ື≀⏝་⸆ရ䛾ಖ⟶ᡭ㡰̺ ື≀⏝་⸆ရ䛾ฟⲴᡭ㡰̺ ㏉ရཬ䜃ᮇ㝈ษ䜜〇ရ䛾ྲྀᢅ䛔ᡭ㡰̺ ປാᏳ඲⾨⏕䝅䝇䝔䝮䛻㛵䛩䜛ᡭ㡰̺ᗘ┘ど䛾ᡭ㡰̺ ᐖ⹸㥑㝖䝃䞊䝡䝇䜢㑅ᢥ䛩䜛䛯䜑䛾ᡭ㡰̺ ື≀⏝་⸆ရ䛾ᅇ཰䠄䝸䝁䞊䝹䠅ᡭ⥆̺ ື≀⏝་⸆ရ䜢䝃䝥䝷䜲䝲䞊䛻㏉༷䛩䜛䛯䜑䛾ᡭ㡰̺ ື≀⏝་⸆ရ䛾ᗫᲠᡭ㡰
3. ὶ㏻ᴗ⪅ཬ䜃ື≀⏝⸆ᒁ䛿䚸௨ୗ䜢ᡤ᭷䛧䛶䛔䜛ᚲせ䛜䛒䜛䚹a. ஦ᴗάື䜢⾜䛖䛯䜑䛾᪋タཬ䜃タഛb. ရ㉁䜢⥔ᣢ䛷䛝䜛ື≀⏝་⸆ရ䛾ಖ⟶ሙᡤ
c. ὶ㏻ᴗ⪅䛾ሙྜ䚸PJTOH 䛸䛧䛶ᖖ໅䛩䜛⋇་ᖌཪ䛿⸆๣ᖌd. ື≀⏝⸆ᒁ䛾ሙྜ䚸PJTOH 䛸䛧䛶ᖖ໅䛩䜛⋇་ᖌཬ䜃⸆๣ᖌ
4. ື≀⏝་⸆ရಖ⟶/㈓ⶶᗜᴗ⪅䚸䝨䝑䝖䝅䝵䝑䝥䚸ᐙ⚺ᗑ䚸ື≀⏝་⸆ရ㈍኎ᗑ䛿䚸௨ୗ䜢ᡤ᭷䛧䛶䛔䜛ᚲせ䛜䛒䜛䚹a. ஦ᴗάື䜢⾜䛖䛯䜑䛾᪋タཬ䜃タഛb. ရ㉁䜢⥔ᣢ䛷䛝䜛ື≀⏝་⸆ရ䛾ಖ⟶ሙᡤ
c. PJTOH 䛸䛧䛶㠀ᖖ໅䛾⋇་ᖌཪ䛿⸆๣ᖌd. 䝇䝍䝑䝣
1. ⋇་ᖌ䛾┘╩ୗ䛷ᖖ໅䛩䜛ື≀ᩆ࿨ኈ䚹ཪ䛿
2. ⸆๣ᖌ䛾┘╩ୗ䛷ᖖ໅䛩䜛⸆๣ᖌ䛾䜰䝅䝇䝍䞁䝖
5. ື≀⏝་⸆ရ஦ᴗチྍド䛿䚸⏦ㄳ᭩㢮䛻ᇶ䛵䛝Ⓨ⾜䛥䜜䜛䚹

81

82

2.2.1.2 ⏦ㄳᡭ㡰ཬ䜃ὶ䜜ື≀⏝་⸆ရ஦ᴗチྍド䛾⏦ㄳᡭ㡰ཬ䜃኱䜎䛛䛺ὶ䜜䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. ⏦ㄳ⪅䛿䚸OSS 䛷⏦ㄳ᭩㢮䜢ᥦฟ䛩䜛䚹
2. ᳜≀ရ✀ಖㆤ䞉㎰ᴗチㄆྍ䝉䞁䝍䞊䠄PPVTPP䠅䛿䚸Ditjen PKH ෆ䛾ᢏ⾡䝏䞊䝮䛸㐃ᦠ䛧䛶 2 ᪥௨ෆ䛻⏦ㄳ᭩㢮䜢ฎ⌮䛩䜛䚹
3. ᢏ⾡䝏䞊䝮䛿䚸14 ᪥௨ෆ䛻ホ౯䛩䜛䚹
4. ᢏ⾡䝏䞊䝮䛿ホ౯⤖ᯝ䛻ᇶ䛵䛝䚸⏦ㄳ䜢ᢎㄆ䛩䜛䛛༷ୗ䛩䜛䛛䜢Ỵᐃ䛩䜛䚹
5. ᢎㄆཪ䛿༷ୗ䛥䜜䛯ሙྜ䚸PPVTPP 䛿 OSS 䝅䝇䝔䝮䛻㏻▱䛩䜛䚹
6. OSS 䝅䝇䝔䝮䜈䛾ホ౯⤖ᯝ䛾㏻▱䛿䚸㐜䛟䛸䜒 2 ᪥௨ෆ䛻⾜䜟䜜䜛䚹
7. ༷ୗ䛾ሙྜ䚸௨ୗ䛾䛔䛪䜜䛛䛾⌮⏤䛜⾲♧䛥䜜䜛䚹a. ⏦ㄳ᭩㢮䛻୙ഛ䛜䛒䜛䛯䜑䛾༷ୗ䚹b. ᏶඲༷ୗ䚹ㄝ᫂/༷ୗ⌮⏤䛜ῧ䛘䜙䜜䜛䚹
8. ⏦ㄳ᭩㢮䛻୙ഛ䛜䛒䜛䛯䜑䛾༷ୗ䛿䚸⏦ㄳ᭩㢮䛾䝕䞊䝍䛜୙㊊䛧䛶䛔䜛ཪ䛿ሙᡤ䛾ྜ⌮ᛶ䛾ホ౯⤖ᯝ䛜䛒䜛ሙྜ䛻༷ୗ䛥䜜䜛䚹
9. ᏶඲༷ୗ䛿䚸᮲௳䜢‶䛯䛧䛶䛔䛺䛔ሙྜ䛻༷ୗ䛥䜜䜛䚹
10. ୙ഛ䛜䛒䜛䛯䜑䛾༷ୗ䛾㏻▱䜢ཷ䛡䛯ሙྜ䚸⏦ㄳ⪅䛿⏦ㄳ᭩㢮䜢ಟṇ䛩䜛᪨䛾⏦ฟ䜢䛩䜛䛣䛸䛜䛷䛝䜛䚹
11. ᏶඲༷ୗ䛥䜜䛯ሙྜ䚸⏦ㄳ᭩㢮䜢෌ᥦฟ䛩䜛䛣䛸䛜䛷䛝䜛䚹12. ᢎㄆ䛥䜜䜛䛸䚸PPVTPP 䜢㏻䛧䛶 2 ᪥௨ෆ䛻 OSS 䝅䝇䝔䝮䛛䜙䛂ື≀⏝་⸆ရ஦ᴗチྍド䛃䛜Ⓨ⾜䛥䜜䜛䚹
⏦ㄳ䛛䜙Ⓨ⾜䜎䛷䛾ᡤせᮇ㛫䠖18 Ⴀᴗ᪥49⏦ㄳᩱ㔠䠖2,000,000 䝹䝢䜰50

49 ᢞ㈨ㄪᩚᗇ䠄BKPM䠅OSS 䝅䝇䝔䝮䠄https://oss.go.id/informasi/kbli-kode?kode=G&kbli=46444䚸᭱⤊䜰䜽䝉䝇᪥䠖

2022 ᖺ 7 ᭶ 12 ᪥䠅
50 ㎰ᴗ┬䛷᭷ຠ䛺㠀ㄢ⛯ᅜᗜṓධ䛾✀㢮ཬ䜃ᩱ㔠䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつไ 2016 ᖺ➨ 35 ྕ䠄https://peraturan.bpk.go.id/Home/Details/5756䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅

83

84

2.2.1.3 ື≀⏝་⸆ရ஦ᴗチྍド䜢ྲྀᚓᚋ䛾⩏ົ᭷ຠ䛺ື≀⏝་⸆ရ஦ᴗチྍド䜢ྲྀᚓᚋ䚸஦ᴗ䜢㛤ጞ䛩䜛஦ᴗ⪅䛿䚸ḟ䛾⩏ົ䜢㈇䛖䚹
a.
b.
c.
d.
e.
f.

3 䛛᭶䛻୍ᗘ䚸஦ᴗάືሗ࿌᭩䜢ᐃᮇⓗ䛻ᥦฟ䛩䜛䚹ἲつᐃ䛻ᇶ䛵䛝Ⓨ⾜䛥䜜䛯஦ᴗチྍド䛾䝕䞊䝍䛻ኚ᭦䛜䛒䛳䛯ሙྜ䚸ኚ᭦ᢎㄆሗ࿌᭩
ཬ䜃⏦ㄳ᭩䜢ᥦฟ䛩䜛䚹
ရ㉁䜢☜ಖ䛷䛝䜛᪋タ/タഛ䚸ཬ䜃ື≀⏝་⸆ရ䛾ಖ⟶ሙᡤ䜢ᡤ᭷䚸ཪ䛿⟶⌮䛩䜛䚹せ௳䛻ἢ䛳䛯ື≀⏝་⸆ရᢏ⾡㈐௵⪅䛾せဨ䜢☜ಖ䛩䜛䚹つᐃ䛥䜜䛯せ௳ཬ䜃ᇶ‽䛻ᚑ䛔஦ᴗ䜢⾜䛖䚹Ⓩ㘓῭䛾ື≀⏝་⸆ရ䜢౑⏝䛩䜛䚹␆⏘ື≀⾨⏕⥲ᒁ䛿䚸┘どᶵᵓ䠄mekanisme pengawasan/post-audit䠅䛻䜘䛳䛶ୖグ⩏ົ䛾ᒚ⾜᳨ᰝ䜢⾜䛖䚹

2.3 ື≀⏝་⸆ရⓏ㘓
2.3.1 ື≀⏝་⸆ရⓏ㘓チྍ䠄᪂つⓏ㘓ཪ䛿෌Ⓩ㘓䠅51
ື≀⏝་⸆ရ䜢Ⓩ㘓䛩䜛䛯䜑䛾せ௳䜢௨ୗ䛻♧䛩䚹
1. ୍⯡せ௳a. ᅜෆ⏕⏘⪅⏝䛾ື≀⏝་⸆ရ஦ᴗチྍド䜢᭷䛩䜛௻ᴗ䚸ཪ䛿ື≀⏝་⸆ရ஦ᴗ䛻㛵䛩䜛ཎ๎ⓗ䛺ᢎㄆ䜢ཷ䛡䛶䛔䜛௻ᴗ䛿䚸ື≀⏝་⸆ရ䛾Ⓩ㘓⏦ㄳ䜢⾜䛖䛣䛸䛜䛷䛝䜛䚹㍺ධ䛾ື≀⏝་⸆ရ䜢Ⓩ㘓䛷䛝䜛⏦ㄳ⪅䛿䚸㍺ධᴗ⪅ཪ䛿ཎ⏘ᅜ䛾⏕⏘⪅䛜௵࿨䛧䛯ື≀⏝་⸆ရ㍺ධᴗ⪅䛾❧ሙ䜢᭷䛩䜛௦⌮ே䛷䛒䜚䚸௻ᴗ䛿䜲䞁䝗䝛䝅䜰ඹ࿴ᅜෆ䛷タ❧䛥䜜䛶䛔䜛ᚲせ䛜䛒䜛䚹
b. ື≀⏝་⸆ရ䜢Ⓩ㘓䛩䜛㍺ධᴗ⪅䛿䚸Ⓩ㘓䛩䜛〇ရ䛾Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛜⮬♫䛷䛒䜛䛣䛸䜢᫂グ䛧䛯〇㐀ᴗ⪅䛛䜙䛾ᣦྡ᭩䜢ᡤᣢ䛩䜛ᚲせ䛜䛒䜛䚹c. Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛜௚♫ྡ䛷Ⓩ㘓䛥䜜䛶䛔䛺䛔䛣䛸䚹d. ື≀⏝་⸆ရⓏ㘓␒ྕ䛿䚸ື≀⏝་⸆ရ䛾᏶ᡂရ䚸༙᏶ᡂရ䚸ཎᮦᩱ䛻ᑐ䛧䛶Ⓨ⾜䛥䜜䜛䚹e. ື≀⏝་⸆ရⓏ㘓␒ྕ䛾᭷ຠᮇ㝈䛿䚸ື≀⏝་⸆ရⓏ㘓␒ྕ䛾௜୚᪥䛛䜙 10 ᖺ㛫䛷䛒䜛䚹f. ␆⏘⾨⏕ᒁ㛗Ỵᐃ➨ 54/TN.260/Kpts/DJP/2001 ྕཬ䜃ྠ➨ 55/TN.260/Kpts/DJP/2001ྕ䛻グ㍕䛥䜜䛶䛔䜛䛂ື≀⏝⏕⸆Ⓩ㘓⏦ㄳ᭩グධせ㡿䛃ཬ䜃䛂ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩グ
ධせ㡿䛃䛻ᚑ䛔⏦ㄳ᭩䛻グධ䛧䚸Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛾䝕䞊䝍䜢ῧ௜䛩䜛䛣䛸䚹䠄␆⏘ᒁ䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸➨ 55/TN.260/Kpts/DJP/2001 ྕ䛿⌧ᅾධᡭ୙ྍ䠅g. ␗䛺䜛ື≀⏝་⸆ရ〇㐀ᴗ⪅㛫䛷〇㐀ጤクዎ⣙䠄Toll Manufacturing䠅䛻䜘䜚〇㐀䛥䜜䜛ື≀⏝་⸆ရ䛻䛴䛔䛶䛿䚸ጤクᴗ⪅䛸ཷクᴗ⪅㛫䛾ྠព᭩䜢ᥦฟ䛩䜛ᚲせ䛜䛒䜛䚹h. ື≀⏝་⸆ရⓏ㘓␒ྕ䛾᭷ຠᮇ㛫୰䚸஦ᴗ⪅䛿ḟ䛾஦᯶䛻␃ព䛩䜛ᚲせ䛜䛒䜛䚹51 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun-

2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 19 ᪥䠅

85̺ ὶ㏻䛩䜛ື≀⏝་⸆ရ䛜Ⓩ㘓␒ྕ䛾᭷ຠᮇ㝈䜢㉺䛘䛺䛔䜘䛖䛻䛩䜛䚹̺ ὶ㏻䛩䜛ື≀⏝་⸆ရ䛜ရ㉁ᇶ‽䛻㐺ྜ䛧䛶䛔䜛䛣䛸䜢☜ㄆ䛩䜛䚹̺ ὶ㏻䛩䜛ື≀⏝་⸆ရ䛜Ⓩ㘓᫬䛻ᢎㄆ䛥䜜䛯㐺ษ䛺䝷䝧䝹䜔䝬䞊䜽䛜௜䛥䜜䛶䛔䜛䛣䛸䜢☜ㄆ䛩䜛䚹̺ ἲつไ䛻㐺ྜ䛧䛺䛔ື≀⏝་⸆ရ䛾ᅇ཰䠄recall䠅䜢⾜䛖䚹̺ ㏉ရ䠄return䠅䛥䜜䛯་⸆ရ䛻ᑐ䛧䛶ἲつไ䛻ᚑ䛔⥅⥆ฎ⨨䜢䛸䜛䚹̺ ὶ㏻䛩䜛ື≀⏝་⸆ရ䛜Ⓩ㘓ෆᐜ䛻ἢ䛳䛯ෆᐜཪ䛿ᡂศ䛷䛒䜛䛣䛸䜢☜ㄆ䛩䜛䚹̺ ᖺ䛻୍ᗘ䚸ື≀⏝་⸆ရⓏ㘓␒ྕ䛾᭷↓䛻㛵䛩䜛ሗ࿌᭩䜢ᥦฟ䛩䜛䚹
2. ື≀⏝⏕≀Ꮫⓗ〇๣ཬ䜃་⸆ရ䛾Ⓩ㘓⏦ㄳ䛾ᑐ㇟⪅52
a. ஦ᴗయ
b. ἲே
c. බඹ䝃䞊䝡䝇ᶵ㛵
3. ᅜෆ〇㐀ᴗ⪅䛻䜘䜛ື≀⏝་⸆ရ䛾⏕⏘䛿䚸ḟ䛾᪉ἲ䛻䜘䜚⾜䜟䜜䜛䚹53
a. ⮬♫⏕⏘b. 䝷䜲䝉䞁䝇䛻ᇶ䛵䛟⏕⏘c. 〇㐀ጤクዎ⣙䛻䜘䜛⏕⏘䠄Toll Manufacturing䠅
4. Ⓩ㘓᪉ἲ
a. ⏦ㄳ⪅䛿䚸OSS 䛷⏦ㄳ䛩䜛䚹b. ⏦ㄳ⪅䛿䚸OSS 䛷௨ୗ䛾つᐃ䜢‶䛯䛧䛶䛔䜛䛣䛸䜢グ䛧䛯ㄋ⣙᭩䜢ᥦฟ䛩䜛䚹
5. ᥦฟ䛩䜛ᚲせ䛾䛒䜛ᢏ⾡䝕䞊䝍䠖a. ῧ௜㈨ᩱ A䠖ື≀⏝་⸆ရ䛾ᡂศb. ῧ௜㈨ᩱ B䠖ື≀⏝་⸆ရ䛜᏶ᡂ䛩䜛䜎䛷䛾〇๣〇㐀᪉ἲ
c. ῧ௜㈨ᩱ C䠖ື≀⏝་⸆ရ䛜᏶ᡂ䛩䜛䜎䛷䛾་⸆ရ᳨ᰝ
d. ῧ௜㈨ᩱ D䠖ཎᮦᩱ䛾᳨ᰝe. ῧ௜㈨ᩱ E䠖Ᏻᐃᛶ䛾᳨ᰝf. ῧ௜㈨ᩱ F䠖ື≀⏝་⸆ရ䛾⸆⌮స⏝g. ῧ௜㈨ᩱ G䠖㔝እ⮫ᗋヨ㦂䛾㈨ᩱ䠄ᾏእ䛷䛾⮫ᗋヨ㦂㈨ᩱ䛾ᥦฟ䛷䜘䛔䠅h. ῧ௜㈨ᩱ H䠖ᐜჾཬ䜃ໟ⿦ᮦ䛻㛵䛩䜛ㄝ᫂i. ῧ௜㈨ᩱ I䠖ᐜჾ䛾⵹䛻㛵䛩䜛ㄝ᫂j. ῧ௜㈨ᩱ J䠖䝷䝧䝹䛻㛵䛩䜛ㄝ᫂k. ῧ௜㈨ᩱ K䠖〇๣䝃䞁䝥䝹ཬ䜃ᶆ‽᭷ຠᡂศl. ῧ௜㈨ᩱ L䠖䛭䛾௚䛾᝟ሗ
6. ື≀⏝་⸆ရⓏ㘓䜢ึ䜑䛶⾜䛖ሙྜ䠄ື≀⏝་⸆ရ䛾᪂つⓏ㘓䠅54
52 ㎰ᴗศ㔝䛻䛚䛡䜛஦ᴗㄆྍド䛾ᡭ⥆䛝䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ┬つᐃ 2019 ᖺ➨ 5 ྕ䠄https://peraturan.bpk.go.id/Home/Details/201248/permentan-no-05-tahun-2019䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 2᪥䠅
53 ㎰ᴗศ㔝䛷䛾㞠⏝๰ฟ䛻㛵䛩䜛 2020 ᖺἲᚊ➨ 11 ྕ᪋⾜つ๎䛻䛴䛔䛶䛾 2020 ᖺ䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつ๎ⲡ᱌(https://uu-ciptakerja.go.id/wp-content/uploads/2020/11/RPP-Pelaksanaan-Undang-Undang-tentang-CiptaKerja-Sektor-Pertanian-2.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 10 ᪥䠅
54 䜸䞁䝷䜲䞁䞉䝅䞁䜾䝹䞉䝃䝤䝭䝑䝅䝵䞁䠄OSS䠅䝅䝇䝔䝮䠄https://oss.go.id/informasi/kbli-kode?kode=G&kbli=46444䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶ 14 ᪥)

86

1. ୖグ➨ 4 㡯䛾ᢏ⾡䝕䞊䝍䛻ຍ䛘䛶ᥦฟ䛩䜛ᚲせ䛾䛒䜛᭩㢮䠖a. ື≀⏝་⸆ရ஦ᴗチྍドb. ື≀⏝་⸆ရ䛾ᢏ⾡ᩥ᭩䠄dossier䠅䛻ᑐ䛩䜛ື≀⏝་⸆ရⓏ㘓ᑂᰝ఍䠄PPOH䠅䛛䜙䛾ᢎㄆཬ䜃/ཪ䛿ື≀⏝་⸆ရጤဨ఍䠄KOH䠅䛛䜙䛾⤖ᯝド᫂᭩c. 㑇ఏᏊ⤌᥮䛘〇ရ䛾ሙྜ䚸㑇ఏᏊ⤌᥮䛘⏕≀䠄GMO䠅⏤᮶䛾ື≀⏝་⸆ရ䛻㛵䛩䜛䛂㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄KKH PRG䠅䛃䛛䜙䛾⎔ቃᏳ඲ド᫂᭩䠄Sertifikat
Keamanan Lingkungan䠅䠄ヲ⣽䛻䛴䛔䛶䛿䚸䛂5.3 㑇ఏᏊ⤌᥮䛘⏕≀䠄GMO䠅⏤᮶䛾ື≀⏝་⸆ရ䛻㛵䛩䜛䛄㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄KKH PRG䠅䛅䛛䜙䛾⎔ቃᏳ඲ド᫂᭩䠄Sertifikat Keamanan Lingkungan䠅䛃䜢ཧ↷䠅d. ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠅䛛䜙䛾ရ㉁ヨ㦂⤖ᯝド᫂᭩Ɣᅜෆ〇㐀ᴗ⪅䛾ሙྜ䠖
a. Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛾⠊ᅖ䛻ᛂ䛨䛯㐺ṇ〇㐀つ⠊䠄CPOHB䠅ド᫂᭩b. ື≀⏝་⸆ရⓏ㘓␒ྕ䛜᭱ึ䛻Ⓨ⾜䛥䜜䛶䛛䜙㐜䛟䛸䜒 1 ᖺ௨ෆ䛻 CPOHB 䜢㐺⏝䛧 CPOHB ド᫂᭩䜢ྲྀᚓ䛩䜛⬟ຊ䛜䛒䜛䛣䛸䜢グ㍕䛧䛯ྠព᭩c. ᕤሙ䛾෗┿Ɣᅜእ〇㐀ᴗ⪅䛾ሙྜ䠖➨ 4 㡯䛾ῧ௜㈨ᩱ A 䛛䜙ῧ௜㈨ᩱ F 䜎䛷䛾ᢏ⾡䝕䞊䝍䜢䛭䜝䛘䜛䛣䛸䛻ຍ䛘䚸㍺ධཎ⏘ရ䛻䛴䛔䛶䚸ῧ௜㈨ᩱ L 䛻ヱᙜ䛩䜛௨ୗ䛾᭷ຠ䛺᭩㢮䠄㐣ཤ 5 ᖺศ䠅䜢ᥦฟ䛩䜛䚹a. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯ཎ⏘ᆅド᫂᭩䠄CoO䠅䚸ཪ䛿ཎ⏘ᅜ䛾ື≀⏝་⸆ရᙜᒁ䛛䜙䛾〇ရⓏ㘓䛜୙せ䛷䛒䜛䛣䛸䜢グ䛧䛯ド᫂᭩b. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯⮬⏤㈍኎ド᫂᭩䠄Certificate of Free Sale䠅䚸ཪ䛿ཎ⏘ᅜ䛾ື≀⏝་⸆ရᙜᒁ䛜Ⓨ⾜䛧䛯䚸⏕⏘ᅜ௨እ䠄ᑡ䛺䛟䛸䜒 2 䛛ᅜ௨ୖ䠅䛷ྲྀᘬ䛥䜜䛶䛔䜛䛣䛸䜢♧䛩ド᫂᭩䚹㎰ᴗ኱⮧Ỵᐃ➨ 455/KPTS/TN.260/9/2000 ྕ䛻㛵㐃䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 695/Kpts/TN.260/8/96 ྕ䛻グ㍕䛥䜜䛶䛔䜛᪂䛧䛔ື≀⏝་⸆ရ䛻ศ㢮䛥䜜䜛ື≀⏝་⸆ရ䛿 2 䛛ᅜ௨ୖ䛷ྲྀᘬ䛥䜜䚸䛭䛾䛖䛱 1 䛛ᅜ䛿ඛ㐍ᅜ䠄᪥ᮏ䚸䜲䜼䝸䝇䚸䜸䝷䞁䝎䚸䝣䝷䞁䝇䚸䝗䜲䝒䚸䝇䝨䜲䞁䚸䜲䝍䝸䜰䚸䜰䝯䝸䜹䚸䜸䞊䝇䝖䝷䝸䜰䚸䜹䝘䝎䚸䝙䝳䞊䝆䞊䝷䞁䝗䠅䛷䛒䜛ᚲせ䛜䛒䜛䚹≉ู䛺≧ἣ䛷౑⏝䛥䜜䜛᪂䛧䛔ື≀⏝་⸆ရ䛻㛵䛩䜛Ⓩ㘓ド᫂᭩䛾せ௳䛿䚸௒ᚋ䛥䜙䛻Ỵᐃ䛥䜜䜛ணᐃc. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯 GMP ᇶ‽ド᫂᭩䠄Certificate of Good
Manufacturing Practices䠅䚸ཪ䛿ྠ➼䛾ド᫂᭩d. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯䝥䝻䝞䜲䜸䝔䜱䜽䝇䚸㓝⣲䚸䜰䝭䝜㓟ཬ䜃⏕≀〇๣
䛾 GMO/non-GMO䠄Certificate of GMO/nonGMO䠅䛾ド᫂᭩䠄䜲䞁䝗䝛䝅䜰䛷せồ䛥䜜䛶䛔䜛Ᏻ඲ド᫂᭩䛾せồ㡯┠䛻䛴䛔䛶䛿䚸䛂5.3 㑇ఏᏊ⤌᥮䛘⏕≀䠄GMO䠅⏤᮶䛾ື≀⏝་⸆ရ䛻㛵䛩䜛䛄㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄KKH PRG䠅䛅䛛䜙䛾⎔ቃᏳ඲ド᫂᭩䠄Sertifikat Keamanan Lingkungan䠅䛃䜢ཧ↷䠅e. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯Ⓩ㘓ド᫂᭩䠄Certificate of Registration䠅
f. Ⓩ㘓ド᫂᭩䛜ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛛䜙Ⓨ⾜䛥䜜䛶䛔䛺䛔ሙྜ䛿䚸䠄➨ 4 㡯 a䡚d䛾ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯䚸ᙜヱᅜ䛾つไ䛻ᇶ䛵䛝䚸〇ရ䛾ရ㉁䚸᭷ຠᛶཬ䜃Ᏻ඲ᛶ䛻㛵䛩䜛┘╩䜢⾜䛳䛶䛔䜛䛣䛸䛜グ㍕䛥䜜䛯⋇་ᖌ೺ᗣデ᩿᭩/ྠ➼䛾ᩥ᭩䠅䜢Ⓨ⾜ᅜ䛾䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ䛾௦⾲⪅䛜⿬᭩䛝䛧䛶ῧ௜g. ᕤሙ䛾෗┿h. 䜲䞁䝗䝛䝅䜰䛾Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䠄registration holder䠅䛸䛧䛶䚸ཎ⏘ᅜ䛾⏕⏘⪅ཪ䛿

87䛭䛾௦⌮ே䛛䜙䛾௵࿨≧䠄Letter of Appointment䠅Ɣື≀⏝་⸆ရ䛾〇㐀ጤクዎ⣙䠄Toll Manufacturing䠅䛾ሙྜ䠖a. ཷク䛧䛯་⸆ရ〇๣䛻ᛂ䛨䛯䚸ཷクᴗ⪅䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅ CPOHB ド᫂᭩
b. 〇㐀ጤクዎ⣙᭩Ɣື≀⏝་⸆ရ䝷䜲䝉䞁䝇⏕⏘䛾ሙྜ䠖
a. 䝷䜲䝉䞁䝃䞊䠄ᅜእ〇㐀ᴗ⪅䠅ཬ䜃䝷䜲䝉䞁䝅䞊䠄ᅜෆ〇㐀ᴗ⪅䠅㛫䛾䝷䜲䝉䞁䝇ዎ⣙᭩b. 䝷䜲䝉䞁䝇໬䛥䜜䛯ື≀⏝་⸆ရ䛾〇๣䛻ᛂ䛨䛶䚸䝷䜲䝉䞁䝃䞊䛜ྲྀᚓ䛧䛯䚸ື≀⏝་⸆ရ〇㐀ᴗ⪅䛸䛧䛶䛾〇㐀⟶⌮ཬ䜃ရ㉁⟶⌮䛻㛵䛩䜛䚸᭷ຠ䛺 GMP ド᫂᭩c. 䝷䜲䝉䞁䝇໬䛥䜜䛯ື≀⏝་⸆ရ䛾〇๣䛻ᛂ䛨䛶䚸䝷䜲䝉䞁䝅䞊䛜ྲྀᚓ䛧䛯䚸ື≀⏝་⸆ရ〇㐀ᴗ⪅䛸䛧䛶䛾᭷ຠ䛺 CPOHB ド᫂᭩ື≀⏝་⸆ရ䜢Ⓩ㘓䛩䜛ୖ䛷ᚲせ䛺᭩㢮䜢௨ୗ䛻䜎䛸䜑䜛䚹

88

89

90

2.3.1.1 ῧ௜㈨ᩱ䛾グධ᪉ἲ䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䠄ASOHI䠅䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸䛂2.3.1 ື≀⏝་⸆ရⓏ㘓チྍ䛃䛾➨ 5 㡯䛻䛒䜛䛂ᥦฟ䛩䜉䛝ᢏ⾡䝕䞊䝍 A䡚K䛃䛾ෆᐜ䛻㛵䛧䛶䚸䛂᪥ᮏ䛷⏦ㄳ䛾䛯䜑䛻᪤䛻౑⏝䛥䜜䛶䛔䜛䝗䝅䜶䛺䛹䛜䛒䜜䜀䚸䛭䛾ෆᐜ䜢ヲ⣽䛻䜟䛯䜚グ㍕䛩䜛䛺䜙ᚲせ䛺䝕䞊䝍䜢ໟྵ䛩䜛䛣䛸䛜䛷䛝䜛䛃䛸䛾᝟ሗ䜢ᚓ䛯䚹䛥䜙䛻䚸␆⏘ᒁ䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸ศὀ〇ရ䛻㛵䛧䛶䚸䛂௚ᅜ䛾ᮦᩱ䜢౑⏝䛧䛯䜚ໟ⿦䛧䛯䜚䛧䛶䛔䛶䜒䚸᪥ᮏ䛷Ⓩ㘓䛧䛯⸆ရ䜢㍺ฟ䛩䜛ሙྜ䛿䚸᪥ᮏ䛾Ⓩ㘓ド᫂᭩㢮୍ᘧ䛷༑ศ䛷䛒䜛䚹䛧䛛䛧䚸GMO 〇ရ䛾ሙྜ䛿䚸㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄KKH PRG䠅䛾Ᏻ඲ᛶヨ㦂䛻ྜ᱁䛩䜛ᚲせ䛜䛒䜛䚹䛃䛸䛾ᅇ⟅䜢ᚓ䛯䚹␆⏘ᒁ䛿௨๓䚸䛂ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩グධせ㡿䛃䛜グ䛥䜜䛯䛂␆⏘⾨⏕ᒁ㛗Ỵᐃ➨
55/TN.260/Kpts/DJP/2001 ྕ䛃䜢‽ഛ䛧䛶䛔䛯䛜䚸BBPMSOH 䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸⌧ᅾ䛿ධᡭ䛩䜛䛣䛸䛜䛷䛝䛺䛔䚹䛧䛛䛧䚸ྠෆᐜ䛻㛵䛧䛶䚸㡑ᅜ䛾㎰ᯘ␆⏘᳨␿ᮏ㒊䛾䝩䞊䝮䝨䞊䝆䛷බ♧䛥䜜䛶䛔䜛䜲䞁䝗䝛䝅䜰㎰ᴗ┬␆⏘ᒁ䠄MINISTRY OF AGRICULTURE OF REPUBLIC OF INDONESIADIRECTORATE GENERAL OF LIVESTOCK SERVICE䠅䛻䜘䜛䛂ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩グධせ㡿䠄GUIDANCE ON APPLICATION OF VETERINARY DRUG䠅䛃55 䜢ཧ↷䛩䜛䛣䛸䛜䛷䛝䜛䚹ヲ䛧䛟
䛿䚸䛂5.4 ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩グධせ㡿䠄GUIDANCE ON APPLICATION OF VETERINARY
DRUG䠅䛃䜢ཧ↷䛧䛶䛔䛯䛰䛝䛯䛔䚹䜎䛯䚸䛂ື≀⏝⏕⸆䛻㛵䛩䜛Ⓩ㘓⏦ㄳ᭩グධせ㡿䛃䛜グ䛥䜜䛯䛂␆⏘⾨⏕ᒁ㛗Ỵᐃ➨54/TN.260/Kpts/DJP/2001 ྕ䛃䛿⌧ᅾ䜒ධᡭྍ⬟䛷䛒䜚䚸BBPMSOH 䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸⏕≀Ꮫⓗ〇๣䚸་⸆ရ䛾⏦ㄳ䛻䛚䛔䛶䜒ཧ↷䛩䜛䛣䛸䛜䛷䛝䜛䚹ヲ䛧䛟䛿䚸䛂5.5 ␆⏘⾨⏕ᒁ㛗Ỵᐃ➨54/TN.260/Kpts/DJP/2001 ྕ䛃䜢䛤ぴ䛔䛯䛰䛝䛯䛔䚹

2.3.2 ෌Ⓩ㘓䠄Ⓩ㘓␒ྕ᭦᪂䠅䛻䛴䛔䛶Ⓨ⾜䛥䜜䛯ື≀⏝་⸆ရⓏ㘓␒ྕ䛻䛿 10 ᖺ䛾᭷ຠᮇ㝈䛜䛒䜚䚸᭷ຠᮇ㝈䛜ษ䜜䛯ሙྜ䛿෌Ⓩ
㘓䛜ᚲせ䛷䛒䜛䚹෌Ⓩ㘓䛾㝿䛻ᥦฟ䛩䜉䛝䝕䞊䝍䛿䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. ෌Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛻ኚ᭦䛜䛺䛔ሙྜ䚸ᥦฟ䛩䜉䛝ᢏ⾡䝕䞊䝍䠖a. ῧ௜㈨ᩱ A䠖ື≀⏝་⸆ရ䛾ᡂศb. ῧ௜㈨ᩱ C䠖ື≀⏝་⸆ရ䛜᏶ᡂ䛩䜛䜎䛷䛾་⸆ရ᳨ᰝ
c. ῧ௜㈨ᩱ J䠖䝷䝧䝹䛻㛵䛩䜛ㄝ᫂䠄䝺䝑䝔䝹/䝷䝧䝹౛ཬ䜃䝟䞁䝣䝺䝑䝖䠄insert leaflet䠅䚸ໟ⿦౛䠄༢఩䠖gram/ml ཪ䛿 kg/L䠅ཬ䜃ᑐ㇟ື≀䛾ㄝ᫂䠅Ɣᅜෆ〇㐀ᴗ⪅䛾ሙྜ䠖
a. CPOHB ド᫂᭩
b. ஦ᴗチྍドc. ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ㏻▱᭩d. ෌Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛿䚸ᡂศ䚸ຠ⬟䚸ᕤሙᡤᅾᆅ䚸〇㐀ᕤ⛬䚸ಖᏑᮇ㛫䚸᭹⏝᪉ἲ䚸ᑐ㇟ື≀ཬ䜃/ཪ䛿ໟ⿦ᮦᩱ䛻䛴䛔䛶ኚ᭦䛜䛺䛔䛣䛸䜢♧䛩༳⣬௜䛝䛾ド᫂᭩
e. BBPMSOH 䛜Ⓨ⾜䛧䛯ရ㉁ヨ㦂⤖ᯝド᫂᭩
f. Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛾⠊ᅖ䛻ᛂ䛨䛯 CPOHB ド᫂᭩

55 㡑ᅜ㎰ᯘ␆⏘᳨␿ᮏ㒊, Ѱ‫_૽ߟࢂࡈי‬ҟԼए৚(ʯ‫)ࡈݤ‬

GUIDANCE ON APPLICATION OF VETERINARY
DRUG䠄㡑ᅜㄒ䚸ⱥᩥేグ㈨ᩱ䠅䚸2013(https://www.qia.go.kr/viewwebQiaCom.do?id=34312&type=2_14dwyp䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 9 ᭶ 30 ᪥䠅

91

g. ᕤሙ䛾෗┿Ɣᅜእ〇㐀ᴗ⪅䛾ሙྜ䠖
a. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯ཎ⏘ᆅド᫂᭩䠄CoO䠅
b. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯⮬⏤㈍኎ド᫂᭩䠄Certificate of Free Sale䠅c. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯Ⓩ㘓ド᫂᭩䠄Certificate of Registration䠅
d. ཎ⏘ᅜ䛾බㄆᨻᗓᶵ㛵䛜Ⓨ⾜䛧䛯 GMP ᇶ‽ド᫂᭩䠄Certificate of Good
Manufacturing Practices䠅/ྠ➼䛾ド᫂᭩
e. ㍺ධື≀⏝་⸆ရ䛾ሙྜ䠖ཎ⏘ᅜ䛾⏕⏘⪅䛛䜙䛾௵࿨≧䠄Letter of Appointment䠅f. ᕤሙ䛾෗┿g. ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ㏻▱᭩h. ᢏ⾡㠃ཬ䜃⟶⌮㠃䛷䛾ኚ᭦䛿䛺䛔䛣䛸䛾ㄝ᫂i. BBPMSOH 䛜Ⓨ⾜䛧䛯ရ㉁ヨ㦂⤖ᯝド᫂᭩
j. 㑇ఏᏊ⤌᥮䛘〇ရ䛾ሙྜ䚸1 ᖺ㛫䛾⎔ቃᏳ඲ド᫂᭩䠄sertifikat keamanan hayati䠅Ɣື≀⏝་⸆ရ䝷䜲䝉䞁䝇䛾ሙྜ䠖a. 䝷䜲䝉䞁䝃䞊䠄ᅜእ〇㐀ᴗ⪅䠅䛸䝷䜲䝉䞁䝅䞊䠄ᅜෆ〇㐀ᴗ⪅䠅䛾㛫䛾䝷䜲䝉䞁䝇ዎ⣙᭩b. 䝷䜲䝉䞁䝇໬䛥䜜䛯ື≀⏝་⸆ရ䛾๣ᙧ䛻ᛂ䛨䛶䚸䝷䜲䝉䞁䝃䞊䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅䛸䛧䛶䛾〇㐀⟶⌮ཬ䜃ရ㉁⟶⌮䛻㛵䛩䜛䚸᭷ຠ䛺 GMP ド᫂᭩c. 䝷䜲䝉䞁䝇໬䛥䜜䛯ື≀⏝་⸆ရ䛾๣ᙧ䛻ᛂ䛨䛶䚸䝷䜲䝉䞁䝅䞊䠄ᅜෆ〇㐀ᴗ⪅䠅䛾᭷ຠ䛺 CPOHB ド᫂᭩

2. ෌Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛻ኚ᭦䛜䛒䜛ሙྜ䠖ῧ௜㈨ᩱ A 䛛䜙ῧ௜㈨ᩱ K 䜎䛷䛾ᢏ⾡䝕䞊䝍䜢ᥦฟ䛩䜛䚹ὀព䛜ᚲせ䛺Ⅼ䛿ḟ䛾䛸䛚䜚䛷䛒䜛䚹a. ᡂศ䚸ຠ⬟ཬ䜃⏝㏵䛻ኚ᭦䛜䛒䛳䛯ሙྜ䚸ᙜヱື≀⏝་⸆ရ䛿䚸᪂䛯䛺ື≀⏝་⸆ရ䛸䛧
䛶Ⓩ㘓䛩䜛ᚲせ䛜䛒䜛䚹b. Ⓩ㘓␒ྕ䛾᭷ຠᮇ㛫ෆ䛻ᢏ⾡ⓗ䛺ኚ᭦䠄〇㐀ᢏ⾡䛾ኚ᭦䛺䛹䠅䛜⏕䛨䛯ሙྜ䚸Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛿䚸ື≀⾨⏕ᒁ䛻᪤Ꮡᢏ⾡䝕䞊䝍䛾ኚ᭦䜢ῧ௜䛧ᢎㄆ䜢ᚓ䜛ᚲせ䛜䛒䜛䚹
3. ⏕⏘ᣐⅬ䛾ኚ᭦/⛣ື䛺䛹⟶⌮ⓗ䛺ኚ᭦䛜䛒䜛ሙྜ䠖ᨻᗓ⊂⮬䛾᪉㔪䛷つไ䛥䜜䜛䚹෌Ⓩ㘓䛾
㝿䛻ὀព䛜ᚲせ䛺Ⅼ䛿ḟ䛾䛸䛚䜚䛷䛒䜛䚹a. ෌Ⓩ㘓᭩㢮䜢 11 㒊‽ഛ䛩䜛䚹⥳Ⰽ䛾෌Ⓩ㘓⏝䜹䝞䞊䛻ධ䜜䚸PPOH ཪ䛿 KOH ఍㆟䛷ᑂᰝ䛥䜜䜛Ⓩ㘓᭩㢮䛸୍⥴䛻ᥦฟ䛩䜛䚹b. Ⓩ㘓⏦ㄳ⪅䛛䜙䚸෌Ⓩ㘓䛩䜛ື≀⏝་⸆ရ〇๣䛻ኚ᭦䛜䛒䜛䛛ྰ䛛䜢グ㍕䛧䛯බᘧኌ᫂ᩥ䛜ᚲせ䛷䛒䜛䚹
c. Ⓩ㘓⏦ㄳ⪅䛷䛒䜛௻ᴗ䛾≧ἣ䜢᫂☜䛻䛩䜛ᚲせ䛜䛒䜚䚸⏕⏘⪅ཪ䛿㍺ධ⪅⏝䛾ື≀⏝་⸆ရ஦ᴗチྍド䚸ཬ䜃ື≀⏝་⸆ရ㍺ධᴗ⪅䛾㍺ධ㆑ู␒ྕ䠄API䠅䛾෗䛧䛜ᚲせ䛷䛒䜛䚹d. ᡂศཬ䜃䛭䛾௚䛾ᢏ⾡䝕䞊䝍䛻ኚ᭦䛜䛺䛡䜜䜀䚸ᑂᰝ㐣⛬䛷ᚲせ䛺⿵ຓ㈨ᩱ䛸䛧䛶᪂䛧䛔䝕䞊䝍䜢ῧ௜䛧䛶䚸ྂ䛔ᩥ᭩䜢෌Ⓩ㘓䛻౑⏝䛩䜛䛣䛸䛜䛷䛝䜛䚹e. ෌Ⓩ㘓ᑂᰝ䛿䚸⌧ᅾ䜒 PPOH 䛜⾜䛳䛶䛔䜛䚹92

2.3.3 ື≀⏝་⸆ရⓏ㘓␒ྕ䛾ㆡΏ䛾せ௳ື≀⏝་⸆ရⓏ㘓␒ྕ䜢ㆡΏ䛩䜛ሙྜ䚸௨ୗ䛾᭩㢮䜢‽ഛ䛧䛶⏦ㄳ䛩䜛ᚲせ䛜䛒䜛䚹a. ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ㏻▱᭩b. Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛷䛒䜛⏦ㄳ⪅䛜䚸Ⓩ㘓␒ྕ䜢ㆡΏ䛩䜛ពᛮ䛜䛒䜛䛣䛸䜢♧䛩ド᫂᭩
c. Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛఍♫䛜䚸Ⓩ㘓␒ྕ䛾ㆡΏ䜢ཷ䛡䜛ពᛮ䛜䛒䜛䛣䛸䜢♧䛩ド᫂᭩
d. Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛸Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛఍♫㛫䛾䚸Ⓩ㘓␒ྕㆡΏዎ⣙䛻㛵䛩䜛බṇド᭩
e. Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛఍♫䛾ື≀⏝་⸆ရ䛻ᑐ䛩䜛䚸BBPMSOH 䛜Ⓨ⾜䛧䛯ရ㉁ヨ㦂⤖ᯝド᫂᭩䛥䜙䛻䚸ㆡΏ䛥䜜䜛〇ရ䛜ᅜෆ〇ရ䛛㍺ධ〇ရ䛛䛻䜘䜚䚸௨ୗ䛾᭩㢮䛜ᚲせ䛷䛒䜛䚹Ɣ ᅜෆ〇ရ䛾Ⓩ㘓␒ྕㆡΏ䛾ሙྜ䠖f. ື≀⏝་⸆ရ䛾䝬䝇䝍䞊䝣䜯䜲䝹䠄Drug master file/DMF䠅g. 䛩䜉䛶䛾ື≀⏝་⸆ရ䝬䝇䝍䞊䝣䜯䜲䝹ཬ䜃〇㐀ᕤ⛬䛜ኚ᭦䛥䜜䛶䛚䜙䛪䚸⌧ᅾ䜒Ⓩ㘓ฎ᪉䛻‽䛨䛶䛔䜛᪨䜢グ䛧䛯䚸Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛௻ᴗ䛛䜙䛾ᐉㄋ᭩Ɣ ㍺ධ〇ရⓏ㘓␒ྕ䛾ㆡΏ䛾ሙྜ䠖h. Ⓩ㘓␒ྕ䜢ᡤ᭷䛩䜛௻ᴗ䛸䛾ྲྀᘬ䜢⤊஢䛧䚸Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛௻ᴗ䛻༠ຊ㛵ಀ䜢⛣⾜䛩䜛᪨䜢グ䛧䛯䚸ཎ⏘ᅜ䛾⏕⏘⪅䛛䜙䛾ᐉㄋ᭩i. Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛఍♫䜈䛾䚸ཎ⏘ᅜ䛾⏕⏘⪅䛛䜙䛾௵࿨≧Ɣ ㍺ධ〇ရ䛾Ⓩ㘓␒ྕ䜢ᅜෆ〇㐀ᴗ⪅䛻ㆡΏ䛩䜛ሙྜ䠖j. ື≀⏝་⸆ရ䛾䝬䝇䝍䞊䝣䜯䜲䝹䠄Drug master file/DMF䠅k. 䛩䜉䛶䛾ື≀⏝་⸆ရ䝬䝇䝍䞊䝣䜯䜲䝹ཬ䜃〇㐀ᕤ⛬䛜ኚ᭦䛥䜜䛶䛚䜙䛪䚸⌧ᅾ䜒Ⓩ㘓ฎ᪉䛻‽䛨䛶䛔䜛᪨䜢グ䛧䛯䚸Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛఍♫䛛䜙䛾ᐉㄋ᭩䠄〇㐀ᕤ⛬䚸ฎ᪉䚸ᡂศཬ䜃ရ㉁⟶⌮䛻ኚ᭦䛜䛒䛳䛯ሙྜ䛿䚸᪂〇ရ䛸䛧䛶Ⓩ㘓䛩䜛ᚲせ䛜䛒䜛䠅l. Ⓩ㘓␒ྕ䜢ᡤ᭷䛩䜛௻ᴗ䛸䛾ྲྀᘬ䜢⤊஢䛧䚸ື≀⏝་⸆ရ䛾〇㐀ᕤ⛬䛜Ⓩ㘓␒ྕ䜢ㆡΏ䛥䜜䜛௻ᴗ䛻⛣⾜䛩䜛䛣䛸䜢♧䛩䚸ཎ⏘ᅜ䛾⏕⏘⪅䛛䜙䛾ᐉㄋ᭩
2.3.4 ⥭ᛴ᫬䛻౑⏝䛩䜛ື≀⏝་⸆ရ䛾Ⓩ㘓せ௳⥭ᛴ᫬䛻౑⏝䛩䜛ື≀⏝་⸆ရ䛾Ⓩ㘓せ௳䛿䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. ᅜෆ〇㐀ᴗ⪅䛷䛒䜛䛣䛸
2. ḟ䛾஦㡯䜢ᐉゝ䛩䜛⏦ㄳ⪅䛛䜙䛾ᐉㄋ᭩a. Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛿䚸䛔䛟䛴䛛䛾ᆅᇦ䛷ື≀䛾Ṛஸ䛾ཎᅉ䛸䛺䜛⑌⑓䜢ண㜵䛩䜛䛯䜑䛻᪩ᛴ䛻ᚲせ䛸䛥䜜䛶䛚䜚䚸㐺ษ䛺௦᭰἞⒪ἲ䛜䜎䛰䛺䛔䚹b. ື≀⏝་⸆ရ䛾ရ㉁䛻ᑐ䛩䜛㈐௵䜢㈇䛖䚹
c. ᭷ຠᛶཬ䜃Ᏻ඲ᛶ䜢☜ㄆ䛩䜛䛯䜑䚸ᐇᆅㄪᰝ䜢ᐇ᪋䛩䜛䚹d. ື≀⏝་⸆ရ䛾๪స⏝䝰䝙䝍䝸䞁䜾䠄MESOH䠅䜢ᐇ᪋䛩䜛䚹e. ⥭ᛴ౑⏝ᢎㄆ୰䛾ື≀⏝་⸆ရ䛾⏕⏘ཬ䜃ὶ㏻䛾ᐇ⌧ᛶཬ䜃ື≀⏝་⸆ရ䛾๪స⏝䝰䝙䝍䝸䞁䜾䛾⤖ᯝ䜢␆⏘ື≀⾨⏕ᒁ㛗䛻ሗ࿌䛩䜛䚹
3. ᐇᆅㄪᰝ䛾ᥦ᱌᭩
4. ື≀⏝་⸆ရ䛾ᢏ⾡ᩥ᭩䠄dossier䠅䛻ᑐ䛩䜛ື≀⏝་⸆ရⓏ㘓ᑂᰝ఍䠄PPOH䠅ཬ䜃/ཪ䛿ື≀93⏝་⸆ရጤဨ఍䠄KOH䠅䛛䜙䛾ᢎㄆཬ䜃➨ 2 㡯䛾 c ཬ䜃 d 䛾ᢎㄆ⤖ᯝ
5. 㑇ఏᏊ⤌᥮䛘〇ရ䛾ሙྜ䚸㑇ఏᏊ⤌᥮䛘⏕≀䠄GMO䠅⏤᮶䛾ື≀⏝་⸆ရ䛻㛵䛩䜛䛂㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䛃䛛䜙䛾⎔ቃᏳ඲ド᫂᭩䠄ヲ⣽䛻䛴䛔䛶䛿䚸䛂5.3 㑇ఏᏊ⤌᥮䛘⏕≀
䠄GMO䠅⏤᮶䛾ື≀⏝་⸆ရ䛻㛵䛩䜛䛄㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄KKH PRG䠅䛅䛛䜙䛾⎔ቃᏳ඲ド᫂᭩䠄Sertifikat Keamanan Lingkungan䠅䛃䜢ཧ↷䠅
6. Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛾⠊ᅖ䛻ᛂ䛨䛯 CPOHB ド᫂᭩
2.3.5 ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕኚ᭦䛾せ௳௨ୗ䛾ኚ᭦䛜Ⓨ⏕䛧䛯ሙྜ䚸ື≀⏝་⸆ရⓏ㘓␒ྕ䜢ኚ᭦䛩䜛ᚲせ䛜䛒䜛䚹䛭䛾㝿䛻ᚲせ䛺せ௳䛿䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. ᡂศ䚸〇㐀ሙᡤ䚸〇㐀ᕤ⛬䚸ಖᏑᮇ㛫䚸᭹⏝᪉ἲ䚸ᑐ㇟ື≀ཬ䜃/ཪ䛿ໟ⿦ᮦ䛾ኚ᭦a. ື≀⏝་⸆ရ䛾ᢏ⾡ᩥ᭩䠄dossier䠅䛻ᑐ䛩䜛 PPOH 䛛䜙䛾ᢎㄆ⤖ᯝb. ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ᭩c. ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠅䛛䜙䛾ရ㉁ヨ㦂⤖ᯝド᫂᭩
2. ඙ೃ䛾ኚ໬ཬ䜃/ཪ䛿་⸆ရ౑⏝୰Ṇ᫬䛾ኚ໬
a. ື≀⏝་⸆ရ䛾ᢏ⾡ᩥ᭩䠄dossier䠅䛻ᑐ䛩䜛 PPOH 䛛䜙䛾ᢎㄆ⤖ᯝb. ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ᭩
3. 〇ရྡ䚸䝯䞊䜹䞊ྡ䚸ᐜჾ/ໟ⿦䝃䜲䝈ཬ䜃/ཪ䛿ໟ⿦ᐜ㔞䛾ኚ᭦a. ື≀⏝་⸆ရ䛾ᢏ⾡ᩥ᭩䠄dossier䠅䛻ᑐ䛩䜛ᢎㄆ⤖ᯝb. ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ᭩
4. 䝷䝧䝹/䝺䝑䝔䝹䛾䝕䝄䜲䞁䛾ኚ᭦a. ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ᭩b. 䝷䝧䝹/䝺䝑䝔䝹䛾䝕䝄䜲䞁ኚ᭦䛾ṇᙜ䛺⌮⏤ͤື≀⏝་⸆ရ䛾Ⓩ㘓⏦ㄳᩱ㔠䛻䛴䛔䛶56
1. ⏕≀Ꮫⓗ〇๣䛿䚸〇๣䛾✀㢮䛤䛸䛻 6,000,000 䝹䝢䜰
2. ་⸆ရ䚸䝥䝺䝭䝑䜽䝇〇๣ཬ䜃⏕⸆䛿䚸〇๣䛾✀㢮䛤䛸䛻 5,000,000 䝹䝢䜰
2.3.6 ື≀⏝་⸆ရⓏ㘓⏦ㄳ䛾ὶ䜜57
ື≀⏝་⸆ရ䜢Ⓩ㘓䛻䛴䛔䛶䛿䚸䛂2.3.1 ື≀⏝་⸆ရⓏ㘓チྍ䠄᪂つⓏ㘓ཪ䛿෌Ⓩ㘓䠅䛃䛾㡯䛷䚸䛂䜲䞁䝗䝛䝅䜰䛻䛚䛡䜛ື≀⏝་⸆ရⓏ㘓䛾ὶ䜜䚸ᡤせ᫬㛫䚸㈝⏝䛃䜢ᅗ♧䛧䛯䚹ᙜヱᅗ䛷♧䛧䛯䛸䛚
䜚䚸Ⓩ㘓䛻䛒䛯䛳䛶䚸䛂஦๓᭩㢮ᑂᰝ䛃䚸䛂᭩㢮ホ౯䛃䚸䛂ရ㉁ヨ㦂䠄䝃䞁䝥䝹ヨ㦂䠅䛃䚸䛂ື≀་⸆ရⓏ㘓
␒ྕ䛾Ỵᐃ䞉௜୚䛃䚸䛸䛔䛖 4 䛴䛾ẁ㝵䜢⤒䜛ᚲせ䛜䛒䜛䚹௨ୗ䛻䚸䛭䜜䛮䜜䛾ẁ㝵䛻䛴䛔䛶䛾᝟ሗ䜢♧䛩䚹
2.3.6.1 ஦๓᭩㢮ᑂᰝ
Ⓩ㘓⏦ㄳ䛻䛚䛡䜛஦๓᭩㢮ᑂᰝ䛾ὶ䜜䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. ື≀⾨⏕ᒁ䛾ື≀⏝་⸆ရ⟶⌮䠄POH䠅ㄢ䛾᳨ド䝏䞊䝮䛜஦๓ᑂᰝ䜢⾜䛖䚹஦๓᭩㢮ᑂᰝ䛿䚸56 ㎰ᴗ┬䛷᭷ຠ䛺㠀ㄢ⛯ᅜᗜṓධ䛾✀㢮ཬ䜃ᩱ㔠䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつไ 2016 ᖺ➨ 35 ྕ䠄https://peraturan.bpk.go.id/Home/Details/5756䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅
57 ື≀⏝་⸆ရⓏ㘓⏦ㄳᡭ⥆䛝䛻㛵䛩䜛␆⏘ᒁ㛗つᐃ➨ 02/Kpts/LB.450/F/03/06 ྕ䠄https://dokumen.tips/documents/peraturan-direktur-jenderal-peternakan-nomor-02kptslb450f0306tentang.html?page=11䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅94ྠ䛨᭷ຠᡂศ䜢ྵ䜏䚸㓄ྜ䚸ฎ᪉ཪ䛿ຠ⬟䛜ྠ䛨䛷䛒䜛ື≀⏝་⸆ရ䠄me-too drug䠅〇๣䛻䛴䛔䛶䛿ື≀⏝་⸆ရⓏ㘓ጤဨ఍䠄PPOH䠅఍㆟䛷ᑂ㆟䛥䜜䜛䚹᪂⸆䛻䛴䛔䛶䛿ື≀⏝་⸆ရጤဨ఍䠄KOH䠅఍㆟䛷ᑂ㆟䛥䜜䜛䚹Ⓩ㘓⏦ㄳ䛜⌧ᐇⓗ䛺䜒䛾䛷䛒䜛䛛䛜ホ౯䛥䜜䚸᭷ຠ䛛䛴ຠ⋡ⓗ䛺ᑂᰝ䛜ᮇᚅ䛥䜜䜛䚹
2. ᳨ド䝏䞊䝮䛿䚸ື≀⾨⏕ᒁ䚸PPOH ཬ䜃 BBPMSOH 䛛䜙ὴ㐵䛥䜜䛯䝯䞁䝞䞊䛷ᵓᡂ䛥䜜䜛䚹
3. Ⓩ㘓⏦ㄳ᭩䛻୙ഛ䛜䛒䜛䛸ุ᩿䛥䜜䛯ሙྜ䛿䚸⏦ㄳ⪅䛻㏻▱䛥䜜䜛䚹
4. PPOH ཬ䜃/ཪ䛿 KOH 䛾఍㆟䛾䛯䜑䛻䚸Ⓩ㘓⏦ㄳ᭩䜢 11 㒊సᡂ䛩䜛䚹ື≀⾨⏕ᒁ䛾 POH ㄢ䛻ᥦฟ䛧䚸Ⓩ㘓⏦ㄳ᭩㢮䛾ᥦฟ䜢ド᫂䛩䜛᭩㢮䜢 2 㒊Ⓨ⾜䛩䜛䚹ͤⓏ㘓⏦ㄳ᭩㢮䛾ᥦฟ䛿ẖႠᴗ᪥䛻⾜䜟䜜䚸஦๓᭩㢮ᑂᰝ䛾⤖ᯝ䛿ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩䛾ᥦฟ䛛䜙 10 Ⴀᴗ᪥௨ෆ䛻ุ᫂䛩䜛䚹
2.3.6.2 ᭩㢮ホ౯᭩㢮ホ౯ẁ㝵䛻䛚䛔䛶␃ព䛩䜉䛝᝟ሗ䛿䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. PPOH ཪ䛿 KOH 䛾ホ౯me-too drug 〇๣䛻䛴䛔䛶䛿䚸㐣ཤ䛻 PPOH ཪ䛿 KOH 䛷ᢎㄆ䛥䜜䛯་⸆ရ䛷䛒䜛䛯䜑䚸
PPOH 䝺䝧䝹䛷䛾ᑂᰝ䛷༑ศ䛷䛒䜛䛸䛥䜜䛶䛔䜛䚹䛂᪂⸆䛃䛻ศ㢮䛥䜜䜛ື≀⏝་⸆ရ〇๣䛿䚸つᐃ䛻ᚑ䛔 KOH 䝺䝧䝹䛷᳨ウཪ䛿ホ౯䛥䜜䜛䚹㎰ᴗ኱⮧Ỵᐃ➨ 695/Kpts/TN.260/8/96 ྕ䛻ᇶ䛵䛝䚸௨ୗ䛾ື≀⏝་⸆ရ〇๣䛜᪂⸆䛻ศ㢮䛥䜜䜛䚹䠄㻝䠅㻌᪂䛧䛔᭷ຠᡂศ䜢ྵ䜐㻌䠄㻞䠅㻌ྂ䛔᭷ຠᡂศ䜢ྵ䜐䛜䚸᪂䛧䛔ຠ⬟䜢ྵ䜐㻌䠄㻟䠅㻌ྂ䛔᭷ຠᡂศ䛛䜙᪂㓄ྜ䜢ྵ䜐㻌䠄㻠䠅㻌ῧຍ≀䜢ྵ䜐᪂䛧䛔ฎ᪉䛷䛒䜛㻌
2. PPOH ཪ䛿 KOH 䛾ホ౯⤖ᯝື≀⾨⏕ᒁ㛗䛿䚸PPOH ཪ䛿 KOH 䛛䜙䛾Ⓩ㘓ᑂᰝ⤖ᯝ䜢ᥦ᱌/᳨ウᮦᩱ䛸䛧䛶䚸Ⓩ㘓⏦ㄳ䜢ḟ䛾䛸䛚䜚ᢎㄆ䛩䜛䛛䛹䛖䛛ุ᩿䛩䜛䚹䠄㻝䠅㻌䝕䞊䝍䛜䛩䜉䛶䛭䜝䛳䛶䛚䜚ᙜヱつไ䛻ᚑ䛳䛶䛔䜛䛯䜑䚸ᢎㄆ䛩䜛㻌䠄㻞䠅㻌᮲௳௜䛷ᢎㄆ䛩䜛㻌䠄㻟䠅㻌䝕䞊䝍䛜඲䛟䛭䜝䛳䛶䛔䛺䛔ཪ䛿ศ㢮䛜ᮍ☜ᐃ䛷䛒䜛䛯䜑䚸ཪ䛿 㻷㻻㻴 䛾Ỵᐃ䜢ᚅ䛯䛺䛡䜜䜀䛺䜙䛺䛔䛯䜑ᘏᮇ䚸෌᳨ウ䛩䜛㻌䠄㻠䠅㻌⚗Ṇ≀㉁ཪ䛿ᙜヱつไ䛻཯䛩䜛᭷ຠᡂศ䛜ྵ䜎䜜䛶䛔䜛䛯䜑୙ᢎㄆ䛸䛩䜛䚹㻼㻼㻻㻴㻛㻷㻻㻴䛛䜙䛾ホ౯䛿䚸௒ᚋ䛾Ⓩ㘓㐣⛬䛷䚸␆⏘ᒁ㛗䜈䛾ᥦ᱌㻛᳨ウᮦᩱ䛸䛥䜜䜛㻌
3. ⏕⏘⪅/㍺ධᴗ⪅䛸䛾┦஫☜ㄆ
Ⓩ㘓᭩㢮䛾ᑂᰝ㐣⛬䛷┦஫☜ㄆ䛜ᚲせ䛸ุ᩿䛥䜜䛯ሙྜ䚸PPOH ཪ䛿 KOH 䛿䚸ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩䛾ྛ᭩㢮䛾᏶඲ᛶ䚸┿ᐇᛶ䛻䛴䛔䛶䚸Ⓩ㘓⏦ㄳ⪅䛻┤᥋☜ㄆ䛩䜛䛣䛸䛜䛷䛝䜛䚹
4. Ⓩ㘓ᡭ⥆䛾ᮇ㛫
a. Ⓩ㘓ᡭ⥆䛾ᮇ㛫⟬ฟ䛿䚸Ⓩ㘓⏦ㄳ᭩䛜᳨ド䝏䞊䝮䛻䜘䛳䛶 PPOH ཬ䜃/ཪ䛿 KOH ఍㆟䛻⛣⾜䛩䜛㈨᱁䛜䛒䜛䛸ᐉゝ䛥䜜䛯᫬Ⅼ䛛䜙ィ⟬䛥䜜䜛䚹PPOH ఍㆟䛛䜙఍㆟⤖ᯝ㏻▱䠄ホ౯䠅䛻㛵䛩䜛ື≀⾨⏕ᒁ㛗ᐄ䛶䛾䝺䝍䞊䜢ᥦฟ䛩䜛䜎䛷䛻せ䛩䜛඲య䛾᫬㛫䛿䚸ື≀⏝་⸆ရ䜢ᑂ㆟䛧䛯 PPOH ఍㆟䛾ᐇ᪋᪥䛛䜙᭱኱ 50 Ⴀᴗ᪥䛷䛒䜛䚹

95୍᪉䚸᳨ド䝏䞊䝮䛜ホ౯䛧䛯ື≀⏝་⸆ရ〇๣䛻䛴䛔䛶䛿 KOH ఍㆟䛷ᑂ㆟䛥䜜䛺䛡䜜䜀䛺䜙䛺䛔䛜䚸ື≀⏝་⸆ရ䜢ᑂ㆟䛧䛯 KOH ఍㆟䛾ᐇ᪋᪥䛛䜙᭱኱ 120 Ⴀᴗ᪥䛜ᚲせ䛷䛒
䜛䚹PPOH ホ౯఍㆟䛾⤖ᯝ䚸KOH 䝺䝧䝹䛷䛥䜙䛻ᑂ㆟䛜ᚲせ䛺ሙྜ䛿䚸ḟ䛾 KOH ఍㆟䛷ᑂ㆟䛻⛣䜛䚹
b. PPOH ཪ䛿 KOH 䛾఍㆟䛜つᐃ䛥䜜䛯ᮇ㛫ෆ䛻㛤ദ䛷䛝䛺䛔ሙྜ䚸つᐃᮇ㛫⤒㐣ᚋ㐜䛟䛸
䜒 7 Ⴀᴗ᪥௨ෆ䛻䚸ື≀⾨⏕ᒁ䛿䚸⌮⏤䜢ῧ䛘䛯ື≀⏝་⸆ရⓏ㘓⏦ㄳ䛾ᑂᰝ㐣⛬ᘏᮇ䛻㛵䛩䜛㏻▱᭩䜢Ⓨ⾜䛩䜛䚹c. PPOH 䛜㏣ຍ䝕䞊䝍ᥦฟ䜢᮲௳䛸䛧䛶 PPOH ఍㆟Ỵᐃ䛜ᢎㄆ䛥䜜䛯ሙྜ䚸⏦ㄳ⪅䛿䚸
PPOH ఍㆟⤖ᯝ㏻▱᭩䛾Ⓨ⾜᪥䛛䜙㐜䛟䛸䜒 40 Ⴀᴗ᪥௨ෆ䛻㏣ຍ䝕䞊䝍䜢ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹⏦ㄳ⪅䛜 40 Ⴀᴗ᪥௨ෆ䛻㏣ຍ䝕䞊䝍䜢ᥦฟ䛩䜛䛣䛸䛜䛷䛝䛺䛔ሙྜ䚸Ⓩ㘓ᡭ⥆䛿⮬ືⓗ䛻䜻䝱䞁䝉䝹䛥䜜䜛䚹
ͤPPOH ఍㆟䛿䚸䝟䞁䝕䝭䝑䜽୰䚸䜸䞁䝷䜲䞁䛷ᐇ᪋䛥䜜䛶䛔䜛䚹2022 ᖺ䚸PPOH ఍㆟䛿 11 ᅇ㛤ദ䛥䜜䚸ྜィ 421 䛾ື≀⏝་⸆ရ䛜ᑂᰝ䛥䜜䛯䚹䛭䛾⤖ᯝ䛿 201 〇ရ䛜ᢎㄆ䚸151 〇ရ䛜㏣ຍ䝕䞊䝍䛾ᥦฟ䛷ᢎㄆ䚸58 〇ရ䛜෌ᑂ㆟ᘏᮇ䚸10 〇ရ䛜 KOH 䛷䛾㏣ຍᑂ㆟䛻ᘏᮇ䚸1 〇ရ䛜୙ᢎㄆ䛸䛥䜜䛯䚹582.3.6.3 䝃䞁䝥䝹䛾ㄪ㐩ཬ䜃ヨ㦂59
PPOH/KOH 䛻䜘䜛ホ౯ᶵᵓ䛻䜘䛳䛶Ⓩ㘓⏦ㄳ䛜ᢎㄆ䛥䜜䛯ື≀⏝་⸆ရ䛿䚸䛭䛾ᚋ BBPMSOH
䛻䜘䜛ရ㉁ヨ㦂䜢ཷ䛡䛺䛡䜜䜀䛺䜙䛺䛔䚹ရ㉁ヨ㦂䛾䛯䜑䛻䚸≉䛻ὀព䛧䛺䛡䜜䜀䛺䜙䛺䛔Ⅼ䛿ḟ䛾䛸䛚䜚䛷䛒䜛䚹
1. 䝃䞁䝥䝹䛾ㄪ㐩䝻䞊䜹䝹〇ရཪ䛿㍺ධ䛾ື≀⏝་⸆ရ䛻ᑐ䛧䚸BBPMSOH 䛷ရ㉁ヨ㦂䜢⾜䛖䛯䜑䚸ཪ䛿⊂❧䛧䛯ྜἲⓗ䛺➨୕⪅䛜ᐇ᪋䛩䜛⌧ᆅヨ㦂䜢⾜䛖䛯䜑䚸ྛ䝃䞁䝥䝹䛿䚸ᙜヱつ๎䛻ᚑ䛔ᑠつᶍ⏕⏘䠄small scale production䠅ཪ䛿㍺ධ䛷ㄪ㐩䛩䜛䛣䛸䛜䛷䛝䜛䚹
2. 䝃䞁䝥䝹䛾㏦௜
ヨ㦂䛾䛯䜑䛻 BBPMSOH 䛻㏦௜䛥䜜䜛ື≀⏝་⸆ရ䛾䝃䞁䝥䝹䛿䚸⏦ㄳ⪅䛷䛒䜛௻ᴗ䛾ᢏ⾡ᢸᙜ⪅䠄⋇་ᖌ/⸆๣ᖌ䠅䛜䚸௨ୗ䛾஦᯶䛻ὀព䛧䛶㏦௜ཪ䛿㓄㏦䛩䜛䚹
a. BBPMSOH 䛻㏦௜䛩䜛ྛ䝃䞁䝥䝹䛻䛿䚸ື≀⾨⏕ᒁ㛗䛛䜙䛾⤂௓≧ཬ䜃Ⓩ㘓⏦ㄳ⪅䛻䜘䜛⏦ㄳ᭩䜢ῧ௜䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹b. BBPMSOH 䛻㏦௜䛩䜛䝃䞁䝥䝹ᩘ䛿䚸ᙜヱつ๎䛻ᇶ䛵䛟䚹䠄ᚲせ䛺䝃䞁䝥䝹ᩘ䛻䛴䛔䛶䛿䚸
BBPMSOH 䛾䜴䜵䝤䝃䜲䝖60䜢ཧ↷䠅
3. 䝃䞁䝥䝹ヨ㦂ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䛿䚸ື≀⏝་⸆ရ䛾ရ㉁䚸᭷ຠᛶ䚸Ᏻ඲ᛶ䛾ᇶ‽䜢‶䛯䛧䛶䛔䜛䛛䛹58 䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍

䠄https://www.asohi.org/index.php?option=com_content&view=article&id=1925:asohi-hadiri-sosialisasi-danworkshop-sistem-pendaftaran-obat-hewan-online&catid=1:latest-news&Itemid=11䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12
᭶ 26 ᪥䠅
59 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 19 ᪥䠅
60 ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠅䠄https://bbpmsohgunungsindur.com/pelayanan/jumlahsampel-uji/䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅96䛖䛛☜ㄆ䛩䜛䛯䜑䛻ᐇ᪋䛥䜜䜛䚹ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂⤖ᯝド᫂᭩䛿䚸BBPMSOH 䛛䜙Ⓨ⾜䛥䜜䜛䚹ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂ᇶ‽䛸䛿䚸䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ⸆ᒁ᪉䠄FOHI䠅ཪ䛿ྠ➼䛾௚ᅜ䛾ື≀⏝་⸆ရ⸆ᒁ᪉
䛻䛚䛡䜛᭱ᑠ㝈䛾せồ஦㡯䜢ᣦ䛩䚹᳨ᰝ䛩䜛ື≀⏝་⸆ရ䝃䞁䝥䝹䠖̺ ື≀⏝་⸆ရ䛾䝃䞁䝥䝹䛻䛿䝷䝧䝹䜢㈞䜛䚹άᛶᡂศ䜢ྵ䜏䚸ྠ䛨䝞䝑䝏␒ྕ䜢ᣢ䛱䚸⏕≀Ꮫⓗ〇๣䛿 9 䛛᭶௨ୖ䚸་⸆ရཬ䜃䝥䝺䝭䝑䜽䝇〇๣䛿 6 䛛᭶௨ୖ䛾᭷ຠᮇ㝈䜢᭷䛩䜛ᚲせ䛜䛒䜛䚹
̺ ྠ୍ၟရྡ䚸ྠ୍⤌ᡂ䛾ໟ⿦䝃䜲䝈䛜␗䛺䜛ື≀⏝་⸆ရ䛿䚸ရ㉁ヨ㦂⏦㎸᭩䛻ໟ⿦䝃䜲䝈䜢᫂グ䛩䜛ᚲせ䛜䛒䜛䚹̺ ື≀⏝་⸆ရ䛾䝃䞁䝥䝹ᩘ䛿䚸ヨ㦂䛾✀㢮䛻‽䛪䜛䚹䠄ᚲせ䛺䝃䞁䝥䝹ᩘ䛻䛴䛔䛶䛿䚸
BBPMSOH 䛾䜴䜵䝤䝃䜲䝖䜢ཧ↷䠅̺ ᪂つⓏ㘓䛾ሙྜ䚸ᑂᰝ䛻ᚲせ䛺ရ㉁䛾ᶆ‽ⓗ䛺ຠ⬟≀㉁ཬ䜃/ཪ䛿㠀ຠ⬟≀㉁䜢ཎᮦᩱ䛸䛧䛶ᥦ౪䛩䜛ᚲせ䛜䛒䜛䚹
4. ⤖ᯝ㏻▱
1) 䝃䞁䝥䝹ヨ㦂䛻ྜ᱁䛧䛯ሙྜ䛿㐺᱁䠄MS䠅䚸୙ྜ᱁䛾ሙྜ䛿୙㐺᱁䠄TMS䠅䛾㏻▱䛜䛺䛥䜜䜛䚹㐺᱁䛸䛥䜜䛯䝃䞁䝥䝹䛻䛿 BBPMSOH 䛛䜙ရ㉁ヨ㦂⤖ᯝド᫂᭩䛜ᤵ୚䛥䜜䚸୙㐺᱁䛸䛥䜜䛯䝃䞁䝥䝹䛻䛿 BBPMSOH 䛛䜙ᙜヱ⏦ㄳ⪅䛻බᘧᩥ᭩䛷㏻▱䛥䜜䜛䚹2) 㠀㑇ఏᏊ⤌᥮䛘⏕≀ཬ䜃㠀㑇ఏᏊ⤌᥮䛘⏕≀䛾ὴ⏕〇ရ䠄GMO Derrivative Prosuct䠅䛾ື≀⏝་⸆ရ䝃䞁䝥䝹䛷䚸䝞䜲䜸䝉䞊䝣䝔䜱䝺䝧䝹䠄BSL䠖Bio Safety Level䠅3 䛾ᐇ㦂᪋タ䜢ྵ䜐ᐇ㦂᪋タ/ᶵჾ䛻ไ㝈䛜䛒䜚䚸ヨ㦂ᑐ㇟䛾ື≀་⸆ရᶆ‽ཎᩱ䛾ධᡭ䛜䛷䛝䛺䛔䛯䜑䛻ヨ㦂䛷䛝䛺䛔䝃䞁䝥䝹䛻䛴䛔䛶䛿䚸᭱኱ 10 Ⴀᴗ᪥௨ෆ䛻⏦ㄳ⪅䛻᭩㠃䛷㏻▱䛥䜜䜛䚹௬
Ⓩ㘓␒ྕ䛿䚸BBPMSOH 䛛䜙䛾㏻▱᭩䛾᪥௜䛛䜙㐜䛟䛸䜒 35 Ⴀᴗ᪥௨ෆ䛻␆⏘⥲ᒁ䛛䜙Ⓨ⾜䛥䜜䜛䚹
5. ᡤせ᫬㛫䛣䛾ヨ㦂ẁ㝵䛿䚸ື≀⏝་⸆ရ䛾᏶඲䛺䝃䞁䝥䝹䜢ཷ㡿ᚋ䚸BBPMSOH 䛛䜙ရ㉁ヨ㦂⤖ᯝ䠄ド
᫂᭩ཪ䛿㏻▱᭩䠅䛜Ⓨ⾜䛥䜜䜛䜎䛷䛾ᮇ㛫䛾䛣䛸䛷䛒䜛䚹ᮏヨ㦂ẁ㝵䛾ᡤせ᫬㛫䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹1) ᭱኱ 2 ✀㢮䛾⤌ྜ䛫䛷䛒䜛་⸆ရ〇๣ཬ䜃䝥䝺䝭䝑䜽䝇〇๣䛾䜾䝹䞊䝥䛿䚸᭱኱ 35 Ⴀᴗ᪥䛸䛩䜛䚹⤌ྜ䛫䛾᭷ຠᡂศ䛜 1 ✀㢮ቑ䛘䜛䛤䛸䛻䚸㏣ຍ䛾᭱኱ヨ㦂᫬㛫䛿䚸2 ✀㢮䛾⤌ྜ䛫䛾ヨ㦂䛻せ䛩䜛ヨ㦂᫬㛫䛸ྠ䛨䛸䛩䜛䚹2) ⏕≀Ꮫⓗ〇๣䠄䝽䜽䝏䞁䚸ᢠཎ䚸୍౯ᢠ⾑Ύ䠅䛾䜾䝹䞊䝥䛿䚸䝁䝸䞊䝄䠄Coryza䠅䝽䜽䝏䞁䠇᭱኱ 10 Ⴀᴗ᪥䚸ᐙ⚺䝁䝺䝷䠄Fowl Cholera䠅䝽䜽䝏䞁䠇᭱኱ 45 Ⴀᴗ᪥䜢㝖䛔䛶䚸᭱኱ 75Ⴀᴗ᪥䛸䛩䜛䚹⤌ྜ䛫䛾୰䛻ᢠཎ䛾✀㢮䜢ቑ䜔䛩ሙྜ䚸᭱኱ヨ㦂᫬㛫䛿୍౯䛾ヨ㦂䛷せ䛩䜛᫬㛫䛸ྠ䛨䛸䛩䜛䚹3) ⏕⸆ཬ䜃䝥䝻䝞䜲䜸䝔䜱䜽䝇〇๣䛾䜾䝹䞊䝥䠄᭱኱ 2 ✀㢮䛾᭷ຠᡂศ䛾⤌ྜ䛫䠅䛿䚸᭱኱35 Ⴀᴗ᪥䛸䛩䜛䚹⤌ྜ䛫䛾᭷ຠᡂศ䛜䠍✀㢮ቑ䛘䜛䛤䛸䛻䚸㏣ຍ䛾᭱኱ヨ㦂᫬㛫䛿䚸2 ✀㢮䛾⤌ྜ䛫䛾ヨ㦂䛻せ䛩䜛ヨ㦂᫬㛫䛸ྠ䛨䛸䛩䜛䚹

2.3.6.4 ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ䠄Ỵᐃ᭩Ⓨ⾜䠅97

ရ㉁ヨ㦂䛻ྜ᱁䛩䜛䛸䚸ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕ䛜Ỵᐃ䛥䜜䚸Ⓩ㘓␒ྕỴᐃ᭩䛜Ⓨ⾜䛥䜜䜛䚹䛣䛾ẁ㝵䛻㛵䛩䜛᝟ሗ䜢௨ୗ䛻䜎䛸䜑䜛䚹ື≀⏝་⸆ရⓏ㘓␒ྕ䛾Ỵᐃཬ䜃௜୚1) Ⓩ㘓␒ྕཬ䜃Ⓩ㘓␒ྕ䝁䞊䝗Ỵᐃẁ㝵䛸䛿䚸⏦ㄳ⪅䛜 BBPMSOH 䛛䜙䛾ရ㉁ヨ㦂⤖ᯝド᫂᭩䛾෗䛧䜢ື≀⾨⏕⥲ᒁ䛻ᥦฟ䛧䛶䛛䜙䚸ື≀⏝་⸆ရⓏ㘓␒ྕ䛾௜୚䛻㛵䛧䛶ື≀⾨⏕⥲ᒁ䛛䜙Ỵᐃ᭩䛜Ⓨ⾜䛥䜜䜛䜎䛷䛾ẁ㝵䜢ᣦ䛩䚹2) Ⓩ㘓ᑂᰝ䛾ᢏ⾡ⓗせ௳䜢‶䛯䛧䚸BBPMSOH 䛛䜙䛾ရ㉁ヨ㦂⤖ᯝド᫂᭩䜢᭷䛩䜛ື≀⏝་⸆ရ䛻䛴䛔䛶䛿䚸␆⏘ᒁ㛗Ỵᐃ䜢㏻䛧䛶䚸☜ᐃ䛧䛯Ⓩ㘓␒ྕ䛾௜୚ᡭ⥆䜢⾜䛖䛣䛸䛜䛷䛝䜛䚹3) ௬Ⓩ㘓␒ྕ䛿䚸PPOH/KOH 䛷ᢏ⾡ⓗ䛻ᢎㄆ䛥䜜䚸BBPMSOH 䛛䜙䛾ᐉㄋ᭩䛜ῧ௜䛥䜜䜛䚹ᙜヱ〇ရ䛜ヨ㦂䛷䛝䛺䛔䛣䛸䜢᮲௳䛻䚸☜ᐃ␒ྕ䛜๭䜚ᙜ䛶䜙䜜䜛๓䛻ฎ⌮䛩䜛䛣䛸䛜ྍ⬟䛷䛒䜛䚹4) ື≀⾨⏕ᒁ㛗䛛䜙䛾ᡭ⣬䛻ᇶ䛵䛝Ⓩ㘓␒ྕ䜢ྲྀᚓ䛧䛯ື≀⏝་⸆ရ䛻䛴䛔䛶䛿䚸Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛻ᨭᡶ࿨௧᭩䠄SPP䠖Surat Perintah Pembayaran䠅䛜Ⓨ⾜䛥䜜䜛䚹᪂つⓏ㘓䞉
෌Ⓩ㘓䛸䜒䛻䚸ᨭᡶ㢠䛿 10 ᖺศ䛸䛩䜛䚹Ⓩ㘓ᩱ䛿䚸ᅜႠ䝬䞁䝕䜱䝸㖟⾜䠄Bank Mandiri
䠄Persero䠅䠅Jakarta Ragunan ᨭᗑ䛾␆⏘⥲ᒁ≉ูᅜᗜ䠄Bendahara Khusus䠅ྡ⩏䛾ཱྀᗙ䛻ධ㔠䛩䜛䚹
5) ␆⏘ᒁ㛗Ỵᐃ䛻グ㍕䛥䜜䛯ື≀⏝་⸆ရ䛾☜ᐃⓏ㘓␒ྕཪ䛿௬Ⓩ㘓␒ྕ䛾஺௜䛿䚸ᨭᡶド᫂᭩䜢ཷ㡿䛧䛯ᚋ䚸Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛻஺௜䛥䜜䜛䚹6) ື≀⏝་⸆ရⓏ㘓␒ྕ䛾௜୚䛻㛵䛩䜛␆⏘ᒁ㛗䛾Ỵᐃ䛿䚸BBPMSOH 䛛䜙ရ㉁ヨ㦂⤖ᯝド᫂᭩䛾෗䛧䜢ཷྲྀ䛳䛶䛛䜙䚸㐜䛟䛸䜒 10 Ⴀᴗ᪥௨ෆ䛻Ⓨ⾜䛥䜜䜛䚹Ⓩ㘓␒ྕ䝁䞊䝗ཬ䜃ᙧᘧື≀⏝་⸆ရⓏ㘓␒ྕ䛾グ㍕䛿䚸ỌஂⓏ㘓␒ྕ䛾ሙྜ䛻䛿䛂DEPTAN RI䛃䚸௬Ⓩ㘓␒ྕ䛾ሙྜ䛻䛿䛂DPS䛃䛷ጞ䜎䜛䚹ື≀⏝་⸆ရⓏ㘓␒ྕ䛿䚸13 ᱆䛾ⱥᩘᏐ䛷ᵓᡂ䛥䜜䜛䚹௨ୗ䛾ᅗ䛿ື≀⾨⏕ᒁ䛾䝣䜵䜲䝇䝤䝑䜽䛻㍕䛫䜙䜜䛶䛔䜛䜒䛾䛷䛒䜛䚹䛣䜜䜙䛾ྛ᱆䜢㏻䛧䛶䚸〇ရ䛻㛵䛩䜛௨ୗ䛾᝟ሗ䜢ᚓ䜛䛣䛸䛜䛷䛝䜛䚹1) 1 ᱆┠䛿䚸௨ୗ䛾ព࿡䜢ᣢ䛴ᩥᏐ䝁䞊䝗䛷ᵓᡂ䛥䜜䜛䚹ᅜෆ〇ရ䛿䝁䞊䝗 D䠄Domestik䠅䚸㍺ධ〇ရ䛿䝁䞊䝗 I䠄Impor䠅䛜௜୚䛥䜜䜛䚹2) 2 ᱆┠ཬ䜃 3 ᱆┠䛿䚸Ⓩ㘓␒ྕ䛾Ⓨ⾜ᖺ䜢♧䛩ᩘᏐ䝁䞊䝗䛷ᵓᡂ䛥䜜䜛䚹3) 4 ᱆┠ཬ䜃 5 ᱆┠䛿䚸Ⓩ㘓␒ྕ䛾Ⓨ⾜᭶䜢♧䛩ᩘᏐ䝁䞊䝗䛷ᵓᡂ䛥䜜䜛䚹4) 6䚸7䚸8 ཬ䜃 9 ᱆┠䛿䚸Ⓩ㘓䛾䝅䝸䜰䝹␒ྕ䜢♧䛩ᩘᏐ䝁䞊䝗䛷ᵓᡂ䛥䜜䜛䚹5) 10䚸11 ཬ䜃 12 ᱆┠䛿䚸ື≀⏝་⸆ရ䛾つ᱁䜢♧䛩ᩥᏐ䝁䞊䝗䛷ᵓᡂ䛥䜜䜛䚹
10 ᱆┠䛾ᩥᏐ䛿䚸௨ୗ䛾ព࿡䜢ᣢ䛴ື≀⏝་⸆ရ䛾䜽䝷䝇䛜♧䛥䜜䜛䚹981) P 䛿䚸་⸆ရ2) F 䛿䚸䝥䝺䝭䝑䜽䝇〇๣
3) V 䛿䚸䝽䜽䝏䞁4) G 䛿䚸㣧ᩱỈ䜢௓䛧䛯ᡂ㛗ಁ㐍๣5) A 䛿䚸⏘ᴗ⏝⏕⸆6) J 䛿䚸㠀⏘ᴗ⏝⏕⸆7) MHK 䛿䚸ື≀⏝་⸆ရ䜢ྵ䜐䝨䝑䝖⏝㣫ᩱ8) OHK 䛿䚸≉ู䛺ື≀⏝་⸆ရ䠄customix 〇๣⏝䠅9) BOH 䛿䚸ື≀⏝་⸆ရ䛾ཎᩱ10) PRG 䛿䚸㑇ఏᏊ⤌᥮䛘〇ရ䛾ື≀⏝་⸆ရ
11 ᱆┠䛾ᩥᏐ䛿䚸ື≀⏝་⸆ရ䛾ศ㢮䛜グ㍕䛥䜜䜛䚹1) K 䛿䚸๻⸆2) T 䛿䚸ไ㝈௜䛝་⸆ရ3) B 䛿䚸ᕷ㈍⸆
12 ᱆┠䛾ᩥᏐ䛿䚸๣ᙧ䛜グ㍕䛥䜜䜛䚹1) C 䛿䚸ᾮయ2) S 䛿䚸⢊ᮎ3) M 䛿䚸௚䛾๣ᙧ䠄㌾⭯䚸㘄๣䚸䝪䞊䝷䝇䚸䜹䝥䝺䝑䝖䛺䛹䠅6䠅13 ᱆┠䛿䚸෌Ⓩ㘓䠄1 ᅇ┠䚸2 ᅇ┠䛺䛹䠅䛥䜜䛯䛣䛸䜢♧䛩ᩘᏐ䝁䞊䝗䛜グ㍕䛥䜜䜛䚹
2.3.7 Ⓩ㘓ᚋ䛾ㅖ⯡௨ୖ䛾䝥䝻䝉䝇䜢䜒䛳䛶䚸ື≀⏝་⸆ရ䛾Ⓩ㘓⏦ㄳ䛿⤊஢䛩䜛䚹௨ୗ䛻Ⓩ㘓ᚋ䛻Ẽ䜢௜䛡䜛䜉䛝᝟ሗ䜢䜎䛸䜑䜛䚹
1. ᭷ຠᮇ㝈ษ䜜䛾Ⓩ㘓␒ྕ䛻䛴䛔䛶
᪤䛻Ⓩ㘓␒ྕ䜢᭷䛧䛶䛔䛯䛜䚸ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛜᭦᪂䠄෌Ⓩ㘓䠅䜢⾜䜟䛪䚸᭷ຠᮇ㝈䜢 3 ᖺ⤒㐣䛧䛯ሙྜ䚸䛭䛾ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕ䛿↓ຠ䛸䛺䜛䚹
2. Ⓩ㘓ᶒ฼䛾ㆡΏ/Ⓩ㘓␒ྕ䛾ᡤ᭷ᶒ䛻䛴䛔䛶
㍺ධ䛾ື≀⏝་⸆ရ䛻䛴䛔䛶䛿䚸ື≀⏝་⸆ရⓏ㘓␒ྕ䛜᭷ຠ䛷䛒䜛㝈䜚䚸ື≀⏝་⸆ရⓏ
㘓␒ྕᡤ᭷⪅䛾ྠព䛜䛒䜛ሙྜ䜢㝖䛝䚸ື≀⏝་⸆ရⓏ㘓␒ྕ䛾ᡤ᭷ᶒ䜢ㆡΏ䛩䜛䛣䛸䛿䛷䛝
䛺䛔䚹Ⓩ㘓␒ྕ䛾ᡤ᭷ᶒ䜢ㆡΏ䛧䛯ሙྜ䚸䛭䛾ᚋ䛾Ⓩ㘓ᡭ⥆䛿䚸䛩䜉䛶᪂䛧䛔Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛾㈐௵䛷⾜䛖䚹ᙜヱື≀⏝་⸆ရ䜢㍺ධ䛩䜛ᶒ฼䛿䚸Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛾ᢎㄆ䜢ᚓ䛶䚸௚䛾㍺ධᴗ⪅䛻ㆡΏ䛷䛝䜛䚹
3. Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛻䛴䛔䛶ᅜෆ⏕⏘䛾ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕ䛿䚸⏕⏘⪅䛜ᡤ᭷䛩䜛䜒䛾䛸䛩䜛䚹ཷク〇㐀䛷ᅜෆ〇㐀䛥䜜䛶䛔䜛ື≀⏝་⸆ရ䛾ሙྜ䚸Ⓩ㘓␒ྕ䛾ᡤ᭷ᶒ䛿ཷク〇㐀ዎ⣙䜢ᥦ౪䛩䜛఍♫䛻䛒䜛䚹
㍺ධ䛧䛯ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕ䛾ᡤ᭷ᶒ䛿䚸ື≀⏝་⸆ရ䛾㍺ධᴗ⪅ཪ䛿ཎ⏘ᅜ䛛䜙௵࿨䛥䜜䛯ື≀⏝་⸆ရ䛾㍺ධᴗ⪅䛾ᆅ఩䜢᭷䛩䜛௦⌮ே䛻䛒䜚䚸ᙜヱ఍♫䛿䜲䞁䝗䝛䝅䜰ඹ࿴ᅜෆ䛷タ❧䛥䜜䛶䛔䜛ᚲせ䛜䛒䜛䚹99

4. ື≀⏝་⸆ရ䛾ရ㉁ド᫂᭩䛾᭷ຠᮇ㛫䛻䛴䛔䛶Ⓩ㘓䛾䛯䜑䛾ື≀⏝་⸆ရ䛾ရ㉁ド᫂᭩䛿䚸1 ᅇ䛾Ⓩ㘓䛷᭷ຠ䛷䛒䜛䛸つᐃ䛥䜜䛶䛔䜛䚹ᙜヱື≀⏝་⸆ရ䛜䚸BBPMSOH 䛻䜘䜛䝰䝙䝍䝸䞁䜾ཪ䛿ヨ㦂䛾ᯟ⤌䜏䛷㝶᫬᳨ᰝ䛥䜜䛶䛔䜛ሙྜ䚸Ⓨ⾜䛥䜜䛯ရ㉁ド᫂᭩䜢෌Ⓩ㘓䛾䛯䜑䛾᏶඲䛺⏦ㄳ᭩䛸䛧䛶౑⏝䛩䜛䛣䛸䛜䛷䛝䜛䚹
5. ཎ⏘ᅜ䛾බㄆᶵ㛵䛜Ⓨ⾜䛧䛯⮬⏤㈍኎ド᫂᭩䠄Certificate of Free Sale䠅䚸ཎ⏘ᆅド᫂᭩
䠄CoO䠅䚸GMP ド᫂᭩䠄Certificate of GMP䠅䚸ཎᮦᩱ䚸᏶ᡂ〇ရศᯒド᫂᭩ཬ䜃䚸Ᏻᐃᛶヨ㦂䝕䞊䝍䛾᭷ຠᮇ㛫䛻䛴䛔䛶a. ື≀⏝་⸆ရⓏ㘓᭩㢮䜢⿵᏶䛩䜛ῧ௜㈨ᩱ䠄ཎ⏘ᅜ䛾බㄆᶵ㛵䛜Ⓨ⾜䛧䛯⮬⏤㈍኎ド᫂᭩䚸ཎ⏘ᆅド᫂᭩䚸GMP ド᫂᭩䠅䛾᭷ຠᮇ㝈䛿䚸Ⓨ⾜䛛䜙 5 ᖺ㛫䛸つᐃ䛥䜜䛶䛔䜛䚹b. ື≀⏝་⸆ရⓏ㘓᭩㢮䜢⿵᏶䛩䜛ῧ௜㈨ᩱ C ཬ䜃 D 䛿䚸᭱᪂䛾䜒䛾䛜せồ䛥䜜䜛䚹c. ື≀⏝་⸆ရⓏ㘓᭩㢮䜢⿵᏶䛩䜛ῧ௜㈨ᩱ C䚸D ཬ䜃 E䠄䝕䞊䝍䠅䛾᭷ຠᮇ㝈䛿䚸Ⓨ⾜䛛䜙
5 ᖺ㛫䛸つᐃ䛥䜜䛶䛔䜛䚹
6. ື≀⏝་⸆ရⓏ㘓〇ရ䛾ྡ⛠ኚ᭦䛻䛻䛴䛔䛶ື≀⏝་⸆ရ䛾ྡ⛠ኚ᭦⏦ㄳ᭩䜢ᥦฟ䛩䜛䛻䛿䚸Ⓩ㘓␒ྕ䛾ᡤ᭷⪅䛿௨ୗ䛾᭩㢮䜢‽ഛ䛩䜛ᚲせ䛜䛒䜛䚹
a. ᪧྡ⛠䛾〇ရཬ䜃᪂ྡ⛠䛾〇ရ䛾ศᯒド᫂᭩䚸䝷䝧䝹ཬ䜃䝤䝻䝅䝳䜰䞊b. ᡂศ䚸ຠ⬟䚸⏝ἲ䛻ኚ᭦䛜䛺䛔᪨䛾ᐉㄋ᭩c. ື≀⏝་⸆ရ䛾ྡ⛠ኚ᭦⏦ㄳ䛻ᑐ䛩䜛ᢎㄆ᭩䚹䛭䛾෗䛧䛿䚸BBPMSOH 㛗ཬ䜃㛵㐃ᶵ㛵/༠఍䛻㏦௜䛥䜜䜛䚹┘ど䛻䛴䛔䛶61
1. ື≀⏝་⸆ရ䛾ὶ㏻䛾┘ど䛿䚸ື≀⏝་⸆ရ䛾Ⓩ㘓䚸䝰䝙䝍䝸䞁䜾ཬ䜃┘ど䛸䛔䛖ほⅬ䛛䜙䚸┬䚸ᕞ䚸ཬ䜃/ཪ䛿┴/ᕷ䛾ື≀⏝་⸆ရ┘どᐁཬ䜃 BBPMSOH 䛜䛭䜜䛮䜜䛾ᶒ㝈䛻ᇶ䛵䛝㝶᫬⾜䛖䚹
2. ┘ど䛿䚸௨ୗ䜢ྵ䜐ື≀⏝་⸆ရ䛾ရ㉁䚸᭷ຠᛶཬ䜃Ᏻ඲ᛶ䛻㛵䛧䛶ᐇ᪋䛥䜜䜛䚹a. ື≀⏝་⸆ရⓏ㘓␒ྕ䛸〇ရྡ䚸⤌ᡂ䚸ຠ⬟䚸ᑐ㇟ື≀䚸⏝ἲ/⏝㔞ཬ䜃ᢞ୚᪉ἲ䛸䛾㐺ྜᛶ䚹b. ᪤䛻Ⓩ㘓␒ྕ䛜௜୚䛥䜜ὶ㏻䛥䜜䛶䛔䜛ື≀⏝་⸆ရ䛻㛵䛧䚸ᐇᆅㄪᰝ䛾⤖ᯝ䜔⛉Ꮫᢏ⾡䛾Ⓨᒎ䛻䜘䜚䚸ື≀䚸ே䚸⎔ቃ䛾Ᏻ඲ᛶ䛻᭷ᐖ䛺≀㉁䛜ྵ䜎䜜䛶䛔䜛䛣䛸䛜ุ᫂䛧䛯ሙ
ྜ䚸Ⓩ㘓␒ྕⓎ⾜ᚋ䛷䛒䛳䛶䜒䚸ぢ┤䛧䜔ྲྀᾘ䛧䜢䛩䜛䛣䛸䛜䛷䛝䜛䚹
3. ┘ど䛿䚸ᑡ䛺䛟䛸䜒 1 ᖺ䛻 1 ᗘᐃᮇⓗ䛻⾜䜟䜜䜛䛜䚸ື≀⏝་⸆ရ䛾ὶ㏻䛻䛚䛡䜛つᐃ䛛䜙㐓⬺䛧䛶䛔䜛ሙྜ䛿㝶᫬⾜䜟䜜䜛䚹
4. ື≀⏝་⸆ရ┘どᐁ䛿䚸ᐃᮇⓗ䛻ཪ䛿㝶᫬䚸┘ど⤖ᯝሗ࿌᭩䜢㛵ಀ㒊㛛䛾㛗䛻ᥦฟ䛩䜛䚹
5. ㄆᐃ/◊ಟ/஺ὶ䛻䜘䛳䛶䚸ື≀⏝་⸆ရ┘どᐁ䛾⬟ຊཬ䜃㈨㉁䜢㧗䜑䜛䚹
6. බඹ䛾┦ㄯ❆ཱྀ䜢㛤タ䛩䜛䚹ᐙ␆䠄㣗⏝ື≀䠅䛾ே⋇ඹ㏻ឤᰁ⑕ཬ䜃㠀ே⋇ඹ㏻ឤᰁ⑕ண㜵䛻౑⏝䛥䜜䜛⏕≀Ꮫⓗ〇๣䠄άᛶཬ䜃୙άᛶ䝽䜽䝏䞁䠅䛷䚸⑓ᆺ䛜䜎䛰䜲䞁䝗䝛䝅䜰䛻Ꮡᅾ䛧䛺䛔ሙྜ䚸〇㐀ཪ䛿㍺ධ䛜ㄆ䜑䜙䜜䛶䛔䛺䛔䚹䜲䞁䝗䝛䝅䜰䛷ᐙ␆䠄㣗⏝ື≀䠅䛾⑌⑓䛾᭷↓䜢ุ᩿䛩䜛䛻䛿䚸䜎䛪⮫ᗋⓗ䚸␿Ꮫⓗ䚸ᐇ㦂ⓗ䠄ཎ
61 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun-

2021 䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 19 ᪥䠅

100ᅉ≀㉁䛾ศ㞳ཬ䜃≉ᐃ䜢ྵ䜐䠅䛻ド᫂䛥䜜䜛ᚲせ䛜䛒䜛䚹䝨䝑䝖䛾ே⋇ඹ㏻ឤᰁ⑕ண㜵䛻౑⏝䛥䜜䜛⏕≀Ꮫⓗ〇๣䠄άᛶཬ䜃୙άᛶ䝽䜽䝏䞁䠅䛷䚸⑓ᆺ䛜䜎䛰䜲䞁䝗䝛䝅䜰䛻Ꮡᅾ䛧䛺䛔ሙྜ䚸䜲䞁䝗䝛䝅䜰䛷䛾〇㐀ཬ䜃㍺ධ䛜チྍ䛥䜜䛶䛔䛺䛔䚹䜲䞁䝗䝛䝅䜰䛷䝨䝑䝖䛾ື≀⑌⑓䛾᭷↓䜢ุ᩿䛩䜛䛻䛿䚸䜎䛪⮫ᗋⓗ䚸␿Ꮫⓗ䚸ᐇ㦂ⓗ䠄⑌⑓䛾ཎᅉ≀㉁䛾ศ㞳ཬ䜃≉ᐃ䜢ྵ䜐䠅䛻ド᫂䛩䜛ᚲせ䛜䛒䜛䚹䝨䝑䝖䛾㠀ே⋇ඹ㏻ឤᰁ⑕ண㜵䛻౑⏝䛥䜜䜛୙ά໬䝽䜽䝏䞁䛷䚸⑓ᆺ䛜䜎䛰䜲䞁䝗䝛䝅䜰䛻Ꮡᅾ䛧䛺䛔ሙྜ䚸䜲䞁䝗䝛䝅䜰䛷䛾〇㐀ཪ䛿㍺ධ䛿チྍ䛥䜜䛶䛔䛺䛔䚹䜲䞁䝗䝛䝅䜰䛷䝨䝑䝖䛾ື≀⑌⑓䛾᭷↓䜢ุ᩿䛩䜛䛻䛿䚸⑓Ẽ䛾ཎᅉ≀㉁䜢≉ᐃ䛩䜛䛣䛸䛺䛟䚸ᨻᗓᶵ㛵䜔Ẹ㛫ᶵ㛵䛾⋇་ᖌ䛜ሗ࿌䛧䛯⮫ᗋ᳨ᰝ䚸ཬ䜃/ཪ䛿⑓⌮᳨ᰝ䚸ཬ䜃/ཪ䛿⾑Ύ᳨ᰝ䚸ཬ䜃/ཪ䛿␿Ꮫ᳨ᰝ䛷ド᫂䛥䜜䛺䛡䜜䜀䛺䜙䛺䛔䚹

2.4 ື≀⏝་⸆ရ䛾〇㐀ཬ䜃ရ㉁⟶⌮2.4.1 ᥇⏝䛥䜜䛶䛔䜛 GMP ᇶ‽䜲䞁䝗䝛䝅䜰䛷䛿䚸ື≀⏝་⸆ရ䛾〇㐀ᕤ⛬඲యཬ䜃ရ㉁⟶⌮䜢㐺ษ䛻ṇ䛧䛟つไ䛧䚸Ᏻ඲䛷㧗ရ㉁䛺ື≀⏝་⸆ရ䛾᭱⤊〇ရ䜢〇㐀䛷䛝䜛䜘䛖䚸1999 ᖺ䛻䛂CPOHB 䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛㎰ᴗ኱⮧つ๎➨ 466/Kpts/TN.260/V/99 ྕ䛃䛜Ⓨ௧䛥䜜䛯䚹ྠつ๎䛾ῧ௜㈨ᩱ䛷䛂CPOHB 䜺䜲䝗䝷䜲䞁䠄Pedoman Cara Pembuatan Obat Hewan yang Baik䠅䛃䛜ྲྀ䜚Ỵ䜑䜙䜜䛯䚹CPOHB 䛾┠ⓗ䛿䚸⏕⏘䛥䜜䜛ື≀⏝་⸆ရ䛾ᛶ㉁ཬ䜃ရ㉁䛜䚸タᐃ䛥䜜䛯せ௳ཪ䛿ရ㉁ᇶ‽䛻㐺ྜ䛧䛶䛔䜛䛣䛸䜢☜ㄆ䛩䜛䛣䛸䛷䛒䜛䚹䛧䛯䛜䛳䛶䚸ື≀⏝་⸆ရ䛾〇㐀䛻䛛䛛䜟䜛䛩䜉䛶䛾㛵ಀ⪅䛿䚸䛣䛾 CPOHB 䜺䜲䝗䝷䜲䞁䛻‽ᣐ䛩䜛ᚲせ䛜䛒䜛䚹CPOHB 䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛㎰ᴗ኱⮧つ๎➨ 466KptsTN.260V99 ྕ䛾ῧ௜㈨ᩱ䛷つᐃ䛥䜜䛶䛔䜛ෆᐜ䜢኱䜎䛛䛻♧䛩䛯䜑䚸௨ୗ䛻኱㡯┠䜢♧䛩䚹ྛ㡯┠䛾ヲ⣽䛺ෆᐜ䛻㛵䛧䛶䛿䚸ᕳᮎ䛾ཧ⪃㈨
ᩱ䛂5.6 CPOHB 䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 466KptsTN.260V99 ྕ䛃䛾ⱥㄒヂ䠄ཎᩥ䛿䜲䞁䝗䝛䝅䜰ㄒ䠅䛾䛸䛚䜚䛷䛒䜛䚹
CPOHB 䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 466KptsTN.260V99 ྕ
኱㡯┠
1

୍⯡つᐃ

2

ึᮇᮦᩱ

3

ᡤᅾᆅཬ䜃ᘓ≀

4

ᐊෆ䛾つᐃ

5

ᶵჾ

6

ே஦

7

⾨⏕⟶⌮

8

⏕⏘

9

ရ㉁┘ど

10

ෆ㒊᳨ᰝ

11

ほᐹ⤖ᯝ䞉ⱞ᝟䛾ᑐᛂཬ䜃ὶ㏻䛩䜛ື≀⏝་⸆ရ䛾ᅇ཰

12

᭩㢮

101

2.4.1.1 CPOHB 䜢‶䛯䛩䛯䜑䛾せ௳
1999 ᖺ䛾䛂CPOHB 䜺䜲䝗䝷䜲䞁䛃䛜ᘬ䛝⥆䛝᭷ຠ䛷䛒䜛䛣䛸䛿䝠䜰䝸䞁䜾䛷☜ㄆ῭䛷䛒䜛䚹䛧䛛䛧䚸
2021 ᖺ䛾䛂䝸䝇䜽䝧䞊䝇䛾஦ᴗチྍᑟධ䛻㛵䛩䜛 2021 ᖺᨻᗓつ๎➨ 5 ྕ䛃䛜Ⓨ௧䛥䜜䛯䛣䛸䛻క
䛔䚸䛂2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䛃䛜Ⓨ௧䛥䜜䛯䚹ᮏつ๎䛾୰䛻䚸1999 ᖺ䛾䛂CPOHB 䜺䜲䝗䝷䜲䞁䛃䜢䜒䛸䛻䛧䛶 CPOHB 䜢‶䛯䛩䛯䜑䛾せ௳䛜ḟ䛾䛸䛚䜚つᐃ䛥䜜䛯䚹
1. ື≀⏝་⸆ရ䛾✀㢮ู〇㐀᪉ἲ䛻㛵䛩䜛せ௳䠖62a. ⏕≀Ꮫⓗ〇๣䠖ே⋇ඹ㏻ឤᰁ⑕䝽䜽䝏䞁ཬ䜃㠀ே⋇ඹ㏻ឤᰁ⑕䝽䜽䝏䞁䚸䜴䜲䝹䝇ཬ䜃㠀䜴䜲䝹䝇ᛶ䝽䜽䝏䞁䠄䝞䜽䝔䝸䜰䚸ཎ⹸䛺䛹䠅䚸デ᩿⸆䜢䛭䜜䛮䜜ู䛾〇㐀᪋タ䛷〇㐀䛩䜛䛣䛸䚹b. ་⸆ရ䠖↓⳦ཬ䜃㠀↓⳦๣䚸䝧䞊䝍䝷䜽䝍䝮ཬ䜃㠀䝞䝷䜽䝍䝮⣔໬ྜ≀䚸䝩䝹䝰䞁๣䚸ẅ⳦๣䜢䛭䜜䛮䜜ู䛾〇㐀タഛ䛷〇㐀䛩䜛䛣䛸䚹c. 䝥䝺䝭䝑䜽䝇〇๣䠖⢊ᮎཬ䜃ᾮయ䛾䝥䝺䝭䝑䜽䝇〇๣䜢䛭䜜䛮䜜ู䛾〇㐀タഛ䛷〇㐀䛩䜛䛣䛸䚹
2. CPOHB 䛻ᚑ䛳䛶་⸆ရ䜢〇㐀䛧䛶䛔䜛䛣䛸䜢ド᫂䛩䜛䛯䜑䛾ရ㉁䜺䜲䝗䝷䜲䞁/ྠ➼䛾ᩥ᭩ 䠄ရ㉁䝬䝙䝳䜰䝹䚸ရ㉁ᡭ㡰䚸సᴗᣦ♧ཬ䜃సᴗ䝣䜷䞊䝮䠅䛿䚸ᴗົᡭ㡰䜢᏶඲䛻ㄝ᫂䛧䛯䜒䛾䛸䛧䚸௨ୗ䛾ෆᐜ䜢ྵ䜑䜛ᚲせ䛜䛒䜛䚹
1. ື≀⏝་⸆ရ䛾ရ㉁䝅䝇䝔䝮
2. ே஦
3. ᘓ≀䚸᪋タ
4. ᶵჾ
5. ⏕⏘
6. 㐺ṇ་⸆ရ䛾ಖ⟶᪉ἲཬ䜃ฟⲴ᪉ἲ
7. ရ㉁⟶⌮
8. ⮬ᕫⅬ᳨
9. ⱞ᝟ཬ䜃〇ရ䝸䝁䞊䝹
10. ㈨ᩱసᡂ
11. እ㒊ጤクάື
12. 㐺᱁ᛶཬ䜃ጇᙜᛶ䛾☜ㄆ
13. ↓⳦〇๣䛾〇㐀
14. ື≀⏝䛾⏕≀Ꮫⓗᮦᩱཬ䜃〇ရ䛾〇㐀
15. ⣽⬊ᇵ㣴/Ⓨ㓝䛻䜘䜚〇㐀䛥䜜䛯ື≀⏝་⸆ရ䛾ᮦᩱ〇㐀
16. ⾑ᾮ〇๣䛾〇㐀
17. 䝁䞁䝢䝳䞊䝍໬䛥䜜䛯䝅䝇䝔䝮
18. ẚ㍑䝃䞁䝥䝹ཬ䜃ṧ␃䝃䞁䝥䝹19. 䝸䜰䝹䝍䜲䝮䝟䝇ཬ䜃䝟䝷䝯䝖䝸䝑䜽䝟䝇20. ရ㉁䝸䝇䜽䝬䝛䝆䝯䞁䝖
3. ᘓ≀䛾ᘓ⠏ᅗ㠃ཬ䜃✵ㄪ䝅䝇䝔䝮タィ䝁䞁䝉䝥䝖䠄KDSTU䠖Konsep Desain Sistem Tata
Udara䠅䛿 CPOHB 䜺䜲䝗䝷䜲䞁䛻ᇶ䛵䛔䛶䛔䜛䛣䛸䚹
4. ㄆド䜢ཷ䛡䜛ྛ๣ᙧ䛻ᚲせ䛺䛩䜉䛶䛾〇㐀タഛ୍ぴ䚹
5. බᐃ᭩䛻グ㍕䛥䜜䛶䛔䜛᪉ἲ䛻ᚑ䛳䛶〇㐀䛥䜜䜛〇ရ䜢᳨ᰝ䛩䜛䛯䜑䛻ᚲせ䛺䛩䜉䛶䛾ᐇ㦂⿦

62 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun-

2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 19 ᪥䠅

102

⨨୍ぴ䚹
6. 䛩䜉䛶䛾⏕⏘タഛཬ䜃ᐇ㦂⿦⨨䛾౑⏝䛻㛵䛩䜛ᡭᘬ᭩䛾␒ྕཬ䜃䝍䜲䝖䝹୍ぴ䚹
7. ᑡ䛺䛟䛸䜒➨ 1 ẁ㝵䛾ᛶ⬟㐺᱁ᛶホ౯ẁ㝵䜎䛷䛾㔜せ䛺ᨭ᥼᪋タ䚸Ỉฎ⌮䝅䝇䝔䝮䛾㐺᱁ᛶホ౯ሗ࿌᭩䛾せ⣙䚹
8. ື≀⏝་⸆ရ䛾ཎᮦᩱド᫂᭩䜢⏦ㄳ䛩䜛ሙྜ䛿䚸〇㐀ᕤ⛬䛾ὶ䜜ཪ䛿䝏䝱䞊䝖䚹
9. ရ㉁ಖド䜢ᢸᙜ䛩䜛⸆๣ᖌ䛛䜙䛾䚸௨ୗ䛾᭩㢮䛜‽ഛ䛥䜜䛶䛔䜛䛣䛸䜢᫂グ䛧䛯ኌ᫂ᩥ䚹a. ရ㉁䝅䝇䝔䝮ཬ䜃ᩥ᭩໬䝅䝇䝔䝮䚸ึᮇᮦᩱཬ䜃᏶ᡂရ䛾௙ᵝ䚸◊✲㛤Ⓨ䠄R&D䠅䛛䜙⏕⏘䜈䛾ᢏ⾡⛣㌿䛻㛵䛩䜛ᡭ㡰䚸ᐇ᪋䛥䜜䜛άື䛻㛵㐃䛩䜛ฎ⌮䚸Ὑίཬ䜃ヨ㦂䛻㛵䛩䜛ᡭ㡰b. ⤌⧊ᵓ㐀䛻グ㍕䛥䜜䛶䛔䜛⫋ົཬ䜃㈐௵䛻ᛂ䛨䛯⬟ຊ䜢᭷䛩䜛୺せ䛺ேᮦ୍ぴc. 䝇䞊䝟䞊䝞䜲䝄䞊䝺䝧䝹䜎䛷䛾⫋ົෆᐜd. ⏕⏘タഛཬ䜃ヨ㦂タഛ䛾タ⨨ཬ䜃㐠⏝䛻㛵䛩䜛㐺᱁ᛶホ౯ᩥ᭩䚸≉䛻ᛶ⬟㐺᱁ᛶ䜢ྵ䜐⁛⳦ჾ䛻㛵䛩䜛䜒䛾e. ↓⳦〇๣䛜↓⳦ⓗ䛻〇㐀䛥䜜䜛ሙྜ䛿䚸↓⳦ᕤ⛬䛾ጇᙜᛶ☜ㄆᡭ㡰᭩
f. ศᯒἲ䚸タഛᛶ⬟/ᕤ⛬㐺᱁ᛶཬ䜃Ὑίጇᙜᛶ☜ㄆᡭ㡰᭩
10. ᪋タ䛻㛵䛩䜛せ௳䠖
a. ᡤ᭷䛩䜛⏕⏘᪋タ䛿䚸௚䛾බඹ᪋タ䠄ఫᏯ䚸䜸䝣䜱䝇⾤䛺䛹䠅䛸䛿ู䛾ሙᡤ䛻䛒䜚䚸⏕⏘ᕤ⛬䛻≉໬䛧䛯᪋タ䛷䛒䜛ᚲせ䛜䛒䜛䚹b. ་⸆ရ䠄䝧䞊䝍䝷䜽䝍䝮⣔ᢠ⏕≀㉁䠅䛾ື≀⏝་⸆ရ〇㐀᪋タ䛿䚸௚䛾ື≀⏝་⸆ရ〇㐀᪋タ䛸≀⌮ⓗ䛻ศ㞳䛩䜛ᚲせ䛜䛒䜛䚹c. ື≀⏝་⸆ရ〇㐀᪋タ䛿䚸ື≀⏝་⸆ရ〇㐀᪋タ䛛䜙Ⓨ⏕䛩䜛ᗫᲠ≀䠄ᅛᙧ≀䚸༙ᅛᙧ≀ཬ䜃ᾮయ≀䠅䜢ฎ⌮䛩䜛䛯䜑䛾⤫ྜᗫᲠ≀ฎ⌮᪋タ䜢᭷䛩䜛䛛䚸➨୕⪅䛸༠ຊ䛩䜛䛣䛸䛜ᚲせ䛷䛒䜛䚹
2.4.2 䜲䞁䝗䝛䝅䜰ᅜෆᴗ⪅䛾⏦ㄳ䝥䝻䝉䝇䜲䞁䝗䝛䝅䜰ᅜෆ஦ᴗ⪅䛻䜘䜛 CPOHB ⏦ㄳ䝥䝻䝉䝇䛻㛵䛩䜛᝟ሗ䛿䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹
1. ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊䠄CPOHB䠅䛿䚸ᅜෆ䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅ཬ䜃㍺ධඖ䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅䛻㐺⏝䛥䜜䜛䚹63
CPOHB 䛾せ௳䜢‶䛯䛧䛯ື≀⏝་⸆ရ䛾〇㐀ᴗ⪅䛿䚸␆⏘ᒁ㛗䛛䜙 5 ᖺ㛫᭷ຠ䛺 CPOHBド᫂᭩䛜௜୚䛥䜜䜛䚹ド᫂᭩䜢ྲྀᚓ䛧䛯⏕⏘⪅䛻䛿䚸ື≀⏝་⸆ရ䛾䝷䝧䝹䛻 CPOHB 䝬䞊䜽
䜢㈞௜䛩䜛ᶒ฼䛜௜୚䛥䜜䜛䚹
2. ୡ⏺ᕷሙ䛻䛚䛡䜛ື≀⏝་⸆ရ䛾Ⓨᒎ䚸≉䛻ᅜෆ䛾ື≀⏝་⸆ရ䜢〇㐀䛩䜛ື≀⏝་⸆ရ〇๣䛾ရ㉁ಖド䠄quality assurance䠅䛸Ᏻ඲ᛶ䠄safety䠅䚸᭷ຠᛶ䠄efficacy䠅䛻㛵䛩䜛➇தຊ䛾ྥୖ䜢ぢᤣ䛘䜛䛯䜑䚸ᙜヱ⏕⏘⪅䛾⏕⏘ᣐⅬ䛷┤᥋⏕⏘䛩䜛ᕤ⛬䚸᪋タ䚸䜲䞁䝣䝷䜢ᐇ⌧䛩䜛ྍ⬟ᛶ䜢ホ౯䛩䜛௙⤌䜏䛻䜘䛳䛶Ⓨ⾜䛥䜜䜛 CPOHB ド᫂᭩䛜ᚲせ䛷䛒䜛䚹
3. ㍺ධඖ䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅䛻䛴䛔䛶䛿䚸⏕⏘ᕤ⛬䚸᪋タ䚸䜲䞁䝣䝷䜢⏕⏘⪅䛾⏕⏘ᣐⅬ䛷┤᥋᳨ᰝ䛩䜛௙⤌䜏䛻䜘䜚䚸ື≀⏝་⸆ရ䛾〇㐀⟶⌮ཬ䜃ရ㉁⟶⌮䛻㛵䛩䜛 GMP ᇶ‽䜢‶䛯䛩⏕⏘⪅䛛䜙䛾㍺ධ䛷䛒䜛䛣䛸䜢☜ㄆ䛩䜛ᚲせ䛜䛒䜛䚹
4. ୖグ䛻㛵㐃䛧䛶䚸ື≀⏝་⸆ရ䛾〇㐀⟶⌮᪉ἲ䛾ᑂᰝ䛜෇⁥䛻ᐇ᪋䛥䜜䜛䜘䛖䛻ᨭ᥼䛩䜛䛯
䜑䚸1992 ᖺ䛻䚸㎰ᴗ኱⮧Ỵᐃ䛻䜘䜚䛂CPOHB ホ౯ጤဨ఍䠄Panitia Penilai Cara Pembuatan
Obat Hwan Yang Baik䠅䛃䛜タ⨨䛥䜜䛯䚹63 ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊䠄CPOHB䠅ホ౯ጤဨ఍タ⨨䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 302/Kpts/KP.150/6/2003 ྕ䠄https://jdihn.go.id/files/609/SK-302-03.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 16 ᪥䠅

103

5. ⫋ົ䜢㐙⾜䛩䜛䛾䛿 CPOHB ホ౯ጤဨ఍䛻㈐௵䛜䛒䜚䚸ᮏᐇ᪋䛻㛵䛩䜛ሗ࿌᭩䜢㎰ᴗ㛤Ⓨᒁ㛗䛻ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
6. ᚲせ䛸ุ᩿䛥䜜䛯ሙྜ䚸CPOHB ホ౯ጤဨ఍䛾ጤဨ㛗䛿䚸CPOHB ศ㔝䛾ᑓ㛛ᐙ䜢ᣍ㞟䛩䜛䛣䛸䛜䛷䛝䜛䚹
7. CPOHB ホ౯ጤဨ఍䛾෇⁥䛺㐠Ⴀ䜢ᨭ᥼䛩䜛䛯䜑䚸ጤဨ㛗䛿ᚲせ䛻ᛂ䛨䛶ጤဨ఍䛾䜰䝅䝇䝍䞁䝖䜢௵࿨䛩䜛䛣䛸䛜䛷䛝䜛䚹
8. CPOHB ホ౯ጤဨ఍䛾⫋ົ䛻㛵㐃䛩䜛䛩䜉䛶䛾ᚲせ⤒㈝䛿䚸␆⏘㛤Ⓨ⥲ᒁ䛾ண⟬䛷㈥䜟䜜
䜛䚹
CPOHB ド᫂᭩䛾ྲྀᚓ᮲௳䠖64
1. ⏦ㄳ⪅䠖a. ஦ᴗయ
b. ἲே
2. ᚲせ᭩㢮䠖a. 〇㐀ᴗ⪅⏝䛾ື≀⏝་⸆ရ஦ᴗチྍドb. ື≀⏝་⸆ရ䛾〇㐀ィ⏬᭩䠄master design䠅ཬ䜃〇㐀䛩䜛ື≀⏝་⸆ရ䝸䝇䝖᪂つ⏦ㄳ䛾ሙྜ䚸ḟ䛾᭩㢮䜢䛥䜙䛻ᥦฟ䛩䜛䚹a. CPOHB 䜺䜲䝗䝷䜲䞁䛻ἢ䛳䛯✵Ẽ䝅䝇䝔䝮ཬ䜃Ỉฎ⌮䝅䝇䝔䝮䜢ഛ䛘䛯ᕤሙ䛾ᘓ≀ᖹ㠃ᅗ䠄䝺䜲䜰䜴䝖ᅗ㠃䠅b. CPOHB 䛾ရ㉁䝬䝙䝳䜰䝹ཪ䛿ᴗົᡭ㡰䜢᏶඲䛻ᴫㄝ䛧䛯䝃䜲䝖䝬䝇䝍䞊䝣䜯䜲䝹䠄SMF䠖
site master file䠅ཪ䛿ྠ➼䛾ᩥ᭩
c. CPOHB ᑂᰝဨ䠄PCOHB䠖Penilai Cara Pembuatan Obat Hewan yang Baik䠅䛛䜙䛾ᢎㄆd. ⏦ㄳᩱ㔠䠄㠀ㄢ⛯ᅜᗜṓධ䠄PNBP䠅䠅䛾ᨭᡶド᫂᭩෌⏦ㄳ/᭦᪂䛾ሙྜ䚸ḟ䛾᭩㢮䜢䛥䜙䛻ᥦฟ䛩䜛䚹a. ๓ᅇ䛾 CPOHB ᳨ᰝ௨㝆䛾㔜せ䛺ኚ᭦Ⅼ䝸䝇䝖b. ๓ᅇ䛾 CPOHB ᳨ᰝ௨㝆䛾᫝ṇฎ⨨ཬ䜃ண㜵ฎ⨨䠄CAPA䠖corrective action andpreventive action䠅⤖ᯝ㏻▱᭩ཬ䜃ಖ⟶䝸䝇䝖c. ẖᖺᐇ᪋䛥䜜䜛ෆ㒊┘ᰝ/⮬ᕫホ౯/እ㒊┘ᰝ䛾ホ౯㆟஦㘓䠄BAP䠖berita acara penilaian䠅䛾୍ぴd. ௨๓䛻Ⓨ⾜䛥䜜䛯 CPOHB ド᫂᭩䛾෗䛧
CPOHB ド᫂᭩䜢ኚ᭦䛩䜛ሙྜ䚸ḟ䛾᭩㢮䜢䛥䜙䛻ᥦฟ䛩䜛䚹a. タഛኚ᭦୍ぴb. ኚ᭦⟶⌮ᩥ᭩c. ኚ᭦䛻㛵㐃䛩䜛ㄆᐃ/᳨ドᩥ᭩
3. ⏦ㄳᡭ㡰ཬ䜃ὶ䜜䠖
1. ື≀⏝་⸆ရ஦ᴗチྍド䛾ຠຊⓎ⏕ᚋ䚸ୖグ䛾⏦ㄳ᭩㢮䜢 OSS 䝅䝇䝔䝮䛷ᥦฟ䛩䜛䚹
2. ୖグ䛾 CPOHB ド᫂᭩䛾⏦ㄳ᭩㢮ᡭ⥆䛻䛚䛔䛶䚸PVTPP 䛿䚸␆⏘ື≀⾨⏕⥲ᒁ䛸㐃ᦠ䛩䜛䚹

64 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun-

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3. ␆⏘ື≀⾨⏕⥲ᒁ䛿䚸஦ᴗ⪅䛜䛩䜉䛶ᥞ䛳䛯ṇ☜䛺⏦ㄳ᭩㢮䜢ᥦฟ䛧䛯ᚋ䚸㐜䛟䛸䜒 30 ᪥௨ෆ䛻ホ౯䜢ᐇ᪋䛩䜛䚹
4. 㐺ྜᛶホ౯䛿䚸CPOHB ⏦ㄳ᭩㢮ᑂᰝ䠄ondesk review䠅ཬ䜃ື≀⏝་⸆ရ〇㐀᪋タ䛻ᑐ䛩䜛ホ౯/┘ᰝ䠄onsite review䠅䜢㏻䛧䛶ᐇ᪋䛥䜜䜛䚹65
5. ⏦ㄳ᭩㢮䛾ホ౯⤖ᯝ䛻ᇶ䛵䛝䚸␆⏘ື≀⾨⏕⥲ᒁ䛿䚸⏦ㄳ᭩㢮䜢ᢎㄆཪ䛿༷ୗ䛩䜛䚹
6. ᢎㄆཪ䛿༷ୗ䛥䜜䛯ሙྜ䚸PVPPP 䝉䞁䝍䞊䛿 OSS 䝅䝇䝔䝮䛻㏻▱䛩䜛䚹
7. ⏦ㄳ᭩㢮䛻㛵䛩䜛ホ౯⤖ᯝ䛾㏻▱䚸ᢎㄆཪ䛿༷ୗ䛾㐃⤡䚸ཬ䜃 OSS 䝅䝇䝔䝮䜈䛾㏻▱
䛿䚸㐜䛟䛸䜒 2 ᪥௨ෆ䛻ᐇ᪋䛥䜜䜛䚹
8. ༷ୗ䛾ሙྜ䚸௨ୗ䛾䛔䛪䜜䛛䛾⌮⏤䛜⾲♧䛥䜜䜛䚹a. ⏦ㄳ᭩㢮䛻୙ഛ䛜䛒䜛䛯䜑䛾༷ୗ䚹b. ᏶඲༷ୗ䚹ㄝ᫂/༷ୗ⌮⏤䛜ῧ䛘䜙䜜䜛䚹
8. ⏦ㄳ᭩㢮䛻୙ഛ䛜䛒䜛䛯䜑䛾༷ୗ䛿䚸⏦ㄳ᭩㢮䛾䝕䞊䝍䛜୙㊊䛧䛶䛔䜛䛯䜑䛻⾜䜟䜜䜛䚹
9. ᏶඲༷ୗ䛿⏦ㄳ᭩㢮䛾ᇶ‽䜢‶䛯䛧䛶䛔䛺䛔஦ᴗ⪅䛻ᑐ䛧䛶⾜䛖䚹10. ୙ഛ䛜䛒䜛䛯䜑䛾༷ୗ䛾㏻▱䜢ཷ䛡䛯ሙྜ䚸஦ᴗ⪅䛿⏦ㄳ᭩㢮䛾ಟṇ䛜䛷䛝䜛䚹
11. ᏶඲༷ୗ䛥䜜䛯ሙྜ䚸஦ᴗ⪅䛿⏦ㄳ᭩㢮䜢෌ᥦฟ䛷䛝䜛䚹12. ᢎㄆ䛾㏻▱䜢ཷ䛡䛯ሙྜ䚸OSS 䛷᭷ຠ䛺 CPOHB ド᫂᭩䛜Ⓨ⾜䛥䜜䜛䚹CPOHB ド᫂᭩䛾⏦ㄳᩱ㔠䠖66
1. ᪂つ⏦ㄳ䚸1 〇๣䛻䛴䛝 1 ᯛ䛾ド᫂᭩䛤䛸䛻 10,000,000 䝹䝢䜰䚹
2. ኚ᭦ᡭᩘᩱ
a. ௻ᴗྡ䚸ఫᡤ䚸1 〇๣䛻䛴䛝 1 ᯛ䛾ド᫂᭩䛤䛸䛻 300,000 䝹䝢䜰䚹b. ᪤Ꮡ䛾㠀↓⳦〇㐀タഛ䚸1 〇๣䛻䛴䛝 1 ᯛ䛾ド᫂᭩䛤䛸䛻 3,000,000 䝹䝢䜰䚹c. ᪤Ꮡ䛾⁛⳦〇㐀タഛ䚸1 〇๣䛻䛴䛝 1 ᯛ䛾ド᫂᭩䛤䛸䛻 3,500,000 䝹䝢䜰䚹
3. ඹ⏝᪋タ䛾౑⏝ᢎㄆ䠄⏕⸆䚸໬⢝ရ䚸ື≀⏝་⸆ရ䜢౑⏝䛧䛯㣫ᩱ䠅1 〇๣䛻䛴䛝 1 ᯛ䛾ド᫂᭩䛤䛸䛻 3,000,000 䝹䝢䜰䚹
4. CPOHB ド᫂᭩䛾᭦᪂ᡭᩘᩱ䛿 7,500,000 䝹䝢䜰䚹
CPOHB ド᫂᭩䛾ྲྀᚓᚋ䛾⩏ົ䠖
1. ᭷ຠ䛺ື≀⏝་⸆ရ䛾 CPOHB ド᫂᭩䜢ྲྀᚓᚋ䚸஦ᴗάື䜢⾜䛖ୖ䛷ḟ䛾つᐃ䜢ᒚ⾜䛩䜛⩏ົ䛜䛒䜛䚹
a. CPOHB 䜢୍㈏䛧䛶ᐇ᪋䛩䜛䛣䛸䚹b. Ⓨ⾜῭䛾䛭䛾௚ື≀⏝་⸆ရ䛾 CPOHB ド᫂᭩䛻グ㍕䛥䜜䛶䛔䜛⏕⏘タഛ䚸᭩㢮ෆᐜཬ䜃䝃䝫䞊䝖䝕䞊䝍䛻ኚ᭦䛜䛒䜛ሙྜ䛿䚸ኚ᭦ᢎㄆ⏦ㄳ᭩䜢ᥦฟ䛩䜛䛣䛸䚹⏕⏘タഛ䛾ㆡΏ䚸⏕⏘タഛ䛾ቑタ/ᣑᙇ䚸⏕⏘タഛ䛾ྡ⛠ཬ䜃ᡤᅾᆅ䜢ኚ᭦䛩䜛ሙྜ䛾ᚲせ᭩㢮䠖
67

1. ⏕⏘タഛ䜢ㆡΏ䛩䜛ሙྜ
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66 ㎰ᴗ┬䛷᭷ຠ䛺㠀ㄢ⛯ᅜᗜṓධ䛾✀㢮ཬ䜃ᩱ㔠䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᨻᗓつไ 2016 ᖺ➨ 35 ྕ䠄https://peraturan.bpk.go.id/Home/Details/5756䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅
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a. タഛኚ᭦୍ぴb. ኚ᭦⟶⌮ᩥ᭩c. ኚ᭦䛻㛵䛩䜛ㄆᐃ/᳨ドᩥ᭩
2. ⏕⏘タഛ䜢ቑタ/ᣑᙇ䛩䜛ሙྜa. ᭦᪂䛥䜜䛯〇㐀ᴗ⪅䛾ື≀⏝་⸆ရ஦ᴗチྍドb. ⏕⏘タഛ䛾ቑタ/ᣑᙇィ⏬䛾ᖹ㠃ᅗ/䝺䜲䜰䜴䝖c. ቑタ/ᣑᙇ䛻క䛔᭦᪂䛥䜜䛯ရ㉁䝅䝇䝔䝮㛵㐃䛾ᩥ᭩d. CPOHB 䛻ᚑ䛳䛶ᚲせ䛸䛥䜜䜛䛭䛾௚䛾⿵㊊᭩㢮
3. ⏕⏘タഛ䛻㛵䛩䜛⾜ᨻୖ䛾ኚ᭦䛜䛒䛳䛯ሙྜa. ⾜ᨻୖ䛾ኚ᭦䛻㛵䛩䜛⿵㊊᭩㢮┘ど䠖
1. ㎰ᴗ┬ཬ䜃ᆅ᪉ᨻᗓ䛻䜘䜛┘ど䛻䛿䚸〇㐀䛾ㅖ᮲௳䛜 CPOHB 䛾ㅖ᮲௳䛻㐺ྜ䛧䛶䛔䜛䛛䛹䛖䛛䛾᳨ᰝ/䝰䝙䝍䝸䞁䜾/᳨ド䛜ྵ䜎䜜䜛䚹
2. ┘どᶵᵓ䠄post-audit䠅䛻䜘䛳䛶ᑡ䛺䛟䛸䜒 2 ᖺ䛻୍ᗘ䚸ᐃᮇⓗ䛻䝰䝙䝍䝸䞁䜾/᳨ド䛜ᐇ᪋䛥䜜䜛䚹
2.4.3 ᅜእᴗ⪅䛾⏦ㄳ䝥䝻䝉䝇䜲䞁䝗䝛䝅䜰ᅜእ஦ᴗ⪅䛻䜘䜛 CPOHB ⏦ㄳ䝥䝻䝉䝇䛻㛵䛩䜛᝟ሗ䜢௨ୗ䛻♧䛩䚹
GMP ᑂᰝ䠖
1. 䜲䞁䝗䝛䝅䜰䛷ὶ㏻䛩䜛㍺ධື≀⏝་⸆ရ䛾ရ㉁䚸᭷ຠᛶཬ䜃Ᏻ඲ᛶ䜢ಖド䛩䜛䛯䜑䛻䚸␆⏘ື≀⾨⏕⥲ᒁ䛜ᐃ䜑䛯ື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊䠄CPOHB䠅䛾ᇶ‽䛻ᑐ䛧䚸እᅜ䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅䛾 GMP ᇶ‽䛜 CPOHB ᇶ‽䛻㐺ྜ䛧䛶䛔䜛䛛䜢ホ౯䛩䜛ᚲせ䛜䛒䜛䚹
2. GMP ᑂᰝ䛿䚸ᐇᆅㄪᰝ๓䛾᭩㢮ホ౯䠄ᮘୖᑂᰝ䠅䚸ᐇᆅㄪᰝ䠄onsite review/Kajian Lapang䠅䚸ᐇᆅㄪᰝ⤖ᯝ䛾᭩㢮ホ౯䛾 3 ẁ㝵䜢⤒䛶ᐇ᪋䛥䜜䜛䚹68㍺ධື≀⏝་⸆ရ〇㐀ᴗ⪅䛾 GMP ᑂᰝ䛻㛵䛩䜛つᐃ䠖69
1. ḟ䛾ሙྜ䚸ື≀⏝་⸆ရ䛾㍺ධ䛻ᑐ䛧䛶 GMP ᑂᰝ䜢⾜䛖ᚲせ䛜䛒䜛䚹a. ື≀⏝་⸆ရᕤሙ䛛䜙ึ䜑䛶㍺ධ䛩䜛ሙྜb. ື≀⏝་⸆ရ䛾᪂〇ရ䜢㍺ධ䛩䜛ሙྜc. ື≀⏝་⸆ရ〇㐀஦ᴗ㒊㛛䛜᪂つཪ䛿㏣ຍ䛾〇㐀஦ᴗ㒊㛛䛷䛒䜛ሙྜd. ཎ⏘ᅜ䛾ື≀⏝་⸆ရ䛾Ᏻ඲ᛶ䚸᭷ຠᛶ䚸ရ㉁䛜㐓⬺䛧䛶䛔䜛␲䛔䛜䛒䜛ሙྜ
2. GMP ᑂᰝ䛿䚸ཎ⏘ᅜ䛾ື≀⏝་⸆ရ⏕⏘⪅䜢௦⾲䛩䜛ື≀⏝་⸆ရ㍺ධᴗ⪅䛛䜙䛾せㄳ䛻ᇶ䛵䛝ᐇ᪋䛥䜜䜛䚹㍺ධᴗ⪅䛿䚸GMP ᑂᰝ⏦ㄳ᭩䜢␆⏘ື≀⾨⏕⥲ᒁ䛾 SIMREK䠄᥎ዡ᝟ሗ䝅䝇䝔䝮䠅䠄https://simrek.ditjenpkh.pertanian.go.id/䠅䛷䜰䜹䜴䞁䝖䜢సᡂ䛩䜛䚹䛭䛾ᚋ䚸ᚲせ䛺᭩㢮䜢䜰䝑䝥䝕䞊䝖䛧䚸䜸䞁䝷䜲䞁⏦ㄳ䛩䜛䚹⏦ㄳ᭩㢮䠖
1. GMP ᑂᰝ䛾䜸䞁䝷䜲䞁⏦ㄳ䛻䛿䚸ḟ䛾᭩㢮䜢ῧ௜䛩䜛䚹

68 䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍

䠄http://www.asohi.org/index.php?option=com_content&view=article&id=1330:produsen-obat-hewan-asal-imporwajib-audit-gmp&catid=1:latest-news&Itemid=11䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶ 22 ᪥䠅69ື≀⏝་⸆ရ䛾ᐇᆅㄪᰝཬ䜃┘╩䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 16 ྕ
䠄 https://peraturan.bpk.go.id/Home/Details/175307/permentan-no-16-tahun-2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶
17 ᪥䠅

106

a.
b.
c.
d.

GMP ᑂᰝ⏦ㄳ᭩ື≀⏝་⸆ရ㍺ධ஦ᴗチྍド䠄izin usaha impotir Obat Hewan䠅ཎ⏘ᅜ䛾ື≀⏝་⸆ရ⏕⏘⪅䛛䜙䛾᭷ຠ䛺௵࿨≧䠄letter of appointment䠅ཎ⏘ᅜ䛾ᡤ㎄ᐁᗇཪ䛿ㄆྍ䛥䜜䛯ᶵ㛵䛜Ⓨ⾜䛧䛯䚸᭷ຠ䛺 GMP ド᫂᭩䠄certificate ofgood manufacturing practices䠅ཪ䛿ྠ➼䛾ᩥ᭩
e. Ⓩ㘓䛩䜛ື≀⏝་⸆ရ䛾ணᐃ୍ぴf. 〇๣䛾✀㢮䛻ᛂ䛨䛯ື≀⏝་⸆ရ䛾 CPOHB ෆᐜ䠄checklist䠅୍ぴ䛾⏦ㄳ᭩g. GMP ᑂᰝᮇ㛫୰䚸ཎ⏘ᅜ䛷ື≀⏝་⸆ရ䛾⏕⏘䛜⥅⥆䛥䜜䜛䛣䛸䜢♧䛩ㄋ⣙᭩h. ື≀⏝་⸆ရ⏕⏘⪅䛾ཎ⏘ᅜᨻᗓ䛛䜙䛾 GMP ᑂᰝᐇ᪋䛻㛵䛩䜛ᢎㄆ᭩i. ᭩㢮ᑂᰝ䛾䛯䜑䛾㠀ㄢ⛯ᅜᗜṓධ䛾ᨭᡶド᫂᭩
j. ᥦฟ䛥䜜䛯᭩㢮䛜᏶඲䛛䛴ṇ☜䛷䛒䜛䛣䛸䜢♧䛩༳⣬௜䛝䛾ㄋ⣙᭩
2. GMP ᑂᰝ⏦ㄳ᭩ཬ䜃ᐇᆅㄪᰝ䛾ㄪᰝ⚊䛿䚸䜲䞁䝗䝛䝅䜰ㄒཬ䜃ⱥㄒ䛷ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹ᐇᆅㄪᰝ๓䛾᭩㢮ᑂᰝ䠖
1. PPVTPP 䛾㈐௵⪅䛿䚸⏦ㄳ᭩ཷ㡿ᚋ䚸㐜䛟䛸䜒 1 Ⴀᴗ᪥௨ෆ䛻䚸GMP ᑂᰝ⏦ㄳ᭩㢮䛾᏶඲ᛶཬ䜃ṇ☜ᛶ䛻䛴䛔䛶ᑂᰝ䜢⾜䛖䚹
2. ᭩㢮ᑂᰝ䛾⤖ᯝ䛜䚸
a. ᏶඲䛛䛴ṇ☜䛺ሙྜ䚸GMP ᑂᰝ⏦ㄳ᭩䛿䚸ᢏ⾡᭩㢮䛾ᑂᰝ䜢⾜䛖䛯䜑䛻ᒁ㛗䛻ᥦฟ䛥䜜䜛䚹b. ୙᏶඲ཪ䛿୙ṇ☜䛺ሙྜ䚸GMP ᑂᰝ⏦ㄳ᭩䛿䚸㍺ධᴗ⪅䛻ᕪ䛧ᡠ䛥䜜䚸᏶ᡂ䛥䛫䜛䚹
3. ㍺ධᴗ⪅䛿䚸᭩㢮ᑂᰝ䛾⤖ᯝ䜢ཷ䛡䛶䛛䜙 2 䛛᭶௨ෆ䛻䚸GMP ᑂᰝ⏦ㄳ᭩㢮䛾୙ഛ䜢‶䛯䛥䛺䛡䜜䜀䛺䜙䛺䛔䚹
4. ㍺ධᴗ⪅䛜ᮇ㛫ෆ䛻᭩㢮䜢᏶ᡂ䛥䛫䛯ሙྜ䚸GMP ᑂᰝ⏦ㄳ᭩䛿ᢏ⾡ᩥ᭩ᑂᰝ䜢ཷ䛡䜛䛯䜑䛻ᒁ㛗䛻ᥦฟ䛥䜜䜛䚹᭩㢮䛻୙ഛ䛜䛒䜛ሙྜ䛿䚸GMP ᑂᰝ⏦ㄳ᭩䛿༷ୗ䛥䜜䜛䚹
5. ༷ୗ䛥䜜䛯ሙྜ䚸PPVTPP 䛾㈐௵⪅䛿䚸༷ୗ⌮⏤䜢ῧ䛘䛶㍺ධᴗ⪅䛻ᘬ䛝Ώ䛩䚹
6. GMP ᑂᰝ⏦ㄳ᭩䛜᏶඲䛛䛴ṇ☜䛷䛒䜛䛸ᐉゝ䛥䜜䛯ᚋ䚸PPVTPP 䛾㈐௵⪅䛿䚸㐜䛟䛸䜒 1 Ⴀᴗ᪥௨ෆ䛻ᒁ㛗䛻ᥦฟ䛩䜛䚹ᒁ㛗䛿䚸⏦ㄳ᭩䜢ཷ⌮䛧䛯ᚋ㐜䛟䛸䜒 14 Ⴀᴗ᪥௨ෆ䛻ᢏ⾡᭩㢮ᑂᰝ䜢⾜䛖䚹
7. ᒁ㛗䛿䚸ᢏ⾡᭩㢮䜢ᑂᰝ䛩䜛䛯䜑䛻ᢏ⾡᭩㢮ᑂᰝ䝏䞊䝮䜢௵࿨䛩䜛䚹
8. ᢏ⾡᭩㢮ᑂᰝ䝏䞊䝮䛿䚸ᒁ㛗䛜௵࿨䛩䜛䚹
9. ᢏ⾡᭩㢮䛾ᑂᰝ䛷䛿䚸ḟ䛾Ⅼ䜢☜ㄆ䛩䜛䚹
a. CPOHB つᐃ䛻䜘䜛 CPOHB ᩥ᭩䛾㐺ྜᛶ䜢‶䛯䛧䛶䛔䜛䛣䛸䚹b. CPOHB つᐃ䛻䜘䜛 GMP ᑂᰝ䛾ㄪᰝ⚊䜢‶䛯䛧䛶䛔䜛䛣䛸䚹
11. ᭩㢮ᑂᰝ䛾⤖ᯝ䚸
a. CPOHB 䛾ᇶ‽䜢‶䛯䛧䛶䛔䜛䚸ཬ䜃/ཪ䛿䜲䞁䝗䝛䝅䜰䜘䜚㧗䛔ື≀⏝་⸆ရᇶ‽䜢ᣢ䛳䛶䛔䜛ሙྜ䚸ື≀⏝་⸆ရ㍺ධ䛾᥎⸀≧௜୚䛜ᥦ᱌䛥䜜䜛䚹b. CPOHB 䛾ᇶ‽䜢‶䛯䛧䛶䛚䜙䛪䚸ᐇᆅㄪᰝ䜢䛧䛺䛡䜜䜀䛺䜙䛺䛔ሙྜ䚸ཎ⏘ᅜ䛷䛾ᐇᆅㄪᰝ䛜ᥦ᱌䛥䜜䜛䚹
12. ᢏ⾡᭩㢮ᑂᰝ䝏䞊䝮䛿䚸␆⏘ື≀⾨⏕⥲ᒁ䛾ᒁဨ䛻ື≀⏝་⸆ရ䛾㍺ධ䛻㛵䛩䜛᥎⸀≧௜୚ᥦ᱌᭩䜢ᥦฟ䛩䜛䚹
13. ␆⏘ື≀⾨⏕⥲ᒁ䛾ᒁဨ䛿䚸ື≀⏝་⸆ရ䛾㍺ධ䛻㛵䛩䜛᥎⸀≧䜢኱⮧䛻ᥦฟ䛩䜛䚹
14. ᢏ⾡᭩㢮ᑂᰝ䝏䞊䝮䛿䚸␆⏘ື≀⾨⏕⥲ᒁ䛾⫋ဨ䜢㏻䛧䛶ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠅䛾⫋ဨ䛻ᐇᆅㄪᰝ䛾ᥦ᱌᭩䜢ᥦฟ䛩䜛䚹107ᐇᆅㄪᰝ䠖
1. BBPMSOH 䛾⫋ဨ䛿䚸ᐇᆅㄪᰝ䛾ᢎㄆᥦ᱌᭩䜢␆⏘ື≀⾨⏕⥲ᒁ㛗䛻ᥦฟ䛩䜛䚹
2. ␆⏘ື≀⾨⏕⥲ᒁ㛗䛿䚸
a. PPVTPP 䛾䝉䞁䝍䞊㛗䜢㏻䛧䛶㍺ධᴗ⪅䛻ᐇᆅㄪᰝ䛾ᢎㄆ䜢ᥦฟ䛩䜛䚹b. ᩥ᭩ホ౯⤖ᯝ䜢䚸ཎ⏘ᅜ䛾ᶒ㝈䛾䛒䜛ᙜᒁཪ䛿ㄆྍ䛥䜜䛯ᶵ㛵䜈ᥦฟ䛩䜛䚹
3. ㍺ධᴗ⪅䛿䚸ཎ⏘ᅜ䛷ᐇᆅㄪᰝ䛾䛯䜑䛾㠀ㄢ⛯ᅜᗜṓධ䜢ᨭᡶ䛖䚹
4. ᐇᆅㄪᰝ䝏䞊䝮䛜ᐇᆅㄪᰝ䜢⾜䛖䚹
5. ᐇᆅㄪᰝ䝏䞊䝮䛿䚸␆⏘ື≀⾨⏕⥲ᒁ㛗䛜௵࿨䛩䜛䚹
6. ᐇᆅㄪᰝ䝏䞊䝮䛿䚸㠀ㄢ⛯ᅜᗜṓධ䛾ᨭᡶ᪥䛛䜙 12 䛛᭶௨ෆ䛻ᐇᆅㄪᰝ䜢⾜䛖䚹
7. ᐇᆅㄪᰝ䛿䚸7 Ⴀᴗ᪥௨ෆ䛻᏶஢䛥䛫䜛䜒䛾䛸䛩䜛䚹ᐇᆅㄪᰝ⤖ᯝ䠖
1. ᐇᆅㄪᰝ⤖ᯝ䛷䛿䚸ḟ䛾䛣䛸䛜ᐉゝ䛥䜜䜛䚹a. 㔜኱䛺ᡤぢ䛜䛒䜛ሙྜ䛿䚸ື≀⏝་⸆ရ䛾㍺ධ䛿༷ୗ䛥䜜䜛b. 㔜኱ཪ䛿㍍ᚤ䛺ᡤぢ䛜䛒䜛ሙྜ䚸᫝ṇᥐ⨨䠄corrective action䠅䛜ᥦ᱌䛥䜜䜛c. ᡤぢ䛺䛧䛾ሙྜ䛿䚸ື≀⏝་⸆ရ㍺ධ᥎⸀≧䛜௜୚䛥䜜䜛
2. ୖグ䛾ᡤぢ䛿䚸䛂ື≀⏝་⸆ရ䛾ᐇᆅㄪᰝཬ䜃┘╩䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ
2021 ᖺ➨ 16 ྕ䛃䛾 43̺63 䝨䞊䝆䛻䛒䜛䛂ῧ௜㈨ᩱϨ䠖ᐇᆅㄪᰝ⤖ᯝホ౯ᇶ‽䚸ཎ⏘ᅜ䛾⏕⏘᪋タ䛻䛚䛡䜛 GMP 㐺⏝䛾㐺ྜᛶ䛃70䛻ᥖ䛢䜛ᇶ‽䛻ᚑ䛳䛶ホ౯䛩䜛䠄ῧ௜㈨ᩱϨ䛻䛴䛔䛶
䛿䚸䛂5.2 ᐇᆅㄪᰝ⤖ᯝホ౯ᇶ‽䛃䜢ཧ↷䠅䚹
3. ᐇᆅㄪᰝ䝏䞊䝮䛿䚸ᐇᆅㄪᰝ⤖ᯝ䜢␆⏘ື≀⾨⏕⥲ᒁ䛾⫋ဨ䛻ᥦฟ䛩䜛䚹
4. ␆⏘ື≀⾨⏕⥲ᒁ䛾⫋ဨ䛿䚸ື≀⏝་⸆ရ㍺ධ᥎⸀≧ཪ䛿䚸ື≀⏝་⸆ရ䛾㍺ධᣄྰ䜢኱⮧䛻ሗ࿌䛩䜛䚹
5. ᣄྰ䛻䛴䛔䛶䛿䚸ᣄྰ⌮⏤䜢ῧ䛘䛶 PPVTPP 䛾䝉䞁䝍䞊㛗䜢㏻䛧䛶␆⏘ື≀⾨⏕⥲ᒁ㛗䛛䜙㍺
ධᴗ⪅䛻ᥦฟ䛥䜜䜛䚹
6. ᐇᆅㄪᰝ䝏䞊䝮䛿䚸ᢏ⾡᭩㢮ᑂᰝ䝏䞊䝮䜢㏻䛧䛶ᐇᆅㄪᰝ⤖ᯝ䜢␆⏘ື≀⾨⏕⥲ᒁ㛗䛻ᥦฟ
䛩䜛䚹
᫝ṇᥐ⨨䠖
1. ␆⏘ື≀⾨⏕⥲ᒁ㛗䛿䚸
a. PPVTPP 䛾䝉䞁䝍䞊㛗䜢㏻䛧䛶䚸㍺ධᴗ⪅䛻ᥦฟ䛩䜛䚹b. ཎ⏘ᅜ䛾ᡤ㎄ᐁᗇཪ䛿ㄆྍᶵ㛵䛻᫝ṇᥐ⨨䠄corrective action䠅䜢ㅮ䛨䜛䜘䛖䛻㏻▱䛩䜛䚹
2. ㍺ධᴗ⪅䛿䚸᫝ṇᥐ⨨䛾⤖ᯝ䜢ホ౯䛩䜛䛯䜑䛾㠀ㄢ⛯ᅜᗜṓධ䜢ᨭᡶ䛖䚹
3. ཎ⏘ᅜ䛾ᡤ㎄ᐁᗇཪ䛿ㄆྍᶵ㛵䛿䚸ᐇᆅㄪᰝ⤖ᯝ䛜ฟ䛯᪥䛛䜙 6 䛛᭶௨ෆ䛻 CPOHB つᐃ䛻ᇶ䛵䛝䚸᫝ṇᥐ⨨䜢ㅮ䛨䜛䚹
4. ␆⏘ື≀⾨⏕⥲ᒁ㛗䛿䚸᫝ṇᥐ⨨䛾⤖ᯝ䜢ཷ䛡ྲྀ䛳䛯᪥䛛䜙 14 Ⴀᴗ᪥௨ෆ䛻᫝ṇᥐ⨨䛾⤖ᯝ䜢ホ౯䛩䜛䚹
᫝ṇᥐ⨨䛾ホ౯䠖
1. ␆⏘ື≀⾨⏕⥲ᒁ㛗䛿䚸᫝ṇᥐ⨨䛾⤖ᯝ䜢ホ౯䛩䜛䛯䜑䛻ホ౯䝏䞊䝮䜢ὴ㐵䛩䜛䚹70 ື≀⏝་⸆ရ䛾ᐇᆅㄪᰝཬ䜃┘╩䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 16 ྕ䛾ῧ௜㈨ᩱ 43̺
63 䝨䞊䝆䠄 https://peraturan.bpk.go.id/Home/Details/175307/permentan-no-16-tahun-2021䚸᭱⤊䜰䜽䝉䝇᪥䠖
2022 ᖺ 7 ᭶ 18 ᪥䠅

108

2. ホ౯䝏䞊䝮䛿䚸␆⏘ື≀⾨⏕⥲ᒁ㛗䛜௵࿨䛩䜛䚹
3. ホ౯⤖ᯝ䛿䚸ḟ䛻ᇶ䛵䛟䜒䛾䛸䛩䜛䚹a. CPOHB 䛾つᐃ䛻ᇶ䛵䛝䚸᫝ṇᥐ⨨䛷ゝཬ䛥䜜䛯ᮇ㝈ෆ䛻ᥦฟ䛥䜜䛯ሙྜ䛿䚸ື≀⏝་⸆
ရ㍺ධ䛾᥎⸀≧௜୚䛜ᥦ᱌䛥䜜䜛䚹b. CPOHB 䛾つᐃ䛻ᚑ䛳䛶䛔䛺䛔䚸ཪ䛿᫝ṇᥐ⨨䛷ゝཬ䛥䜜䛯ᮇ㝈ෆ䛻ᥦฟ䛥䜜䛺䛔ሙྜ䚸ື≀⏝་⸆ရ䛾㍺ධ䜢༷ୗ䛩䜛䛣䛸䛜ᥦ᱌䛥䜜䜛䚹
4. ホ౯䝏䞊䝮䛿䚸␆⏘ື≀⾨⏕⥲ᒁ䛾⫋ဨ䛻ື≀⏝་⸆ရ㍺ධ䛾᥎⸀≧ᥦฟ䜢ᥦ᱌䛩䜛䚹
5. ␆⏘ື≀⾨⏕⥲ᒁ䛾⫋ဨ䛿䚸ື≀⏝་⸆ရ㍺ධ䛾᥎⸀≧䛾ᥦ᱌䜢኱⮧䛻ᥦฟ䛩䜛䚹
6. ホ౯䝏䞊䝮䛿䚸␆⏘ື≀⾨⏕⥲ᒁ䛾⫋ဨ䜢㏻䛧䛶␆⏘ື≀⾨⏕⥲ᒁ㛗䛻༷ୗ䛾ᥦ᱌䜢ᥦฟ䛩䜛䚹
7. ␆⏘ື≀⾨⏕⥲ᒁ㛗䛿䚸PPVTPP 䛾䝉䞁䝍䞊㛗䜢㏻䛧䛶䚸ື≀⏝་⸆ရ㍺ධ༷ୗ䜢䚸༷ୗ⌮⏤䜢ῧ䛘䛶㍺ධᴗ⪅䛻ᥦฟ䛩䜛䚹チྍド䛾Ⓨ⾜䠖1. ␆⏘ື≀⾨⏕⥲ᒁ䛾⫋ဨ䛛䜙䛾ື≀⏝་⸆ရ㍺ධ᥎⸀≧䛻ᇶ䛵䛝䚸኱⮧䛿䛂ື≀⏝་⸆ရ䛾㍺ධチྍド䠄Izin Pemasukan Obat Hewan䠅䛃䜢Ⓨ⾜䛩䜛䚹ᩱ㔠䠖71ḟ䛾 3 ẁ㝵䛷䛾 GMP ᑂᰝ䛾ᨭᡶ䛿䚸㠀ㄢ⛯ᅜᗜ⣡௜㔠䛾ἲつᐃ䛻ᚑ䛳䛶⾜䜟䜜䜛䚹a. ᐇᆅㄪᰝ๓䛾᭩㢮ホ౯䠄ᮘୖᑂᰝ䠅䠖〇๣䛾✀㢮䛤䛸䛻 7,500,000 䝹䝢䜰72䚹
b. ᐇᆅㄪᰝ䛾ᐇ᪋䠖┘ᰝே 1 ே䛒䛯䜚〇๣䛾✀㢮䛤䛸䛻 15,000,000 䝹䝢䜰䚹c. ᫝ṇᥐ⨨䛾⤖ᯝホ౯䠖〇๣䛾✀㢮䛤䛸䛻 4,000,000 䝹䝢䜰䚹ͤ♫እ䛷䛾άື䛻ᑐ䛧䛶Ỵᐃ䛥䜜䜛䚸㠀ㄢ⛯ᅜᗜṓධ䛾✀㢮䛻㛵䛩䜛ᩱ㔠䛻䛿䚸බ⏝᪑㈝䛿ྵ䜎䜜䛶䛔䛺䛔䚹බ⏝᪑㈝䛾㢠䛿䚸䛂⤒㈝䛾ᇶ‽䛻㛵䛩䜛㈈ົ┬つ๎䛃73䜢ཧ↷䛾䛣䛸䚹බ⏝᪑㈝䛿䚸ᨭᡶ⪅䛻ㄳồ䛥䜜䚸ᅜᗜ䛻㡸䛡䜙䜜䜛䚹ὀព஦㡯䠖
1. ୙ྍᢠຊཬ䜃/ཪ䛿䜸䞁䝷䜲䞁 GMP ᑂᰝ⏦ㄳ䝃䞊䝡䝇ᶵ⬟䛻䝅䝇䝔䝮㞀ᐖ䛜⏕䛨䛯ሙྜ䚸ື≀⏝་⸆ရ஦ᴗ⪅䛿䚸䜸䝣䝷䜲䞁䛷 GMP ᑂᰝ⏦ㄳ᭩䜢ᥦฟ䛷䛝䜛䚹
2. ኱⤫㡿䛜ᅜᐙ⅏ᐖ䛸䛧䛶ᐉゝ䛩䜛⮬↛⅏ᐖཬ䜃㠀⮬↛⅏ᐖ䛜Ⓨ⏕䛧䛯ሙྜ䚸ᐇᆅㄪᰝ䛿䚸䜸䞁䝷䜲䞁ཪ䛿䝔䝺䝡఍㆟䛷⾜䛖䛣䛸䛜䛷䛝䜛䚹
ͤ㍺ධື≀⏝་⸆ရ䛾 GMP 㐺ྜᛶ䛻㛵䛩䜛 CPOHB ホ౯䝏䞊䝮䛻䜘䜛ᑂᰝ౫㢗䛿䚸Ⓩ㘓ື≀⏝་⸆ရ䛾ᢏ⾡᭩㢮䛾ᑂᰝ⤖ᯝ䜢ᢎㄆ䛷䛝䜛᪨䛾ື≀⏝་⸆ရⓏ㘓ᑂᰝ఍䠄PPOH䠅䛾ᑂᰝ఍㆟⤖ᯝ䛜Ⓨ⾜䛥䜜䛯ᚋ䛻䚸㍺ධᴗ⪅䛛䜙ᥦฟ䛩䜛䛣䛸䛜䛷䛝䜛䚹ͤBBPMSOH 䛷䛾ື≀⏝་⸆ရ䛾ရ㉁ヨ㦂䛿䚸CPOHB ホ౯䝏䞊䝮䛻䜘䜚ᑂᰝ᭩㢮䛾ື≀⏝་⸆ရ〇㐀ᴗ⪅䛻 GMP 㐺ྜᛶ䛜䛒䜛䛸ᐉゝ䛥䜜䛯ホ౯⤖ᯝⓎ⾜ᚋ䛻ᥦฟ䛩䜛䛣䛸䛜䛷䛝䜛䚹
71 䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍

䠄http://www.asohi.org/index.php?option=com_content&view=article&id=1330:produsen-obat-hewan-asal-imporwajib-audit-gmp&catid=1:latest-news&Itemid=11䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅
72 ㎰ᴗ┬䛷᭷ຠ䛺㠀ㄢ⛯ᅜᗜṓධ䛾✀㢮ཬ䜃ᩱ㔠䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつไ 2016 ᖺ➨ 35 ྕ䠄https://peraturan.bpk.go.id/Home/Details/5756䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅
73 2023 ᖺᗘ䛾⤒㈝䛾ᇶ‽䛻㛵䛩䜛㈈ົ┬つ๎➨ 83/PMK.02/2022 ྕ䠄https://peraturan.bpk.go.id/Home/Details/215945/pmk-no-83pmk022022䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅109ͤ␆⏘ᒁ䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸㐣ཤᐇ㝿䛻ᐇᆅㄪᰝ䛜⾜䜟䜜䛯⤒⦋䛜䛒䜛䛸䛾᝟ሗ䛜ᚓ䜙䜜䛯䚹䛥䜙䛻䚸ရ㉁ヨ㦂䛛䜙ᐇ᪋䛩䜛䛣䛸䛿䛷䛝䛪䚸KOH ཪ䛿 PPOH 䛷䛾᭩㢮ᑂᰝ䜢⤒䛶 GMP 㐺ྜᛶ䛜ㄆ䜑䜙䜜䛯ᚋ䚸BBPMSOH 䛷䛾䝃䞁䝥䝹᳨ᰝ䛾㡰␒䛷⾜䜟䜜䜛䛸䛾ᅇ⟅䜢ᚓ䛯䚹

2.5 ື≀⏝་⸆ရ䛾㍺ධチྍ䛸㍺ධ᫬䛾᳨ᰝ
2.5.1 ㍺ධチྍື≀⏝་⸆ရⓏ㘓␒ྕ䛜௜୚䛥䜜䛯ື≀⏝་⸆ရ䜢㍺ධ䛩䜛๓䛻䚸䛂ື≀⏝་⸆ရ㍺ධチྍド
䠄Izin Pemasukan Obat Hewan䠅䛃䜢 OSS 䛷⏦ㄳ䛩䜛ᚲせ䛜䛒䜛䚹䛭䛾㝿䛻ᚲせ䛺᭩㢮䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹74
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㍺ධ஦ᴗチྍド⏦ㄳ᭩/ㄋ⣙᭩஦ᴗ⪅㆑ู␒ྕ䠄NIB䠖Nomor Induk Berusaha䠅䜲䞁䝪䜲䝇/䝥䝻䝣䜷䞊䝬䞉䜲䞁䝪䜲䝇/㉎ධⓎὀ᭩ື≀⏝་⸆ရศᯒド᫂᭩䠄CoA䠖Certificate of Analysis䠅ཎ⏘ᆅド᫂᭩䠄CoO䠖Certificate of Origin䠅䠄ཎ⏘ᅜ䛜⏕⏘ᅜ䛸␗䛺䜛ሙྜ䠅ື≀⏝་⸆ရⓏ㘓␒ྕỴᐃ᭩ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕᡤ᭷⪅䛛䜙䛾ᢎㄆ᭩䠄ື≀⏝་⸆ရⓏ㘓␒ྕ䛾ᡤ᭷⪅䛜ື≀⏝་⸆
ရ㍺ධ䜢⾜䜟䛺䛔ሙྜ䠅
9. ᳨ᰝド᫂᭩䠄VHC䠖Veterinary Health Certificate䠅䠄⏕≀Ꮫⓗ〇๣䛾ሙྜ䠅ᡤせ᫬㛫䠖7 Ⴀᴗ᪥ື≀⏝་⸆ရ㍺ධチྍド⏦ㄳᩱ㔠 䠖
1. ཎᮦᩱ䛾㍺ධド᫂᭩䚸1 〇ရ䛤䛸䛻 100,000 䝹䝢䜰
2. CPOHB ド᫂᭩䚸1 〇ရ䛤䛸䛻 100,000 䝹䝢䜰㍺ධ〇ရ䛻ㄢ䛥䜜䜛㛵⛯䛻䛴䛔䛶䛿䚸䛂2022 ᖺၟရศ㢮䝅䝇䝔䝮䛾Ỵᐃ䛻㛵䛩䜛㈈ົ኱⮧つ๎➨
26/PMK.010/2022 ྕ䛃75䛾䛂䜲䞁䝗䝛䝅䜰㛵⛯⋡⾲䠄BTK䠖Buku Tarif Kepabeanan Indonesia䠅䛃䛻䜘䜚つᐃ䛥䜜䛶䛔䜛䚹

2.6 ື≀⏝་⸆ရ䝷䝧䝹䝷䝧䝹䛻䛴䛔䛶䛿䚸䛂5.4 ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩グධせ㡿䠄GUIDANCE ON APPLICATIONOF VETERINARY DRUG䠅䛃䛾䛂ῧ௜᭩㢮 J 䠖䝷䝧䝹䛻㛵䛩䜛ㄝ᫂䛃ཬ䜃䛂5.5 ␆⏘⾨⏕ᒁ㛗Ỵᐃ➨54/TN.260/Kpts/DJP/2001 ྕ䛃䛾䛂ῧ௜㈨ᩱ G䠖⾲♧䛻㛵䛩䜛ㄝ᫂䛃䜢ཧ↷䛧䛶䛔䛯䛰䛝䛯䛔䚹

74

2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 19 ᪥䠅
75 2022 ᖺၟရศ㢮䝅䝇䝔䝮䛾Ỵᐃ䛻㛵䛩䜛㈈ົ኱⮧つ๎➨ 26/PMK.010/2022 ྕ䠄https://jdih.kemenkeu.go.id/download/04d90736-33d5-4b72-92a3-0d2b7c6bb8bd/26~PMK.010~2022Per.pdf䚸
᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥䠅

110

2.7 ື≀⏝་⸆ရไᗘ䜢䜑䛠䜛ືྥ2.7.1 VICH 䛻ᑐ䛩䜛ືྥ␆⏘ᒁ䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸VICH 䛻୙ཧຍ䛷䛿䛒䜛䛜䚸㐃ᦠ䜢䛸䛳䛶䛚䜚䚸ཧຍ䛻ྥ䛡䛶ྲྀ䜚⤌䜣䛷䛔䜛䛸䛾᝟ሗ䜢ᚓ䛯䚹
2.7.2 PIC/S 䛻㛵䛩䜛ືྥ␆⏘ᒁ䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸PIC/S 䛻㠀ຍ┕䛷䛿䛒䜛䛜䚸㐃ᦠ䜢䛸䛳䛶䛚䜚䚸ຍ┕䛻ྥ䛡䛶ྲྀ䜚⤌䜣䛷䛔䜛䛸䛾᝟ሗ䜢ᚓ䛯䚹
2.7.3 ASEAN 䛾㛵୚ཬ䜃௚䛾ᅜ㝿ᇶ‽䛻ᑐ䛩䜛ືྥ
2020 ᖺ 5 ᭶ 20 ᪥䚸ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄BBPMSOH䠅 䛿䚸➨ 29 ᅇ䛂ASEAN ␆⏘ศ㔝ูసᴗ㒊఍䠄ASWGL䠖Asean Sectoral Working Group on Livestock䠅䛃䛻䛚䛔䛶䚸ASEAN ஦ົᒁ䛾 Pham Quang Minh ௦⾲䛛䜙 ASEAN 䛻䛚䛡䜛ື≀䝽䜽䝏䞁ヨ㦂䛾ཧ↷ヨ㦂ᡤ䛸䛧䛶෌ㄆᐃド䜢ྲྀᚓ䛧䛯䚹ື≀⏝䝽䜽䝏䞁ヨ㦂䛷䛾ᡂຌ䛜ホ౯䛥䜜䛶䛾ㄆドྲྀᚓ䛸䛺䛳䛯䚹ᮏㄆド䛿 ASEAN ຍ┕ᅜ䛾ᢎㄆ䜢ᚓ䛶䛚䜚䚸2020 ᖺ 10 ᭶䛻㛤ദ䛥䜜䛯➨ 43 ᅇ ASEAN 㛶൉఍㆟䠄AMAF䠅䛷ṇᘧ䛻ᢎㄆ䛥䜜䛯䚹䛣䛾䛣䛸䛻㛵㐃䛧䛶䚸␆⏘ື≀⾨⏕⥲ᒁ䠄Ditjen PKH䠅䛾 Nasrullah ᒁ㛗䛿䚸䛂௒ᅇ䛾෌ㄆᐃド䛿䚸
ASEAN ᆅᇦ䛾ື≀⾨⏕ಖド䛾ほⅬ䛛䜙䜒䚸䜲䞁䝗䝛䝅䜰䛾኱䛝䛺㈉⊩䜢ド᫂䛩䜛䜒䛾䛷䛒䜚䚸䜲䞁䝗䝛䝅䜰䛾㍺ฟඛᅜ䛜ၟရ䛾ື≀⾨⏕䛸㣗ရᏳ඲䛾せ௳䜢‶䛯䛩䛯䜑䛾ಙ㢗ᛶ䜢㧗䜑䜛䛣䛸䛻䛺䜛䚹䛥䜙䛻䚸䜲䞁䝗䝛䝅䜰䛾㍺ฟ➇தຊ䜢㧗䜑䜛䛣䛸䜒䛷䛝䜛䚹ASEAN ᆅᇦ䛷䜲䞁䝗䝛䝅䜰䛾䝽䜽䝏䞁〇ရ䜢㈍኎䛩䜛ᶵ఍䛜ቑ䛘䜛䛣䛸䜢ᮇᚅ䛧䛶䛔䜛䛃䛸㏙䜉䛶䛔䜛䚹䛥䜙䛻䚸BBPMSOH 䛾 Maidaswar 䝉䞁䝍䞊㛗䛿䚸䛂ASEAN ຍ┕ᅜ䛾ཧ↷ヨ㦂ᡤ䛸䛧䛶䚸ASEAN 䛻䛚䛡䜛䝽䜽䝏䞁䛾つ᱁䜔ㄆド䛾ㄪ࿴䜢ᅗ䜛䛣䛸䛜ᐜ᫆䛻䛺䜛䛰䜝䛖䛃䛸㏙䜉䚸㎰ᴗ┬䛾 Kasdi Subagyono ஦ົᒁ㛗䛿䚸䛂ASEAN ㅖᅜ䛾ື≀⏝䝽䜽䝏䞁䜢 BBPMSOH 䛷ヨ㦂䛩䜛䛃䜘䛖䛻࿧䜃䛛䛡䛶䛔䜛䚹76䜲䞁䝗䝛䝅䜰䛿䚸ື≀་⒪ศ㔝䛷䛾ඃ⚽ᛶ䛜ㄆ䜑䜙䜜䚸ASWGL 䛾ື≀䝽䜽䝏䞁᳨ᰝ䝛䝑䝖䝽䞊䜽䛻㛵䛩䜛㆟ᐃ᭩䛾సᡂ䛷䜲䞁䝗䝛䝅䜰䛜୺ᑟᅜ䛸䛧䛶௵࿨䛥䜜䛶䛔䜛䚹䜎䛯䚸ᮏᩥ᭩䛿 2022 ᖺ䛾┠ᶆάື䠄key deliverables䠅䛸䛺䜛ணᐃ䛷䛒䜛䚹䜎䛯䚸ASEAN 䛻䛚䛡䜛䝙䝳䞊䜹䝑䝇䝹⑓䛻㛵䛩䜛ᆅᇦホ౯ㄪᰝ䛾䝸䞊䝎䞊䜒䜲䞁䝗䝛䝅䜰䛻ク䛥䜜䛶䛔䜛䚹77

76 䝍䝤䝻䜲䝗䝅䝘䞊䝹䝍䝙䠄https://tabloidsinartani.com/detail/indeks/ternak/16736-BBPMSOH-Raih-Sertifikat-Re-

Akreditasi-Laboratorium-Referensi-ASEAN䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 9 ᪥䠅
77 䝷䝎䞊䝹䝇䜰䝷䠄https://www.radarsuara.com/berita/1635441795/syl-dan-menteri-pertanian-se-asean-bahaskerjasama-bidang-kesehatan-hewan-di-forum-amaf-ke-43䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 9 ᪥䠅111

2.7.4 䝝䝷䞊䝹ㄆドไᗘ䛻䛴䛔䛶䝝䝷䞊䝹ㄆドไᗘ䛻㛵䛩䜛ᨻ௧䛂䝝䝷䞊䝹〇ရಖド䛾ᐇ᪋䛻㛵䛩䜛ᨻᗓつ๎ 2021 ᖺ➨ 39 ྕ䛃䛾➨ 2 ᮲䛻䛿䚸䛂ཎ๎䛸䛧䛶䚸䜲䞁䝗䝛䝅䜰㡿ᅵෆ䛻ὶ㏻䛩䜛䛩䜉䛶䛾〇ရ䜢䝝䝷䞊䝹ㄆド䛾ᑐ㇟䛸䛩䜛䛃䛸䛒䜚䚸䝝䝷䞊䝹ㄆド䛜ẁ㝵ⓗ䛻⩏ົ໬䛥䜜䛯䚹䛯䛰䛧䚸㠀䝝䝷䞊䝹䛾ᮦᩱ䛛䜙〇㐀䛥䜜䛯㠀䝝䝷䞊䝹〇ရ䛻䛴䛔䛶䛿䝝䝷䞊䝹ㄆド⩏ົ䛾ᑐ㇟እ䛷䛒䜚䚸䛂䝝䝷䞊䝹䛷䛿䛺䛔䛃䛸䛔䛖ㄝ᫂䜢ᙜヱ〇ရ
䛻グ㍕䛩䜛ᚲせ䛜䛒䜛䚹䝝䝷䞊䝹ㄆド䛾⩏ົ໬䛻㛵䛩䜛ᑐᛂᮇ㝈䛿䚸〇ရ䛻䜘䜚␗䛺䜚䚸2026 ᖺ䛛䜙 2034 ᖺ䜎䛷䛾ᮇ㝈䛜タᐃ䛥䜜䛶䛔䜛䚹78␆⏘ᒁ䜈䛾䝠䜰䝸䞁䜾䛛䜙䚸⌧ᅾ䛿䚸䝝䝷䞊䝹ㄆド䜢ྲྀᚓ䛧䛶䛔䛺䛔ື≀⏝་⸆ရ䜢ὶ㏻䛥䛫䜛䛣䛸䛿ྍ⬟䛷䛒䜛䛜䚸䝝䝷䞊䝹〇ရ䜢ᮃ䜐ኌ䛜ከ䛔䛸䛔䛖᝟ሗ䜢ᚓ䛯䚹䛥䜙䛻䚸䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䛻ᑐ䛩䜛䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸䝝䝷䞊䝹ㄆド䜢ྲྀᚓ䛧䛶䛔䛺䛔ሙྜ䚸ᕷሙ䛜ไ㝈䛥䜜䜛ྍ⬟ᛶ䛜䛒䜚䚸䜲䝇䝷䝮ᩍ䛜኱ከᩘ䜢༨䜑䜛䜲䞁䝗䝛䝅䜰䛻䛚䛔䛶䛿䚸䝝䝷䞊䝹ㄆド䜢᪩ᛴ䛻ྲྀᚓ䛩䜛䛾䛜ᮃ䜎䛧䛟䚸➇த䛻᭷฼䛷䛒䜛䛸䛾᝟ሗ䜢ᚓ䛯䚹

78 䝝䝷䞊䝹〇ရಖド䛾ᐇ᪋䛻㛵䛩䜛ᨻᗓつ๎ 2021 ᖺ➨ 39 ྕ
䠄https://jdih.setkab.go.id/PUUdoc/176351/PP_Nomor_39_Tahun_2021.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 6 ᪥䠅112

3. ὶ㏻䛾௙⤌䜏
3.1 ື≀⏝་⸆ရ䛾ὶ㏻䛾௙⤌䜏䠄᪥ᮏ䛸䛾ẚ㍑䠅
ື≀⏝་⸆ရ䛾ὶ㏻䛾௙⤌䜏䛿䚸䛚䛚䜐䛽᪥ᮏ䛸ྠᵝ䛷䛒䜛䛸䛔䛘䜛䚹䜲䞁䝗䝛䝅䜰䛷䛿䚸኱䛝䛟ศ䛡䛶ὶ㏻㈍኎䝹䞊䝖䛜 2 䛴䛒䜚䚸බⓗᶵ㛵䛷䛒䜛ື≀ಖ೺ᡤ䠄PUSKESWAN䠖Pusat Kesehatan
Hewan䠅䜢⤒⏤䛩䜛ሙྜ䛸䚸Ẹ㛫䛾⸆ᒁ䜔ື≀⑓㝔䜢⤒⏤䛩䜛ሙྜ䛜䛒䜛䚹79㍺ධᴗ⪅䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸㤳㒔ᅪෆ䛷䛒䜜䜀䝇䝮䞊䝈䛺ὶ㏻䝅䝇䝔䝮䛜☜❧䛥䜜䛶䛔䜛䛜䚸ᆅ᪉㒔ᕷ䜔㐲㝸ᆅ䛾ሙྜ䚸」ᩘ䛾㓄㏦ᴗ⪅䜢౑⏝䛩䜛䛯䜑䚸㐜ᘏ䛜Ⓨ⏕䛩䜛䛣䛸䛜䛒䜛䚹79 ື≀⾨⏕ᒁ㛗 2018 ᖺᗘື≀⏝་⸆ရ㍺ฟධ⏘ᴗ䛾㐍ᒎ䠄

https://drive.google.com/file/d/19u6iF1lLnjV57ANiq9mDTdRquLTjiWxr/view?usp=share_link䚸᭱⤊䜰䜽䝉䝇᪥䠖
2022 ᖺ 11 ᭶ 15 ᪥䠅

113

3.2 ୺䛺ᅜෆ〇㐀ᴗ⪅䚸㍺ධᴗ⪅ཬ䜃ὶ㏻ᴗ⪅୺䛺ᅜෆ〇㐀ᴗ⪅䚸ὶධᴗ⪅ཬ䜃ὶ㏻ᴗ⪅䜢௨ୗ䛻♧䛩䚹
䞉
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Zoetis Animal Health Indonesia
Elanco Animal Health Indonesia
Sumber Bima Makmur䠄SBM䠅
MSD Animal Health
MKVet
Sistar Indonesia
Nestle Purina Petcare
VirbacBoehringer Ingelheim
Sanbe Farma
RomindoTunas Daya Vetamaᅜෆ〇㐀ᴗ⪅䚸㍺ධᴗ⪅ཬ䜃ὶ㏻ᴗ⪅䛾᭱᪂䝸䝇䝖䛿䚸䛂䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ䜲䞁䝕䝑䜽䝇
䠄IOHI䠖Indeks Obat Hewan Inodonesia䠅䛃https://www.indeksobathewanindonesia.com 䜢ཧ↷䛧䛶䛔䛯䛰䛝䛯䛔䚹䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䠄ASOHI䠅䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸఍ဨ௻ᴗᩘ䛿 2021 ᖺ᫬Ⅼ䛷⣙
400 ♫䛷䛒䜛䚹ෆヂ䛿䚸〇㐀ᴗ⪅䛜 113 ♫䠄2015 ᖺ䛾 77 ♫䛛䜙 42%ቑ䚸䛭䛾䛖䛱䛂CPOHB ド᫂᭩䛃ྲྀᚓ῭䠖62 ♫䚸ᮍྲྀᚓ䠖18 ♫䚸⏦ㄳ୰䠖26 ♫䠅䚸㍺ධᴗ⪅䛜 272 ♫䚸㍺ฟᴗ⪅䛜 44 ♫䠄2015 ᖺ
䛾 16 ♫䛛䜙 126%ቑ䠅䛷䛒䜚䚸㍺ฟධᴗ⪅ᩘ䛿ቑຍ䛾୍㏵䜢䛯䛹䛳䛶䛔䜛䛸䛾᝟ሗ䜢ᚓ䛯䚹80, 81
䛥䜙䛻䚸㍺ධᴗ⪅䛾㑅ᐃ䛻㛵䛧䛶䛿䚸≉ᐃ䛾௻ᴗ䜢᥎⸀䛩䜛䛣䛸䛿❧ሙୖ㞴䛧䛔䛯䜑䚸ୖ㏙䛾䜲䞁䝕䝑䜽䝇䜢ཧ↷䛧䛶䛔䛯䛰䛝䛯䛔䛸䛾ᅇ⟅䜢ᚓ䛯䚹

3.3 ᅜෆື≀⏝་⸆ရ䛾ᕷሙつᶍ䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䛜 2020 ᖺ䛻Ⓨ⾲䛧䛯㈨ᩱ䛻䜘䜛䛸䚸2019 ᖺ䜲䞁䝗䝛䝅䜰䛾ື≀⏝་⸆ရ䠄ᐙ⚺㢮䚸㇜䚸∵⏝䛾་⸆ရཬ䜃䝥䝺䝭䝑䜽䝇䠅䛾ᕷሙつᶍ䛿䚸10,9 ඙䝹䝢䜰䠄⣙ 936 ൨෇䚸⣙6 ൨ 9,725 ୓ USD䠅䛷䛒䛳䛯䛜䚸䝟䞁䝕䝭䝑䜽䛾ᙳ㡪䛷 2020 ᖺ䛿๓ᖺẚ䝬䜲䝘䝇 15%䛾 9,28 ඙䝹䝢䜰䠄⣙ 793 ൨෇䚸⣙ 5 ൨ 9,339 ୓ USD䠅䛷䛒䛳䛯䚹䛧䛛䛧䚸2021 ᖺ䛿๓ᖺẚ 5-6%䚸2022 ᖺ䛿๓ᖺẚ 5䠂䛾ᡂ㛗䛜ぢ㎸䜎䜜䛶䛔䛯䚹2019 ᖺ䛛䜙 2021 ᖺ䛾ண᝿᥎⛣䜢௨ୗ䛻♧䛩䚹82

80agrina-online(http://www.agrina-online.com/detail-berita/2022/01/05/7/8031/2022-industri-obat-hewan-optimis-

tumbuh-5䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 26 ᪥)
81 ື≀⏝་⸆ရ஦ᴗ⪅䛾๭ྜ䠄https://drive.google.com/file/d/1vgcuHfRh4N6FLfJ6yolmkZhU7NOTqxF/view?usp=sharing䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 15 ᪥䠅
82 2020 ᖺ䛾ື≀⏝་⸆ရ䝡䝆䝛䝇≧ἣཬ䜃 2021 ᖺ䛾ᒎᮃ䠄https://www.agropustaka.id/wpcontent/uploads/2021/01/agropustaka.id_Asohi_Situasi-Bisnis-Obat-Hewan-2020-dan-Prospek-2021ASOHI.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 15 ᪥䠅114඙㸦ࣝࣆ࢔㸧࢖ࣥࢻࢿࢩ࢔ࡢື≀⏝་⸆ရᕷሙつᶍ
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2019

2020

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ᐙ⚺㢮ࡢ⏕≀〇๣ & ་⸆ရ㇜ + ∵ࡢ⏕≀〇๣ & ་⸆ရࣉ࣑ࣞࢵࢡࢫ〇๣ྜィ2018 ᖺ䜎䛷䛾Ⓩ㘓␒ྕྲྀᚓ῭䛾ື≀⏝་⸆ရ䛿 6,987 〇ရ䛷䛒䛳䛯䛜䚸䛥䜙䛻䛭䛾ᚋ 2020 ᖺ
11 ᭶䜎䛷䛻 614 〇ရ䛾᪂つⓏ㘓䛜䛺䛥䜜䛯䚹83
ᢞ㈨ᐙ䛿䚸ື≀⏝་⸆ရᕷሙ䛾኱䛝䛺ྍ⬟ᛶ䛻䜂䛛䜜䚸ື≀⏝་⸆ရ䝡䝆䝛䝇䛻ᢞ㈨䛩䜛䜘䛖䛻䛺䜚䚸ື≀⏝་⸆ရ䛾᪂఍♫䛜ቑຍ䛧䛶䛔䜛䚹2020 ᖺ䚸ື≀⏝་⸆ရ఍♫䛿 200 ♫⛬ᗘ䛧䛛άື䛧䛶䛔䛺䛔䜒䛾䛾䚸300 ♫௨ୖ䛜Ⓩ㘓䛥䜜䛶䛔䜛䚹䛣䜜䛿䚸䜲䞁䝗䝛䝅䜰䛻䛚䛔䛶ື≀⏝་⸆ရ䝡䝆䝛䝇䛜䜎䛰䜎䛰㨩ຊⓗ䛷䛒䜛䛣䛸䜢♧䛧䛶䛔䜛䚹䜲䞁䝗䝛䝅䜰䛾᪤Ꮡ䛾ື≀⏝་⸆ရ఍♫䛿䚸㍺ධရ䜢୰ᚰ䛸䛧䛯ၟ♫䛜୰ᚰ䛷䚸⮬♫〇ရ䜢〇㐀䛧䛶䛔䜛䛸䛣䜝䛿䜎䛰ᑡ䛺䛔䚹84䛧䛯䛜䛳䛶䚸ື≀⏝་⸆ရᕷሙ䛿౫↛䛸䛧䛶㍺ධရ䛜ඃໃ䛷䛒䜛䚹
3.3.1 ᅜෆ䝙䞊䝈ື≀⏝་⸆ရᴗ⏺䛾䝍䞊䝀䝑䝖䛿䚸౫↛䛸䛧䛶ᕷሙ䝅䜵䜰䛾䝖䝑䝥䛷䛒䜛ᐙ⚺䠄㣗⏝㭜⫗䠅ྥ䛡䛷䛒䜛䚹䛧䛛䛧䚸ᐙ⚺㢮௨እ䛾㣗⏝ື≀䠄⨺䚸䝲䜼䚸∵䠅䛻䛴䛔䛶䛿䚸ᐙ␆⏕⏘㔞䛾ቑຍ䛻క䛔䚸䝽䜽䝏䞁䚸་⸆ရ䚸䝥䝺䝭䝑䜽䝇䛺䛹䛾ື≀⏝་⸆ရ䛾䝡䝆䝛䝇䝏䝱䞁䝇䛜௒ᚋ䜒ᣑ኱䛧䛶䛔䛟䛸⪃䛘䜙䜜䜛䚹䛥䜙䛻䚸䝨䝑䝖⏝䛾䝽䜽䝏䞁ཬ䜃་⸆ရ䛾䝙䞊䝈䜒ቑຍഴྥ䛻䛒䜚䚸ᕷሙ䜈䛾ཧධ䛜ᮇᚅ䛥䜜䛶䛔
䜛䚹85௒ᚋ䚸ᢠ⏕≀㉁䛾௦᭰ရ䠄౛䠖䝝䞊䝤䚸㓝⣲䚸䝥䝻䝞䜲䜸䝔䜱䜽䝇䚸䝥䝺䝞䜲䜸䝔䜱䜽䝇䚸⢭Ἔ䚸⣽⳦ᛶ⑌ᝈ䝽䜽䝏䞁䠅䛾㛤Ⓨ䛜ᮇᚅ䛥䜜䛶䛚䜚䚸⊛ጾ䜢᣺䜛䛳䛶䛔䜛⑌⑓䠄౛䠖ASF䚸AI䠅䛻㛵㐃䛩䜛ື≀⏝་⸆ရ䠄౛䠖ᾘẘ๣䚸ච␿ㄪᩚ๣䚸䝽䜽䝏䞁䠅䛾ධᡭ䛜⪃៖䛥䜜䛶䛔䜛䚹ᨻᗓ䛿䚸௨ୗ䛾 3 䛴䛾᪉㔪䜢┠ᶆ䛸䛧䛶ᥖ䛢䛶䛔䜛䚹
1. ≉ᐃ䛾✀㢮䛾ᢠ⏕≀㉁ཬ䜃ᢠ⏕≀㉁ే⏝䛾⚗Ṇィ⏬
2. ື≀⏝་⸆ရ䛾㍺ධཬ䜃Ⓩ㘓ಁ㐍
3. ㍺ฟ 3 ಸィ⏬

83 ື≀⏝་⸆ရ䛾Ⓩ㘓ᩘ䛾⤒⦋ཬ䜃✀㢮䠄https://drive.google.com/file/d/1qWRmInZkeD6zA11NWrNGO5vT-

MdTfIzF/view?usp=sharing䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 15 ᪥䠅
84 ␆⏘䝡䝆䝛䝇䝯䝕䜱䜰䝖䝻䝪䝇䠄http://troboslivestock.com/detail-berita/2020/10/01/68/13506/budi-tangendjajapeluang-menjanjikan-di-industri-obat-hewan–䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 15 ᪥䠅
85 ㎰ᴗ䝡䝆䝛䝇䝯䝕䜱䜰䝇䝽䝎䝲䜸䞁䝷䜲䞁䠄https://www.swadayaonline.com/artikel/4672/Tahun-2020-IndustriObat-Hewan-Harus-Survive-Optimis-dan-Realistis/䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 15 ᪥䠅

115

3.4 ㍺ධ་⸆ရ䛾ᕷሙつᶍཬ䜃ᕷሙᐇែ
2021 ᖺ䛾ື≀⏝་⸆ရ㍺ධ⥲㢠䛿䚸2.63 ൨ USD䠄⣙ 350 ൨෇䠅䛷䛒䛳䛯䚹㐣ཤ 5 ᖺ㛫䛾᥎⛣䜢௨ୗ䛻♧䛩䚹䠄ྛᅜู䛾㍺ධ㢠䛿බ⾲䛥䜜䛶䛔䛺䛔ᶍᵝ䠅൨ࢻࣝ࢖ࣥࢻࢿࢩ࢔ࡢື≀⏝་⸆ရ㍺ධ⥲㢠
3
2.5
2
1.5
1
0.5
0
2017

2018

2019

2020

2021

ື≀⏝་⸆ရ㸦ྜィ㸧࣡ࢡࢳࣥᚤ⏕≀⏤᮶ࡢ་⸆ရ

ࡑࡢ௚㸦ࣉ࣑ࣞࢵࢡࢫࠊࣜࢪࣥ➼㸧ື≀⏝་⸆ရ䛾㍺ධඖ䛸䛧䛶䚸2018 ᖺ᫬Ⅼ䛷௨ୗ䛾 39 䛛ᅜ䛸ྲྀᘬ䛜䛒䛳䛯䠖༡䜰䝣䝸䜹䚸䝶䝹䝎䞁䚸䜰䝯䝸䜹䚸䜹䝘䝎䚸䜰䝹䝊䞁䝏䞁䚸㡑ᅜ䚸䜸䞊䝇䝖䝷䝸䜰䚸䝬䝺䞊䝅䜰䚸䜸䞊䝇䝖䝸䜰䚸䝯䜻䝅䝁䚸䜸䝷䞁䝎䚸䝜䝹䜴䜵䞊䚸䝧䝹䜼䞊䚸䝣䝷䞁䝇䚸䝤䝷䝆䝹䚸䝫䞊䝷䞁䝗䚸䝤䝹䜺䝸䜰䚸䝻䝅䜰䚸୰ᅜ䚸䝅䞁䜺䝫䞊䝹䚸䝁䝻䞁䝡䜰䚸䝇䝻䝞䜻䜰䚸䝏䜵䝁䚸䝇䝨䜲䞁䚸䝕䞁䝬䞊䜽䚸䝇䜲䝇䚸䝣䜱䞁䝷䞁䝗䚸ྎ‴䚸䝝䞁䜺䝸䞊䚸䝍䜲䚸䜲䞁䝗䚸䝏䝳䝙䝆䜰䚸䜲䜼䝸䝇䚸䝧䝛䝈䜶䝷䚸䜲䝍䝸䜰䚸䝧䝖䝘䝮䚸᪥ᮏ䚸䜼䝸䝅䝱䚸䝗䜲䝒䚹
2021 ᖺ䛾ື≀⏝་⸆ရ㍺ฟ⥲㢠䛿䚸1.73 ൨ USD䠄⣙ 231 ൨෇䠅䛷䛒䜚䚸2020 ᖺ䛸ẚ䜉䜛䛸
26.8%䛾ቑຍ䛜ぢ䜙䜜䛯䚹86⋇་ᖌཬ䜃䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸␆⏘ศ㔝䛻䛚䛡䜛་⸆ရ䠄≉䛻ᐙ⚺䚸㣗⏝㭜⫗䠅䛿ᅜෆ⏕⏘䛷䜹䝞䞊䛷䛝䛶䛔䜛䛯䜑䚸㍺ධ䜢ไ㝈䛩䜛ᨻ⟇䛜䛸䜙䜜䛶䛔䜛䛜䚸⌧≧䛷䛿䝨䝑䝖⏝䝽䜽䝏䞁ཬ䜃་⸆ရ䜢䜋䜌㍺ධ䛻㢗䛳䛶䛔䜛䚹

86 2022 ᖺ␆⏘ཬ䜃ື≀⾨⏕䛾⤫ィ䠄https://ditjenpkh.pertanian.go.id/storage/photos/shares/konten/publikasi/files/Buku%20Statistik%202022%20IS
SN.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 26 ᪥)

116

3.4.1 ㍺ධ་⸆ရ䛾௒ᚋ䛾ぢ㏻䛧䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ༠఍䠄ASOHI䠅䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸⤒῭䛾Ⓨᒎ䛻䜘䜚䝨䝑䝖㣫⫱䛜ቑ䛘䜛䛣䛸䛜ண᝿䛥䜜䜛䚹⫗䚸༸〇ရ䛛䜙䛾䝥䝻䝔䜲䞁ᦤྲྀ䛜᥎㐍䛥䜜䛶䛔䜛䛯䜑䚸␆⏘ᴗ⏺䛾㣗⫗౪⤥㔞䛻ᛂ䛨䛶௒ᚋ䚸་⸆ရ䛾౑⏝䜒ቑຍ䛩䜛䛣䛸䛜ண᝿䛥䜜䜛䚹௨ୖ䛾䛣䛸䛛䜙䚸䛩䜉䛶䛾ື≀䛻ᑐ䛧㍺ධ་⸆ရ䛾㟂せ䛜ቑ䛩ྍ⬟ᛶ䛜䛒䜛䛸䛾᝟ሗ䛜ᚓ䜙䜜䛯䚹䛥䜙䛻䚸⋇་ᖌ䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸䝨䝑䝖⏝䝽䜽䝏䞁䚸㯞㓉⸆䛿䜋䜌㍺ධရ䛻㢗䛳䛶䛔䜛䛯䜑䚸௒ᚋ䜒䝨䝑䝖㟂せ䛸䛸䜒䛻ᣑ኱䛜ぢ㎸䜎䜜䜛䚹⥆䛔䛶䚸㍺ධᴗ⪅䜈䛾䝠䜰䝸䞁䜾䛻䜘䜛䛸䚸䝨䝑䝖⏝㥑⹸⸆䛾ෆእ⸆䜢୰ᚰ䛻㟂せ䛜䜰䝑䝥䛧䛶䛔䜛䚹䛧䛛䛧䚸㍺ධရ䜢ไ㝈䛧䚸㍺ฟ䜢ቑ䜔䛩䛸䛔䛖ᨻ⟇䛿䚸䜲䞁䝗䝛䝅䜰䛻〇ရ䜢㍺ฟ䛩䜛ᅜ䛻䛸䛳䛶ㄢ㢟䛸䛺䜛ྍ⬟ᛶ䛜㧗䛔䚹87䛥䜙䛻䚸㍺ධ䛾ᗘ䛻་⸆ရ䛾䝺䞊䝖䛜ኚື䛩䜛䛯䜑䚸㈍኎౯᱁䜒㝶᫬ㄪᩚ䛩䜛ᚲせ䛜䛒䜚䚸౯᱁タᐃ䛜ㄢ㢟䛸䛺䛳䛶䛔䜛䛸䛾ពぢ䜒⪺䛛䜜䛯䚹
3.4.2 ື≀⏝་⸆ရᴗ⏺䛾ㄢ㢟ㄪᰝ䛷ศ䛛䛳䛯䜲䞁䝗䝛䝅䜰ᅜෆ䛻䛚䛡䜛ື≀⏝་⸆ရᴗ⏺䛾ㄢ㢟䜢䚸௨ୗ䛻 6 䛴ᣲ䛢䜛䚹
1. ື≀⏝་⸆ရ䛜䝠䝖⏝་⸆ရ䜘䜚㧗౯䛻䛺䛳䛶䛔䜛䚹䛭䛾䛯䜑䚸ື≀⏝་⸆ရ䛾௦᭰䛸䛧䛶䝠䝖⏝་⸆ရ䜢౑⏝䛩䜛䜿䞊䝇䛜┠❧䛳䛶䛔䜛䚹
2. 㐪ἲ䛺ື≀⏝་⸆ရ䚸↓Ⓩ㘓་⸆ရ䛾䜸䞁䝷䜲䞁㈍኎䚸ὶ㏻䛜ྎ㢌䛧䛶䛔䜛䚹
3. ᅜෆ〇㐀఍♫䛾〇ရ㛤Ⓨ䚸◊✲㛤Ⓨ㈨※䚸㈨㔠䛜䜎䛰㝈䜙䜜䛶䛔䜛䚹
4. ᅜෆ〇ရ䛾ཎᮦᩱ䛿䚸౫↛䛸䛧䛶㍺ධရ䛻೫䛳䛶䛔䜛䚹
5. ㍺ධཎᮦᩱ䛾ධᡭ䛿㍺ධチྍ䛾ไ⣙䛜䛒䜚䚸᏶ᡂရ䛾౪⤥⥅⥆䛻ᙳ㡪䜢ཬ䜌䛧䛶䛔䜛䚹88
6. ㍺ධᴗ⪅䚸ὶ㏻ᴗ⪅䛜⏕⏘ᴗ⪅䚸㍺ฟᴗ⪅䜢ୖᅇ䛳䛶䛔䜛䚹

3.5 ᪥ᮏ〇ရ䛻ᑐ䛩䜛ホ౯䞉ពぢ䜲䞁䝗䝛䝅䜰䛷⌧ᆅἲே䜢❧䛱ୖ䛢䚸⌧ᆅ⏕⏘䛧䛶䛔䜛᪥ᮏ䛾〇⸆఍♫䛻䜘䜛ື≀⏝་⸆ရ䛾▱ྡᗘ䛿㧗䛔䚹䛧䛛䛧䚸᪥ᮏ䛛䜙┤᥋㍺ධ䛥䜜䛶䛔䜛ື≀⏝་⸆ရ䛿䜎䛰ᑡ䛺䛔䛯䜑▱ྡᗘ䛿ప䛔䚹䝠䜰䝸䞁䜾䛛䜙䚸᪥ᮏ〇ရ䛻ᑐ䛩䜛ಙ㢗ᗘ䛿㧗䛔䛜䚸ᅜ⏘䜘䜚䜒㧗౯䛷䛒䜛༳㇟䛜ᙉ䛔䛸䛾᝟ሗ䜢ᚓ䛯䚹

87 ື≀⏝་⸆ရရ㉁ヨ㦂ㄆド䝉䞁䝍䞊䠄http://bbpmsoh-ppid.pertanian.go.id/index.php/news/view/965䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 8 ᭶ 3 ᪥䠅
88 ື≀⏝་⸆ရ⏘ᴗ䛾㈉⊩ཬ䜃㍺ฟධ䛾ྍ⬟ᛶ䠄http://www.asohi.org/index.php?option=com_phocadownload&view=category&download=17:presentasidirkeswan&id=4:materi-seminar䚸᭱⤊䜰䜽䝉䝇᪥䠖2023 ᖺ 1 ᭶ 10 ᪥)117

4. ⏝ㄒ
௨ୗ䛾⏝ㄒ䛻䛴䛔䛶⬮ὀ䛜䛺䛔䜒䛾䛿䛂㎰ᴗศ㔝䛾ᐇ᪋䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつ๎
2021 ᖺ➨ 26 ྕ䛃89䛛䜙ᘬ⏝䛧䛯䜒䛾䛷䛒䜛䚹ƔƔື≀䛸䛿䚸㝣ୖ䚸Ỉ୰䚸✵୰䛷⏕ά䛩䜛ື≀䜔⏕䛝≀䛾䛣䛸䛷䚸㣫⫱ୗཪ䛿⏕ᜥᆅ䛷⏕ά䛩䜛ື≀䜢ᣦ䛩䚹90ື≀⏝་⸆ရ㍺ධᴗ⪅䛸䛿䚸ᾏእ䛛䜙䜲䞁䝗䝛䝅䜰ඹ࿴ᅜෆ䛻ື≀⏝་⸆ရ䜢㍺ධ䛩䜛஦ᴗ䜢⾜䛖ື≀⏝་⸆ရ䛾㛵㐃௻ᴗ䜢ᣦ䛩䚹Ɣື≀⏝་⸆ရὶ㏻ᴗ⪅䛸䛿䚸ື≀⏝་⸆ရ䜢⏕⏘⪅䜔㍺ධ⪅䛛䜙౪⤥䚸ὶ㏻䛥䛫䜛ື≀⏝་⸆ရ䛾㛵㐃௻ᴗ䜢ᣦ䛩䚹Ɣື≀⏝་⸆ရᢏ⾡㈐௵⪅䠄PJTOH䠅䛸䛿䚸䜲䞁䝗䝛䝅䜰ᅜ⡠䛷⋇་Ꮫᩍ⫱䜢ཷ䛡䛯デ⒪チྍド䠄SIP䠅䜢᭷䛩䜛ᢏ⾡⪅䚸ປാチྍド䠄SIK䠅䜢᭷䛩䜛⸆๣ᖌ䚸䝟䝷䝯䝕䜱䜹䝹䝃䞊䝡䝇チྍド䠄SIPP䠅䜢᭷䛩䜛ື≀ᩆᛴ་⒪ኈ䚸་⸆ရᢏ⾡ປാチྍド䠄SIKTTK䠅䜢᭷䛩䜛⸆๣ᖌຓᡭ䜢ᣦ䛧䛶䛚䜚䚸ື≀⏝་⸆ရ஦ᴗ䛻䛚䛔䛶㐺⏝䛥䜜䜛つᐃ䛻ᚑ䛳䛶ື≀⏝་⸆ရ䛾〇㐀/㍺ฟ/㍺ධ/ὶ㏻/㈍኎䛻㈐௵䜢ᣢ䛴䚹ƔƔື≀⏝་⸆ရ䛾㐺ṇ〇㐀つ⠊䠄CPOHB䠅䛸䛿䚸ື≀⏝་⸆ရ䛾〇㐀䛻䛚䛔䛶䚸せ௳ཬ䜃౑⏝┠ⓗ䛻ᇶ䛵䛝୍㈏䛧䛶⏕⏘䛥䜜䚸Ᏻ඲ᛶ䚸᭷ຠᛶ䚸ཬ䜃ရ㉁䜢☜ಖ䛩䜛䛯䜑䛻䚸ྛẁ㝵䛜ᐃ䜑䜙䜜䛯ᡭ㡰ཬ䜃せ௳䛻ᚑ䛳䛶ᐇ᪋䛥䜜䜛〇㐀᪉ἲ䛾䛣䛸䛷䛒䜛䚹91᪂䛧䛔ື≀⏝་⸆ရ䠄᪂⸆䠅䛸䛿䚸᪂䛧䛔ຠ⬟䜢ᣢ䛴≀㉁䚸ྂ䛔ຠ⬟䛻ຍ䛘䛶᪂䛧䛔ຠ⬟䜢ᣢ䛴≀㉁䚸ྂ䛔ຠ⬟䜢ᣢ䛴≀㉁䛾᪂䛧䛔⤌ྜ䛫䜢ྵ䜐ື≀⏝་⸆ရ䚸ῧຍ≀䜢ྵ䜐᪂䛧䛔〇๣ཬ䜃/ཪ䛿᪂䛧䛔ᢞ୚᪉ἲ䛺䛹䚸䜲䞁䝗䝛䝅䜰䛷ᢎㄆ䛥䜜䛯䛣䛸䛾䛺䛔་⸆ရ䜢ᣦ䛩䚹Ɣ᪂つⓏ㘓䛸䛿䚸䜲䞁䝗䝛䝅䜰䛷ึ䜑䛶Ⓩ㘓䛥䜜䜛ື≀⏝་⸆ရ䛻Ⓩ㘓␒ྕ䜢௜୚䛩䜛䛣䛸䛷䛒䜛䚹Ɣ෌Ⓩ㘓䛸䛿䚸10 ᖺ䛾᭷ຠᮇ㛫䛜⤊஢䛧䛯ື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕ䜢᭦᪂䛩䜛䛣䛸䛷䛒䜛䚹Ɣື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕ䛸䛿䚸ື≀⏝་⸆ရ䜢㆑ู䛩䜛䛯䜑䛾ᩥᏐཬ䜃ᩘᏐ䜢ྵ䜐᝟ሗ䛾䛣䛸䛷䛒䜚䚸ὶ㏻ྍ⬟䛺ື≀⏝་⸆ရ䛾᭷ຠᛶ䜢ド᫂䛩䜛䚹Ɣື≀⏝་⸆ရ䛾Ⓩ㘓␒ྕỴᐃ᭩䛸䛿䚸㎰ᴗ኱⮧䛾ྡ䛾ୗ䛻㎰ᴗᒁ㛗䛻䜘䛳䛶ṇᘧ䛻ㄆྍ䛥䜜䛯䚸Ⓨ⾜᪥䛛䜙 10 ᖺ㛫䛾᭷ຠᮇ㛫䜢ᣢ䛴Ⓩ㘓῭䛾ື≀⏝་⸆ရ䛻ᑐ䛧䛶㎰ᴗ኱⮧䛜Ⓨ⾜䛩䜛Ỵᐃ᭩䛾䛣䛸䛷䛒䜛䚹Ɣ䝷䜲䝉䞁䝇䛻ᇶ䛵䛟ື≀⏝་⸆ရ䛾〇㐀䠄Produksi Obat Hewan dengan Lisensi䠅䛸䛿䚸

89 ㎰ᴗศ㔝䛾ᐇ᪋䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつ๎ 2021 ᖺ➨ 26 ྕ䠄https://peraturan.go.id/common/dokumen/ln/2021/pp26-2021bt.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 11 ᭶ 10 ᪥䠅
90 ື≀⏝་⸆ရ䛾ศ㢮䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ➨

14/PERMENTAN / PK.350 /5/2017 ྕ䠄https://simrek.ditjenpkh.pertanian.go.id/fileinfo/Regulasi-3Permentan142017.pdf䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶ 1 ᪥䠅91ື≀⏝་⸆ရ䛾ᐇᆅㄪᰝཬ䜃┘╩䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ㎰ᴗ኱⮧つᐃ 2021 ᖺ➨ 16 ྕ
䠄 https://peraturan.bpk.go.id/Home/Details/175307/permentan-no-16-tahun-2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 7 ᭶
17 ᪥䠅

118

ᅜእ〇㐀ᴗ⪅䛛䜙䛾䝷䜲䝉䞁䝇䛻ᇶ䛵䛔䛶䚸ᅜෆ〇㐀ᴗ⪅䛜〇㐀ᕤ⛬䛾୍㒊ཪ䛿䛩䜉䛶䜢⾜䛖䛣䛸䛷䛒䜛䚹
Ɣື≀⏝་⸆ရ䛾ཷク〇㐀䠄Pembuatan Obat Hewan Berdasarkan Kontrak/Toll
Manufacturing䠅䛸䛿䚸ጤク⪅䛸ཷク⪅㛫䛾ዎ⣙䛻ᇶ䛵䛝䚸ᐃ䜑䜙䜜䛯ᮇ㛫ෆ䛻ཷク⪅䛜ື≀⏝་⸆ရ䜢〇㐀䛩䜛䛣䛸䛷䛒䜛䚹Ɣື≀⏝་⸆ရ㍺ධチྍド䠄Izin Pemasukan Obat Hewan䠅䛸䛿䚸ື≀⏝་⸆ရ䛜㍺ධ䛾᮲௳䜢‶䛯䛧䛶䛔䜛䛣䛸䜢᫂グ䛧䛯ド᫂᭩䛾䛣䛸䛷䛒䜚䚸3 䛛᭶㛫᭷ຠ䛷 1 ᗘ㝈䜚౑⏝䛜ྍ⬟䛷䛒䜛䚹92Ɣື≀ಖ೺ᡤ䠄PUSKESWAN䠖Pusat Kesehatan Hewan䠅䛸䛿䚸ື≀ಖ೺䛻㛵䛩䜛㎰ᴗ኱⮧ཬ䜃ෆົ኱⮧䛾ඹྠἲ௧➨ 690/Kpts/TN.510/10/1993 ྕཬ䜃➨ 88 ྕ䛷ゝཬ䛥䜜䛶䛔䜛⥲ྜⓗ䛺ື≀ಖ೺ศ㔝䛾䝃䞊䝡䝇䜢ᥦ౪䛩䜛ື≀ಖ೺᪋タ䛾䛣䛸䛷䛒䜚䚸ᆅᇦ♫఍䜈䛾䝃䞊䝡䝇䚸⑓Ẽ䛾デ᩿䚸἞⒪䚸⦾Ṫ䚸⋇་ᖌ䛾㉁䛾ྥୖ䛻㔜せ䛺ᙺ๭䜢ᢸ䛳䛶䛔䜛䚹93Ɣ䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ䜲䞁䝕䝑䜽䝇䠄IOHI䠖Indeks Obat Hewan Inodonesia䠅䛸䛿䚸㎰ᴗ┬䛾␆⏘ື≀⾨⏕⥲ᒁ䛻Ⓩ㘓䛥䜜䛶䛔䜛ື≀⏝་⸆ရ䛾䝕䞊䝍䛜䝸䝇䝖໬䛥䜜䛶ᥖ㍕䛥䜜䛶䛔䜛၏୍䛾ᮏ䚹᭱᪂∧䛿 2021 ᖺ∧䛷䚸༳ๅ∧䛿䚸2 ᖺ䛻 1 ᗘฟ∧䛥䜜䜛䚹䜸䞁䝷䜲䞁∧䠄https://www.indeksobathewanindonesia.com/䠅䛿᪂〇ရ䛜Ⓩ㘓䛥䜜䜛䛤䛸䛻ཪ䛿ྲྀ䜚ᾘ䛥䜜䜛䛤䛸䛻᭦᪂䛥䜜䜛䚹Ⓩ㘓␒ྕ䜢ᣢ䛴ື≀⏝་⸆ရ䛾୍ぴ䚸ື≀⏝་⸆ရ〇㐀䞉㍺ධ䞉㈍኎ᴗ⪅䛾ఫᡤ୍ぴ䚸ື≀⏝་⸆ရ䛾ఇ⸆ᮇ㛫୍ぴ䚸㎰ᴗ┬䛾⾜ᨻᶵ㛵䛺䛹ື≀⏝་⸆ရ䛻㛵㐃䛩䜛䝕䞊䝍䛜ᥖ㍕䛥䜜䛶䛔䜛䚹ᮏ᭩䜢ཧ↷䛩䜛䛣䛸䛷ᕷ㈍䛥䜜䛶䛔䜛ື≀⏝་⸆ရ䛜ṇつ䛾Ⓩ㘓῭〇ရ䛛䛹䛖䛛䜢☜ㄆ䛩䜛䛣䛸䛜䛷䛝䜛䚹94

92 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun-

2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 19 ᪥䠅
93 䝞䝍䝮ᕷᙺᡤ㣗ရಖ೺㎰ᴗ㒊䠄https://distankp.batam.go.id/pusat-kesehatan-hewan-puskeswan-kotabatam/#:~:text=Pusat%20Kesehatan%20Hewan%20(Puskeswan)%20sebagai,veteriner%20di%20wilayah%20
Kota%20Batam.䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 29 ᪥䠅
94 ື≀⏝་⸆ရ䜲䞁䝕䝑䜽䝇䛾⤂௓䝃䜲䝖䠄http://www.majalahinfovet.com/2018/03/indeks-obat-hewan-versionline.html䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶ 6 ᪥䠅119

5. ཧ⪃㈨ᩱ
5.1 ື≀⏝་⸆ရ〇㐀ᴗ⪅ཬ䜃㍺ධᴗ⪅䛜ྲྀᚓ䛩䜉䛝⏘ᴗศ㢮䝁䞊䝗
5.1.1 KBLI 21013䚸ື≀⏝་⸆ရ〇㐀ᴗ䠄Industri Produk Farmasi Untuk Hewan䠅䛾஦ᴗᇶ‽95
䛂KBLI 21013䚸ື≀⏝་⸆ရ〇㐀ᴗ䠄Industri Produk Farmasi Untuk Hewan䠅䛾஦ᴗᇶ‽䛃
KBLI 21013
No.
ື≀⏝་⸆ရ〇㐀ᴗ
1

ᑐ㇟⠊ᅖ

2

୍⯡せồ
஦㡯

ᮏᇶ‽䛻䛿䚸⢊ᮎ䚸㘄๣䚸䜹䝥䝉䝹䚸㌾⭯䚸⁐ᾮ䚸ᠱ⃮ᾮ䚸䜶䜰䝌䞊䝹䛺䛹䛾ᙧ≧䜢䛧䛯᭱⤊ᙧែ䛾ື≀⏝་⸆ရ䠄〇๣䠅䛾〇㐀䚸ຍᕤཬ䜃෌ໟ⿦䛾஦ᴗ䛻㛵䛩䜛つ๎䛜ྵ䜎䜜䜛䚹ື≀⏝䛾ᡭ⾡⏝⣒〇ရ⏘ᴗ䚸་⒪デ᩿ᶵჾ⏘ᴗ䚸ᨺᑕᛶ་⸆ရ䛾ᨺᑕᛶྠ఩య〇㐀⏘ᴗ䚸䝞䜲䜸䝔䜽䝜䝻䝆䞊〇⸆⏘ᴗ䚸་⒪⏝⏕⌮⏝䝘䝥䜻䞁ཬ䜃ໟᖏ䛺䛹䛾⏘ᴗ䜢ྵ䜐䚹
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ

3

≉ᐃせồ
஦㡯

Ɣ

ື≀⏝་⸆ရᢏ⾡㈐௵⪅䠄PJTOH䠖Penanggung Jawab Teknis Obat
Hewan䠅䜢㓄⨨䛩䜛䚹ື≀⏝་⸆ရ䛾⏕⏘ሙᡤ䜢ᡤ᭷/⟶⌮䛩䜛䚹ື≀⏝་⸆ရ䜢〇㐀ཬ䜃ಖ⟶䛩䜛䛯䜑䛾㐺ษ䛺ᘓ≀ཬ䜃タഛ䛾䝺䜲䜰䜴䝖/タィᅗ䛜䛒䜛䚹ᗫᲠ≀⟶⌮䝅䝇䝔䝮䛾タィᅗ䛜䛒䜛䚹ƔƔ䛝䜜䛔䛺Ỉ※䛜䛒䜛䚹஦ᴗᡤ䛾ᡤᅾᆅ䛜ఫᏯᆅ䛷䛿䛺䛔䚹

Ɣ
Ɣ
Ɣ

4

᪋タ

஦ᴗᙧែ䠖஦ᴗయ䚸ἲே䚸බඹ䝃䞊䝡䝇ᶵ㛵᭱ึ䛾ື≀⏝་⸆ရⓏ㘓␒ྕⓎ⾜ᚋ 1 ᖺ௨ෆ䛻 CPOHB 䜢ᐇ᪋䛧䚸
CPOHB ド᫂᭩䜢ྲྀᚓ䛩䜛⬟ຊ䛜䛒䜛䛣䛸䜢⾲᫂䛩䜛䚹⤌⧊ᵓ㐀䜢ᡤᣢ䛩䜛䚹ᾘ㈝⪅┦ㄯ❆ཱྀ䜢タ⨨䛩䜛䚹ື≀⏝་⸆ရศ㔝䛾ἲ௧㞟䜢ಖ᭷䛩䜛䚹
OSS 䛜つᐃ䛧䛶䛔䜛ᮇ㛫䚸せ௳䜢ᒚ⾜䛧䛶䛔䜛䚹

95 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ 2229䡚2308 䝨䞊䝆䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun-2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶
19 ᪥䠅

120

5

ேᮦ䛾⤌
⧊ᵓ㐀ཬ
䜃ேᮦ

Ɣ
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ

⤌⧊ᵓ㐀䜢ᩥ᭩໬䛧䛶䛚䜚䚸஦ᴗ⤌⧊ෆ䛾௵ົ䚸ᶵ⬟ཬ䜃ᶒ㝈䛾ศᢸ䜢ᴫㄝ䛧䛶䛔䜛䚹
ヱᙜศ㔝䛻ᛂ䛨䛯䝇䜻䝹䜢ᣢ䛱䚸ᴗົ䝸䝇䜽䜢⌮ゎ䛧䛯ேᮦ䜢㓄⨨䛩䜛䚹ື≀⏝་⸆ရ〇㐀ศ㔝䛻䛚䛡䜛⬟ຊཬ䜃▱㆑䜢᭷䛩䜛ேᮦ䜢㓄⨨䛩䜛䚹ປാศ㔝䛾ἲ௧䛻ᇶ䛵䛝䚸ປാᏳ඲⾨⏕䜢ᐇ᪋䛩䜛⬟ຊ䜢᭷䛩䜛ேᮦ䜢㓄⨨䛩䜛䚹
ṇ♫ဨ䛷䝣䝹䝍䜲䝮໅ົ䛾⋇་ᖌ 1 ྡ䚸⸆๣ᖌ 1 ྡ䛾ィ 2 ྡ䛾
PJTOH 䜢ᡤ᭷䛩䜛䚹
PJTOH 䛿ᅜᐙබົဨ䛷䛿䛺䛟䚸఍♫௦⾲⪅䜢ව௵䛧䛺䛔䚹
PJTOH 䛿䚸⮬䜙䛾⫋ົཬ䜃㈐௵䜢⌮ゎ䛧䚸஦ᴗチྍドⓎ⾜ᚋ 1 ᖺ௨ෆ䛻䚸䛭䛾ศ㔝䛾◊ಟ䛻ཧຍ䛩䜛䛣䛸䜢⣙᮰䛩䜛䚹

6

䝃䞊䝡䝇

Ɣ
Ɣ

⏕⏘䛥䜜䛯〇ရ䛾᝟ሗ䜢ᥦ౪䛩䜛䚹ᾘ㈝⪅┦ㄯ❆ཱྀ䜢タ⨨䛩䜛䚹7〇ရ/ຍᕤ/
ᴗົ䛻㛵䛩
䜛せ௳

Ɣ

⏕⏘䛩䜛〇ရ䛻㛵䛩䜛せ௳- ື≀⏝་⸆ရⓏ㘓␒ྕ䜢᭷䛩䜛䚹- ᭷ຠᛶ䚸ရ㉁䚸Ᏻ඲ᛶ䜢ಖド䛩䜛䚹- 䜲䞁䝗䝛䝅䜰䛾ື≀⏝་⸆ရ⸆ᒁ᪉ཪ䛿ྠ➼䛾ཧ⪃ᩥ⊩䛻‽ᣐ䛩䜛䚹- 㐺⏝䛥䜜䜛つไ䛻ᚑ䛳䛯䝬䞊䜽䜢௜䛡䜛䚹ຍᕤ䛻㛵䛩䜛せ௳CPOHB 䜺䜲䝗䝷䜲䞁䛻ᇶ䛵䛟ື≀⏝་⸆ရ䛾〇㐀

Ɣ
Ɣ
8

⤒Ⴀ⟶⌮䝅
䝇䝔䝮

Ɣ

Ɣ

Ɣ

ḟ䜢ྵ䜐ຠᯝⓗ䛷ᩥ᭩໬䛥䜜䛯ᡭ㡰䜢☜❧䛧䚸ᐇ᪋䛩䜛䚹
- ௻⏬
- ⟶⌮
- 㢳ᐈ䛸䛾䝁䝭䝳䝙䜿䞊䝅䝵䞁- ⥅⥆ⓗ䛺ྥୖ䠖䝃䞊䝡䝇䜔⏕⏘䛾ྥୖ䛻ྥ䛡䛯ྲྀ䜚⤌䜏౛䛘䜀䚸᪤Ꮡ䛾䝕䞊䝍䛛䜙୙㐺ྜ䛺⤖ᯝ䛜ぢ䛴䛛䜚䚸䛭䜜䜢䛹䛾䜘䛖䛻ᨵၿ䛩䜛ணᐃ䛺䛾䛛䜢ㄝ᫂䛩䜛䚹- ᫝ṇᥐ⨨䠖ᨵၿ䛾ᐇ᪋ཬ䜃䛭䛾⤖ᯝ- ண㜵⟇䠖䝸䝇䜽ཬ䜃㉳䛣䜚䛖䜛஦㇟䛾ணぢຠᯝⓗ䛷ᩥ᭩໬䛥䜜䛯䝰䝙䝍䝸䞁䜾䚸ホ౯ཬ䜃䝣䜷䝻䞊䜰䝑䝥䜢ᐇ᪋䛩䜛䚹- ୍⯡せồ஦㡯ཬ䜃≉ᐃせồ஦㡯䛾ᒚ⾜- 〇ရཬ䜃ຍᕤ䛻㛵䛩䜛せ௳䛾ᒚ⾜- ⤒Ⴀ⟶⌮䝅䝇䝔䝮䛾ຠᯝⓗ䛺ᐇ᪋ሗ࿌᭩䛾సᡂ
⏕⏘άືሗ࿌᭩䜢ᐃᮇⓗ䛻ᥦฟ䛩䜛䚹

121

9

㐺ྜᛶホ
౯ཬ䜃┘
ど

Ɣ

Ɣ

㐺ྜᛶホ౯
- ື≀⏝་⸆ရ〇㐀ᴗ䛾஦ᴗ䝸䝇䜽䝺䝧䝹䠖㧗- つ᱁䛻ᑐ䛩䜛㐺ྜᛶホ౯䛿䚸せồ஦㡯䛾᭩㢮ᑂᰝཬ䜃⌧ᆅㄪᰝ䛻䜘䛳䛶⾜䜟䜜䜛䚹- ᪉ἲ䠖䝏䜵䝑䜽䝸䝇䝖ཬ䜃ㄝ᫂- ᐇ᪋ᶵ㛵䠖ᕞཬ䜃┴/ᕷ䛾ᙺဨ䛸䛸䜒䛻㎰ᴗ┬䛜ᐇ᪋- ᫬ᮇ䠖஦ᴗ㛤ጞ๓- ᙧᘧ䠖ホ౯⤖ᯝሗ࿌᭩- 㐺ྜᛶホ౯䛾ドᣐ䛿䚸஦ᴗ⪅䛜ㄆྍ䛥䜜䛯㛵ಀ┬ᗇ/ᶵ㛵䛛䜙ṇᘧ䛺チྍド䜢ྲྀᚓ䛩䜛䛯䜑䛻౑⏝䛥䜜䜛䚹┘ど- ḟ䜢ྵ䜐ᇶ‽䛜‶䛯䛥䜜䛶䛔䜛䛛䛹䛖䛛䛾┘ど䛜⾜䜟䜜䜛䚹䞉୍⯡ⓗ䛺せồ஦㡯ཬ䜃≉ᐃ䛾せồ஦㡯䛾ᒚ⾜䞉〇ရཬ䜃ᕤ⛬䛻㛵䛩䜛せ௳䛾ᒚ⾜- ᐃᮇⓗཪ䛿ᚲせ䛻ᛂ䛨䛶㝶᫬┘ど䛜⾜䜟䜜䜛䚹- ┘ど䛿䚸┤᥋ⓗ䚸㛫᥋ⓗ䛻⾜䜟䜜䜛䚹䞉┤᥋ⓗ䛺┘ど䛿䚸஦ᴗᡤ䛷䛾᳨ᰝ䛸䛔䛖᪉ἲ䛷⾜䜟䜜䜛䚹䞉㛫᥋ⓗ䛺┘ど䛿䚸஦ᴗ୺䛛䜙ᐃᮇⓗ䛻ᥦฟ䛥䜜䜛ሗ࿌᭩䜔䚸බඹ䛾┦ㄯ❆ཱྀ䛷⾜䜟䜜䜛䚹- ᪉ἲ䠖䝏䜵䝑䜽䝸䝇䝖ཬ䜃ㄝ᫂- ᐇ᪋ᶵ㛵䠖୰ኸཬ䜃/ཪ䛿ᆅ᪉䛾ື≀⏝་⸆ရ┘どᐁ- ᙧᘧ䠖┘ど⤖ᯝሗ࿌᭩- ┘どᐁ䛾ᶒ฼ཬ䜃⩏ົ䠖⌧⾜䛾つᐃ䛻ᇶ䛵䛟䚹- බඹ䛾┦ㄯ❆ཱྀ䞉┤᥋ⓗཪ䛿㛫᥋ⓗ䛻 OSS 䛾┦ㄯ䝃䞊䝡䝇䛷ᥦ౪䛥䜜䜛䚹䞉㛵ಀ┬ᗇ/ᶵ㛵䛾᪤Ꮡ䛾┦ㄯ䝅䝇䝔䝮䛻‽ᣐ䛩䜛䚹

122

5.1.2 KBLI 46444䚸ື≀⏝་⸆ရ኱つᶍၟᴗ䠄Perdagangan Besar Obat Farmasi Untuk
Hewan䠅䛾஦ᴗᇶ‽96

䛂KBLI 46444䚸ື≀⏝་⸆ရ኱つᶍၟᴗ䠄Perdagangan Besar Obat Farmasi Untuk Hewan䠅䛃䛾஦ᴗᇶ‽
KBLI 46444
ື≀⏝་⸆ရ኱つᶍၟᴗ

No
.
1

ᑐ㇟⠊ᅖ

2

஦ᴗ༊ศ

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Ɣ
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ື≀⏝་⸆ရ䛾㍺ฟᴗົ䜢⾜䛖䛂ື≀⏝་⸆ရ㍺ฟᴗ⪅䛃ື≀⏝་⸆ရ䛾㍺ධᴗົ䜢⾜䛖䛂ື≀⏝་⸆ရ㍺ධᴗ⪅䛃ᅜෆ䛷ື≀⏝་⸆ရ䛾ὶ㏻άື䜢⾜䛖䛂ື≀⏝་⸆ရὶ㏻ᴗ⪅䛃

3

୍⯡せồ
஦㡯

Ɣ

Ɣ
Ɣ
Ɣ
Ɣ

஦ᴗᙧែ䠖
- ື≀⏝་⸆ရ㍺ฟධᴗ⪅䠖௻ᴗయ䚸ἲே䚸ཬ䜃බඹ䝃䞊䝡䝇ᶵ㛵- ື≀⏝་⸆ရὶ㏻ᴗ⪅䠖௻ᴗయ䚸ἲே䚸ཬ䜃ಶே⤌⧊ᵓ㐀䜢᭷䛧䛶䛔䜛䚹ᾘ㈝⪅┦ㄯ❆ཱྀ䜢タ⨨䛧䛶䛔䜛䚹ື≀⏝་⸆ရศ㔝䛾ἲ௧㞟䜢ᡤ᭷䛧䛶䛔䜛䚹
OSS 䛜つᐃ䛧䛶䛔䜛ᮇ㛫䚸せ௳䜢ᒚ⾜䛧䛶䛔䜛䚹ᮏᇶ‽䛻䛿䚸㍺ධ䚸㍺ฟཬ䜃ὶ㏻άື䜢ྵ䜐䚸ື≀⏝་⸆ရ䛾኱つᶍၟᴗ䛾஦ᴗ䛻㛵䛩䜛つไ䛜ྵ䜎䜜䜛䚹

4

≉ᐃせồ
஦㡯

Ɣ
Ɣ
Ɣ
Ɣ
Ɣ

PJTOH 䜢㓄⨨䛩䜛䚹஦ᴗάື䜢⾜䛖䛯䜑䛾᪋タ/タഛ䜢ᡤ᭷ཪ䛿⟶⌮䛩䜛䚹
ရ㉁䜢☜ಖ䛷䛝䜛ື≀⏝་⸆ရ䛾ಖ⟶ሙᡤ䜢ᡤ᭷ཪ䛿⟶⌮䛩䜛䚹ᶆ‽ᴗົᡭ㡰᭩䠄SOP䠅䛜䛒䜛䚹◊ಟ䝙䞊䝈䛾ᢕᥱཬ䜃ᐇ᪋ィ⏬䜢ྵ䜐䚸ேᮦ⫱ᡂ䝥䝻䜾䝷䝮䛜䛒䜛䚹

5

᪋タ

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Ɣ
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ
Ɣ

Ύᤲタഛ䛜䛒䜛䚹
䝨䝇䝖䝁䞁䝖䝻䞊䝹䛜ྍ⬟䛷䛒䜛䚹᳨␿䚸୙ྜ᱁ཬ䜃ྜ᱁䜶䝸䜰䛜䛒䜛䚹㘽䛜䛛䛛䜛ሙᡤ䛻୙ྜ᱁䜶䝸䜰䛜䛒䜛䚹༑ศ䛺᥮Ẽཬ䜃↷᫂䛜䛒䜛䚹་⸆ရ䛾ಖ⟶ᇶ‽䛻ἢ䛳䛯㐺ษ䛺ಖ⟶䝇䝨䞊䝇䛜䛒䜛䚹ື≀⏝་⸆ရಖ⟶䝇䝨䞊䝇䛿௚䛾ၟရ䛸䛿ู䛻タ⨨䛩䜛䚹ື≀⏝་⸆ရ䜢ಖ⟶䛩䜛䛯䜑䛾䝟䝺䝑䝖/䝷䝑䜽䛜䛒䜛䚹ᾘⅆჾ䛜䛒䜛䚹ㄪᩚ῭䛾 ᗘ┘ど⿦⨨䛜䛒䜛䚹

96 2021 ᖺ␆⏘኱⮧つ๎➨ 15 ྕ 2342䡚2359 䝨䞊䝆䠄https://peraturan.bpk.go.id/Home/Details/224954/permentan-no-15-tahun-2021䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 12 ᭶
19 ᪥䠅

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ேᮦ䛾⤌
⧊ᵓ㐀ཬ
䜃ேᮦ

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Ɣ
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Ɣ

⤌⧊ᵓ㐀䜢ᩥ᭩໬䛧䛶䛚䜚䚸஦ᴗ⤌⧊ෆ䛾௵ົ䚸ᶵ⬟ཬ䜃ᶒ㝈䛾ศᢸ䜢ᴫㄝ䛧䛶䛔䜛䚹
ศ㔝䛻ᛂ䛨䛯䝇䜻䝹䜢ᣢ䛱䚸ᴗົ䛾䝸䝇䜽䜢⌮ゎ䛧䛯ேᮦ䜢㓄⨨䛩䜛䚹ື≀⏝་⸆ရศ㔝䛻䛚䛡䜛⬟ຊ䜔▱㆑䜢᭷䛩䜛ேᮦ䜢㓄⨨䛩䜛䚹ປാศ㔝䛾ἲ௧䛻ᇶ䛵䛝䚸ປാᏳ඲⾨⏕䜢ᐇ᪋䛩䜛⬟ຊ䜢᭷䛩䜛ேᮦ䜢㓄⨨䛩䜛䚹
ṇ♫ဨ䛷䝣䝹䝍䜲䝮໅ົ䛾⋇་ᖌ 1 ྡཪ䛿⸆๣ᖌ 1 ྡ䛻䜘䜛 PJTOH䛜 1 ྡ䛔䜛䚹
PJTOH 䛿ᅜᐙබົဨ䛷䛿䛺䛟䚸఍♫௦⾲⪅䜢ව௵䛧䛺䛔䚹
PJTOH 䛿䚸⮬䜙䛾⫋ົཬ䜃㈐௵䜢⌮ゎ䛧䚸஦ᴗチྍドⓎ⾜ᚋ 1 ᖺ௨ෆ䛻䚸䛭䛾ศ㔝䛾◊ಟ䛻ཧຍ䛩䜛䛣䛸䜢⣙᮰䛩䜛䚹

7

䝃䞊䝡䝇

Ɣ
Ɣ
Ɣ

ᾘ㈝⪅┦ㄯ❆ཱྀ䛜䛒䜛䚹
ὶ㏻䛩䜛〇ရ䛻㛵㐃䛩䜛᝟ሗ䜢ᥦ౪䛩䜛䚹
ὶ㏻䛩䜛ື≀⏝་⸆ရ䛾᭷ຠᛶ䚸ရ㉁ཬ䜃Ᏻ඲ᛶ䜢ಖド䛩䜛䚹

8

〇ရ/ຍᕤ
/ᴗົ䛻㛵
䛩䜛せ௳

Ɣ

⏕⏘䛩䜛〇ရ䛻㛵䛩䜛せ௳- ື≀⏝་⸆ရⓏ㘓␒ྕ䜢ᣢ䛳䛶䛔䜛䚹- ᭷ຠᛶ䚸ရ㉁ཬ䜃Ᏻ඲ᛶ䜢ಖド䛩䜛䚹- 䜲䞁䝗䝛䝅䜰ື≀⏝་⸆ရ⸆ᒁ᪉ཪ䛿ྠ➼䛾ཧ⪃ᩥ⊩䛻‽ᣐ䛩䜛䚹- 㐺⏝䛥䜜䜛つไ䛻ᚑ䛳䛯䝬䞊䜽䜢௜䛡䜛䚹- ὶ㏻䛩䜛〇ရ䛿䚸つᐃ䛻ᚑ䜟䛺䛡䜜䜀䛺䜙䛺䛔䚹ຍᕤ䛻㛵䛩䜛せ௳- ἲつᐃཬ䜃఍♫䛜ಖ᭷䛩䜛ᡭ㡰䛻ᚑ䛖䚹- 〇ရ䛾ධⲴཬ䜃ฟⲴ䛿䚸PJTOH 䛾┘╩ୗ䛷⾜䛖䚹

Ɣ

9

⤒Ⴀ⟶⌮
䝅䝇䝔䝮

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Ɣ

ḟ䜢ྵ䜐ຠᯝⓗ䛷ᩥ᭩໬䛥䜜䛯ᡭ㡰䜢☜❧䛧䚸ᐇ᪋䛩䜛䚹
- ௻⏬
- ⟶⌮
- 㢳ᐈ䛸䛾䝁䝭䝳䝙䜿䞊䝅䝵䞁- ⥅⥆ⓗ䛺ྥୖ䠖䝃䞊䝡䝇䜔⏕⏘䛾ྥୖ䛻ྥ䛡䛯ྲྀ䜚⤌䜏౛䛘䜀䚸᪤Ꮡ䛾䝕䞊䝍䛛䜙୙㐺ྜ䛺⤖ᯝ䛜ぢ䛴䛛䜚䚸䛭䜜䜢䛹䛾䜘䛖䛻ᨵၿ䛩䜛ணᐃ䛺䛾䛛䜢ㄝ᫂䛩䜛䚹- ᫝ṇᥐ⨨䠖ᨵၿ䛾ᐇ᪋ཬ䜃䛭䛾⤖ᯝ- ண㜵⟇䠖䝸䝇䜽ཬ䜃㉳䛣䜚䛖䜛஦㇟䛾ணぢḟ䛾ᡭ㡰䛜䛒䜛䚹
- 䝹䞊䝮䜽䝸䞊䝙䞁䜾䛾ᡭ㡰- ື≀⏝་⸆ရ䛾ㄪ㐩/㉎ධ䛾ᡭ㡰- ᭩㢮ᩚ⌮䛾ᡭ㡰- ື≀⏝་⸆ရ䛾ධⲴᡭ㡰- ື≀⏝་⸆ရ䛾ಖ⟶ᡭ㡰- ື≀⏝་⸆ရ䛾ฟⲴᡭ㡰- ㏉ရཬ䜃ᮇ㝈ษ䜜〇ရ䛾ྲྀᢅ䛔ᡭ㡰
- K3䠄ປാᏳ඲⾨⏕䠅䝅䝇䝔䝮䛻㛵䛩䜛ᡭ㡰- ᗘ┘ど䛾ᡭ㡰- 䝨䝇䝖䝁䞁䝖䝻䞊䝹䝃䞊䝡䝇䛾㑅ᢥᡭ㡰

124

Ɣ

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10

㐺ྜᛶホ
౯ཬ䜃┘
ど

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Ɣ

- ື≀⏝་⸆ရ䛾ᅇ཰䠄Recall䠅ᡭ㡰- ື≀⏝་⸆ရ䛾䝃䝥䝷䜲䝲䞊䜈䛾㏉ရᡭ㡰- ື≀⏝་⸆ရ䛾ᗫᲠᡭ㡰ຠᯝⓗ䛷ᩥ᭩໬䛥䜜䛯䝰䝙䝍䝸䞁䜾䚸ホ౯ཬ䜃䝣䜷䝻䞊䜰䝑䝥䜢ᐇ᪋䛩䜛䚹- ୍⯡せồ஦㡯ཬ䜃≉ᐃせồ஦㡯䛾ᒚ⾜- 〇ရཬ䜃ຍᕤ䛻㛵䛩䜛せ௳䛾ᒚ⾜- ⤒Ⴀ⟶⌮䝅䝇䝔䝮䛾ຠᯝⓗ䛺ᐇ᪋ሗ࿌᭩సᡂᐃᮇⓗ䛻஦ᴗάືሗ࿌᭩䜢ᥦฟ䛩䜛䚹㐺ྜᛶホ౯- ື≀⏝་⸆ရ䛾኱つᶍၟᴗ䛾䝸䝇䜽䝺䝧䝹䠖㧗- ᇶ‽䛻ᑐ䛩䜛㐺ྜᛶᑂᰝ䛿䚸せồ஦㡯䛾᭩㢮ᑂᰝཬ䜃⌧ᆅᑂᰝ䛻䜘䛳䛶⾜䜟䜜䜛䚹- ᪉ἲ䠖䝏䜵䝑䜽䝸䝇䝖ཬ䜃ㄝ᫂- ᐇ᪋ᶵ㛵䠖
䞉ື≀⏝་⸆ရ䛾㍺ฟධᴗ⪅䠖㎰ᴗ┬䛿䚸ᕞཬ䜃┴/ᕷ䛾⫋ဨ䛸䛸䜒䛻㎰ᴗ┬䛜ᐇ᪋䛩䜛䚹䞉ື≀⏝་⸆ရὶ㏻ᴗ⪅䠖┴䛾⫋ဨ䛸䛸䜒䛻ᕞ䛾⫋ဨ䛜ᐇ᪋䛩䜛䚹- ᫬ᮇ䠖஦ᴗ⪅䛜஦ᴗ䜢㛤ጞ䛩䜛๓- ᙧᘧ䠖ホ౯⤖ᯝሗ࿌᭩- 㐺ྜᛶホ౯䛾ドᣐ䛿䚸஦ᴗ⪅䛜ㄆྍ䛥䜜䛯㛵ಀ┬ᗇ/ᶵ㛵䛛䜙ṇᘧ䛺チྍド䜢ྲྀᚓ䛩䜛䛯䜑䛻౑⏝䛥䜜䜛䚹┘ど- ḟ䜢ྵ䜐ᇶ‽䛜‶䛯䛥䜜䛶䛔䜛䛛䛹䛖䛛䛾┘ど䛜⾜䜟䜜䜛䚹䞉୍⯡ⓗ䛺せồ஦㡯ཬ䜃≉ᐃ䛾せồ஦㡯䛾ᒚ⾜䞉〇ရཬ䜃ᕤ⛬䛻㛵䛩䜛せ௳䛾ᒚ⾜- ᐃᮇⓗཪ䛿ᚲせ䛻ᛂ䛨䛶㝶᫬┘ど䛜⾜䜟䜜䜛䚹- ┘ど䛿䚸┤᥋ⓗ䚸㛫᥋ⓗ䛻⾜䜟䜜䜛䚹䞉┤᥋ⓗ䛺┘ど䛿䚸஦ᴗᡤ䛷䛾᳨ᰝ䛸䛔䛖᪉ἲ䛷⾜䜟䜜䜛䚹䞉㛫᥋ⓗ䛺┘ど䛿䚸஦ᴗ୺䛛䜙ᐃᮇⓗ䛻ᥦฟ䛥䜜䜛ሗ࿌᭩䜔䚸බඹ䛾┦ㄯ❆ཱྀ䛷⾜䜟䜜䜛䚹- ᪉ἲ䠖䝏䜵䝑䜽䝸䝇䝖ཬ䜃ㄝ᫂- ᐇ᪋ᶵ㛵䠖
䞉ື≀⏝་⸆ရ䛾㍺ฟධᴗ⪅䠖୰ኸື≀⏝་⸆ရ┘どᐁ䚸ཬ䜃/ཪ䛿ᕞ䚸ཬ䜃┴/ᕷ䛾ື≀⏝་⸆ရ┘どᐁ䞉ື≀⏝་⸆ရὶ㏻ᴗ⪅䠖ᕞཬ䜃┴/ᕷ䛾ື≀⏝་⸆ရ┘どᐁ䚸䛭䛾⤖ᯝ䜢୰ኸື≀⏝་⸆ရ┘どᐁ䛻ሗ࿌䛩䜛䚹- ᙧᘧ䠖┘ど⤖ᯝሗ࿌᭩- ┘どᐁ䛾ᶒ฼ཬ䜃⩏ົ䠖⌧⾜䛾つᐃ䛻ᇶ䛵䛟䚹- බඹ䛾┦ㄯ❆ཱྀ䞉┤᥋ⓗཪ䛿㛫᥋ⓗ䛻 OSS 䛾┦ㄯ䝃䞊䝡䝇䛷ᥦ౪䛥䜜䜛䚹䞉㛵ಀ┬ᗇ/ᶵ㛵䛾᪤Ꮡ䛾┦ㄯ䝅䝇䝔䝮䛻‽ᣐ䛩䜛䚹

125

5.2 ᐇᆅㄪᰝ⤖ᯝホ౯ᇶ‽ཎ⏘ᅜ䛾⏕⏘᪋タ䛻䛚䛡䜛 GMP 㐺⏝䛾㐺ྜᛶ␒ྕホ౯䜹䝔䝂䝸䞊ホ౯䝫䜲䞁䝖
OK

1

ሙᡤ

1.1

ᕤሙ/⏕⏘⌧ሙ䛻㛵䛩䜛⪃៖஦㡯
a.ᕤሙ/⏕⏘⌧ሙ䛜ởᰁ䛥䜜䛯⎔ቃཪ䛿ởᰁ䛥䜜䛯䝡䝆䝛䝇⏘ᴗᆅᖏ䛻఩⨨䛧䛶䛔䜛䚹b.ᕤሙ/⏕⏘⌧ሙ䛻㏻䛨䜛㐨㊰䛿ᇕ䛜ከ䛔䚸ཪ䛿Ỉ⁀䜚䛜䛒䜛䚹▼ཪ䛿䝤䝻䝑䜽䛺䛹䛷⯒⿦䛥䜜䛶䛔䛺䛔䚹Ύᤲ䛜ᐜ᫆䛺᤼Ỉ⁁䛜タ⨨䛥䜜䛶䛔䛺䛔䚹c.ᕤሙ/⏕⏘⌧ሙ䛾⎔ቃ䛿୙₩䛷䚸䝂䝭䛜ᒣ✚䛧䛶䛔䜛䚹d.ᕤሙ/⏕⏘⌧ሙ䛜ෙỈཪ䛿ᾐỈ䛾༴㝤ᆅᇦ䛻䛒䜛䚹e.ᕤሙ/⏕⏘⌧ሙ䛜⸭ཪ䛿ᐖ⹸䛾⶝ᘏᆅᇦ䛻䛒䜛䚹f.ᕤሙ/⏕⏘⌧ሙ䛜බඹ䛾䝂䝭ᤞሙ䚸ᗫᲠ≀䚸䝇䝷䝮⾤䚸ᗫရ⨨ሙ䛺䛹䛾ởᰁ※䛸䛺䜚ᚓ䜛ሙᡤ䛻㏆᥋䛧䛶䛔䜛䚹
g.ᕤሙ/⏕⏘⌧ሙ䛾ᒇእ䜢⏕⏘άື䛻฼⏝䛧䛶
䛔䜛䚹

2

ᕤሙ䛾ᘓ≀

2.1

タィཬ䜃䝺䜲䜰䜴䝖ᕤሙ/⏕⏘⌧ሙ䛾ෆ㒊ཬ䜃䝺䜲䜰䜴䝖䛾タィ䛜ື≀⏝་⸆ရ䛾⾨⏕ᇶ‽䜢‶䛯䛧䛶䛚䜙䛪䚸ື≀⏝་⸆ရ䛾ရ㉁ཬ䜃Ᏻ඲ᇶ‽䛜ඃඛ䛥䜜䛶䛔䛺䛔䚹Ύᤲཬ䜃ᾘẘ䛜ᅔ㞴䛷䛒䜚䚸〇㐀㐣⛬䛷஺ᕪởᰁ䜢㜵Ṇ䛷䛝䛺䛔䚹

2.2

ᐊෆ䛾ᵓ㐀
ᐊෆᵓ㐀䛿⪏ஂᛶ䛾䛺䛔ᘓᮦ䛜౑⏝䛥䜜䛶䛚䜚䚸䝯䞁䝔䝘䞁䝇ཬ䜃Ύᤲ䚸ཪ䛿ᾘẘ䛜ᅔ㞴䛷䛒䜛䚹ື≀⏝་⸆ရ䛾⏕⏘䛜⾜䜟䜜䜛ᕤሙ䛾ෆ㒊ᵓ㐀䛻ྵ䜎䜜䜛ᗋ䚸ቨ䚸ᒇ᰿䚸䝗䜰䚸❆䚸᥮Ẽ䚸సᴗ㠃ཬ䜃䜺䝷䝇⣲ᮦ䛾ᇶ‽䛿ḟ䛾䛸䛚䜚
䛷䛒䜛䚹

2.2.1

ᗋ

126

MI

MJ

ヲ⣽
CR

TA

ᗋ䛾ᵓ㐀䛿䚸⪏ஂᛶ䛜䛒䜚䚸᤼Ỉ䛜ᐜ᫆䛷䚸Ỉ䛜⁫␃䛫䛪䚸Ύᤲཬ䜃ᾘẘ䛜ᐜ᫆䛷䛒䜛䛺䛹䛾ື≀⏝་⸆ရ䛸䛧䛶䛾㐺ṇ䛺⾨⏕ᇶ‽䜢‶䛯䛧䛶䛔䜛䚹
a.〇㐀ᐊ䛾ᗋ䛾㜵Ỉᛶ䚸⪏ሷᛶ䚸⪏ሷᇶᛶ䚸⪏㓟ᛶཬ䜃䛭䛾௚䛾⪏⸆ရᛶ䛜ప䛔䚹⾲㠃䛜ᖹ䜙䛷䛿䛺䛟⁥䜚䜔䛩䛔䛯䜑䚸Ύᤲ䛜ᅔ㞴䛷䛒䜛䚹
b.〇㐀ᐊ䛾ᗋ䜢Ὑί䛩䜛㝿䚸᤼Ỉ䜢ᐜ᫆䛻䛩䜛໙㓄䚸᤼Ỉ⁁䚸᤼ỈᏍ䛻ὶ䜜䜛༑ศ䛺ഴᩳ䛜䛺䛔䛯䜑䚸Ỉ⁀䜚䜔ᝏ⮯䛜Ⓨ⏕䛩䜛䚹c.ᗋ䛸ቨ䛾ቃ┠䛿䚸Ỉ䜔ở䜜䛜⁀䜎䜚䜔䛩䛔㝮
䜔ゅᗘ䛜䛒䜚䚸R ᵓ㐀䛷䛿䛺䛔䛯䜑䚸㜵Ỉᛶ䛜䛺䛔䚹d.ᾎᐊ䛾ᗋ䚸ᡭὙ䛔ሙ䚸䝖䜲䝺䛾タഛ䛻ୗỈ㐨䛻ὶ䜜䜛༑ศ䛺໙㓄䛜䛺䛔䛯䜑䚸Ỉ⁀䜚䜔ᝏ⮯䛜Ⓨ⏕䛩䜛䚹
2.2.2

ቨቨཪ䛿㛫௙ษ䜚䛾ᵓ㐀䛿䚸Ύᤲཬ䜃ᾘẘ䛜ᐜ᫆䛷䚸〇㐀㐣⛬䛾஺ᕪởᰁ䜢㜵Ṇ䛩䜛䛺䛹䛾ື≀⏝་⸆ရ䛸䛧䛶䛾㐺ṇ䛺⾨⏕ᇶ‽䜢‶䛯䛧䛶䛔䜛䚹
a. 〇㐀ᐊ䛾ቨ䛻䚸᭷ᐖ≀㉁䜢ྵ䜐⣲ᮦ䛜౑⏝䛥䜜䛶䛔䜛䚹
b.〇㐀ᐊ䛾ෆቨ㠃䛜ᖹ⁥䚸ῐⰍ䛷䛿䛺䛔䚹⪏ஂᛶ䛜䛺䛟䚸๤䛜䜜䜔䛩䛔䛯䜑䚸Ύᤲ䛜ᅔ㞴䛺⣲ᮦ䛜౑⏝䛥䜜䛶䛔䜛䚹c.〇㐀ᐊ䛾ቨ䛾㧗䛥䛜ᗋ䛛䜙 2m ௨ୗ䛷䛒䜛䚹Ỉศ䜢྾཰䛧䜔䛩䛟䚸⪏ሷᛶ䚸⪏ሷᇶᛶ䚸⪏㓟ᛶཬ䜃䛭䛾௚䛾⪏⸆ရᛶ䛜ప䛔䚹
d.〇㐀ᐊ䛾ቨ䛸ቨ䛾᥋ྜ㒊ศ䛿䚸Ỉ䜔ở䜜䛜⁀䜎䜚䜔䛩䛔ゅᗘ䛜䛒䜚䚸R ᵓ㐀䛷䛿䛺䛔䛯䜑䚸Ύᤲ䛜ᅔ㞴䛷䛒䜛䚹e.ᾎᐊ䚸ᡭὙ䛔ሙ䚸䝖䜲䝺䛾ቨ䛾㧗䛥䛜ᗋ䛛䜙
2m ௨ୗ䛷䛒䜛䚹Ỉศ䜢྾཰䛧䜔䛩䛟䚸ⓑཪ䛿ῐⰍ䛷䛺䛔䝉䝷䝭䝑䜽䝍䜲䝹䜢౑⏝䛧䛶䛔䜛䚹

2.2.3

ᒇ᰿ཬ䜃ኳ஭
ᒇ᰿ཬ䜃ኳ஭䛿䚸ᐊෆ䜢ಖㆤ䛩䜛ᵓ㐀䛻䛺䛳䛶䛔䜛䚹〇ရ䛻ởᰁ䜢ᘬ䛝㉳䛣䛩䛣䛸䛿䛺䛟䚸ື≀⏝་⸆ရ䛸䛧䛶䛾㐺ṇ䛺⾨⏕ᇶ‽䜢‶䛯䛧䛶
䛔䜛䚹

127

a.ᒇ᰿䛿䚸⪏ஂᛶ䚸⪏Ỉᛶ䛜ప䛟䚸㞵₃䜚䛧䜔䛩䛔⣲ᮦ䛷స䜙䜜䛶䛔䜛䚹b.ኳ஭䛿䚸๤䛜䜜䜔䛩䛟䚸⭉㣗䛧䜔䛩䛔⣲ᮦ䛜౑⏝䛥䜜䛶䛔䜛䚹Ύᤲ䛜ᅔ㞴䛷䚸䜂䜃๭䜜䛧䜔䛩䛔䚹
c.ኳ஭䛻䛿✰䜔䜂䜃๭䜜䛜䛒䜚䚸䝛䝈䝭䜔⹸䛺䛹䛾౵ධ䜔㞵₃䜚䛜䛧䜔䛩䛔䚹d.ᗋ䛛䜙ኳ஭䜎䛷䛾㧗䛥䛜 3m ௨ୗ䛷䛒䜛䛯䜑䚸✵Ẽ䛜༑ศ䛻ὶ䜜䛪䚸〇㐀ᕤ⛬䛷Ⓨ⏕䛩䜛⇕䛜䛣䜒䜚䜔䛩䛔䚹f.Ỉ⵨Ẽ䜢౑⏝䛧䛯䜚䚸Ⓨ⏕䛥䛫䛯䜚䛩䜛〇㐀ᐊ䛾ኳ஭㠃䛻䛿Ỉ䜢྾཰䛧䜔䛩䛔⣲ᮦ䛜౑⏝䛥䜜䛶䛚䜚䚸⪏⇕ሬᩱ䛜ሬᕸ䛥䜜䛶䛔䛺䛔䚹g.〇㐀ᐊ䛾సᴗ䜶䝸䜰䛾↷᫂䛜ᬯ䛟䚸೺ᗣୖ䛾ᚲせཬ䜃せ௳䛻㐺ྜ䛧䛶䛚䜙䛪䚸Ύᤲ䛜ᅔ㞴
䛷䛒䜛䚹
2.2.4

䝗䜰
a.⪏ஂᛶ䜔ᙉᗘ䛜ప䛟䚸ቯ䜜䜔䛩䛔⣲ᮦ䜢౑⏝䛧䛶䛔䜛䚹
b.ᐊෆ䝗䜰䛾⾲㠃䛜ᖹ⁥䚸ῐⰍ䛷䛿䛺䛟䚸Ύᤲ䛜ᅔ㞴䛷䛒䜛䚹
c.⥙ᡞ䜔䜶䜰䜹䞊䝔䞁䜢ྵ䜐ᐊෆ䝗䜰䛜䛝䛱䜣䛸㛢䜎䜙䛺䛔䚹
d.〇㐀ᐊ䛾䝗䜰䛿እഃ䛻㛤䛛䛪䚸እ㒊䛛䜙ᇕ䜔௚䛾ở䜜䛜౵ධ䛩䜛䚹

2.2.5

❆ཬ䜃᥮Ẽ
❆
a.⪏ஂᛶ䛾䛒䜛⣲ᮦ䜢౑⏝䛧䛶䛚䜙䛪䚸ᙉᗘ䛜ప䛔䚹◚ᦆ䛧䜔䛩䛟䚸ቯ䜜䜔䛩䛔䚹b.❆䛾⾲㠃䛜ᖹ⁥䚸ῐⰍ䛷䛿䛺䛟䚸Ύᤲ䛜ᅔ㞴䛷䛒䜛䚹
c.ᗋ䛛䜙䛾❆䛾㧗䛥䛜 1m ᮍ‶䛷䛒䜚䚸㛤㛢䛜ᅔ㞴䛷䚸❆䛾㧗䛥䛜ప䛩䛞䛶ᇕ䛜ධ䜚䜔䛩䛔䚹d.❆䛾ᩘཬ䜃኱䛝䛥䛜ᘓ≀䛾኱䛝䛥䛻㐺ྜ䛧䛶䛔䛺䛔䚹e.❆䛿ᇕ䛜⁀䜎䜚䜔䛩䛔タィ䛷䛒䜛䚹f.㜵⹸⥙ᡞ䛜⿦ഛ䛥䜜䛶䛔䛺䛔䚸ཪ䛿ྲྀ䜚እ䛧䜔Ύᤲ䛜ᅔ㞴䛷䛒䜛䚹᥮Ẽ128

a.✵Ẽ䛾ᚠ⎔䛜ᝏ䛟䚸ຍᕤ୰䛻Ⓨ⏕䛩䜛ᚑᴗဨ䛾೺ᗣ䛻᭷ᐖ䛺⵨Ẽ䚸䜺䝇䚸↮䚸⮯Ẽ䚸ᇕཬ䜃⇕䜢᤼㝖䛧䛶䛔䛺䛔䚹b.ᬬ䛟䛺䜚䛩䛞䛺䛔䜘䛖䛻䛿䛔䚹ᗘ䜢ㄪ⠇䛷䛝䛺

c.Ⓨ⏕䛩䜛ໝ䛔䜢ᢚไ䛷䛝䛺䛔䚹d.ᚲせ䛛䛴㐺ษ䛺ᗘ䛻ㄪ⠇䛷䛝䛺䛔䚹e.ὶධ䛩䜛✵Ẽ䛻䜘䛳䛶〇㐀୰䛾ື≀⏝་⸆ရ䜢ởᰁ䛩䜛䚹
f.᥮Ẽཱྀ䛻⹸䛾౵ධ䜔ᐊෆ䜈䛾ở䜜䛾ὶධ䜢㜵Ṇ䛩䜛䛯䜑䛾⥙ᡞ䛜⿦ഛ䛥䜜䛶䛔䛺䛔䚸ཪ䛿ྲྀ䜚እ䛧䜔Ύᤲ䛜ᅔ㞴䛷䛒䜛䚹
2.2.6

సᴗሙ䛾⾲㠃
a.ື≀⏝་⸆ရ䛾ཎᮦᩱ䛻┤᥋ゐ䜜䜛సᴗ㠃䛿䚸ḟ䛾䜘䛖䛺≧ែ䜢㑊䛡䜛䠖୙Ⰻ䛺≧ែ䛷䛒䜛䚸⪏ஂᛶ䛜ప䛔䚸䝯䞁䝔䝘䞁䝇䛜ᅔ㞴䛷䛒䜛䚸Ύᤲཬ䜃ᾘẘ䛜ᅔ㞴䛷䛒䜛䚹b.సᴗ㠃䛿䚸྾Ỉ䛧䜔䛩䛟䚸⾲㠃䛜⢒䛔䚸ຍᕤ㣗ရ䚸Ὑ๣䚸ᾘẘᾮ䛻཯ᛂ䛩䜛⣲ᮦ䜢౑⏝䛧䛶
䛔䜛䚹

2.2.7

䜺䝷䝇⣲ᮦ䛾౑⏝௻ᴗ䛿䚸䜺䝷䝇䛜◚ᦆ䛧䛯ሙྜ䛻〇ရ䜈䛾≀⌮ⓗ䛺ΰධ䛾༴㝤䜢㜵䛠䛣䛸䛜䛷䛝䜛䜘䛖䛺䜺䝷䝇ᮦᩱ䛾౑⏝䛻㛵䛩䜛ᣦ㔪䜢ᣢ䛳䛶䛔䛺䛔䚹

3

⾨⏕タഛ

3.1

⤥Ỉタഛ
a.㈓Ỉᵴ䜔⤥Ỉ⏝䛾䝟䜲䝥䜢ྵ䜐⤥Ỉ᪋タ䠄஭ᡞỈ䚸Ỉ㐨Ỉ䠅䛜タ⨨䛥䜜䛶䛔䛺䛔䚹b.〇㐀ᕤ⛬䛷౑⏝䛩䜛㣧ᩱỈཪ䛿ίỈ䛾Ỉ※䛜୙༑ศ䛷䚸䛭䛾Ỉ㉁䛜ἲつᐃ䛻ᇶ䛵䛟ಖ೺せ௳䜢‶䛯䛧䛶䛔䛺䛔䚹c.〇㐀ᕤ⛬䛷౑⏝䛩䜛Ỉཬ䜃ື≀⏝་⸆ရ䛾ཎᮦᩱ䛻┤᥋᥋ゐ䛩䜛Ỉ䛜䚸ίỈ䛾Ỉ㉁せ௳䜢‶䛯䛧䛶䛔䛺䛔䚹d.〇㐀ᕤ⛬䛷౑⏝䛫䛪䚸ື≀⏝་⸆ရ䛾ཎᮦᩱ䛻┤᥋᥋ゐ䛧䛺䛔Ỉ䛸䚸ᾘ㈝⏝ཪ䛿㣧ᩱ⏝䛾Ỉ䛸䛜ู䛾䝅䝇䝔䝮䛻䛺䛳䛶䛔䛺䛔䚹129

e.㓄⟶䝅䝇䝔䝮䛷䛿䚸㣧ᩱỈ䜔ື≀⏝་⸆ရ䛾ཎᮦᩱ䛻┤᥋᥋ゐ䛩䜛Ỉ䛸䚸ື≀⏝་⸆ရ䛾ཎᮦᩱ䛻┤᥋᥋ゐ䛧䛺䛔Ỉ䜢䚸␗䛺䜛༳䜔Ⰽ䛺䛹䛷༊ู䛧䛶䛔䛺䛔䚹
3.2

᤼Ỉཬ䜃ᗫᲠ≀ฎ⌮᪋タa.᤼Ỉཬ䜃ᗫᲠ≀䜢ᾮయ䚸༙ᅛయ/ᅛయ䛾ᗫᲠ≀ฎ⌮᪋タ䛻༊ู䛧䛶ฎ⌮䛧䛶䛔䛺䛔䚹b.᤼Ỉཬ䜃ᗫᲠ≀ฎ⌮䝅䝇䝔䝮䛜䚸ື≀⏝་⸆ရ䚸㣧ᩱỈཬ䜃ίỈ䛾ởᰁ䜢㜵䛠䜘䛖䛻タィ䚸᪋ᕤ䛥䜜䛶䛔䛺䛔䚹c.䛢䛳ṑ㢮䚸᪻⹸ཪ䛿௚䛾ື≀䛜⦾Ṫ䛩䜛䛾䜢㜵Ṇ䛧䚸ཎᮦᩱ䚸ື≀⏝་⸆ရ䚸Ỉ※䜢ởᰁ䛧䛺䛔䛯䜑䛻䚸ᗫᲠ≀䜢┤䛱䛻ᑓ⏝䛾ሙᡤ䛻ᗫᲠ䛩䜛ᚲせ䛜䛒䜛䛜䚸Ᏺ䜙䜜䛶䛔䛺䛔䚹d.୰㌟䛜䛒䜅䜜䛶〇ရ䛜ởᰁ䛥䜜䛺䛔䜘䛖䛻䛩䜛䛯䜑䚸᭷ᐖᗫᲠ≀⏝䛾䝂䝭⟽䛿䚸㡹୔䛺⣲ᮦ䛷స䜙䜜䚸༳䛜௜䛥䜜䚸ᐦ㛢䛥䜜䛶䛔䜛ᚲせ䛜䛒䜛䛜䚸Ᏺ䜙䜜䛶䛔䛺䛔䚹

3.3

Ύᤲ/Ὑίタഛa.㣗ᮦ䚸ჾල䚸ഛရཬ䜃ᘓ≀䠄ᗋཬ䜃ቨ䠅䛾Ύᤲ/Ὑίタഛ䜢༑ศ䛻ഛ䛘䛶䛔䛺䛔䚹b.Ύᤲ᪋タ䛻Ύ₩䛺Ỉ※ཬ䜃 ෭Ỉ䛾౪⤥タഛ䜢⿦ഛ䛧䛶䛔䛺䛔䚹⇕‫‮‬䛷Ἔ⬡䜢⁐ゎ䛥䛫䚸ჾල䜢ᾘẘ䛩䜛䚹

3.4

䝖䜲䝺タഛ
a.䝖䜲䝺タഛ䛜䚸ὶỈ※ཬ䜃ୗỈ㊰䛾⾨⏕ᇶ‽䛻ᇶ䛵䛔䛶タィ䚸᪋ᕤ䛥䜜䛶䛔䛺䛔䚹b.䝖䜲䝺䛜ຍᕤᐊ䛻ᑐ䛧䛶┤᥋㛤䛛䜜䛯఩⨨䛻䛒䜚䚸ᖖ᫬㛤䛛䜜䛶䛔䜛䚹c.䝖䜲䝺䛻䚸䛂䝖䜲䝺౑⏝ᚋ䛿ᚲ䛪▼㮯䜔Ὑ๣䛷ᡭ䜢Ὑ䛳䛶䛟䛰䛥䛔䛃䛸䛔䛖ὀព᭩䛝䛜䛺䛔䚹d.䝖䜲䝺䛜䛝䜜䛔䛷䛿䛺䛔䚹e.䝖䜲䝺࿘㎶䛾↷᫂ཬ䜃᥮Ẽ䛜༑ศ䛷䛿䛺䛔䚹f.䝖䜲䝺䛾ᩘ䛜つᐃ㏻䜚䛷䛿䛺䛔䚹

3.5

⾨⏕タഛཬ䜃ᚑᴗဨ䛾⾨⏕

3.5.1

ື≀⏝་⸆ရ〇㐀ᴗ⏺䛷ື≀⏝་⸆ရཎᮦ
ᩱ䛾ởᰁ㜵Ṇ䛾䛯䜑䛻ᚲせ䛸䛥䜜䜛䚸ᚑᴗဨ䛾⾨⏕≧ែ䜢ಖ䛴䛯䜑䛾⾨⏕タഛ䚸䛩䛺䜟䛱ᡭὙ䛔ሙ䚸᭦⾰ᐊ䚸సᴗ㠐Ὑίタഛ䛜ᩚഛ䛥䜜䛶䛔䛺䛔䚹

130

3.5.2ᡭὙ䛔ሙ
a.ຍᕤᐊ䛾ධཱྀ๓䛻タ⨨䛧䚸ὶỈᰦཬ䜃▼㮯䚸ཪ䛿Ὑ๣䜢᏶ഛ䛧䛶䛔䜛䚹b.ᡭ䜢஝⇱䛥䛫䜛ഛရ䠄྾Ỉ䝨䞊䝟䞊䝍䜸䝹ཪ䛿⇕㢼஝⇱ᶵ䠅䜢᏶ഛ䛧䛶䛔䜛䚹c.ᐦ㛢ᘧ䝂䝭⟽䜢タ⨨䛧䛶䛔䜛䚹d.ᚑᴗဨᩘ䛻ᇶ䛵䛔䛯ᩘ䛜☜ಖ䛥䜜䛶䛔䜛䚹

3.5.3

እ⾰䛛䜙సᴗ╔䛻╔᭰䛘䜛䛯䜑䛾᭦⾰ᐊ䛻䚸సᴗ╔䛸እ⾰䜢ู䚻䛻཰⣡䛩䜛/᥃䛡䜛䛯䜑䛾ሙᡤ䛜タ⨨䛥䜜䛶䛔䛺䛔䚹

3.5.4⏕⏘⌧ሙ䛾ධཱྀ䛾๓䛻సᴗ㠐Ὑίタഛ䛜タ⨨䛥䜜䛶䛔䛺䛔䚹

4ᶵᲔཬ䜃⿦⨨

4.1⏕⏘㐣⛬䛷౑⏝䛩䜛ᶵᲔ/⿦⨨䛜ḟ䛾ᇶ‽䜢‶䛯䛧䛶䛔䛺䛔䚹

4.1.1⏕⏘䛾✀㢮䛻ᇶ䛵䛔䛶䛔䛺䛔䚹

4.1.2

ື≀⏝་⸆ရ䛾ཎᮦᩱ䛻┤᥋ゐ䜜䜛㠃䛜⁥䜙䛛䛷䛺䛔䚸✰䜔ட⿣䛜䛒䜛䚸๤䛜䜜䛶䛔䜛䚸ྵỈ䛧䛶䛔䜛䚸䛥䜃䛶䛔䜛䚹

4.1.3

ᚤ⏕≀䚸ᶵᲔ/⿦⨨䛛䜙ᨺฟ䛥䜜䜛㔠ᒓ≀㉁䚸
₶⁥Ἔ䚸⇞ᩱཬ䜃䛭䛾௚䛾᭷ᐖ≀㉁䛻䜘䜚〇ရ䛜ởᰁ䛥䜜䜛ྍ⬟ᛶ䛜䛒䜛䚹

4.1.4

ຍᕤ㣗ရ䛾ཎᮦᩱởᰁ䜢㜵Ṇ䛩䜛䛯䜑䛾Ὑί䚸ᾘẘཬ䜃䝯䞁䝔䝘䞁䝇䛜ᅔ㞴䛷䛒䜛䚹

4.1.5⪏ஂᛶ䚸⪏ẘᛶ䛜ప䛔⣲ᮦ䜢౑⏝䛧䛶䛚䜚䚸⛣ືཪ䛿ศゎ䛜ᅔ㞴䛺䛯䜑䚸䝯䞁䝔䝘䞁䝇䚸䜽䝸䞊䝙䞁䜾䚸ᾘẘ䚸䝰䝙䝍䝸䞁䜾䚸ᐖ⹸㥑㝖䛻ᨭ㞀䛜
䛒䜛䚹

4.2

ᶵᲔ/⿦⨨䛜ᐊෆ䛾㐺ษ䛺ሙᡤ䛻タ⨨䛥䜜䛶䛔
䛺䛔䚹

4.2.1

ᕤ⛬䛾㡰ᗎ䛻ྜ䜟䛺䛔఩⨨䛻䛒䜛䛯䜑䚸⾨⏕⟶⌮䜢ᐇ᪋䛩䜛䛣䛸䛜㞴䛧䛟䚸஺ᕪởᰁ䛜㉳䛣䜚
䜔䛩䛔䚹

4.2.2

䝯䞁䝔䝘䞁䝇䚸䜽䝸䞊䝙䞁䜾ཬ䜃Ὑί䛜ᅔ㞴䛷
䛒䜛䚹

4.2.3

⏕⏘ᕤ⛬䛷䚸౑⏝┠ⓗ䛻ྜ䛳䛯ᶵ⬟䛜䛺䛔䚹

4.3

ᶵᲔ/⿦⨨䛾┘どཬ䜃䝰䝙䝍䝸䞁䜾

4.3.1

ᶵᲔ/⿦⨨䛜䝁䞁䝖䝻䞊䝹䚸᳨ᰝ䚸䝰䝙䝍䝸䞁䜾䛥䜜䛶䛔䛺䛔䛯䜑䚸ື≀⏝་⸆ရ䛾〇㐀㐣⛬䛜つᐃ䛾ᇶ‽䛻ᚑ䛳䛶䛔䜛䛣䛸䜢ಖド䛷䛝䛺䛔䚹131

4.3.2⏕⏘ᕤ⛬䛷౑⏝䛥䜜䜛ᶵᲔ/⿦⨨䛾┘ど䚸䝰䝙䝍䝸䞁䜾䛜ᅔ㞴䛷䛒䜛䚹

4.3.3

ື≀⏝་⸆ရ䛾Ᏻ඲ᛶཬ䜃ရ㉁䛻ᙳ㡪䜢୚䛘䜛‵ᗘㄪᩚ䚸㢼ὶㄪᩚᶵჾ䛜ᶵᲔ/⿦⨨䛻⿦ഛ䛥䜜䛶䛔䛺䛔䚹

4.4

ᶵᲔഛရཬ䜃 ᐃჾ

4.4.1

ᶵᲔ/⿦⨨䛾ഛရ䛿䚸⾨⏕䜢ಖド䛷䛝䜛Ὑί᪉ἲ䛜☜❧䛥䜜䛶䛔䛺䛔䚹

4.4.2

ᶵᲔ/⿦⨨䛻ᦚ㍕䛥䜜䛶䛔䜛 ᐃჾ䛾⢭ᗘ䛜☜ㄆ䛷䛝䛺䛔䚹

5

ཎᮦᩱ

5.1

ཎᮦᩱ䛾ᇶ‽

5.1.1

౑⏝䛥䜜䛶䛔䜛ཎᮦᩱ䛜䚸ື≀⏝་⸆ရ䛾ཎᮦᩱ䛾✀㢮ཬ䜃ရ㉁ᇶ‽䜢♧䛩䚸ᇶᮏⓗ䛺ฎ᪉䛾ᙧ䛷ᴫㄝ䛥䜜䛶䛔䛺䛔䚹

5.1.2

౑⏝䛥䜜䛶䛔䜛ཎᮦᩱ䛾ရ㉁䛜ᝏ䛔䚸⭉ᩋ䛧䛶䛔䜛䚸ཪ䛿᭷ᐖ≀㉁䜢ྵ䜣䛷䛔䜛䚹

5.1.3

౑⏝䛥䜜䛶䛔䜛ཎᮦᩱ䛜᭷ᐖ䛷䚸೺ᗣ䛻ᐖ䜢ཬ䜌䛧䚸つᐃ䛥䜜䛯ရ㉁ᇶ‽ཪ䛿せ௳䜢‶䛯䛧
䛶䛔䛺䛔䚹

5.1.4

ရ㉁ᇶ‽ཬ䜃せ௳䛜☜❧䛥䜜䛶䛔䛺䛔ື≀⏝་⸆ရ䛾ῧຍ≀䜢౑⏝䛧䛶䛚䜚䚸䛭䛾౑⏝䛜ᡤ㎄ᐁᗇ䛛䜙䛾チྍ䜢ᚓ䛶䛔䛺䛔䛣䛸䛜ุ᫂䛧䛯䚹

5.2

Ỉ㉁䛾ᇶ‽䠄౑⏝䛧䛺䛔ሙྜ䛿ᑐ㇟እ䠅

5.2.1

ື≀⏝་⸆ရ䛻ྵ䜎䜜䜛Ỉ䛜ἲつᐃ䛻ᇶ䛵䛟㣧ᩱỈཬ䜃ίỈ䛾ᇶ‽䜢‶䛯䛧䛶䛔䛺䛔䚹

5.2.2

ື≀⏝་⸆ရ䛾ཎᮦᩱ䜢Ὑί䛩䜛䛯䜑䛻౑⏝䛥䜜䜛ཪ䛿┤᥋᥋ゐ䛩䜛Ỉ䛜䚸ἲつᐃ䛻ᇶ䛵䛟ίỈ䛾ᇶ‽䜢‶䛯䛧䛶䛔䛺䛔䚹

5.2.3

Ỉ䚸ịཬ䜃⵨Ẽ䠄䝇䝏䞊䝮䠅䛜እ㒊䛛䜙䛾ởᰁ䜢㑊䛡䜛䜘䛖䛻⟶⌮䛥䜜䛶䛔䛺䛔䚹

5.2.4

ື≀⏝་⸆ရ䛾ཎᮦᩱཪ䛿ᶵᲔ/⿦⨨䛻┤᥋᥋ゐ䛩䜛⵨Ẽ䠄䝇䝏䞊䝮䠅䛜ື≀⏝་⸆ရ䛾Ᏻ඲ᛶཬ䜃ရ㉁䛻༴㝤䜢䜒䛯䜙䛩᭷ᐖ≀㉁䜢ྵ
䜣䛷䛔䜛䚹

5.2.5

⧞䜚㏉䛧౑⏝䠄෌ᚠ⎔䠅䛥䜜䜛Ỉ䛿䚸ື≀⏝་⸆ရ䛾Ᏻ඲ᛶ䜢⥔ᣢ䛩䜛䛯䜑䛾ฎ⌮ཬ䜃䝯䞁䝔䝘䞁䝇䛜䛥䜜䛶䛔䛺䛔䚹

6

ᕤ⛬䛾┘ど

6.1

ᕤ⛬䛾┘ど

132

6.1.1. 〇ရ䛾✀㢮䛤䛸䛻䚸ḟ䛾஦᯶䛻ゝཬ䛩䜛ᣦ♧䛜䛺䛔䚹
a.౑⏝䛩䜛඲ᡂศ䛾✀㢮ཬ䜃㔞
b.〇㐀ᕤ⛬䛾ヲ⣽䛺ྛẁ㝵
c.〇㐀ᕤ⛬䛷⪃៖䛩䜉䛝䝇䝔䝑䝥d.1 ᅇ䛾〇㐀ᕤ⛬䛷ᚓ䜙䜜䜛〇ရᩘe.䛭䛾௚䛾ᚲせ䛺᝟ሗ
6.1.2

ຍᕤ༢఩䠄1 ᅇ䛾ᕤ⛬䠅䛤䛸䛻䚸ḟ䛾஦᯶䛻ゝཬ䛩䜛ᣦ♧䛜䛺䛔䚹a.〇ရྡ
b.〇㐀ᖺ᭶᪥ཬ䜃〇㐀䝁䞊䝗c.1 ᅇ䛾ຍᕤᕤ⛬䛷౑⏝䛩䜛඲ཎᮦᩱ䛾✀㢮ཬ䜃㔞d.ຍᕤ䛩䜛⏕⏘㔞e.䛭䛾௚䛾ᚲせ䛺᝟ሗ

6.1.3

ฎ⌮᫬㛫ཬ䜃 ᗘ䛾┘どື≀⏝་⸆ရ䛾Ᏻ඲ᛶཬ䜃ရ㉁䜢ಖド䛩䜛䛯䜑䛻䚸〇㐀ᕤ⛬䠄〇ရ䛾ຍ⇕䚸෭༷䚸෭෾䚸஝⇱ཬ䜃ಖ⟶䠅䛾᫬㛫ཬ䜃 ᗘ䛜㐺ษ䛻⟶⌮䛥䜜䛶䛔䛺䛔䚹

6.2

ཎᮦᩱ䛾┘ど6.2.1⏕⏘ᕤ⛬䛷౑⏝䛥䜜䜛ཎᮦᩱ䛜ရ㉁ᇶ‽䜢‶䛯䛧䛶䛔䛺䛔䚹

6.2.2

౑⏝䛩䜛ᮦᩱ䛻ᑐ䛧䛶䚸᭷ᶵⓗ䚸≀⌮ⓗ䛺஦๓᳨ᰝ䠄๭䜜䛯䜺䝷䝇䜔◁฼䛾᭷↓䠅䛰䛡䛷䚸ᐇ㦂ᐊ䛷໬Ꮫⓗ䚸ᚤ⏕≀ⓗ䛺᳨ᰝ䛿⾜䛳䛶䛔䛺
䛔䚹

6.2.3

౑⏝䛩䜛ཎᮦᩱ䛻㛵䛩䜛グ㘓䜢ಖᏑ䛧䛶䛔䛺䛔䚹

6.3

ởᰁ䛻ᑐ䛩䜛┘どእ㒊䛛䜙䛾ởᰁ䜔஺ᕪởᰁ䜢㜵䛠䛯䜑䛻䚸ḟ䛾ᑐ⟇䛜ᚲせ䛷䛒䜛䚹

6.3.1〇㐀ᕤ⛬䛷䚸ຍᕤ䛥䜜䛯ື≀⏝་⸆ရ䛻᭷ᐖ䛺໬Ꮫ≀㉁䜔␗≀䠄Ὑί๣䚸๭䜜䛯䜺䝷䝇䚸㔠ᒓ∦䚸◁฼䛺䛹䠅䛜ΰධ䛧䛺䛔䜘䛖䛺௙⤌䜏䛜ᵓ⠏䛥䜜䛶䛔䛺䛔䚹

6.3.2

᭷ẘ≀㉁䛜ື≀⏝་⸆ရಖ⟶ᗜ䛛䜙㞳䜜䛯ሙᡤ䛻ಖ⟶䛥䜜䛶䛚䜙䛪䚸᫂☜䛺䝷䝧䝹䛜㈞䜙䜜
䛶䛔䛺䛔䚹

6.3.3

ཎᮦᩱ䚸ຍᕤ䛥䜜䛯ཎᮦᩱ䚸᭱⤊〇ရ䜢༊ู䛧䛶ಖ⟶䛧䛶䛔䛺䛔䚹133

6.3.4⏕⏘⌧ሙ䛜㐺ษ䛻⟶⌮䛥䜜䛶䛔䛺䛔䚹

6.3.5

ᚑᴗဨ䛜సᴗ╔䚸ᖗᏊ䚸䝂䝮㠐䛺䛹䛾ಖㆤල䜢╔⏝䛧䛶䛚䜙䛪䚸⏕⏘⌧ሙ䛻ධ䜛๓䛻ᚲ䛪ᡭ䜢Ὑ䛳䛶䛔䛺䛔䚹

6.3.6⏕⏘⌧ሙ䛾సᴗྎ䚸ᶵჾཬ䜃ᗋ䛾⾲㠃䛜Ύ₩䛷䛿䛺䛟䚸ཎᮦᩱ䛾ຍᕤ/ྲྀᢅ䛔䛷䛾౑⏝ᚋ䛻ᚲせ䛸䛥䜜䜛ᾘẘ䛜⾜䜟䜜䛶䛔䛺䛔䚹

6.3.7

䜺䝷䝇ᮦᩱ䛾ởᰁa.⏕⏘⌧ሙ䚸ໟ⿦䜶䝸䜰ཬ䜃ಖ⟶ሙᡤ䛷䚸䜺䝷䝇䚸☢ჾᮦᩱ䛾౑⏝䜢㑊䛡䛶䛔䛺䛔䚹b.ຍᕤ䚸ໟ⿦ཬ䜃ಖ⟶ሙᡤ䛾↷᫂䜢๭䜜䛺䛔
ᮦ㉁䛷ಖㆤ䛧䛶䛔䛺䛔䚹c.〇㐀䚸ໟ⿦ཬ䜃ಖ⟶ሙᡤ䛷䛿䚸ᮍ䛰䛻ື≀⏝་⸆ရ䛻᮲௳௜䛥䜜䛶䛔䜛ᐜჾ/㐨ල䜔䜺䝷䝇⣲ᮦ䜢౑⏝䛧䛶䛔䛺䛔䚹d.〇㐀⌧ሙ䛷䜺䝷䝇⣲ᮦ䛾ᐜჾ/㐨ල䜢౑⏝䛧䛶䛔䜛䛜䚸౑⏝๓䛻䛩䜉䛶䛾䜺䝷䝇⣲ᮦ䛾ᐜჾ/㐨ල䜢ៅ㔜䛻☜ㄆ䛧䛶䛚䜙䛪䚸◚ᦆ/ட⿣䛜Ⓨ⏕䛧䛶䛔䜛䜒䛾䛜䛒䜛䚹e.〇㐀㒊㛛䛿䚸ຍᕤ䝴䝙䝑䝖䛷Ⓨ⏕䛧䛯䜺䝷䝇䛾◚ᦆ䛻㛵䛧䛶䚸᪥᫬䚸ሙᡤ䚸ởᰁ䛥䜜䛯〇ရ䚸ྲྀ䜙䜜䛯᫝ṇฎ⨨䜢ྵ䜐グ㘓䜢䛸䛳䛶䛔䛺䛔䚹

6.4≉Ṧ䛺ᕤ⛬䛾┘ど

6.4.1

ື≀⏝་⸆ရ䛻༴㝤䜢ཬ䜌䛩ྍ⬟ᛶ䛾䛒䜛≉Ṧ䛺〇㐀ᕤ⛬䜔䛭䛾௚䛾ᕤ⛬䜢┘ど䛧䛶䛔䛺䛔䚹䛣䛾䜘䛖䛺〇㐀ᕤ⛬䜔ẁ㝵䛻䛿䚸⁛⳦䚸ໟ⿦䛺䛹䛜ྵ䜎䜜䜛䚹

7

᭱⤊〇ရ

7.1

᭱⤊〇ရ䛾ᇶ‽⏕⏘䛥䜜䜛᭱⤊〇ရ䛿䚸ḟ䛾つᐃ䜢‶䛯䛩䜒
䛾䛸䛩䜛䚹

7.1.1

᭱⤊〇ရ䛜ᡤ㎄ᐁᗇ䛾ᐃ䜑䜛ᇶ‽䜢‶䛯䛥䛪䚸ᾘ㈝⪅䛾೺ᗣ䜢ᐖ䛩䜛ཪ䛿༴㝤䛻䛥䜙䛩ྍ⬟ᛶ䛜䛒䜛䚹

7.1.2

ရ㉁ᇶ‽䛜⮬♫䛷☜❧䛥䜜䛶䛚䜙䛪䚸᭱⤊〇ရ䛜᭷ຠ䛺ᇶ‽䜢‶䛯䛧䛶䛔䜛䛛ㄪᰝ䛷䛝䛺
䛔䚹

7.1.3

ὶ㏻๓䛾᭱⤊〇ရ䛾ရ㉁ཬ䜃Ᏻ඲ᛶ䜢ᐃᮇⓗ䛻᭷ᶵⓗ䚸≀⌮ⓗ䚸໬Ꮫⓗ䚸ᚤ⏕≀ⓗཬ䜃⏕≀Ꮫⓗ䛻☜ㄆ䛧䚸䝰䝙䝍䝸䞁䜾䛧䛶䛔䛺䛔䚹

134

8

ヨ㦂ᡤ

8.1

ヨ㦂ᡤ䛾ᡤ᭷

8.1.1

ື≀⏝་⸆ရ䜢〇㐀䛩䜛௻ᴗ䛿䚸ཎᮦᩱ䚸༙〇ရཬ䜃᭱⤊〇ရ䛾ရ㉁ཬ䜃Ᏻ඲ᛶ䜢⟶⌮䛩䜛䛯䜑䛾⮬♫ヨ㦂ᡤ䜢ᡤ᭷䛧䛶䛔䛺䛔䚹

8.1.2

ヨ㦂ᡤ䜢ᡤ᭷䛧䛶䛔䛺䛔௻ᴗ䛜䚸ಙ㢗䛷䛝䜛ᨻᗓཪ䛿Ẹ㛫䛾ヨ㦂ᡤ䜢฼⏝䛧䛶䛔䛺䛔䚹8.2

ඃⰋヨ㦂ᡤ䜢ᡤ᭷䛩䜛᪉ἲ௻ᴗ䛾ヨ㦂ᡤ䛷ඃⰋヨ㦂ᡤつ⠊䠄Good
Laboratory Practice䠅䜢㐺⏝䛧䛶䛚䜙䛪䚸౑⏝䛥䜜䛶䛔䜛 ᐃჾ䜒⢭ᗘ䜢☜ಖ䛩䜛䛯䜑䛾ᐃᮇⓗ䛺ᰯṇ䛜⾜䜟䜜䛶䛔䛺䛔䚹

9

ᚑᴗဨ

9.1

ື≀⏝་⸆ရ〇㐀ᴗ䛾ᚑᴗဨ䛻ᑐ䛩䜛ᇶ‽䛿ḟ䛾䛸䛚䜚䛷䛒䜛䚹

9.1.1

ᚑᴗဨ䛻ື≀⏝་⸆ရ〇㐀䝥䝻䜾䝷䝮䜢ᐇ᪋䛩䜛⬟ຊ䛜䛺䛟䚸᫂☜䛺⫋ົ䛜䛺䛔䚹

9.1.2

ᚑᴗဨ䛾೺ᗣ≧ែ䛜Ⰻዲ䛷䛺䛟䚸യ䜔⓶⭵⑓䛺䛹䛜〇ရ䛾ởᰁཎᅉ䛻䛺䜛ྍ⬟ᛶ䛜䛒䜛䚹

9.1.3

ᚑᴗဨ䛿䚸ᡭ⿄䚸䝦䝑䝗䜻䝱䝑䝥ཬ䜃㠐䛺䛹䚸〇㐀⌧ሙ䛻㐺䛧䛯సᴗ╔/ಖㆤල䜢╔⏝䛧䛶䛔䛺
䛔䚹

9.1.4

ᚑᴗဨ䛿䚸సᴗ๓䛻ᡭ䜢Ὑ䜟䛺䛛䛳䛯䜚䚸⏕⏘⌧ሙ䛷㣧㣗䜔ႚ↮䜢䛧䛯䜚䚸ၚ䜢ྤ䛔䛯䜚䛩䜛䛺䛹䚸〇ရ䛾ởᰁཎᅉ䛻䛴䛺䛜䜛⾜Ⅽ䜢䛧䛶䛔
䜛䚹

9.1.5

ឤᰁ⑕䛻䛛䛛䛳䛶䛔䜛䛣䛸䛜ศ䛛䛳䛶䛔䜛䚸ཪ䛿␲䜟䜜䛶䛔䜛ᚑᴗဨ䛜⏕⏘⌧ሙ䛻ධ䜛䛣䛸䜢チྍ䛧䛶䛔䜛䚹

9.1.6

ຍᕤ㒊㛛䛾ᚑᴗဨ䛜䚸〇ရ䛾Ᏻ඲ᛶ䜢⬣䛛䛩ᐆ▼䚸᫬ィཪ䛿䛭䛾௚䛾䜒䛾䜢㌟䛻╔䛡䛶䛔䜛䚹

9.2〇㐀⌧ሙ䛻ධ䜛ゼၥ⪅䛜䚸ಖㆤ᭹䜢╔⏝䛧䛶䛚䜙䛪䚸ᚑᴗဨ䛻㐺⏝䛥䜜䜛⾨⏕ᇶ‽䜢㡰Ᏺ䛧
䛶䛔䛺䛔䚹

9.3

ື≀⏝་⸆ရ〇㐀ᴗ⏺䛜䚸ຍᕤ㣗ရ䛾Ᏻ඲ᛶ䜢┘╩䛩䜛㈐௵⪅䛸䛧䛶䚸カ⦎䜢ཷ䛡䛯᭷⬟䛺ேᮦ䜢ᣦྡ䛧௵࿨䛧䛶䛔䛺䛔䚹

10

ໟ⿦ᮦ

10.1

〇ရ䜢ໟ⿦䛩䜛ໟ⿦ᇶ‽䛿ḟ䛾䛸䛚䜚䛷䛒䜛䚹135

10.1.1 ≉䛻㛗ᮇಖ⟶䛷ື≀⏝་⸆ရ䜢እ㒊䛾ᙳ㡪䛛䜙ಖㆤ䛧䚸ရ㉁䜢⥔ᣢ䛧䛶䛔䛺䛔䚹10.1.2 ೺ᗣ䜢㜼ᐖ䛧䛯䜚䚸〇ရ䛾ရ㉁䛻ᙳ㡪䜢ཬ䜌䛧䛯䜚䛩䜛ྍ⬟ᛶ䛾䛒䜛≉ᐃ䛾໬ྜ≀䜢⁐ゎཪ䛿ᨺฟ䛩䜛⣲ᮦ䛷స䜙䜜䛶䛔䜛䚹10.1.3 ຍᕤ䚸㍺㏦ཬ䜃ὶ㏻᫬䛾ฎ⌮䛻ᑐ䛧䛶⪏ஂᛶ䛜䛺䛔䠄〇㐀ᕤ⛬୰䜔㍺㏦᫬䛾⾪ᧁ䛷ໟ⿦䛜ᐜ᫆䛻䜈䛣䜣䛰䜚䚸◚䜜䛯䜚䚸ቯ䜜䛯䜚䛩䜛䠅䚹10.1.4 〇ရ䛾୰㌟䛾᏶඲ᛶཬ䜃┿ṇᛶ䜢ಖド䛷䛝䛶䛔䛺䛔䚹
10.1.5 ໟ⿦䛾䝕䝄䜲䞁䜔⣲ᮦ䛿䚸ởᰁ䜢᭱ᑠ㝈䛻ᢚ䛘䚸ᦆയ䜢㜵䛞䚸㐺ษ䛺䝷䝧䝹䜢௜䛡䜛䛯䜑䛻〇ရ䜢ಖㆤ䛩䜛䜒䛾䛷䛿䛺䛔䚹10.1.6 〇ရ䛾ໟ⿦䛻౑⏝䛥䜜䜛ໟ⿦ᮦᩱཪ䛿Ẽయ䛜᭷ẘ䛷䚸〇ရ䛾ရ㉁䜢⥔ᣢ䛷䛝䛪䚸እ㒊䛾ᙳ㡪䛛䜙〇ရ䜢ಖㆤ䛷䛝䛺䛔䚹10.1.7 㡹୔䛷䛿䛺䛟䚸ᚲせ䛺ሙྜ䛾Ὑί䜔ᾘẘ䛜ᅔ㞴䛺෌฼⏝ໟ⿦䠄䝪䝖䝹䜔⎼䠅䛜䚸ື≀⏝་⸆ရ䛾ໟ⿦䛻౑⏝䛥䜜䛶䛔䜛䚹10.1.8 ໟ⿦ᮦ䛜䚸ཎᮦᩱ䜔᭱⤊〇ရ䛸䛿ู䛻䚸⾨⏕ⓗ䛺≧ែ䛷ಖ⟶䛥䜜䚸ྲྀ䜚ᢅ䜟䜜䛶䛔䛺䛔䚹11〇ရ䝷䝧䝹ཬ䜃ㄝ᫂

11.1〇ရ䝷䝧䝹䛜ᐃ䜑䜙䜜䛯つᐃ䜢‶䛯䛧䛶䛔䛺
䛔䚹

11.2

ື≀⏝་⸆ရ䛾䝷䝧䝹䛜䚸ຍᕤ㣗ရ䛾✀㢮䛤䛸䛻኱䛝䛥䚸Ⰽ/ᙧ䛾⤌ྜ䛫䜢ኚ䛘䛶䚸༊ู䛧䜔䛩䛔䜘䛖䛻స䜙䜜䛶䛔䛺䛔䚹

12

ಖ⟶

12.1

ಖ⟶᪉ἲ
a.ຍᕤ㐣⛬䛷౑⏝䛥䜜䜛ᮦᩱཬ䜃᭱⤊〇ရ䜢䚸Ύ₩䛷䚸✵Ẽ䛾ᚠ⎔䛜Ⰻ䛔䚸㐺 䛷䚸᫂䜛䛟䚸ᐖ⹸䛜䛔䛺䛔ᐊෆ䛻༊ศ䛧䛶ಖ⟶䛧䛶䛔䛺䛔䚹
b.ཎᮦᩱ䜢ᗋ䛻ゐ䜜䜛䚸ቨ䛻ᙜ䛯䜛䚸ኳ஭䛻㏆䛔ሙᡤ䛻ಖ⟶䛧䛶䛔䜛䚹ཎᮦᩱཬ䜃᭱⤊〇ရ䛾ಖ⟶ሙᡤ䛻⾲♧䛜䛺䛟䚸ΰᅾ䛧䛶⨨䛛䜜䛶䛔䜛䛯䜑䚸᳨ᰝ๓䛸᳨ᰝᚋ䚸᮲௳䜢‶䛯䛧䛶䛔䜛䛛‶䛯䛧䛶䛔䛺䛔䛛䚸ඛ䛻ධᗜ䛧䛯/ඛ䛻⏕⏘䛥䜜䛯/ඛ䛻౑⏝䛥䜜䜛/ඛ䛻ὶ㏻䛥䛫䜛ᮦᩱཬ䜃᭱⤊〇ရ䛾༊ู䛜䛴
䛛䛺䛔䚹

136

d.ཎᮦᩱ䜢ಖ⟶䛩䜛㝿䛻䚸ཎᮦᩱྡ䚸ཷ㡿᪥䚸ཎᮦᩱ䛾ฟᡤ䚸ฟⲴ᪥ཬ䜃䛭䛾௚䛾ᚲせ䛺᝟ሗ䜢グ㍕䛩䜛䜹䞊䝗䝅䝇䝔䝮䜢౑⏝䛧䛶䛔䛺䛔䚹e.᭱⤊〇ရ䜢ಖ⟶䛩䜛㝿䛻䚸〇ရྡ䚸〇㐀ᖺ᭶᪥䚸〇㐀䝁䞊䝗䚸ฟⲴ᪥䚸ฟⲴಶᩘཬ䜃䛭䛾௚䛾ᚲせ䛺᝟ሗ䜢グ㍕䛩䜛䜹䞊䝗䝅䝇䝔䝮䜢౑⏝䛧䛶䛔䛺䛔䚹
12.1.2 ༴㝤≀䛾ಖ⟶༴㝤≀䠄ᾘẘ๣䚸㥑㝖๣䚸ẅ⹸๣䚸ẅ㰡๣䚸ྍ⇞ᛶ/⇿Ⓨᛶ≀㉁ཬ䜃䛭䛾௚䛾༴㝤≀䠅䜢⟶⌮䛥䜜䛯␗䛺䜛ᐊෆ䛻ಖ⟶䛧䛶䛚䜙䛪䚸ཎᮦᩱཬ䜃᭱⤊〇ရ䛜ởᰁ䛥䜜䚸ᚑᴗဨ䛜༴㝤䛻䛥䜙䛥䜜䜛ྍ⬟ᛶ䛜䛒䜛䚹12.1.3 ᐜჾཬ䜃ໟ⿦ᮦ䛾ಖ⟶ᐜჾ䜔ໟ⿦ᮦ䛜䛝䛱䜣䛸ಖ⟶䛥䜜䛶䛔䛺䛔䚹ở䜜䛯ሙᡤ䜔ಖㆤ䛥䜜䛶䛔䛺䛔ሙᡤ䛻䛒䜛䚹౑⏝䛩䜛㝿䛻〇ရ䜢ởᰁ䛩䜛䚹
12.1.4 䝷䝧䝹䛾ಖ⟶䝷䝧䝹䛜䛝䛱䜣䛸ᩚ㡻䛥䜜䛶ಖ⟶䛥䜜䛶䛔䛺䛔䛯䜑䚸౑⏝ୖ䛾䝭䝇䛜Ⓨ⏕䛩䜛ྍ⬟ᛶ䛜䛒䜛䚹
12.1.5 ⏕⏘ᶵᲔ/⿦⨨䛾ಖ⟶౑⏝䛧䛶䛔䛺䛔䜽䝸䞊䝙䞁䜾῭⏕⏘ᶵᲔ/⿦⨨䛾ಖ⟶≧ែ䛜Ⰻ䛟䛺䛔䚹
13䝯䞁䝔䝘䞁䝇ཬ䜃⾨⏕䝥䝻䜾䝷䝮13.1

䝯䞁䝔䝘䞁䝇ཬ䜃䜽䝸䞊䝙䞁䜾13.1.1 ⏕⏘᪋タ䠄ᘓ≀䚸ᶵᲔ/⿦⨨䠅䛜㐺ษ䛻⥔ᣢ䛥䜜䛶䛚䜙䛪䚸⾨⏕ᡭ㡰䛜ຠᯝⓗ䛷䛿䛺䛔䚹≉䛻㔜せ䛺ẁ㝵䛷ᶵᲔ/⿦⨨䛜☜❧䛥䜜䛯ᡭ㡰䛻ᚑ䛳䛶ᶵ⬟䛫䛪䚸≀⌮ⓗ䚸໬Ꮫⓗ䚸⏕≀Ꮫⓗ/ᚤ⏕≀Ꮫⓗ䛺ởᰁ䛜Ⓨ⏕䛩䜛䚹
13.1.2 〇㐀ᶵᲔ/⿦⨨䛾䜽䝸䞊䝙䞁䜾ཬ䜃㝖⳦
a.ཎᮦᩱ䜔〇ရ䛻┤᥋ゐ䜜䜛⏕⏘ᶵᲔ/⿦⨨䛿䚸ᐃᮇⓗ䛺䜽䝸䞊䝙䞁䜾䜔㝖⳦ᑐ⟇䛜䛸䜙䜜䛶䛔䛺䛔䚹
b.〇ရ䛻┤᥋㛵ಀ䛾䛺䛔〇㐀ᶵᲔ/⿦⨨䛜⾨⏕ⓗ䛺≧ែ䛷䛿䛺䛔䚹c.〇㐀ᶵᲔ/⿦⨨䛾ṧ␃≀㉁䜔ở䜜䜢㝖ཤ䛩䜛䛯䜑䛾ᐃᮇⓗ䛺䜽䝸䞊䝙䞁䜾/Ὑί䜔䚸㝖⳦ᑐ⟇䛜⾜䜟䜜䛶䛔䛺䛔䚹137

d.Ὑί๣䛜ᡭ㡰㏻䜚䛻ྲྀ䜚ᢅ䜟䜜䚸౑⏝䛥䜜䛶䛔䛺䛔䚹ཎᮦᩱཬ䜃〇ရ䛾ởᰁ䜢㜵䛠䛯䜑䛻䝷䝧䝹䛾௜䛔䛯ᐜჾ䛻ಖ⟶䛥䜜䛶䛔䛺䛔䚹e.ᕤሙ/⏕⏘⌧ሙ䛾㍺㏦ჾල䜔ᦙ㏦⿦⨨䛜Ύ₩䛷䛺䛟䚸㍺㏦ཪ䛿⛣ື䛩䜛ရ≀䛻ᦆയ䜢୚䛘䜛ྍ⬟ᛶ䛜䛒䜛䚹
13.2

䜽䝸䞊䝙䞁䜾ཬ䜃㝖⳦䛾ᡭ㡰

13.2.1 ḟ䛾ᡭẁ䛷䜽䝸䞊䝙䞁䜾䛜༑ศ䛻ᐇ᪋䛥䜜䛶䛔䛺䛔䚹
a.䝤䝷䝑䝅䞁䜾䚸ຍᅽỈᄇ㟝ཪ䛿┿✵྾ᘬ䛻䜘䜛≀⌮ⓗฎ⌮b.Ὑί๣䚸ሷᇶཪ䛿㓟䜢౑⏝䛩䜛໬Ꮫⓗฎ⌮c.≀⌮ⓗཬ䜃໬Ꮫⓗฎ⌮䜢⤌䜏ྜ䜟䛫䜛
13.2.2 ḟ䛾ᡭẁ䛷䚸䜽䝸䞊䝙䞁䜾ཬ䜃㝖⳦άື䛜ᐇ᪋䛥䜜䛶䛔䛺䛔䚹
a.⾲㠃䛾ở䜜䜢㝖ཤ䛩䜛䚹b.Ὑί๣䜢⏝䛔䛶ཪ䛿Ὑίᾮ䜈䛾ᾐₕ䛻䜘䜚䚸ᶵᲔ/⿦⨨䛛䜙ở䜜ཬ䜃ᚤ⏕≀ᒙ䜢㝖ཤ䛩䜛䚹
c.ᾋ䛔䛯ở䜜䜔ṧ␃Ὑ๣䜢㝖ཤ䛩䜛䛯䜑䛻䚸ᇶ‽䜢‶䛯䛧䛯䛝䜜䛔䛺Ỉ䛷䛩䛩䛠䚹d.ฎ⌮䛥䜜䛯ᮦᩱ䛾ṧ␃≀䜔୙⣧≀䜢㝖ཤ䛩䜛䛯䜑䛻䚸䝗䝷䜲䜽䝸䞊䝙䞁䜾ཪ䛿௚䛾᪉ἲ䜢⏝䛔䜛䚹
e.ᚲせ䛺ሙྜ䛿ᾘẘ䛩䜛䚹
13.3

䜽䝸䞊䝙䞁䜾䝥䝻䜾䝷䝮

13.3.1 䜽䝸䞊䝙䞁䜾ཬ䜃ᾘẘ䝥䝻䜾䝷䝮䛜䚸Ύᤲ⏝ල䛾Ὑί䜢ྵ䜑䚸ᕤሙ/⏕⏘⌧ሙ䛾䛩䜉䛶䛾ሙᡤ䛻䛴䛔䛶Ύ₩䛥䜢ಖド䛩䜛䜒䛾䛷䛿䛺䛔䚹
13.3.2 䜽䝸䞊䝙䞁䜾ཬ䜃ᾘẘ䝥䝻䜾䝷䝮䛜ᐃᮇⓗ䛻ᐇ᪋䛥䜜䛶䛔䛺䛔䚹ṇ☜ᛶཬ䜃ຠᯝᛶ䛜䝰䝙䝍䝸䞁䜾䛥䜜䛶䛚䜙䛪䚸ᚲせ䛺ሙྜ䛷䜒グ㘓䛥䜜䛶䛔䛺䛔䚹
13.3.3 䜽䝸䞊䝙䞁䜾䝥䝻䜾䝷䝮䛾グ㘓䛻ḟ䛾ෆᐜ䛜ྵ䜎䜜䛶䛔䛺䛔䚹
a.㒊ᒇ䚸ᶵᲔ/⿦⨨ཬ䜃ᶵჾ
b.䜽䝸䞊䝙䞁䜾䜢ᢸᙜ䛩䜛ᚑᴗဨc.䜽䝸䞊䝙䞁䜾᪉ἲཬ䜃㢖ᗘd.Ύᤲ䝰䝙䝍䝸䞁䜾᪉ἲ
13.4

᭷ᐖ⏕≀㥑㝖䝥䝻䜾䝷䝮138

13.4.1 ᭷ᐖ⏕≀䠄䛢䛳ṑ㢮䚸᪻⹸䚸ᐙ⚺䛺䛹䠅䛿䚸ຍᕤ㣗ရ䛾ရ㉁ཬ䜃Ᏻ඲ᛶ䜢పୗ䛥䛫䜛኱䛝䛺ཎᅉ䛷䛒䜛䚹᭷ᐖ⏕≀䛜ᕤሙෆ䛻౵ධ䛩䜛䛾䜢㜵䛠䛯䜑䛾⾨⏕⟶⌮䛜ᚭᗏ䛥䜜䛶䛔䛺䛔䚹᭷ᐖ⏕≀㥑㝖䝥䝻䜾䝷䝮䛜䚸ᐖ⹸౵ධ䛾ྍ⬟ᛶ䜢ῶ䜙䛩䛯䜑䛻ḟ䛾᪉ἲ䛷ᐇ᪋䛥䜜䜛䜉䛝䛷䛒䜛䚹
a.Ⰻዲ䛺⾨⏕⟶⌮䝥䝻䜾䝷䝮b.ᕤሙ/⏕⏘⌧ሙ䛻ධ䜛ཎᮦᩱ䛾┘どc.〇ရ䜢ởᰁ䛩䜛ྍ⬟ᛶ䛾䛒䜛ẅ⳦๣䚸ẅ⹸๣䚸ཬ䜃ẅ㰡๣䛾౑⏝㔞䜢䚸䝰䝙䝍䝸䞁䜾ཪ䛿๐ῶ䛧䛶䛔䜛䚹
13.4.2 ᕤሙ/⏕⏘⌧ሙ䜈䛾᭷ᐖ⏕≀䛾౵ධ䜢㜵䛠䛯䜑䚸ḟ䛾ᑐ⟇䛜䛸䜙䜜䛶䛔䛺䛔䚹a.ᕤሙ/⏕⏘⌧ሙ䛾ᘓ≀䛿䚸᭷ᐖ⏕≀䛾౵ධ䜢㜵䛠䛯䜑䛻Ⰻዲ䛺≧ែ䛷⥔ᣢ䛥䜜䛶䛔䜛䚹b.᭷ᐖ⏕≀䛾౵ධ䜢チ䛩䜘䛖䛺✰䜔⁁䜢ሰ䛔䛷䛔䜛䚹c.❆䚸䝗䜰䚸᥮Ẽཱྀ䛻䛿䚸᭷ᐖ⏕≀䛾౵ධ䜢㜵䛠䛯䜑䛻㔠⥙௜䛝䛾⥙ᡞ䜢ྲྀ䜚௜䛡䛶䛔䜛䚹d.≟䜔⊧䛺䛹䛾ື≀䛜࿘ᅖཬ䜃ᕤሙ/⏕⏘⌧ሙෆ䜢ᚔᚉ䛧䛺䛔䜘䛖䛻䛧䛶䛔䜛䚹
13.4.3 ᕤሙ/⏕⏘⌧ሙ䛷᭷ᐖ⏕≀䛾ᕢ䛾Ⓨ⏕䜢㜵䛠䛯䜑䛻䚸ḟ䛾≧ἣ䛾ᨵၿ䛜ᚲせ䛷䛒䜛䚹a.ື≀⏝་⸆ရ䛜㐺ษ䛻ಖ⟶ཬ䜃㓄⨨䛥䜜䛶䛚䜙䛪䚸ᗋ䛻┤᥋᥋ゐ䛧䛯䜚䚸ቨ䜔ኳ஭䛾㏆䛟䛻⨨䛛䜜䛯䜚䛧䛶䛔䜛䚹b.ᕤሙ/⏕⏘⌧ሙ䛾ᐊෆཬ䜃ᐊእ䛜Ύ₩䛷䛿䛺䛔䚹c.䝂䝭⟽䛜ᐦ㛢ᘧ䛷䛿䛺䛟䚸᭷ᐖ⏕≀䛻ᑐ䛧䛶ᙉ䛔⣲ᮦ䛷స䜙䜜䛶䛔䛺䛔䚹d.ᕤሙ/⏕⏘⌧ሙཬ䜃䛭䛾⎔ቃ䛻䛚䛔䛶䚸᭷ᐖ⏕≀䛾ᕢ䛜Ⓨ⏕䛩䜛ྍ⬟ᛶ䜢᳨ᰝཬ䜃䝰䝙䝍䝸䞁䜾䛧䛶䛔䛺䛔䚹
13.4.4 ᭷ᐖ⏕≀䛾ᕢ䜢䛩䛠䛻㝖ཤ䛧䛶䛔䛺䛔䚹
13.4.5 〇ရ䛾ရ㉁ཬ䜃Ᏻ඲ᛶ䛻ᙳ㡪䜢ཬ䜌䛥䛺䛔䜘䛖䛺໬Ꮫⓗ䚸⏕≀Ꮫⓗཪ䛿≀⌮ⓗ䛺᪉ἲ䛷䛾᭷ᐖ⏕≀㥑㝖䜢⾜䛳䛶䛔䛺䛔䚹
13.5

ᗫᲠ≀ฎ⌮
ᕤሙ/⏕⏘⌧ሙ䛾ᗫᲠ≀䛾ฎ⌮/ฎศ䛿䚸ḟ䛾䜘䛖䛻㐺ษ䛛䛴㎿㏿䛻⾜䜟䜜䛶䛔䜛䚹139

13.5.1 ⏕⏘ᕤ⛬䛷Ⓨ⏕䛧䛯ᗫᲠ≀䛜ᕤሙ/⏕⏘⌧ሙ䛾࿘ᅖ䛻⵳✚䛥䜜䛯䜎䜎䛷䚸䛩䛠䛻ฎ⌮䚸ฎ⨨ཪ䛿ᗫᲠ䛥䜜䛶䛔䛺䛔䚹
13.5.2 ᅛయ䛾ᗫᲠ≀䜢ฎศ䚸↝༷ཪ䛿ฎ⌮䛩䜛䛯䜑䛻䚸䛩䛠䛻ᅇ཰䛧䛶䛔䛺䛔䚹
13.5.3 ᾮయ䛾ᗫᲠ≀䜢ฎ⌮䛫䛪䛻ᕤሙ/⏕⏘⌧ሙ䛾እ䜔Ἑᕝ䛻ὶ䛧䛶䛔䜛䚹
13.5.4 Ẽయ䛾ᗫᲠ≀䜢⟶⌮䛫䛪䚸ฎ⌮䛧䛶䛔䛺䛔䛯䜑䛻䚸ᚑᴗဨ䛾೺ᗣ䜢ᐖ䛧䚸⎔ቃởᰁ䜢ᘬ䛝㉳䛣䛧䛶䛔䜛䚹
14㍺㏦
14.1

䝁䞁䝔䝘ཬ䜃㍺㏦ჾල䛻㛵䛩䜛ᇶ‽䝁䞁䝔䝘ཬ䜃㍺㏦ჾල䛜䚸⪃៖䛧䛶タィ䛥䜜䛶䛔䛺䛔䛯䜑䚸
a.〇ရ䜢ởᰁ䛩䜛䚹b.䜽䝸䞊䝙䞁䜾䛜ᅔ㞴䛷䚸ᚲせ䛻ᛂ䛨䛶ᾘẘ䛷䛝䛺䛔䚹
c.㍺㏦୰䚸㠀㣗ရᮦᩱ䛾〇ရ䜢ศ䛡䛶䛔䛺䛔䚹d.≉䛻ሻ䜔ᇕ䛺䛹䛾ởᰁ䛛䜙〇ရ䜢ಖㆤ䛷䛝䛶䛔䛺䛔䚹e. ᗘ䚸‵ᗘཬ䜃ಖᏑ≧ែ䛾⟶⌮䛜䛷䛝䛶䛔
䛺䛔䚹
f.

14.2

ᗘ䚸‵ᗘ䛺䛹䛾☜ㄆ䛜ᅔ㞴䚹䝁䞁䝔䝘ཬ䜃㍺㏦ჾල䛾䝯䞁䝔䝘䞁䝇

14.2.1 ື≀⏝་⸆ရ䛾䝁䞁䝔䝘ཬ䜃㍺㏦ჾල䛜Ύ₩䛷䜘䛟⥔ᣢ䛥䜜䛯≧ែ䛻䝯䞁䝔䝘䞁䝇䛥䜜䛶䛚䜙䛪䚸༴㝤≀䛾㍺㏦䛻౑⏝䛥䜜䛶䛔䜛䚹
14.2.2 ௚䛾ཎᮦᩱ䜢㍺㏦䛩䜛䛯䜑䛻ື≀⏝་⸆ရ䛾䝁䞁䝔䝘ཬ䜃㍺㏦ჾල䜢౑⏝䛧䛶䛔䜛䛻䜒䛛䛛䜟䜙䛪䚸䜽䝸䞊䝙䞁䜾ཬ䜃ᾘẘ䛜⾜䜟䜜䛶䛔䛺䛔䚹
15᭩㢮ཬ䜃グ㘓
15.1

ᚲせ䛺᭩㢮/グ㘓ධⲴ䛧䛯ཎᮦᩱ䚸⏕⏘ᕤ⛬䚸⏕⏘䚸ὶ㏻䚸᳨ᰝཬ䜃ヨ㦂䛾ᩘཬ䜃᪥௜䚸〇ရᅇ཰ཬ䜃ᮦᩱ䛾䝖䝺䞊䝃䝡䝸䝔䜱䚸ಖ⟶䚸䜽䝸䞊䝙䞁䜾ཬ䜃㝖⳦䚸᭷ᐖ⏕≀㥑㝖䚸ᚑᴗဨ䛾೺ᗣ䚸カ⦎ཬ䜃ᰯṇ䛾グ㘓䜢ྵ䜐䚸௻ᴗ䛜ᡤ᭷ཬ䜃⟶⌮䛩䜉䛝ᩥ᭩/グ㘓䜢ᡤ᭷ཬ䜃⟶⌮䛧䛶䛔䛺䛔䚹

16

カ⦎

16.1

カ⦎䝥䝻䜾䝷䝮

140ḟ䛾஦㡯䛻㛵䛩䜛カ⦎/䜹䜴䞁䝉䝸䞁䜾䛺䛹䚸ᇶᮏཎ๎䛛䜙ඃⰋ⏕⏘᪉ἲ䛾ᐇ㊶䛻⮳䜛䜎䛷䛾カ⦎䝥䝻䜾䝷䝮䛜ᥦ౪䛥䜜䛶䛔䛺䛔䚹16.1.1 ᚑᴗဨ䛾⾨⏕䛾ᇶᮏ䜔䚸ຍᕤ䝇䝍䝑䝣䜈䛾ື≀⏝་⸆ရ䛻㛵䛩䜛⾨⏕䛾ᇶᮏ䚹
16.1.2 ⑓ཎᛶᚤ⏕≀䜔⭉ᩋᛶᚤ⏕≀䛾⦾Ṫ䜢ಁ䛩䜒䛾䛺䛹䚸ື≀⏝་⸆ရ䛾ရ㉁పୗ䜔ຎ໬䛾ཎᅉ䛸䛺䜛せᅉ䚹16.1.3 ຍᕤ㣗ရ䛻䜘䛳䛶⑌⑓ཬ䜃୰ẘ䜢ᘬ䛝㉳䛣䛩せᅉ䚹
16.1.4 ྲྀᢅ䛔䚸ຍᕤ䚸ಖ⟶䚸ໟ⿦ཬ䜃㍺㏦䜢ྵ䜐ඃⰋື≀⏝་⸆ရ䛾〇㐀᪉ἲ䚹
16.1.5 ᶵᲔ/⿦⨨ཬ䜃䛭䛾௚䛾タഛ䛾䜽䝸䞊䝙䞁䜾ཬ䜃㝖⳦䛾ᇶᮏཎ๎䚹16.1.6 ேయ䛻᭷ᐖ䛺Ὑί๣ཪ䛿໬Ꮫ≀㉁䛾ྲྀᢅ䛔䚹17〇ရᅇ཰䠄〇ရᅇ཰䛜Ⓨ⏕䛧䛯ሙྜ䠅

17.1〇ရᅇ཰䛻㛵䛩䜛ᑐᛂ⏕⏘䛥䜜䛯〇ရ䛻༴ᐖ䜢䜒䛯䜙䛩䠄⑓Ẽཪ䛿୰ẘ䠅␲䛔䛜䛒䜛ሙྜ䚸ḟ䛾䜘䛖䛻ᚲせ䛸䛥䜜䜛ᑐᛂ䛜䛺䛥䜜䛶䛔䛺䛔䚹17.1.1 ௻ᴗ䛜ὶ㏻/ᕷሙ䛛䜙〇ရ䛾ᅇ཰䜢ᐇ᪋䛧䛺䛔䚹
17.1.2 ⟶⌮⪅ཪ䛿⏕⏘㈐௵⪅䛜䚸ὶ㏻/ᕷሙ䛛䜙〇ရ䜢ᅇ཰䛩䜛ᡭ㡰䜢‽ഛ䛧䛶䛔䛺䛔䚹17.1.3 ᐖ䜢ཬ䜌䛩〇ရ䛸ྠ䛨᮲௳䛷⏕⏘䛥䜜䛯௚䛾〇ရ䜢䚸ὶ㏻/ᕷሙ䛛䜙ᅇ཰䛧䛶䛔䛺䛔䚹17.1.4 ᐖ䜢ཬ䜌䛩〇ရ䛜ὶ㏻䛩䜛ྍ⬟ᛶ䛜䛒䜛䛣䛸䜢୍⯡䛻㏻▱䛧䛶䛔䛺䛔䚹17.1.5 ᅇ཰䛥䜜䛯〇ရ䛜ᗫᲠ䛥䜜䜛䜎䛷䚸ཪ䛿ᾘ㈝௨
እ䛾௚䛾┠ⓗ䛻౑⏝䛥䜜䜛䜎䛷┘ど䛥䜜䛶䛔䛺䛔䚹
17.1.6 ༴㝤ᛶ䛜ุ᫂䛧䛯〇ရ䛺䛾䛻䚸ၥ㢟䛜ゎỴ䛩䜛䜎䛷〇ရᕤ⛬䜢೵Ṇ䛥䛫䛶䛔䛺䛔䚹18

䜺䜲䝗䝷䜲䞁䛾ᐇ᪋18.1

௻ᴗ䛜 CPOHB 䝥䝻䜾䝷䝮䛾㐠⏝䜢ᩥ᭩໬䛧
䛶䛔䛺䛔䚹

18.2

௻ᴗ䛾⤒Ⴀ㝕䛜 CPOHB 䛾㐺⏝䜢ಖド䛩䜛䛯䜑䛾㈨⏘䛻ᑐ䛧䛶㈐௵䜢ᣢ䛳䛶䛔䛺䛔䚹18.3

ᚑᴗဨ䛜ᚑᴗဨ䛾ᙺ๭ཬ䜃⫋ົ䛻ᛂ䛨䛯
CPOHB 䛾ᐇ᪋䛻ᑐ䛧䛶㈐௵䜢ᣢ䛳䛶䛔䛺䛔䚹141

⥲ホ౯Ⅼᩘホ౯䜹䝔䝂䝸䞊䛾ᇶ‽
1. OK䠄V䠅
2. Ml䠄䝬䜲䝘䞊䠅
3. MJ䠄䝯䝆䝱䞊䠅
4. CR䠄䜽䝸䝔䜱䜹䝹䠅
5. TA䠄䛺䛧䠅142

5.3 㑇ఏᏊ⤌᥮䛘⏕≀䠄GMO䠅⏤᮶䛾ື≀⏝་⸆ရ䛻㛵䛩䜛䛂㑇ఏᏊ⤌᥮䛘〇ရᏳ඲ጤဨ఍䠄KKH PRG䠅䛃䛛䜙䛾⎔ቃᏳ඲ド᫂᭩䠄Sertifikat Keamanan
Lingkungan䠅97㑇ఏᏊ⤌᥮䛘〇ရ䠄PRG䠖Produk Rekayasa Genetik䠅䛾ᇶ‽
1. 䜲䞁䝗䝛䝅䜰䛷䛾ᨺฟཬ䜃/ཪ䛿ὶ㏻䛾䛯䜑䛻ホ౯ཪ䛿ヨ㦂䛥䜜䜛ᅜෆཪ䛿ᾏእ⏤᮶䛾
PRG 䛿䚸〇ရ䛜⎔ቃᏳ඲ᛶ䚸㣗ရᏳ඲ᛶཬ䜃/ཪ䛿㣫ᩱᏳ඲ᛶ䛾ᇶ‽䜢‶䛯䛧䛶䛔䜛䛣䛸䜢♧䛩ᇶᮏ᝟ሗ䜢ῧ௜䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
2. ➨ 1 㡯䛾⎔ቃᏳ඲ᛶ䛻ᑐ䛩䜛せồ஦㡯䜢‶䛯䛧䛶䛔䜛䛣䛸䜢♧䛩ᇶᮏ᝟ሗ䛻䛿䚸ḟ䛾䜒䛾䛜ྵ䜎䜜䜛䚹
a. ㄝ᫂ཬ䜃౑⏝┠ⓗ䚹b. ᳨ฟ䛥䜜䜛䛸ண᝿䛥䜜䜛㑇ఏⓗኚ໬ཬ䜃⾲⌧ᆺ䛾ኚ໬䚹
c. PRG 䛾ศ㢮Ꮫ䚸⏕⌮Ꮫ䚸⏕ṪᏛ䛾᫂☜䛺ྠ୍ᛶ䚹d. 㑇ఏᏊ※䛸䛧䛶౑⏝䛥䜜䛯⏕≀䛻㛵䛩䜛᫂☜䛛䛴᏶඲䛺᝟ሗ䚹e. ⛉Ꮫⓗ䛻ㄝ᫂䛷䛝䜛ᶆ‽ⓗ䛺ᡭ㡰䛷⾜䜟䜜䛯㑇ఏᏊᕤᏛ䛾ᡭἲ䚹f. ᫂☜䛻ヲ㏙䛥䜜䛯 PRG 䛾ศᏊ≉ᛶ䚹
g. PRG 䛻ኚ᥮䛥䜜䛯㑇ఏᏊ䛾Ⓨ⌧䛾Ᏻᐃᛶ䚹h. 㐓⬺䛧䛯ሙྜ䛻౑⏝䛥䜜䜛◚Რ᪉ἲ䚹
3. ➨ 1 㡯䛾㣗ရᏳ඲ᛶཬ䜃㣫ᩱᏳ඲ᛶ䛾せồ஦㡯䜢‶䛯䛧䛶䛔䜛䛣䛸䜢♧䛩ᇶᮏ᝟ሗ䛻䛿䚸௨ୗ䛾䜒䛾䛜ྵ䜎䜜䜛䚹a. ౑⏝䛥䜜䜛㑇ఏᏊᕤᏛ䛾᪉ἲ䛜䚸䛭䛾ጇᙜᛶ䜢⛉Ꮫⓗ䛻ㄝ᫂䛷䛝䜛ᶆ‽໬䛥䜜䛯ᡭ㡰䛻ᚑ䛳䛶䛔䜛䛣䛸䚹b. PRG 䛾ᰤ㣴ᡂศ䛜䚸㠀 PRG 䛾ᰤ㣴ᡂศ䛸ᐇ㉁ⓗ䛻ྠ➼䛷䛒䜛䛣䛸䚹c. PRG 䛾ẘᛶ䚸ᢠᰤ㣴ཬ䜃䜰䝺䝹䜼䞊䛾ཎᅉ䛸䛺䜛໬ྜ≀䛾ྵ᭷㔞䛜䚸㠀 PRG 䛾䛭䜜䛸ᐇ㉁ⓗ䛻ྠ➼䛷䛒䜛䛣䛸䚹d. PRG 䛾ⅣỈ໬≀䚸䝍䞁䝟䜽㉁䚸⅊ศ䚸⬡⫫䚸⧄⥔䚸䜰䝭䝜㓟䚸⬡⫫㓟䚸䝭䝛䝷䝹䚸䝡䝍䝭䞁ྵ᭷㔞䛜䚸㠀 PRG 䛾䛭䜜䛸ᐇ㉁ⓗ䛻ྠ➼䛷䛒䜛䛣䛸䚹e. ⛣㌿䛥䜜䛯㑇ఏᏊ䛜䝁䞊䝗䛩䜛䝍䞁䝟䜽㉁䛜䜰䝺䝹䝀䞁䛷䛺䛔䛣䛸䚹f. 㐓⬺䛧䛯ሙྜ䛾◚Რ᪉ἲ䚹⏦ㄳᡭ㡰䠖
1. ึ䜑䛶ᾏእ䛛䜙 PRG 䜢㍺ධ䛩䜛⪅䛿䚸㛵㐃኱⮧ཪ䛿㠀ᨻᗓᶵ㛵ᗇ䠄LPND䠅㛗䛻⏦ㄳ᭩䜢ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
2. PRG 䛾㍺ධ⏦ㄳ䛻䛿䚸⎔ቃᏳ඲ᛶ䚸㣗ရᏳ඲ᛶཬ䜃/ཪ䛿㣫ᩱᏳ඲ᛶ䛾ᇶ‽䜢‶䛯䛧䛶䛔䜛䛣䛸䜢ㄝ᫂䛩䜛ୖグ䛾ᩥ᭩䜢ῧ௜䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
3. ➨ 2 㡯䛾つᐃ䜢‶䛯䛩䜋䛛䚸ᾏእ䛛䜙䛾 PRG 䛾㍺ධ䛻䛿䚸௨ୗ䛾䜒䛾䜢ῧ௜䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
a. PRG 䛾⮬⏤㈍኎ド᫂᭩䠄certificate of free trade䠅䚹

97 㑇ఏᏊ⤌᥮䛘〇ရ䛾Ᏻ඲ᛶ䛻㛵䛩䜛䜲䞁䝗䝛䝅䜰ඹ࿴ᅜᨻᗓつᐃ 2005 ᖺ➨ 21 ྕ
䠄 https://jdih.kemenkeu.go.id/fulltext/2005/21TAHUN2005PP.htm䚸᭱⤊䜰䜽䝉䝇᪥䠖2022 ᖺ 10 ᭶ 11 ᪥䠅

143

b. 䝸䝇䜽ホ౯䜢ᐇ᪋䛧䛯බㄆᶵ㛵䛛䜙䛾䝸䝇䜽ホ౯ཬ䜃⟶⌮䛻㛵䛩䜛ᩥ᭩䚹
4. ➨ 1 㡯䛾⏦ㄳ᭩䜢ཷ㡿䛧䛯ᚋ䚸㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛿䚸௨ୗ䛾஦᯶䜢⾜䛖䚹a. ➨ 2 㡯ཬ䜃➨ 3 㡯䛾᭩㢮ཬ䜃せồ஦㡯䛾᏶඲ᛶ䜢ᑂᰝ䛩䜛䚹b. PRG ㍺ධ䛻㐺⏝䛥䜜䜛ἲ௧䛻ᇶ䛵䛝䚸⏦ㄳ⪅䛜‶䛯䛩䜉䛝᭩㢮䜔せ௳䛻䛴䛔䛶䚸⏦ㄳ᭩ཷ⌮ᚋ 15 ᪥௨ෆ䛻⏦ㄳ⪅䛻㏻▱䛩䜛䚹
5. ➨ 2 㡯ཬ䜃➨ 3 㡯䛾᭩㢮ཬ䜃せ௳䛜䛭䜝䛳䛶䛔䜛ሙྜ䚸㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛿䚸⎔ቃ኱⮧䛻⎔ቃᏳ඲ド᫂᭩䛾᥎⸀䜢せㄳ䛩䜛䚹
6. 㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛿䚸⎔ቃ኱⮧ཪ䛿 KKH 䛾㛗䛜ᥦ౪䛩䜛⎔ቃᏳ඲ド᫂᭩䛾᥎⸀≧䛻ᇶ䛵䛔䛶Ỵᐃ䜢⾜䛖䚹ホ౯ᡭ㡰䠖
1. 㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛿 14 ᪥௨ෆ䛻䚸PRG ⎔ቃᏳ඲ド᫂᭩䛾⏦ㄳ᭩䜢⎔ቃ኱⮧ཪ䛿
KKH 䛾㛗䛻ᥦฟ䛩䜛䚹
2. KKH 䛜 14 ᪥௨ෆ䛻ホ౯䜢ᐇ᪋䛩䜛䚹
3. ᢏ⾡ⓗ䛺ᑂᰝ䛻㛵䛩䜛ሙྜ䚸KKH 䛿㑇ఏᏊ⤌᥮䛘〇ရ䛾Ᏻ඲ᛶ䛻㛵䛩䜛ᢏ⾡䝏䞊䝮䠄 TTKH䠖Tim Teknis Keamanan Hayati PRG 䠅䛻ᢏ⾡ᩥ᭩䛾ᑂᰝ䛸䚸ᚲせ䛻ᛂ䛨䛶䛥䜙䛻䝔䝇䝖䜢ᐇ᪋䛥䛫䜛䚹
4. ୖグ䛾ᢏ⾡ᩥ᭩䛾ホ౯ᮇ㛫䛿䚸KKH 䛛䜙䛾ጤკ≧䜢ཷ㡿䛧䛶䛛䜙 56 ᪥௨ෆ䛻⾜䛖䚹
5. TTKH 䛜⾜䛳䛯 PRG 䛾Ᏻ඲ᛶ䛻㛵䛩䜛ホ౯/ᢏ⾡ᑂᰝ䛾⤖ᯝ䛿䚸ホ౯/ᢏ⾡ᑂᰝ⤊஢ᚋ 7᪥௨ෆ䛻䚸PRG 䛾Ᏻ඲ᛶ䛻㛵䛩䜛່࿌᱌䜢సᡂ䛩䜛䛯䜑䛾㈨ᩱ䛸䛧䛶 KKH 䛻ᥦฟ䛥䜜䛺䛡䜜䜀䛺䜙䛺䛔䚹
6. KKH 䛻ᥦฟ䛥䜜䛯ホ౯ཬ䜃ᢏ⾡ᑂᰝ䛾⤖ᯝ䛻ᑐ䛧䛶䚸KKH 䛾ᐇ᪋ᶵ㛵䛷䛒䜛㑇ఏᏊ⤌᥮䛘〇ရ䛾Ᏻ඲ᛶホ౯ᶵ㛵䠄BKKH䠖Balai Kliring Keamanan Hayati Produk Rekayasa
Genetik䠅䛿䚸⏦ㄳཷ㡿ᚋ 15 ᪥௨ෆ䛻䚸60 ᪥㛫ᅜẸ䛜䜰䜽䝉䝇䛷䛝䜛ሙᡤ䛻ホ౯䛾㐣⛬ཬ䜃⤖ᯝ䛾ᴫせ䜢ᥖ♧䛧䚸ᅜẸ䛛䜙䛾ពぢ䜢ၥ䛖ᶵ఍䜢ᥦ౪䛩䜛䜒䛾䛸䛩䜛䚹
7. ➨ 13 㡯䛾ᥦฟྍ⬟䛺᝟ሗ䛻䛿䚸Ᏻ඲ᛶ䛸䛿㛵ಀ䛾䛺䛔▱ⓗ㈈⏘ᶒ䠄HKI䠅䛻㛵䛩䜛ၟᴗⓗ䛺᝟ሗ䛿ྵ䜎䜜䛺䛔䚹
8. ➨ 13 㡯䛾බ⾲ᮇ㛫ෆ䛻ᅜẸ䛛䜙䛾ពぢ䛜䛺䛔ሙྜ䚸ᅜẸ䛿 KKH 䛾᥎⸀᱌䛻ᑐ䛧䛶␗㆟䜢ၐ䛘䛺䛔䜒䛾䛸䜏䛺䛥䜜䜛䚹
9. ➨ 13 㡯䛾බ⾲ᮇ㛫⤊஢ᚋ䚸BKKH 䛿䚸㐜䛟䛸䜒 7 ᪥௨ෆ䛻䚸KKH 䛻ᑐ䛧䛶䚸බ⾲䛥䜜䛯ពぢ䛻㛵䛩䜛ሗ࿌᭩䜢ᥦฟ䛩䜛䚹
10. KKH 䛿䚸⎔ቃᏳ඲ᛶ䛻㛵䛩䜛᥎⸀≧䜢⎔ቃ኱⮧䛻ᥦฟ䛧䚸䛥䜙䛻㣗ရᏳ඲ᛶཬ䜃㣫ᩱᏳ඲ᛶ䛻㛵䛩䜛᥎⸀≧䜢䚸BKKH 䛛䜙䛾ሗ࿌᭩䜢ཷ䛡ྲྀ䛳䛶䛛䜙㐜䛟䛸䜒 14 ᪥௨ෆ䛻䚸㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛻ᥦฟ䛩䜛䚹
11. PRG 䛻㛵䛩䜛Ᏻ඲ᛶ䛾᥎⸀≧䜢⎔ቃ኱⮧䚸㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛻ᥦฟ䛩䜛㝿䚸KKH
䛾㛗䛿 TTKH 䛾᥎⸀≧ཬ䜃ᅜẸ䛛䜙䛾ពぢ䛻ὀព䜢ᡶ䛖䜒䛾䛸䛩䜛䚹
12. PRG 䛜⎔ቃ୰䛻ᨺฟ䛥䜜䜛ၟရ䛷䛒䜛ሙྜ䚸KKH 䛛䜙䛾᥎⸀≧䜢ཷ䛡䛶䛛䜙㐜䛟䛸䜒 14 ᪥௨ෆ䛻䚸⎔ቃ኱⮧䛿䚸㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛻⎔ቃᏳ඲᥎⸀≧䜢ᥦฟ䛩䜛䜒䛾䛸䛩䜛䚹
13. PRG 䛾Ᏻ඲ᛶ䛻㛵䛩䜛᥎⸀≧䜢⎔ቃ኱⮧䚸㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛻ᥦฟ䛩䜛㝿䚸KKH
䛾㛗䛿 TTKH 䛛䜙䛾᥎⸀≧䛸ᅜẸ䛛䜙䛾ពぢ䛻ὀព䜢ᡶ䛖䚹
14. PRG 䛜⎔ቃ୰䛻ᨺฟ䛥䜜䜛ၟရ䛷䛒䜛ሙྜ䚸⎔ቃᏳ඲ᛶ䛻㛵䛩䜛᥎⸀≧䜢䚸KKH 䛛䜙䛾᥎⸀≧䜢ཷ䛡ྲྀ䛳䛶䛛䜙㐜䛟䛸䜒 14 ᪥௨ෆ䛻䚸㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛻ᥦฟ䛩䜛䚹144

᭩㢮ᑂᰝ䠖
1. ᭩㢮ᑂᰝ䛿䚸௨ୗ䛻ᑐ䛧䛶⾜䛖䚹a. ⟶⌮䛾᏶඲ᛶb. ᐇ㉁ⓗ䛺᝟ሗc. ḟ䜢ྵ䜐ヨ㦂ᑐ㇟✀䛻㛵䛩䜛㏣ຍ᝟ሗ
i.
ヨ㦂䛾ලయⓗ䛺┠ⓗཬ䜃䛭䛾ሙᡤ䚸⏕ᜥᆅ䚸⏕ែ⣔䚹
ii.
PRG 䛾㑇ఏᏛ䚸ᐇ㦂ᡭ㡰䚸䝰䝙䝍䝸䞁䜾䚸䝕䞊䝍䚸㑇ఏⓗ䛺Ᏻᐃᛶ䛾ㄝ᫂䚹d. ⏦ㄳ⪅䛾㌟ศド᫂᭩䠄タ❧ド᭩/ἲே᱁ド᫂᭩䚸⣡⛯⪅␒ྕ䠄NPWP䠅䜢ྵ䜐䠅䚹
2. ⏦ㄳ⪅䛿䚸ึ䜑䛶⎔ቃ୰䛻ᨺฟཬ䜃/ཪ䛿ὶ㏻䛥䜜䜛 PRG 䛾⏦ㄳ䛻䛴䛔䛶䚸ᐇ㦂ᐊ䚸㝈ᐃヨ㦂᪋タཬ䜃/ཪ䛿㝈ᐃヨ㦂ሙ䛻䛚䛔䛶⎔ቃᏳ඲ᛶヨ㦂䜢ᐇ᪋䛩䜛䛣䛸䛜せồ䛥䜜䜛䚹
3. ⏦ㄳ⪅䛿䚸ึ䜑䛶ὶ㏻䛥䜜䜛⏦ㄳ῭䛾 PRG 䛻䛴䛔䛶䚸ᐇ㦂ᐊ䛷䛾㣗ရᏳ඲ヨ㦂䜢ᐇ᪋䛩䜛⩏ົ䛜䛒䜛䚹
4. ୖグ䛾Ᏻ඲ᛶヨ㦂䛿䚸ᡤ⟶䛩䜛ᶵ㛵䛜ᐇ᪋䛩䜛䚹
5. ➨ 4 㡯䛾ᶵ㛵䛿䚸ḟ䛾せ௳䜢‶䛯䛩䜒䛾䛷䛺䛡䜜䜀䛺䜙䛺䛔䚹a. PRG 䛾⎔ቃᏳ඲ᛶ䚸㣗ရᏳ඲ᛶཬ䜃/ཪ䛿㣫ᩱᏳ඲ᛶ䛾ヨ㦂䜢ᐇ᪋䛷䛝䜛ேᮦ䜢᭷䛧䛶䛔䜛䚹
b. ㄆᐃ䛥䜜䛯ヨ㦂ᡤཬ䜃㝈ᐃヨ㦂タഛ䜢฼⏝䛩䜛䚹
6. ➨ 5 㡯 b 䛾ヨ㦂ᡤཬ䜃㝈ᐃヨ㦂タഛ䛿䚸ḟ䛾䛸䛚䜚䛸䛩䜛䚹a. ༑ศ䛺᪋タཬ䜃タഛ䛜䛒䜛䚹b. Ᏻ඲ᛶヨ㦂䜺䜲䝗䝷䜲䞁䛻ᚑ䛔䚸PRG 䛾⎔ቃᏳ඲ᛶ䚸㣗ရᏳ඲ᛶཬ䜃/ཪ䛿㣫ᩱᏳ඲ᛶ䛻䛴䛔䛶䚸᭷ຠ䛛䛴Ᏻ඲䛺ヨ㦂᪉ἲ䜢౑⏝䛩䜛䚹c. 䝔䝇䝖⤖ᯝ䛾ṇ☜ᛶ䜢ಖド䛩䜛䚹
7. KKH 䛿䚸TTKH 䛜ᐇ᪋䛧䛯 PRG ホ౯⤖ᯝ䛾ᴫせ䜢䚸TTKH 䛛䜙䛾ᢏ⾡ホ౯ཷ㡿ᚋ 60 ᪥㛫䚸༳ๅ፹య䚸㟁Ꮚ፹యཬ䜃 KKH 䛾බᘧ䝙䝳䞊䝇䛷୍⯡䛻බ⾲䛩䜛䛣䛸䜢 BKKH 䛻ጤ௵䛩䜛䚹8. ➨ 7 㡯䛾බ⾲ᮇ㛫୰䚸ᅜẸ䛿䚸KKH 䛻ᑐ䛧䛶᭩㠃䛷ពぢ䜢ᥦฟ䛩䜛ᶵ఍䛜䛒䜛䚹
9. ➨ 7 㡯䛾ᮇ㛫⤒㐣ᚋ䛻ᥦฟ䛥䜜䛯➨ 8 㡯䛾ពぢ䛿䚸᳨ウ㈨ᩱ䛸䛧䛶ཷ䛡௜䛡䜛䛣䛸䛿䛷䛝䛺䛔䚹
10. TTKH 䛾ㄪᰝ⤖ᯝཬ䜃ᅜẸ䛛䜙䛾ពぢ䛻ᇶ䛵䛝䚸KKH 䛿᥎⸀≧䜢ᥦฟ䛩䜛䚹a. PRG 䛜⎔ቃ䛻Ᏻ඲䛛ྰ䛛䚸⎔ቃ኱⮧䛻ሗ࿌䛩䜛䚹b. PRG 䛾㣗ရᏳ඲ᛶཬ䜃/ཪ䛿㣫ᩱᏳ඲ᛶཪ䛿㠀Ᏻ඲ᛶ䛻䛴䛔䛶䚸㛵㐃኱⮧ཬ䜃/ཪ
䛿 LPND 䛾㛗䛻ሗ࿌䛩䜛䚹
11. ᑂᰝ䛻ྜ᱁䛧䛯 PRG 䛿䚸KKH 䛛䜙⎔ቃᏳ඲ᛶ䚸㣗ရᏳ඲ᛶ䚸㣫ᩱᏳ඲ᛶ䛾ヨ㦂⤖ᯝド᫂᭩䛜ᤵ୚䛥䜜䚸➨ 10 㡯䛾᥎⸀≧䛸䛸䜒䛻⎔ቃ኱⮧䛻ᥦฟ䛥䜜䜛䚹
12. PRG 䛜ᑂᰝ䛻ྜ᱁䛧䛺䛛䛳䛯ሙྜ䚸KKH 䛿⎔ቃ኱⮧䚸㛵㐃኱⮧ཬ䜃/ཪ䛿 LPND 䛾㛗䛻䚸୙ྜ᱁䛾⌮⏤䛸䛸䜒䛻୙ྜ᱁䛾່࿌䜢ᥦฟ䛩䜛䚹
13. ➨ 10 㡯䛾⎔ቃᏳ඲ᛶ䚸㣗ရᏳ඲ᛶཬ䜃/ཪ䛿㣫ᩱᏳ඲ᛶ䛻㛵䛩䜛 KKH 䛛䜙䛾᥎⸀≧䛻ᇶ䛵䛝䚸a. ⎔ቃ኱⮧䛿䚸⎔ቃᏳ඲ᛶ䛻㛵䛩䜛᥎⸀≧䜢䚸⎔ቃᏳ඲ド᫂᭩䛸䛸䜒䛻䚸㛵㐃኱⮧ཪ
䛿 LPND 䛾㛗䛻ᥦฟ䛩䜛䚹b. 㛵㐃኱⮧ཪ䛿 LPND 䛾㛗䛿䚸㣗ရᏳ඲ᛶཬ䜃/ཪ䛿㣫ᩱᏳ඲ᛶ䛻㛵䛩䜛ド᫂᭩䜢Ⓨ⾜䛩䜛䚹
14. 䛣䛾ᨻᗓつ๎䛾ᐇ᪋䛻ᚲせ䛺䛩䜉䛶䛾㈝⏝䛿䚸ᅜᐙ㈈ᨻ䛾ศ㔝䛻䛚䛡䜛⌧⾜䛾ἲᚊཬ䜃つ145๎䛻ᇶ䛵䛔䛶Ỵᐃ䛥䜜䜛䚹

5.4 ື≀⏝་⸆ရⓏ㘓⏦ㄳ᭩グධせ㡿䠄GUIDANCE ON APPLICATIONOF VETERINARY DRUG䠅
ῧ௜㈨ᩱ A䠖ື≀⏝་⸆ရ䛾ᡂศI. ་⸆ရ〇๣ཬ䜃䝥䝺䝭䝑䜽䝇䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔
1. ື≀⏝་⸆ရ⤌ᡂ≀
2. ≀㉁ྡ䛿୍⯡ྡ䛷グ㍕䛩䜛䛣䛸
3. ᭷ຠᡂศ䛾໬Ꮫᘧ䚹ཧ⪃ᣦᐃᩥ⊩䛻᪤䛻グ㍕䛥䜜䛶䛔䜛ሙྜ䛿䚸ฟ඾䜢グ㍕䛩䜛䛣䛸
4. ໬Ꮫᘧ䛜୙᫂䛺ཎᮦᩱ䛻䛴䛔䛶䛿䚸༑ศ䛺ㄝ᫂䜢䛩䜛䛣䛸䚹౛䠖Ⓨ㓝〇ရ䚸᳜≀/ື≀/䛭䛾௚䛾⏕≀䛛䜙䛾ᢳฟ≀II. ⏕≀Ꮫⓗ〇๣
1. ⾑Ύ䛾ሙྜ䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹- ⾑Ύ䜢⏘⏕䛧䛯ື≀- ච␿䜾䝻䝤䝸䞁䛻ྵ䜎䜜䜛≉␗ⓗ䛺ᙧែ䛾᭷ຠᡂศ- ᢠయ≀㉁䛾ṇᘧྡ⛠- ᢠయ≀㉁䛾༢఩㔞- 㜵⭉๣䛸䛭䛾ᐜ㔞
2. 䝽䜽䝏䞁䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
2.1. ᢠཎᛶάᛶᡂศ䛿䚸௨ୗ䛾ᙧែ䛸䛩䜛䛣䛸䛜䛷䛝䜛- ⣽⳦䚸䜴䜲䝹䝇䚸ᐤ⏕⹸䚸䛭䛾௚䛾⏕≀Ꮫⓗ≀㉁- 䝖䜻䝋䜲䝗䚸୙άᛶ໬䚸⏕䝽䜽䝏䞁- ᢠཎᰴ䛾䝍䜲䝥䛸䝃䝤䝍䜲䝥䚸ཬ䜃䛭䜜䜙䛾ṇᘧ䛺ᚋ௦- ᚤ⏕≀䞉ᐤ⏕⹸䠄䜴䜲䝹䝇䠅䛾ྵ᭷㔞䚸⣽⳦䛾ᩘ䚸ᐤ⏕⹸䛾ᩘ䚸䛭䛾௚䛾⳦య≀㉁
2.2. ௨ୗ䛾ᶵ⬟䛾㈿ᙧ๣
2.2.1. 㜵⭉๣
2.2.2. ྾཰๣
2.2.3. ⿵ຓ๣䠄adjuvant䠅
2.2.4. Ᏻᐃ๣
2.2.5. 䛭䛾௚≀㉁ྡ䛿୍⯡ྡ䛷⾲♧䛩䜛䛣䛸䛜䛷䛝䜛
3. ⏕≀Ꮫⓗデ᩿⸆䛻䛴䛔䛶䛿䚸㈿ᙧ๣䜢ྵ䜑䛯䝽䜽䝏䞁䛾ሙྜ䛸ྠ䛨஦㡯䜢ᇶᮏⓗ䛻グ㍕䛩䜛ᚲせ䛜䛒䜛㻌㻌

146

ῧ௜㈨ᩱ B䠖〇㐀᪉ἲI. ་⸆ရ〇๣ཬ䜃䝥䝺䝭䝑䜽䝇䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔
1. ື≀⏝་⸆ရ䛾⤌ᡂ≀䛻ྵ䜎䜜䛺䛔㈿ᙧ๣䜢ྵ䜑䛯ྛ䝞䝑䝏ᕤ⛬䛾ཎᮦᩱ䛾㔞䚹䜎䛯䚸ᕤ⛬඲య䛾ཎᮦᩱ䛾㔞
2. ᕤሙ䝺䜲䜰䜴䝖䚸ேᮦ䚸䛭䛾௚䛛䜙䛺䜛〇㐀䜲䞁䝣䝷䛾ㄝ᫂
3. ᚲせ䛺タഛ
4. 〇㐀ᕤ⛬5. ᶵჾ䚸ᮦᩱ䚸㒊ᒇ䛾⁛⳦᪉ἲ䠄ᚲせ䛺ሙྜ䠅
6. 〇㐀ᕤ⛬୰䜔๓ᚋ䛻䛚䛡䜛ཎᮦᩱ䚸ᶵჾ䚸సᴗሙ➼䛾⟶⌮II. ⏕≀Ꮫⓗ〇๣
A. ⾑Ύ䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ౑⏝䛧䛯ື≀✀䜢ྵ䜐䚸〇㐀ᕤ⛬䜔〇㐀᫬䛾㔜せ஦㡯䛾ヲ⣽
2. ච␿䛾䛯䜑䛾≉␗ᢠཎ
3. ⢭〇᪉ἲ䜢ྵ䜐᥇ྲྀ᪉ἲ
4. ᢞ୚㔞䛾Ỵᐃ᪉ἲ
5. 〇㐀๓䚸〇㐀୰䚸〇㐀ᚋ䛾ཎᮦᩱ䚸タഛ䚸㒊ᒇ䛺䛹䛾⟶⌮B. 䝽䜽䝏䞁ཬ䜃⏕≀Ꮫⓗデ᩿⸆䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. 〇㐀ᕤ⛬ཬ䜃〇㐀ୖ䛾㔜せ஦㡯䛾ヲ⣽
2. 䜴䜲䝹䝇䚸ᐤ⏕⹸䚸⣽⳦䚸䛭䛾௚䛾⏕≀Ꮫⓗ≀㉁䛾ᰴ䚸䝍䜲䝥䚸䝃䝤䝍䜲䝥
3. ᙅẘ᪉ἲ䚸≀⌮䞉໬Ꮫⓗ䛺୙άᛶ໬䛺䛹䛾ᐇ᪋᪉ἲ
4. ᢞ୚㔞䛾Ỵᐃ᪉ἲ
5. 〇㐀ᕤ⛬䛾๓ᚋ䛻䛚䛡䜛ཎᮦᩱ䚸タഛ䚸㒊ᒇ䛺䛹䛾⟶⌮ῧ௜㈨ᩱ C䠖ື≀⏝་⸆ရ᭱⤊〇ရ䛾⟶⌮
I. ་⸆ရཬ䜃䝥䝺䝭䝑䜽䝇〇๣䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔
1. ື≀⏝་⸆ရ〇๣䛾ㄝ᫂᭩ཬ䜃௙ᵝ᭩䛻䛿䚸〇๣䛾ᙧែ䚸⃰ᗘ䚸Ⰽ䚸ໝ䛔ཬ䜃࿡䜢ྵ䜑䜛䚹౛䛸䛧䛶䚸௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹- ⢊ᮎ䠖㔜㔞䛾ᆒ୍ᛶ䚸䛛䛥ᐦᗘ䚸⁐ゎᛶ䚸‵ᗘ䛺䛹- 㘄๣䞉୸⸆䠖኱䛝䛥䚸㔜㔞䛾ᆒ୍ᛶ䚸ᖹᆒ㔜㔞䚸ᔂቯ᫬㛫䚸◳ᗘ䞉ᦶᦆᗘ䚸⁐ฟ㏿ᗘ䚸≉ู䛺⾲グ䛺䛹- 䜹䝥䝉䝹䠖኱䛝䛥䚸㔜㔞䛾ᆒ୍ᛶ䚸ᖹᆒ㔜㔞䚸⁐ゎ᫬㛫䚸≉ู䛺⾲グ䛺䛹- ⁐ᾮ䞉ᾮ๣䠖Ύ⃈ᗘ䚸⢓ᗘ䚸ᐜ㔞䚸ẚ㔜䚸pH 䛺䛹- ㌾⭯䞉䝨䞊䝇䝖䞉䝊䝸䞊䞉䜽䝸䞊䝮๣䠖㔜㔞䛾ᆒ୍ᛶ䚸ᆒ㉁ᛶ䚸Ỉᛶᠱ⃮ᾮ䛾 pH 䛺䛹- 䛭䛾௚〇๣ᙧែ
2. ື≀⏝་⸆ရ䛾᭷ຠᡂศ䛾ྠᐃ䛸䜰䝑䝉䜲䠄ྛ᭷ຠᡂศ䛾ศ㞳᪉ἲ䜔䛭䜜䛻㛵䛩䜛ཧ↷㈨ᩱ䜢
ྵ䜐䠅

147

3. ື≀⏝་⸆ရ䛾↓⳦ᛶヨ㦂䚸Ⓨ⇕ᛶヨ㦂䚸᭷ຠᛶヨ㦂䚸ཬ䜃䛭䛾௚䛾ヨ㦂
4. ྛ⏕⏘⪅䛛䜙䛾᭱᪂䛾ศᯒド᫂᭩䠄ศᯒド᫂᭩䛿⨫ྡ䛸ᤫ༳䛜ᚲせ䛷䛒䜚䚸ရ㉁⟶⌮㈐௵⪅䛾ྡ๓䜒グ㍕䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅II. ⏕≀Ꮫⓗ〇๣
A. ⾑Ύ䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ≉␗ච␿䜾䝻䝤䝸䞁䛾ྠᐃἲ䛸䜰䝑䝉䜲ἲ
2. ㈿ᙧ๣䛾ศ㞳ἲ䚸ྠᐃἲཬ䜃䜰䝑䝉䜲ἲ
3. ↓⳦ᛶヨ㦂䚸᭷ຠᛶヨ㦂䚸␗ᖖẘᛶヨ㦂䚸Ᏻ඲ᛶヨ㦂䚸䛭䛾௚䛾ᚲせ䛺ヨ㦂᪉ἲ
4. ྛ⏕⏘⪅䛛䜙䛾᭱᪂䛾ศᯒド᫂᭩䠄ศᯒド᫂᭩䛿⨫ྡ䛸ᤫ༳䛜ᚲせ䛷䛒䜚䚸 ရ㉁⟶⌮㈐௵
⪅䛾ྡ๓䜒グ㍕䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅
B. 䝽䜽䝏䞁ཬ䜃⏕≀Ꮫⓗデ᩿⸆䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ≉␗ᢠཎ䛾ྠᐃἲ䛸䜰䝑䝉䜲ἲ
2. ㈿ᙧ๣䛾ศ㞳ἲ䚸ྠᐃἲཬ䜃䜰䝑䝉䜲ἲ
3. 䝬䜲䝁䝥䝷䝈䝬䚸䛭䛾௚䛾⑓ཎᛶ≀㉁䜢᳨ฟ䛩䜛䛯䜑䛾ุᐃ᪉ἲ
4. ↓⳦ᛶヨ㦂䚸␗ᖖẘᛶヨ㦂䚸₯ᅾⓗ୙άᛶ໬䛾ヨ㦂᪉ἲ䚸䛭䛾௚䛾ᚲせ䛺ヨ㦂᪉ἲ
5. ྛ⏕⏘⪅䛛䜙䛾᭱᪂䛾ศᯒド᫂᭩䠄ศᯒド᫂᭩䛿⨫ྡ䛸ᤫ༳䛜ᚲせ䛷䛒䜚䚸 ရ㉁⟶⌮㈐௵
⪅䛾ྡ๓䜒グ㍕䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅

ῧ௜㈨ᩱ D䠖ཎᮦᩱ䛾᳨ᰝI. ་⸆ရཬ䜃䝥䝺䝭䝑䜽䝇〇๣䛾ሙྜ䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔
1. 䛩䜉䛶䛾ཎᮦᩱ䛾ㄝ᫂䛸௙ᵝ2. 䛩䜉䛶䛾ཎᮦᩱ䛾ྠᐃཬ䜃䜰䝑䝉䜲
3. 䛩䜉䛶䛾ཎᮦᩱ䛾⣧ᗘཬ䜃ྵ᭷㔞䛻㛵䛩䜛せồ஦㡯䚸୪䜃䛻ཎᮦᩱ䛾ศᯒド᫂᭩
4. ཎᮦᩱ䛾↓⳦ᛶ䚸Ⓨ⇕ᛶ≀㉁䚸᭷ຠᛶ䚸䛭䛾௚
5. 䛩䜉䛶䛾ཎᮦᩱ䛾᭱᪂䛾ศᯒド᫂᭩䠄ศᯒド᫂᭩䛿⨫ྡ䛸ᤫ༳䛜ᚲせ䛷䛒䜚䚸ရ㉁⟶⌮㈐௵⪅䛾ྡ๓䜒グ㍕䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅II. ⏕≀Ꮫⓗ〇๣
A. ⾑Ύ䛾ሙྜ䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ච␿య䜢⏕ᡂ䛩䜛≉␗ᢠཎ䛾ྠᐃἲ䛸䜰䝑䝉䜲ἲ
2. ⾑Ύ〇㐀䛻౑⏝䛩䜛ື≀᮲௳䛾Ỵᐃ䠄ᐇ㦂⏝ື≀䛾⣔⤫䚸✀㢮䚸㣫⫱᪉ἲ䛺䛹䠅
3. ཎᩱ䜔㈿ᙧ๣䛾᳨ᰝ
4. 䛩䜉䛶䛾ཎᮦᩱ䛾᭱᪂䛾ศᯒド᫂᭩䠄ศᯒド᫂᭩䛿⨫ྡ䛸ᤫ༳䛜ᚲせ䛷䛒䜚䚸ရ㉁⟶⌮㈐௵⪅ 䛾ྡ๓䜒グ㍕䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅
B. 䝽䜽䝏䞁ཬ䜃⏕≀Ꮫⓗデ᩿⸆䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. 䝬䝇䝍䞊䝅䞊䝗䚸䝽䞊䜻䞁䜾䝅䞊䝗䚸䜴䜲䝹䝇䚸⣽⳦䚸ᐤ⏕⹸ཬ䜃䛭䛾௚䛾⏕≀Ꮫⓗ≀㉁䛻䛴
䛔䛶䚸䛭䛾⏤᮶䛾グ㘓䛸つ᱁

148

2. 䜴䜲䝹䝇䚸⣽⳦䚸ᐤ⏕⹸ཬ䜃⏕≀Ꮫⓗ≀㉁䛾ᇵ㣴䛻౑⏝䛧䛯ᇵᆅ≀㉁䛾ྠᐃἲཬ䜃䜰䝑䝉䜲ἲ䠄ᐇ㦂ື≀䛾✀㢮ཬ䜃ᖺ㱋䚸⤌⧊ᇵ㣴ཬ䜃䛭䛾௚䛾ᇵᆅ䜢ྵ䜐䠅
3. 䜴䜲䝹䝇䚸⣽⳦䚸ᐤ⏕⹸ཬ䜃䛭䛾௚䛾⏕≀Ꮫⓗ≀㉁䛾䝬䝇䝍䞊䝅䞊䝗ཬ䜃䝽䞊䜻䞁䜾䝅䞊䝗䛾ྠᐃἲཬ䜃䜰䝑䝉䜲ἲ
4. 䜴䜲䝹䝇䚸⣽⳦䚸ᐤ⏕⹸ཬ䜃䛭䛾௚䛾⏕≀Ꮫⓗ≀㉁䛾䝬䝇䝍䞊䝅䞊䝗ཬ䜃䝽䞊䜻䞁䜾䝅䞊䝗䚸ᇵᆅ䛻㛵䛩䜛ရ㉁せồ஦㡯
5. ≉䛻⏕≀Ꮫⓗデ᩿⸆䛻䛴䛔䛶䛿䚸౑⏝䛥䜜䜛䜴䜲䝹䝇䚸⣽⳦䚸ᐤ⏕⹸ཬ䜃䛭䛾௚䛾⏕≀Ꮫⓗ≀㉁䛻㛵䛩䜛ᅜ㝿ᶆ‽䛾⾲♧
6. ཎᮦᩱ䛾᭱᪂䛾ศᯒド᫂᭩䠄ศᯒド᫂᭩䛿⨫ྡ䛸ᤫ༳䛜ᚲせ䛷䛒䜚䚸ရ㉁⟶⌮㈐௵⪅ 䛾ྡ๓䜒グ㍕䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅

ῧ௜㈨ᩱ E䠖Ᏻᐃᛶ䛾᳨ᰝ䛩䜉䛶䛾✀㢮䛾〇๣䛻䛴䛔䛶䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔
1. ୍ᐃᮇ㛫䛻ື≀⏝་⸆ရ䛾䛔䛟䛴䛛䛾䝞䝑䝏䛻ᑐ䛧䛶ᐇ᪋䛥䜜䛯Ᏻᐃᛶ᳨ᰝ䛾᪉ἲ䛸⤖ᯝ
2. Ᏻᐃᛶ᳨ᰝ䛾ᇶ‽౛䠖- Ⰽ䚸㏱᫂ᗘ䚸pH 䛺䛹≉ᐃ䛾௙ᵝ䜈䛾㐺ྜᛶ- ྵ᭷㔞/᭷ຠᛶ䛾せ௳- ゎ㞳䛻䜘䜛ྵ㔞䝺䝧䝹
3. ᐇ㦂䛻ᇶ䛵䛟ື≀⏝་⸆ရ䛾Ᏻᐃᛶᮇ㛫
4. ὀᑕ⏝⢊ᮎཪ䛿䝗䝷䜲䝅䝻䝑䝥䛻⁐፹䜢ຍ䛘䛯䜒䛾䛺䛹䚸ໟ⿦䛛䜙ྲྀ䜚ฟ䛥䜜䛯〇๣䛾Ᏻᐃᛶ᳨ᰝ᪉ἲཬ䜃⤖ᯝ
5. Ᏻᐃᛶ䛻ᙳ㡪䜢ཬ䜌䛩ᅉᏊ
6. Ᏻᐃᛶ᳨ᰝ䛾᭱᪂⤖ᯝ䝕䞊䝍䠄⨫ྡ䚸ᤫ༳䚸䜎䛯ရ㉁⟶⌮㈐௵⪅䛾ྡ๓䜒グ㍕䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅ῧ௜㈨ᩱ F䠖ື≀⏝་⸆ရ䛾⸆⌮స⏝I. ་⸆ရ〇๣ཬ䜃䝥䝺䝭䝑䜽䝇䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ௨ୗ䜢ྵ䜐ᐇ㦂ෆᐜ
a. ྾཰䚸ศᕸ䚸⏕యෆኚ໬ཬ䜃⸆≀᤼ἥ䛻㛵䛩䜛ື≀⏝་⸆ရ䛾᭷ຠᡂศཬ䜃᭱⤊〇ရ䛾⸆≀ືែb. ⸆≀స⏝䝯䜹䝙䝈䝮䚸୺స⏝䚸๪స⏝/ẘᛶ䛻㛵䛩䜛ື≀⏝་⸆ရ䛾᭷ຠᡂศཬ䜃᭱⤊〇ရ䛾⸆ຊᏛ- ⸆≀༙ῶᮇ䠄T1/2䠅
- ᛴᛶẘᛶ䠖⑕≧䚸䠄LD50䠅
- ளᛴᛶẘᛶ䚸䝠䝖⮚ჾ䛻ᑐ䛩䜛៏ᛶẘᛶ- ≉Ṧẘᛶ䠖ኚ␗ཎᛶ䚸ദወᙧᛶ䚸䜒䛧䛒䜜䜀䚸Ⓨ䛜䜣ᛶ- ๪స⏝䛾ゎẘ๣
2. ື≀✀䛻ᛂ䛨䛯㐺ᛂ⑕䚸䜒䛧䛒䜜䜀䚸⚗ᚷ⑕ཬ䜃䛭䛾ㄝ᫂䚸ᢞ୚᪉ἲ䚸ᢞ୚㔞
3. ᢠ⏕≀㉁ཬ䜃䛭䛾௚䛾໬Ꮫ⒪ἲ๣䠖ᚤ⏕≀ཬ䜃ᐤ⏕⹸䛾⪏ᛶ䚸௚䛾ᢠ⏕≀㉁䛻ᑐ䛩䜛஺ᕪ⪏149

ᛶ
4. ⏘ᴗື≀䛾ఇ⸆ᮇ㛫䠄௨ୗ䜒グ㍕䠅
- ఇ⸆ᮇ㛫䛾Ỵᐃ᪉ἲ- ⮬♫䛷ᐇ᪋䛧䛶䛔䛺䛔ሙྜ䛿䚸ཧ↷䛧䛯㈨ᩱ䛾グ㍕
5. ௚䛾≀㉁䛸䛾┦஫స⏝
6. ື≀⏝་⸆ရ䛾ṧ␃
7. ᢞ୚㔞Ỵᐃ䛾ᇶᮏⓗ䛺グ㏙䠄༢๣䛸ྜ๣䛾୧᪉䠅
8. ༢๣䛸ẚ㍑䛧䛯ྜ๣䛾౑⏝᪉ἲ䠄䛩䜉䛶䛾ྜ๣䛻䛴䛔䛶䠅II. ⏕≀Ꮫⓗ〇๣䠄⾑Ύ䚸䝽䜽䝏䞁䚸⏕≀Ꮫⓗデ᩿⸆䠅䛻䛴䛔䛶䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ⾑Ύ䚸䝽䜽䝏䞁䚸⏕≀Ꮫⓗデ᩿⸆䛾᭷ຠᡂศ䛾⸆≀స⏝䝯䜹䝙䝈䝮
2. ẘᛶ䚸䜰䝺䝹䜼䞊䚸᥋✀ᚋ཯ᛂ䛾Ⓨ⌧䛾᭷↓ཬ䜃๪స⏝䛾἞⒪ἲ
3. ᐇ㦂䠖ᡭ㡰䚸ᇶ‽䚸⤖ᯝ䚸䝕䞊䝍ศᯒ
4. ண㜵᥋✀䛾⤖ᯝ䚸ච␿ᮇ㛫䠄୍౯䚸ከ౯䜢ྵ䜐䠅
5. デ᩿⸆䛷౑⏝䛥䜜䜛ホ౯ᇶ‽

ῧ௜㈨ᩱ G䠖㔝እ⮫ᗋヨ㦂䛾㈨ᩱ
A. 䛩䜉䛶䛾✀㢮䛾〇๣䛻䛴䛔䛶䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔
1. ᑡ䛺䛟䛸䜒௨ୗ䛾஦㡯䜢ྵ䜐య⣔ⓗ䛺ᥦ♧᪉ᘧ䛻ᚑ䛳䛶సᡂ䛥䜜䛯἞㦂ᐇ᪋ሗ࿌᭩- ᐇ㦂䛾⫼ᬒ䚸ᮦᩱ䛸᪉ἲ䠄౑⏝䛧䛯ື≀䛾ᩘ䚸✀䚸ሙᡤ䚸䛭䛾௚ᚲせ䛸ᛮ䜟䜜䜛䛣䛸䠅䚸ᡭ㡰䚸⤖ᯝ䚸⪃ᐹ䚸⤖ㄽ
2. ๪స⏝䛻㛵䛩䜛ሗ࿌- ་⸆ရ䛾౑⏝ୖዲ䜎䛧䛟䛺䛔஦㡯
3. 䜒䛧䛒䜜䜀䚸⚗ᚷ⑕䛻㛵䛩䜛᝟ሗཬ䜃䛭䛾ෆᐜB. ᪤䛻༑ศ䛺㈨ᩱ䛜ከᩘ䛒䜛〇๣䛻䛴䛔䛶䛿䚸䛩䜉䛶䛾᰿ᣐ㈨ᩱ䜢ῧ௜䛧䛺䛡䜜䜀䛺䜙䛺䛔

ῧ௜㈨ᩱ H䠖ᐜჾཬ䜃ໟ⿦ᮦ䛻㛵䛩䜛ㄝ᫂䛩䜉䛶䛾✀㢮䛾〇๣䛻䛴䛔䛶䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔
1. ㄪ๣ᐜჾ䚸䛩䛺䜟䛱ື≀⏝་⸆ရ䛸┤᥋᥋ゐ䛩䜛ᐜჾ䛾ㄝ᫂䠄ᐜჾᮦᩱ䛾✀㢮䛸ရ㉁ཬ䜃䛭䛾ヨ㦂᪉ἲ䚸ᐜჾ䛾኱䛝䛥ཬ䜃䚸ྍ⬟䛷䛒䜜䜀ᐜჾ䛾ෆഃ䛻䛴䛔䛶䛾ㄝ᫂䠅䚹ᐦ㛢ᐜჾ䛾せ௳䛸ヨ㦂᪉ἲ䚸₃䜜䛾ྍ⬟ᛶ䚸⸆≀䛸ᐜჾ䛾┦஫స⏝䛾ྍ⬟ᛶ
2. 䜒䛧䛒䜜䜀ື≀⏝་⸆ရ䛾ᐜჾ䛾ໟ⿦ᮦ䛻㛵䛩䜛ㄝ᫂䚹ໟ⿦ᮦ䛾✀㢮䛸ရ㉁䚸᳨ᰝ᪉ἲ䚸ໟ⿦ᮦ䛾䝃䜲䝈䛸௙ᵝ3. 䜺䝷䝇䚸䝥䝷䝇䝏䝑䜽䚸㔠ᒓ䛾✀㢮䜢ྵ䜑䛶䚸ୖグ➨ 1 ᮲䛸➨ 2 ᮲䛾ᮦᩱ䛾✀㢮䛸ရ㉁䛻㛵䛩䜛ㄝ᫂
4. ᐜჾ䛾䝃䜲䝈䠄㔜㔞䞉ᐜ㔞䞉⏝ἲ䠅䛾ㄝ᫂

150

ῧ௜㈨ᩱ 㻵䠖ᐜჾ䛾⵹䛻㛵䛩䜛ㄝ᫂䛩䜉䛶䛾✀㢮䛾〇๣䛻䛴䛔䛶䚸ᐜჾ䛻⵹䜢䛩䜛ᚲせ䛜䛒䜛ሙྜ䛿䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ⵹䛾ཎᮦᩱ䛾✀㢮䚸ရ㉁ཬ䜃ヨ㦂᪉ἲ䚸⵹䛾኱䛝䛥ཬ䜃௙ᵝ䛻㛵䛩䜛ㄝ᫂
2. ྍ⬟䛷䛒䜜䜀䚸⵹䛾ෆഃ䛻㛵䛩䜛ㄝ᫂
3. せ௳䚸ᐦ㛢ᐜჾヨ㦂ཬ䜃⸆๣䛸⵹䛾┦஫స⏝䛾ྍ⬟ᛶ
4. Ᏻ඲ᛶ䛻㛵䛩䜛ㄝ᫂䠄౛䛘䜀䚸⵹䜢㛤ᑒᚋ䛾≉ᛶ䛻䛴䛔䛶䛺䛹䠅

ῧ௜㈨ᩱ J䠖䝷䝧䝹䛻㛵䛩䜛ㄝ᫂ື≀⏝་⸆ရ䛾䝷䝧䝹䛿䚸䜲䞁䝗䝛䝅䜰ㄒ䛸䝻䞊䝬Ꮠ䛷⾲♧䛧䛺䛡䜜䜀䛺䜙䛪䚸⡆༢䛻ᾘ䛘䛺䛔༳ๅ䛸䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹䛩䜉䛶䛾✀㢮䛾〇๣䛻䛴䛔䛶䚸௨ୗ䛾஦㡯䜢グ㍕䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. 䝷䝧䝹䜔䝤䝸䝇䝍䞊䚸䝇䝖䝸䝑䝥䚸䜰䝹䝭䝙䜴䝮/䝉䝻䝣䜯䞁䛺䛹䛾እ⿦ᮦ䛻⾲♧䛥䜜䜛䚸䛭䛾௚䛾グ㏙䛾䝃䞁䝥䝹
2. ື≀⏝་⸆ရ䛾䝃䞁䝥䝹䛻௜ᒓ䛩䜛䝟䞁䝣䝺䝑䝖
3. 䝞䝑䝏␒ྕ䛾䝁䞊䝗䛻㛵䛩䜛ㄝ᫂
4. ື≀⏝་⸆ရホ౯ጤဨ఍䛜ᢎㄆ䛧䛯䝷䝧䝹ཬ䜃䝟䞁䝣䝺䝑䝖䛾䝕䝄䜲䞁䛿䚸⏦ㄳ௻ᴗ䛸ື≀⏝་⸆ရホ౯ጤဨ఍䛜ዎ⣙᭩䛻⨫ྡ䛧䛯ᚋ䚸ຠຊ䜢᭷䛩䜛䜒䛾䛸䛩䜛

ῧ௜㈨ᩱ K䠖〇๣䝃䞁䝥䝹ཬ䜃ᶆ‽᭷ຠᡂศ〇๣䝃䞁䝥䝹䚸ᶆ‽᭷ຠᡂศཬ䜃᭷ຠᡂศ䛾ཎᮦᩱ䠄Ⓩ㘓⏦ㄳ᭩䛛䜙ศ㞳䛧䛯䜒䛾䠅䜢ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹

ῧ௜㈨ᩱ L䠖䛭䛾௚䛾᝟ሗ≉䛻䚸㍺ධື≀⏝་⸆ရ〇๣ཬ䜃䝷䜲䝉䞁䝇໬䛥䜜䛯ື≀⏝་⸆ရ䛾ሙྜ䚸௨ୗ䛾஦㡯䜢ᚲ䛪グධ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹
1. ཎ⏘ᆅド᫂᭩䛾ᙜヱᅜᨻᗓ㛵ಀ⪅䛻䜘䜚Ⓨ⾜䛥䜜䛯ῧ௜᭩㢮 䠖⏕⏘ド᫂᭩䚸Ⓩ㘓ド᫂᭩䚸ྛື≀⏝་⸆ရ䛾⮬⏤㈍኎ド᫂᭩䛻ຍ䛘䛶䚸ື≀⏝་⸆ရ䛜ཎ⏘ᅜཬ䜃/ཪ䛿௚䛾ᅜ䛷㈍኎䠄ཪ䛿⮬⏤㈍኎䠅䛥䜜䛶䛔䜛䛣䛸䚸ཬ䜃〇๣㈍኎㛤ጞ᪥䛜グ㍕䛥䜜䛯᥎⸀≧䚹GMP ド᫂᭩䠄䛣䜜䜙䛾ド᫂᭩䛿䛩䜉䛶䚸ᙜヱᅜ䛾䜲䞁䝗䝛䝅䜰ඹ࿴ᅜ኱౑㤋/௦⾲㒊䛻䜘䛳䛶ᢎㄆཪ䛿ド᫂䛥䜜䛺䛡䜜䜀䛺䜙䛺䛔䠅
2. ྛ⏕⏘⪅䛛䜙䜲䞁䝗䝛䝅䜰䛷䛾㈍኎䜢ጤク䛥䜜䛯㍺ධᴗ⪅䜈䛾௵࿨≧
3. 〇㐀ཬ䜃෌ໟ⿦䛾䝷䜲䝉䞁䝇䜢ᥦ౪䛩䜛ᾏእ⏕⏘⪅䛾ㄝ᫂

151

5.5 ␆⏘⾨⏕ᒁ㛗Ỵᐃ➨ 54/TN.260/Kpts/DJP/2001 ྕ
ῧ௜㈨ᩱ A䠖ື≀⏝་⸆ရ䛾ᡂศ䛂ᡂศ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸Ᏻ඲䛷᭷ຠ䛺་⸆ရ䛷䛒䜛䛣䛸䜢ᥦ♧䛧䛶ഇ㐀䜢㑊䛡䜛䛯䜑䚸䛥䜙䛻䚸⣲ᛶ䜢ಖᣢ䛩䜛䛯䜑䛷䛒䜛䚹a. ≉ᐃ䛾ྡ⛠䛻ᚑ䛔䚸౑⏝䛥䜜䜛䛩䜉䛶䛾ᡂศ䛾ྡ⛠䚸᭷ຠᡂศཬ䜃⿵ຓ/ῧຍᡂศ䛻䛴䛔䛶䜒グ㍕䛧䚸ᙧ≧䚸ໟ⿦䚸⢏䠄䝍䝤䝺䝑䝖/䜹䝥䝉䝹/㘄๣䛺䛹䠅༢఩䛻ྵ䜎䜜䜛ྛᡂศ䛾㔞䜢㔜㔞ཪ䛿ᐜ㔞䚸䛒䜛䛔䛿⥲㔜㔞䛻ᑐ䛩䜛䝟䞊䝉䞁䝖䠄䠂䠅䛷グ㍕䛩䜛䚹̺ ྡ⛠䠖᳜≀඲య䜔᳜≀䛾㒊ศ䛜ㄗゎ䛥䜜䛺䛔䜘䛖䛻䚸䝷䝔䞁ྡ䛷ྡ⛠䜢⤫୍䛩䜛ᚲせ䛜䛒䜛䚹᳜≀䚸ື≀䚸㖔≀䛻⏤᮶䛩䜛≀㉁䛾ྡ⛠䛿䚸䜲䞁䝗䝛䝅䜰⸆ᒁ᪉䚸䜲䞁䝗䝛䝅䜰⸆ᒁ᪉䜶䜻䝇䝖䝷ཪ䛿䜲䞁䝗䝛䝅䜰་⒪ᮦᩱ䛻ᇶ䛵䛟䝷䝔䞁ㄒ䛾ྡ⛠䛻䜲䞁䝗䝛䝅䜰/ᆅᇦྡ䜢ῧ䛘䛶⾲グ䛩䜛䚹㍺ධཎᮦᩱ䛾ሙྜ䛿䚸ཎ⏘ᅜ䛾⸆ᒁ᪉ཪ䛿බᐃ᭩䛻‽䛨䛯ྡ⛠䜒グ㍕䛩䜛䛣䛸䚹̺ ᳜≀䚸ື≀䚸㖔≀䛻⏤᮶䛧䛺䛔ῧຍ≀䛿䚸䜲䞁䝗䝛䝅䜰⸆ᒁ᪉ཬ䜃䜲䞁䝗䝛䝅䜰⸆ᒁ᪉䜶䜻䝇䝖䝷䛻グ㍕䛥䜜䛶䛔䜛ྡ๓ཪ䛿䝬䞊䜽䜲䞁䝕䝑䜽䝇䛾䝍䜲䝖䝹䛻ᇶ䛵䛝グ㍕䛥䜜䛶䛔䜛䚹ᢳฟ㐣⛬䛷౑⏝䛥䜜䜛ῧຍ≀䜢ྵ䜑䚸౑⏝䛥䜜䜛ῧຍ≀䛿䚸ཌ⏕኱⮧䛜チྍ䛧䛯ῧຍ≀䛾つᐃ䛻ᚑ䛖ᚲせ䛜䛒䜛䚹̺ ╔Ⰽᩱ䜢౑⏝䛩䜛ሙྜ䚸౑⏝䛩䜛╔Ⰽᩱ䛿䚸ཌ⏕ປാ኱⮧䛜チྍ䛧䛯ῧຍ≀䛾つᐃ䛻ᚑ䛳䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹╔Ⰽᩱ䛿䚸⡆༢䛺୍⯡ྡཬ䜃䜹䝷䞊䜲䞁䝕䝑䜽䝇␒ྕ䠄No.CI䠅䛷グ㍕䛩䜛䚹
ῧ௜㈨ᩱ B䠖〇㐀᪉ἲ〇㐀᪉ἲ䛸䛿䚸ᮦᩱ䛾ㄪ㐩䠄ཎᮦᩱ䛾‽ഛ䜢ྵ䜐䠅䚸ຍᕤ䚸ໟ⿦䚸ရ㉁⟶⌮䜢ྵ䜏䚸ὶ㏻ཪ䛿㈍኎䛻㐺䛧䛯᏶ᡂရ䛻⮳䜛䜎䛷䛾䚸୍㐃䛾άື඲య䛾䛣䛸䜢ᣦ䛩䚹䛂〇㐀᪉ἲ䛃䛾᝟ሗ䜢グ㍕䛩䜛┠ⓗ䛿䚸⏕⏘䛥䜜䛯〇ရ䛜㧗ရ㉁䛷㐺ṇ䛺䜒䛾䛷䛒䜛䛣䛸䜢ᥦ♧䛩䜛䛯䜑䛷䛒䜛䚹
a. 䛂1 ᅇ䛾⏕⏘ィ⏬ᩘ䛃䜢グධ䛩䜛┠ⓗ䛿䚸౑⏝䛩䜛ᶵჾ䜔ᶵᲔ䛾⬟ຊ䛻ྜ䜟䛫䛶⏕⏘㔞䜢ㄪᩚ䛧䚸ᖖ䛻୍ᐃ䛾〇ရ䛜ᚓ䜙䜜䜛䜘䛖䛻䛩䜛䛣䛸䛷䛒䜛䚹1 ᅇ䛾⏕⏘䛾᏶ᡂရᩘ䛿䚸≉ᐃ䛾༢఩䛷⾲グ䛩䜛䚹౛䠖̺ ⢊ᮎ䠖1,000 ໟ@7g
̺ 㘄๣䠖10,000 㘄 @ 300mg
̺ 䜹䝥䝉䝹䠖10,000 䜹䝥䝉䝹@300mg
̺ 㢛⢏䠖⿄ 100gb. 䛂1 ᅇ䛾〇㐀䛻౑⏝䛩䜛ྛᮦᩱ䛾㔞䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸㔜㔞ཪ䛿య✚䛾༢఩䛻䛚䛔䛶ᇶᮏᡂศ䛻ᚑ䛳䛶౑⏝䛥䜜䜛ྛཎᮦᩱ䛾㔞䛜୍ᐃ䛻䛺䜛䜘䛖䛻䛩䜛䛯䜑䛷䛒䜛䚹౑⏝㔞䛿䚸౑⏝䛥䜜䜛ྛᮦᩱ䛾㔜㔞ཪ䛿య✚䠄kg ཪ䛿 L䠅䛾༢఩䛷グ㍕䛩䜛䚹
c. 䛂䛩䜉䛶䛾సᴗẁ㝵䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸ཎᮦᩱ䛾‽ഛ䛛䜙᏶ᡂရ䛜䛷䛝䜛䜎䛷䛾ྛసᴗᐇ᪋䜢ྠ䛨୍ᐃ䛾䜒䛾䛻䛩䜛䛯䜑䛷䛒䜚䚸ᶆ‽సᴗᡭ㡰᭩䠄POS䠖Prosedur Operasional yangStandar䠅䜢ᣢ䛴䛣䛸䛻䜘䜚䚸㛫㐪䛔䜔ேⅭⓗ䜶䝷䞊䜢㑊䛡䜛䛣䛸䛜䛷䛝䜛䚹ᐇ᪋䛧䛯సᴗ䛾඲ẁ㝵䜢᫂☜䛻䚸ヲ⣽䛻ㄝ᫂䛩䜛ᚲせ䛜䛒䜛䚹ὀព䛜ᚲせ䛺䛔䛟䛴䛛䛾సᴗ䜢௨ୗ䛻♧䛩䚹̺ ཎᮦᩱ䛾㑅ู᪉ἲ̺ ཎᮦᩱ䛾Ὑί᪉ἲ䠖

152

Ɣ
Ɣ

Ὑίᮦᩱ
Ὑί๣䠄Ὑ๣ཪ䛿௚䛾ᮦᩱ䛺䛹䠅䜢౑⏝䛩䜛ሙྜ䛿䚸౑⏝䛧䛯⸆๣ྡཬ䜃⃰ᗘ䜢グ㍕
䛩䜛䚹̺ ཎᮦᩱ䜢஝⇱䛥䛫䜛᪉ἲ䛻䛴䛔䛶䚸౛䛘䜀ኴ㝧ග䚸஝⇱ᐊ䚸䜸䞊䝤䞁䚸ᐊෆ䛷㢼䜢ᙜ䛶䛶஝⇱䛥䛫䜛䛺䛹䚸 ᗘཬ䜃஝⇱᫬㛫䜢グ㍕䛩䜛䚹̺ ⢊ᮎ䛾〇㐀᪉ἲཬ䜃⢊ᮎ䛾ᚤ⢊໬ᗘྜ䛔䚹౛䠖ΰྜ≀ཪ䛿ྛཎᮦᩱ/䝅䞁䝥䝸䝅䜰䛾≧ែ䛷〇⢊䛜⾜䜟䜜䜛䛾䛛䜢グ㍕䛩䜛䚹̺ ᕼᮃ䛩䜛๣ᆺ䛻ᛂ䛨䛯䛥䜙䛺䜛〇㐀᪉ἲƔ ᢳฟᢳฟ䛿䚸ΰྜ≀ཪ䛿ྛཎᮦᩱ/䝅䞁䝥䝸䝅䜰䛾≧ែ䛷⾜䜟䜜䜛䛾䛛䜢グ㍕䛩䜛䚹౑⏝䛥䜜䜛ᢳฟ᪉ἲཬ䜃ᢳฟᾮ䛻䛴䛔䛶䚸ᢳฟ᫬㛫䚸ᢳฟᾮ䛾஝⇱᪉ἲ䜢グ㍕䛩䜛䚹஝⇱๣䜢౑⏝䛩䜛ሙྜ䚸䛭䛾඲㔞䜢グ㍕䛩䜛䚹䜎䛯䚸ᢳฟ䛧䛶ᚓ䜙䜜䛯䜶䜻䝇䛾⥲㔞/⥲㔜㔞䛻䛴䛔䛶䜒グ㍕䛩䜛䚹Ɣ ΰྜ/ᨩᢾƔ 㘄๣/䝍䝤䝺䝑䝖ᡂᙧཪ䛿䜹䝥䝉䝹/⁐ᾮ䛾඘䛶䜣Ɣ Ვໟ̺ 〇㐀ᕤ⛬䛷䛾ရ㉁⟶⌮ 䠄౛䠖Ỉศྵ᭷㔞䚸ᆒ㉁ᛶ䚸㔜㔞ᆒ୍ᛶ䚸ᚤ⏕≀ྵ᭷㔞䚸㔜㔠ᒓ䛺䛹䠅d. 䛂౑⏝䛩䜛ᶵჾཪ䛿ᶵᲔ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸ᐇ㦂ᐊ䛷䛾ヨ㦂䛻౑⏝䛩䜛㐨ල䜢㝖䛝䚸≀⌮ⓗ䚸໬Ꮫⓗ䛺≉ᛶཬ䜃⏕⏘䛩䜛〇ရ䛾㔞䛻䜘䛳䛶㐨ල䛾㑅ᢥ䛜ㄪᩚ䛥䜜䛶䛔䜛䛣䛸䜢♧䛩䛯䜑䛷䛒䜛䚹ᶵჾ䛾ྡ⛠䚸䝤䝷䞁䝗䚸ᶵჾ䛾ᇶᮏ⣲ᮦ䠄౛䠖䜰䝹䝭䝙䜴䝮䚸⢓ᅵ䛺䛹䠅䚸౑⏝䛩䜛ᶵჾ䛾ᐜ㔞䜢グ㍕䛩䜛䚹
ῧ௜㈨ᩱ C䠖ཎᮦᩱ䛾ရ㉁᳨ᰝ
1. ཎᮦᩱ䛾ධᡭඛ䛂ཎᮦᩱ䛾ධᡭඛ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸౑⏝䛩䜛ཎᮦᩱ䛾䚸ရ㉁䛾ᆒ୍ᛶཬ䜃⥅⥆ᛶ䜢⥔ᣢ䛩䜛䛯䜑䛷䛒䜚䚸ཎᮦᩱ䛿ྠ୍ᆅᇦ䛛䜙ධᡭ䛩䜛䛾䛜ᮃ䜎䛧䛔䚹ཎᮦᩱ䛿௨ୗ䛛䜙ධᡭ䛷䛝䜛䠖a. ᅜෆ䠖
ὶ㏻ᴗ⪅䛛䜙䛾ሙྜ䛿䚸ὶ㏻ᴗ⪅ྡ䚸ᡤᅾᆅཬ䜃ཎᮦᩱ䛾ධᡭඖ䜢グ㍕䛩䜛䚹
b. ㍺ධရ䠖㍺ධᴗ⪅ྡ䚸ᡤᅾᆅ䚸ཎᮦᩱ䠄䝅䞁䝥䝸䝅䜰ཪ䛿䜶䜻䝇䠅䛾Ⓩ㘓␒ྕ䜢グ㍕䛩䜛䚹
2. ཎᮦᩱ䛾ရ㉁᳨ᰝ
䛂ཎᮦᩱ䛾ရ㉁᳨ᰝ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸་⸆ရ䛾〇㐀䛻䛚䛔䛶䚸〇㐀䛻౑⏝䛥䜜䜛䛩䜉䛶䛾ཎᮦᩱ䛜ྠ୍䛷䛒䜚䚸グ㍕䛩䜛ᡂศ䛻ἢ䛳䛯䜒䛾䛷䛒䜛䛣䛸䜢ಖド䛩䜛䛯䜑䛷䛒䜛䚹䛭䛾䛯䜑䚸ཎᮦᩱ䛾୍⯡ⓗ䛺≉ᛶཬ䜃≉Ṧ䛺≉ᛶ䜢ุ᩿䛩䜛ᚲせ䛜䛒䜛䚹ཎᮦᩱ䛾ရ㉁ホ౯䛻౑⏝䛥䜜䜛୍⯡ⓗ䛺≉ᛶཬ䜃≉Ṧ䛺≉ᛶ䜢グ㍕䛩䜛䚹
a. ཎᮦᩱ䛜䝅䞁䝥䝸䝅䜰䛾ᙧ≧䛾ሙྜ䚸୍⯡ⓗ䛺≉ᛶཬ䜃≉Ṧ䛺≉ᛶ䚹̺ ᳜≀ཬ䜃⛉䛾䝷䝔䞁ྡ̺ ㄝ᫂䠖ໝ䛔䚸࿡䚸Ⰽ䛺䛹䛾ᐁ⬟᳨ᰝ̺ ᕧどⓗ䛺≉ᛶ䠖ᙧ≧ཬ䜃኱䛝䛥䜢グ㍕䛩䜛䚹䝅䞁䝥䝸䝅䜰䛜ⱼ䚸᰿䚸᰿ⱼ䚸ᶞ⓶䛾ᙧ≧䛷䛒䜛ሙྜ䚸ษ䜜┠䛾ᛶ㉁ཬ䜃䛭䛾௚䛾≉ᚩ䜢グ㍕䛩䜛䚹

153

̺

b.

c.

d.
e.

⢊ᮎᮦᩱ䛾⏬ീ䛷♧䛥䜜䜛ᚤどⓗ䛺≉ᛶ䛻䛿䚸୍⯡ⓗ䛺᩿∦ཬ䜃≉ᐃ䛾᩿∦䛜ྵ䜎䜜䜛䚹̺ ࿊Ⰽ཯ᛂ䜢ྵ䜐⌮໬Ꮫヨ㦂⤖ᯝ䛾≉ᛶཎᮦᩱ䛜ຍᕤ〇๣䠄䜶䜻䝇䚸䝏䞁䜻䠅䛾ሙྜ⮬♫䛷〇㐀䛧䛶䛔䛺䛔ຍᕤ〇๣䛻䛴䛔䛶䛿䚸୍⯡ⓗ䛺≉ᛶཬ䜃≉Ṧ䛺≉ᛶ䠖̺ ㄝ̺᫂ 䝬䞊䜹䞊/άᛶ≀㉁䜢♧䛩≀⌮໬Ꮫⓗ䛺ヨ㦂⤖ᯝ䛾≉ᛶ̺ ヨ㦂ᡭ㡰䜢ഛ䛘䛯᏶඲䛺䝬䞊䜹䞊ཪ䛿άᛶ≀㉁䛾䝺䝧䝹Ỵᐃ̺ 〇㐀ᴗ⪅䛛䜙䛾ศᯒド᫂᭩䜢ῧ௜䛩䜛䚹ᚓ䜙䜜䛯୍⯡ⓗ䛺≉ᛶཬ䜃≉Ṧ䛺≉ᛶ䛿䚸つ᱁᭩䠄䜲䞁䝗䝛䝅䜰⸆ᒁ᪉䚸䜲䞁䝗䝛䝅䜰⸆ᒁ᪉䜶䜻䝇䝖䝷䚸䝬䝔䝸䜰䞉䝯䝕䜱䜹䞉䜲䞁䝗䝛䝅䜰䠅䜢ཧ↷䛩䜛䚹౑⏝䛧䛯つ᱁᭩䛻䛴䛔䛶グ㍕䛩
䜛䚹せ௳䛜つ᱁᭩䛻グ㍕䛥䜜䛶䛔䛺䛔ཎᮦᩱ䛻䛴䛔䛶䛿䚸ᴗ⏺⊂⮬䛷ཎᮦᩱ䛾ရ㉁せ௳䜢タᐃ䛩䜛䛣䛸䛜䛷䛝䜛䚹せ௳䛜௚ᅜ䛾つ᱁᭩䛷ゝཬ䛥䜜䛶䛔䜛ཎᮦᩱ䛻䛴䛔䛶䛿䚸◊✲ㄽᩥ䜢ᥦฟ䛧䚸᭩ྡ䚸∧ᩘ䚸Ⓨ⾜ᖺ䜢グ㍕䛩䜛䚹

ῧ௜㈨ᩱ D䠖᏶ᡂရ䛾ရ㉁᳨ᰝ
1. 䛂᏶ᡂရ䛾ရ㉁᳨ᰝ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸་⸆ရ䛾〇㐀䛜䚸௨ୗ䛾ᇶ‽䛻ᚑ䛳䛶⏕⏘䛥䜜䛶䛔䜛䛣䛸䜢☜ㄆ䛩䜛䛯䜑䛷䛒䜛䠖ṇ䛧䛟䚸Ύ₩䛷䚸㐺ษ䛺᪉ἲ䛷ホ౯䛥䜜䛶䛔䜛䚹ホ౯᪉ἲ䛿䚸๣ᙧ䛻ྜ䜟䛫䛶ㄪᩚ䛧䚸䜲䞁䝗䝛䝅䜰⸆ᒁ᪉ཪ䛿䛭䛾௚䛾බᐃ᭩䛻グ㍕䛥䜜䛯᪉ἲ䛻ᚑ䛳䛶ᐇ᪋䛥䜜䜛䚹᳨ᰝ⤖ᯝ䛻䛿ḟ䛾䜒䛾䛜ྵ䜎䜜䜛䚹a. ㄝ᫂ᐁ⬟᳨ᰝ䛷䛿䚸ໝ䛔䚸࿡䚸ᙧཬ䜃Ⰽ䜢᳨ᰝ䛩䜛䚹b. ᡂศ䛾㆑ู̺ 䜲䞁䝥䝸䝅䜰⢊ᮎ䛛䜙䛺䜛ᡂศ䛾᏶ᡂရ䛾ሙྜ䠖ᡂศ⣲ᛶ䛸䛧䛶౑⏝䛷䛝䜛ᚤどⓗ䛺≉ᐃ䛾≉㉁䠄䝣䝷䜾䝯䞁䝖㆑ู䠅䜢グ㍕䛩䜛䚹̺ ຍᕤ〇๣䠄䜶䜻䝇䚸䝏䞁䜻䠅䛛䜙䛺䜛ᡂศ䛾᏶ᡂရ䛾ሙྜ䠖ᡂศ⣲ᛶ䛸䛧䛶౑⏝䛷䛝䜛≉ᐃ䛾≀㉁䠄ⷧᒙ䜽䝻䝬䝖䜾䝷䝣䜱䞊䠄KLT䠖Kromatografi
lapisan tipis䠅ཪ䛿䝎䜲䝘䝰䝸䝅䝇䠄dinamolisa䠅⤖ᯝཪ䛿䛭䛾௚䛾᪉ἲ䠅䜢グ㍕䛩䜛䚹
c. 㔜㔞ᆒ୍ᛶ䛾 ᐃd. Ỉศ㔞䛾 ᐃe. ᚤ⏕≀Ꮫⓗ ᐃ䠄ALT䚸⑓ཎᛶ⣽⳦䚸┿⳦䚸䜹䝡䠅f. 〇ရ䛾ᦆቯ᫬㛫䛾 ᐃ
g. ᾮయ〇๣䛾ሙྜ䠖≀⌮ヨ㦂䠄pH䚸ẚ㔜䠅䛷⿵᏶䛩䜛➨ c䚸d䚸e䚸f䚸g 㡯䛻䛴䛔䛶䛿䚸᪉ἲ䚸ᶵჾ䛾௙ᵝ䚸┘ど⤖ᯝཬ䜃⤖ㄽ䜢グ㍕䛩䜛䚹
2. ᏶ᡂရ䛾ရ㉁䛾⪏ஂᛶ䜢ุ᩿䛩䜛᪉ἲ䛂᏶ᡂရ䛾⪏ஂᛶ/Ᏻᐃᛶ䜢ุ᩿䛩䜛᪉ἲ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸᏶ᡂရ䛾᭷ຠᮇ㝈䜢᥎ᐃ䛩䜛䛯䜑䛷䛒䜛䚹䜎䛯䚸᏶ᡂ䛧䛯〇ရ䛜せ௳䜢‶䛯䛧䚸ṇ䛧䛟Ύ₩䛺≧ែ䜢ಖ䛱䚸≉ᐃ䛾ヨ㦂䛻䜘䜚〇ရ䛾ရ㉁⪏ஂᛶ䜢ุ᩿䛩䜛ᚲせ䛜䛒䜛䚹䛥䜙䛻䚸ရ㉁ཬ䜃Ᏻ඲ᛶ䜢☜ಖ䛩䜛䛯䜑䛻䚸᭷ຠᮇ㝈䜢Ỵᐃ䛩䜛䛯䜑䛷䜒䛒䜛䚹a. ヨ㦂⤖ᯝ
1. ᐃᮇ᳨ᰝ䠄1 䛛᭶䛤䛸䚸2 䛛᭶䛤䛸䚸3 䛛᭶䛤䛸䛺䛹䠅䚹᳨ᰝ䛾✀㢮䛿䚸௨ୗ䛾䛸䛚䜚᏶

154

ᡂရ䛾ရ㉁᳨ᰝ䛻ἢ䛳䛯䜒䛾䛷䛒䜛䛣䛸䛜ᮃ䜎䛧䛔䠖᭷ᶵᛶ䚸㔜㔞ᆒ୍ᛶ䚸Ỉศྵ㔞䚸ᦆቯ᫬㛫䚸ᚤ⏕≀ྵ㔞䚹ᑡ䛺䛟䛸䜒 6 䛛᭶㛫䛾ほᐹ⤖ᯝ䜢⾲ᙧᘧ䛷ᥦฟ䛩䜛䚹
2. ୖグ䛾ほᐹཬ䜃ヨ㦂⤖ᯝ䛻ᇶ䛵䛟⪏ஂᛶ䛾⤖ㄽb. ➨ a 㡯䛷 2 ᖺ㛫ᐇ᪋䛧䛯᭶ḟほ 䛾⤖ᯝ䜢⥅⥆ሗ࿌䛩䜛䚹ほ ⤖ᯝ䛿䚸⾲ᙧᘧ䛷ᥦฟ䛩䜛䚹c. ᭷ຠᮇ㝈䜢グ㍕䛩䜛䚹
ῧ௜㈨ᩱ E䠖ຠ⬟/⏝㏵/౑⏝᪉ἲ
1. ຠ⬟/⏝㏵
䛂ຠ⬟/⏝㏵䛃䛻㛵䛩䜛᝟ሗ䜢グ㍕䛩䜛┠ⓗ䛿䚸་⸆ရ䛜ྛཎᮦᩱ䛾ຠ⬟/⏝㏵䛻኱䛝䛟౫Ꮡ䛧䛶䛔䜛䛯䜑䛷䛒䜛䚹
a. ᡂศ䛻ྵ䜎䜜䜛ྛཎᮦᩱ䛾ຠ⬟/⏝㏵䛻䛴䛔䛶䚸ᑡ䛺䛟䛸䜒 2 䛴䛾᝟ሗ※䛛䜙⿬௜䛡䛥䜜䛯ᩥ⊩䜢ᥦฟ䛩䜛䚹ᩥ⊩䛾䝍䜲䝖䝹䚸ⴭ⪅ྡ䚸Ⓨ⾜ᖺ䜢グ㍕䛩䜛䚹
b. グ㍕䛩䜛་⸆ရ䛾ຠ⬟/⏝㏵䛿䚸ྵ᭷䛩䜛ཎᮦᩱ䛾ຠ⬟/⏝㏵䛻䜘䛳䛶⿬௜䛡䜙䜜䛶䛔䜛ᚲせ䛜䛒䜛䚹̺ ຠ⬟䛿䛂἞⒪䛩䜛䛃䛸䛔䛖ゝⴥ䛷⾲⌧䛷䛝䜛䛜䚸䛂἞䛩䛃ཪ䛿䛂ྲྀ䜚㝖䛟䛃䛸䛔䛖ゝⴥ䛿౑⏝䛧䛺䛔䛣䛸䚹̺ ຠ⬟/⏝㏵䛿䚸䝅䞁䝥䝹䛷┤᥋ⓗ䚸䛛䛴⌮ゎ䛧䜔䛩䛔䜒䛾䛻䛩䜛䛣䛸䚹̺ ᤕ⋓⁺ᴗ⏕⏘⟶⌮䠄P3T䠖pengelola produksi Perikanan Tangkap䠅䝉䞁䝍䞊䛷ຠ⬟䛜☜ㄆ䛥䜜䛯ሙྜ䜢㝖䛝䚸་Ꮫ⏝ㄒ䜢౑⏝䛧䛺䛔䛣䛸䚹̺ ୙㐺ษ䛺ゝⴥཬ䜃/ཪ䛿୍⯡ⓗ䛷䛺䛔䚸䛛䛴㠀೔⌮ⓗ䛺ゝⴥ䜢౑⏝䛧䛺䛔䛣䛸䚹
2. ౑⏝᪉ἲ
䛂౑⏝᪉ἲ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸ㄗ⏝䜢㜵䛠䛯䜑䛷䛒䜚䚸౑⏝┠ⓗ䛻ᛂ䛨䛯⏝ἲ/⏝㔞䜢ྵ䜐౑⏝᪉ἲ䜢ㄝ᫂䛩䜛ᚲせ䛜䛒䜛䚹a. ་⸆ရ䛾౑⏝᪉ἲཬ䜃⏝ἲ/⏝㔞䛾ヲ⣽䜢グ㍕䛩䜛䚹
b. 䜎䛯䚸㆙࿌䚸ὀព䚸ไ㝈/᥎ዡ஦㡯䚸㡰Ᏺ䛩䜉䛝᭹⏝ᮇ㛫䜢グ㍕䛩䜛䚹
3. ⏕⏘䝁䞊䝗␒ྕ䛂⏕⏘䝁䞊䝗␒ྕ䛃䜢グ㍕䛩䜛┠ⓗ䛿䚸〇㐀ᴗ⪅䛜〇ရ䛻㛵䛩䜛䛩䜉䛶䜢㏣㊧䛷䛝䜛䜘䛖䛻䛩䜛䛯䜑䛷䛒䜛䚹౑⏝䛩䜛⏕⏘䝁䞊䝗䛾౛䜢グ㍕䛧䚸䛭䛾ព࿡䜢ㄝ᫂䛩䜛䚹

ῧ௜㈨ᩱ F䠖⵹䚸ᐜჾཬ䜃Ვໟᮦ䛻㛵䛩䜛ㄝ᫂1. ⵹䠖
Ɣ ᐦᑒ᪉ᘧ䠖䝅䞊䝹䜢౑⏝䛩䜛ሙྜ䚸౛䛘䜀⵹䜢㛤䛡䜛䛸ᐦᑒᶵ⬟䛜ᦆ䛺䜟䜜䜛ᮦᩱ䛷⵹䜢そ䛖䚹Ɣ 䝽䝑䜽䝇䚸䝪䝖䝹䜻䝱䝑䝥␃䜑⨁᪉ᘧ
2. ᐜჾ䠖୰㌟䜢ධ䜜䜛䛯䜑䛾䜒䛾䛷䚸⵹䜢ྵ䜑䚸୰㌟䛻┤᥋㛵ಀ䛩䜛㒊ศ䛾䛣䛸䛷䛒䜛䚹Ɣ ᐜჾ䛾ᙧ≧䠖౛䠖⿄䚸䝪䝖䝹䛺䛹Ɣ ⣲ᮦ/ᐜჾ䛾ᮦ㉁䠖౛䠖⣬䚸䜰䝹䝭䝥䝷䝇䝏䝑䜽䛺䛹
3. ໟ⿦䛾༢఩䠖ໟ⿦䚸ᐜჾཬ䜃⾲♧䛻㛵䛩䜛⌧⾜ἲつ䛻ᚑ䛳䛶᏶඲䛺⾲♧䛜᪋䛥䜜䛯䚸᭱ᑠ䛾ໟ⿦䛾䛣䛸䛷䛒䜛䚹
a. ་⸆ရ䛜 1 ໟ⿦䛾䜏䛾ሙྜ䚸グ㍕᪉ἲ䛿௨ୗ䛾䛸䛚䜚䛷䛒䜛䚹Ɣ ⢊ᮎ䠖䝟䜴䝎䞊䛜ໟ䜎䜜䛶䛔䜛ሙྜ䛾᭩䛝᪉䠖ໟ@7g
155

Ɣ
Ɣ

㢛⢏䠖㢛⢏䛜ໟ䜎䜜䛶䛔䜛ሙྜ䛾᭩䛝᪉䠖ໟ@100g㘄๣䠖䝪䝖䝹䛾୰䛻㘄๣䜢ධ䜜䚸⟽䛾୰䛻ಖ⟶䛥䜜䜛ሙྜ䛾᭩䛝᪉䠖⟽䚸䝪䝖䝹䚸30
㘄@300mgƔ 䜹䝥䝉䝹䠖䝇䝖䝸䝑䝥ໟ⿦䛾୰䛻䜹䝥䝉䝹䜢ධ䜜䚸⟽䛾୰䛻ಖ⟶䛩䜛ሙྜ䛾᭩䛝᪉䠖⟽䚸10 䝇䝖䝸䝑䝥ໟ⿦×10 䜹䝥䝉䝹@500mg
b. ་⸆ရ䛜 2 䛴௨ୖ䛾ໟ⿦䛷〇㐀䛥䜜䜛ሙྜ䚸⏦ㄳ⪅䛿䛂㏣ຍໟ⿦䛾⏦ㄳ᭩䛃䛻ᚲせ஦㡯䜢グධ䛩䜛䚹
ῧ௜㈨ᩱ G䠖⾲♧䛻㛵䛩䜛ㄝ᫂
1. ⾲♧䛿䚸ṇ䛧䛔᝟ሗ䛜ྵ䜎䜜䛶䛔䜛ᚲせ䛜䛒䜚䚸a. ⾲♧䛾ᩥᏐ䛿㩭᫂䛷ㄞ䜏ྲྀ䜚䜔䛩䛟䚸⤮䜔䝔䜻䝇䝖䚸䝁䞁䝖䝷䝇䝖䛾䛺䛔Ⰽ䛺䛹䛾⫼ᬒ䛾䛯䜑䛻୙᫂░䛻䛺䛳䛶䛿䛺䜙䛺䛔䚹b. ་⸆ရ䛾⾲♧䛻㛵䛩䜛ㄝ᫂䛿䚸䝷䝔䞁ᩥᏐ䛾䜲䞁䝗䝛䝅䜰ㄒ䛷グ㍕䛩䜛ᚲせ䛜䛒䜛䚹䛥䜙䛻䚸䜲䞁䝗䝛䝅䜰ㄒ䛷グ㍕䛥䜜䛯᝟ሗ䜔ㄝ᫂䛸ព࿡䜔ពᅗ䛜ྠ䛨䛷䛒䜛ሙྜ䛻㝈䜚䚸䝷䝔䞁ㄒ䜔䝷䝔䞁ᩥᏐ䛷᝟ሗ䜔ㄝ᫂䜢㏣ຍ䛩䜛䛣䛸䜒䛷䛝䜛䚹
2. 䝷䝧䝹
䝷䝧䝹䛻䛿ᚲ䛪䚸ḟ䛾஦᯶䜢グ㍕䛩䜛䚹
a. ୸䛷ᅖ䜣䛰䛂ື≀⏝་⸆ရ䠄Obat untuk Hewan䠅䛃䛾ᩥᏐᅜ⏘䛾་⸆ရ䛾ሙྜ䚸୸䛷ᅖ䜣䛰䛂ື≀⏝་⸆ရ䛃䛾ᩥᏐ䜢ᕥഃ䛾ୖ㒊䛻㓄⨨䛩䜛䚹䛂ື≀⏝་⸆ရ䛃䛾ᩥᏐ䛿䚸䛿䛳䛝䜚䛸ㄞ䜏䜔䛩䛟䚸ྠ䛨䝣䜷䞁䝖䛷䚸㧗䛥 5mm ௨ୖ䚸ኴ䛥 0.5mm
௨ୖ䚸ⓑᆅ䛻㯮ཪ䛿༳㇟ⓗ䛺Ⰽ䛷༳ๅ䛩䜛ᚲせ䛜䛒䜛䚹b. ་⸆ရ䛾ྡ⛠་⸆ရ䛾ྡ⛠䛿䚸̺ ୍⯡ྡ䠄䝆䜵䝛䝸䝑䜽䝛䞊䝮䠅̺ ఱୡ௦䛻䜒䜟䛯䛳䛶౑⏝䛥䜜䛶䛝䛯་⸆ရ䛾≉ᛶ䜔⏝㏵䛻ᛂ䛨䛯ྡ⛠䚹ၟရྡ̺ ၟရྡ䛿䚸䛂໬Ꮫ䠄kimia䠅䛃⸆ရ䛾ྡ⛠䜔䚸㎰ᴗ┬䛻Ⓩ㘓䛥䜜䛶䛔䜛௚䛾་⸆ရ䛾ྡ⛠䛸ྠ䛨䛷䛒䛳䛶䛿䛺䜙䛺䛔䚹་⸆ရ䛾ྡ⛠䛿ᚲ䛪䚸̺ ⠇ᗘ䛜䛒䜛䛣䛸䚹̺ ⑓ྡ䛸㛵㐃௜䛡䜙䜜䜛䛂䜰䞁䝏䠄anti䠅䛃䛸䛔䛖ゝⴥ䜔䛭䜜䛻㢮䛩䜛ゝⴥ䜢౑⏝䛧䛺䛔䛣䛸䚹̺ 㛵ಀ⪅䛾ᢎㄆ䛜䛺䛔㝈䜚䚸ⴭྡ䛺ྡ⛠䜢౑⏝䛧䛺䛔䛣䛸䚹̺ BPMSOH 䛷᭷ຠᛶ䛜☜ㄆ䛥䜜䛯ሙྜ䜢㝖䛝䚸⋇་ᖌ䛷䛺䛡䜜䜀デ᩿䛷䛝䛺䛔་Ꮫ⏝ㄒ䜔⑓ྡ䜢౑⏝䛧䛺䛔䛣䛸䚹̺ 䝣䜷䞁䝖䝃䜲䝈䛿䚸௚䛾䝣䜷䞁䝖䝃䜲䝈䜘䜚኱䛝䛟䛩䜛䛣䛸䚹c. ໟ⿦䝃䜲䝈
ྛໟ⿦䝃䜲䝈䛿䚸ṇ࿡㔜㔞䚸ṇ࿡ෆᐜ㔞䚸ཪ䛿ᩘ㔞䛸䛔䛖ᙧᘧ䛷グ㍕䛩䜛䚹̺ ṇ࿡㔜㔞䛿䛂g䛃䛷⾲♧䛩䜛䚹̺ ṇ࿡ෆᐜ㔞䛿䛂ml䛃䛷⾲♧䛩䜛䚹̺ 㘄๣䚸䜹䝥䝉䝹䚸䝍䝤䝺䝑䝖䚸䝟䝺䝮䚸䝢䝸䝇䛺䛹䛾ᅛᙧ๣䛾ሙྜ䛿䚸ྛ༢఩䛾ྜィᩘ䜢ᩘᏐ䛷グ㍕䛩䜛䚹౛䠖30 㘄@300mg
d. Ⓩ㘓␒ྕ
Ⓩ㘓␒ྕ䛿༳Ꮠᙧᘧ䛷グ㍕䛥䜜䚸ᩥᏐཬ䜃ᩘᏐ䛾኱䛝䛥䛿䚸㧗䛥 5mm ௨ୖ䚸ኴ䛥 0.5mm

156௨ୖ䛸䛩䜛ᚲせ䛜䛒䜛䚹⾲♧䛻ྵ䜑䜛䛣䛸䛜䛷䛝䜛Ⓩ㘓␒ྕ䛿䚸᭷ຠ䛺Ⓩ㘓␒ྕ䛻㝈䜙䜜䜛䚹e. ఍♫ྡཬ䜃ᡤᅾᆅ఍♫ྡ䛿䚸஦ᴗチྍド䛻グ㍕䛥䜜䛶䛔䜛఍♫ྡ䛸୍⮴䛧䛶䛔䜛ᚲせ䛜䛒䜛䚹఍♫䛾ᡤᅾᆅ䛿䚸ᑡ䛺䛟䛸䜒㒔ᕷྡཬ䜃ᅜྡ䜢グ㍕䛩䜛ᚲせ䛜䛒䜛䚹ㄆྍ䛥䜜䛯་⸆ရ䛾ሙྜ䛿䚸䝷䜲䝉䞁䝃䞊䛾఍♫ྡཬ䜃ᡤᅾᆅ䜢グ㍕䛩䜛ᚲせ䛜䛒䜛䚹f. ᡂศ
グ㍕䛩䜛ᡂศ䛿䚸Ⓩ㘓᫬䛻ㄆ䜑䜙䜜䛯䜒䛾䛷䚸ຠ⬟䛾䛒䜛ᡂศཬ䜃䛭䛾㔞䜢ඃඛⓗ䛻グ㍕
䛩䜛䚹10䠂䜢㉸䛘䛺䛔䛭䛾௚䛾ཎᮦᩱ䛻䛴䛔䛶䛿䚸᭱ᚋ䛾⟠ᡤ䛻䛂䛭䛾௚䛾ᡂศ䜢ྵ䜑 100䠂ཪ
䛿…mg/g ཪ䛿 ml/l䛃䛸䛔䛖ᩥゝ䛻⨨䛝᥮䛘䜛䛣䛸䛜䛷䛝䜛䚹ཎᮦᩱྡ䛿䚸䜲䞁䝗䝛䝅䜰⸆ᒁ᪉䚸䜲䞁䝗䝛䝅䜰⸆ᒁ᪉䜶䜻䝇䝖䝷䚸䝬䝔䝸䜰䞉䝯䝕䜱䜹䞉䜲䞁䝗䝛䝅䜰ཪ䛿䛭䛾௚䛾⌧⾜ἲつ䛻ᇶ䛵䛝䝷䝔䞁ྡ䜢グ㍕䛩䜛ᚲせ䛜䛒䜛䚹g. ຠ⬟/⏝㏵
グ㍕䛩䜛ຠ⬟/⏝㏵䛿䚸⏦ㄳෆᐜ䛻ᚑ䛳䛶Ⓩ㘓᫬䛻ᢎㄆ䛥䜜䛯ຠ⬟/⏝㏵䜢グ㍕䛩䜛䚹
h. ⏝ἲཬ䜃⏝㔞ෆ᭹⸆䛺䛾䛛እ⏝⸆䛺䛾䛛䚸⏝ἲ䛜᫂☜䛷䛒䜛ᚲせ䛜䛒䜛䚹⏝㔞䛿䚸1 ᅇ䛾౑⏝㔞䚸1 ᪥䛾౑⏝㔞䚸᭹⏝ᮇ㛫䛜䛒䜛ሙྜ䛿䛭䛾ᮇ㛫䜢᫂☜䛻䚸ヲ⣽䛻
グ㍕䛩䜛ᚲせ䛜䛒䜛䚹i. ㆙࿌䝃䜲䞁
Ⓩ㘓䛥䜜䛯་⸆ရ䛻⾲♧䛥䜜䛯ຠ⬟௨እ䛾ຠ⬟䜢ᣢ䛴䛣䛸䛜☜ᐇ䛺ཎᮦᩱ/䝅䞁䝥䝸䝅䜰䛜ྵ䜎䜜䛶䛔䜛ሙྜ䛿䚸㆙࿌䝃䜲䞁䜢グ㍕䛩䜛ᚲせ䛜䛒䜛䚹౛䠖䛂➽ᘱ⦆๣䛃䛸䛧䛶Ⓩ㘓䛥䜜䛶䛔䜛䜒䛾䛿䚸ὶ⏘䛾ྍ⬟ᛶ䛜䛒䜛䝅䞁䝥䝸䝅䜰䜢ྵ䜣䛷䛔䜛䛯䜑䚸௨ୗ䛾グ㍕䛜ᚲせ䛷䛒䜛䚹ὀព䠖ዷፎ୰䛾∵䛻䛿୚䛘䛺䛔䛣䛸䚹j. ⚗ᚷ஦㡯䠄䛒䜛ሙྜ䠅k. ಖ⟶᪉ἲ
≉ู䛺ಖ⟶䛜ᚲせ䛺་⸆ရ䛾ሙྜ䛿䚸ಖ⟶᪉ἲ䜢グ㍕䛩䜛ᚲせ䛜䛒䜛䚹l. ᭷ຠᮇ㝈Ⓩ㘓᫬䛻グ㍕䛥䜜䛯Ᏻᐃᛶヨ㦂⤖ᯝ䛻ᚑ䛳䛶グ㍕䛩䜛䚹
m. ⏕⏘䝁䞊䝗
〇ရ䛻㛵䛩䜛䛩䜉䛶䜢㏣㊧䛩䜛䛯䜑䛻౑⏝䛷䛝䜛⏕⏘䝁䞊䝗䜢グ㍕䛩䜛䚹
3. 䝟䞁䝣䝺䝑䝖䝟䞁䝣䝺䝑䝖䛻䛿䚸䝷䝧䝹䛻グ㍕䛥䜜䛶䛔䜛⾲♧䛾ෆᐜ䜘䜚䜒䜘䜚ヲ䛧䛔ෆᐜ䜢グ㍕䛷䛝䜛䚹
グ㍕ෆᐜ䛿ྜ⌮ⓗ䛷ㄗゎ䜢ᣍ䛛䛺䛔䜒䛾䛷䛒䜛ᚲせ䛜䛒䜛䚹䝟䞁䝣䝺䝑䝖䛻䛿䚸ᑡ䛺䛟䛸䜒௨ୗ䛾ෆᐜ䜢グ㍕䛩䜛ᚲせ䛜䛒䜛䠖a. ୸䛾୰䛻ື≀⏝་⸆ရ䛾ᩥᏐb. ་⸆ရ䛾ྡ⛠c. ྛᐜჾ䛾ṇ࿡㔜㔞䚸ṇ࿡ෆᐜ㔞ཪ䛿ᩘ㔞
d. Ⓩ㘓␒ྕ
e. ஦ᴗ⪅ྡཬ䜃ᡤᅾᆅf. ᡂศ
g. ຠ⬟/⏝㏵
h. ⏝ἲ䚸⏝㔞ཬ䜃᭹⏝ᮇ㛫

157

i. ㆙࿌䝃䜲䞁䠄䛒䜛ሙྜ䠅j. ⚗ᚷ஦㡯䠄䛒䜛ሙྜ䠅k. ᭷ຠᮇ㝈䠄䛒䜛ሙྜ䠅
4. ୖグ䛾⾲♧䛻㛵䛩䜛つᐃ௨እ䛻䚸ᐙ␆⏕⏘㛤Ⓨ⥲ᒁ䛛䜙≉ู䛺チྍ䜢ྲྀᚓ䛩䜛ᚲせ䛜䛒䜛䚹ῧ௜㈨ᩱ H䠖䛭䛾௚䛾᝟ሗ䛂䛭䛾௚䛾᝟ሗ䛃䛸䛧䛶䚸㍺ධ་⸆ရ〇๣䛾ሙྜ䚸་⸆ရ䛾⏕⏘ᅜ䛜ཎ⏘ᆅ䛸䛺䜛䛯䜑䚸ཎ⏘ᆅド᫂᭩䠄CoO䠅䜢ᥦฟ䛩䜛䛸䛸䜒䛻䚸⮬⏤㈍኎ド᫂᭩䠄Certificate of Free Sale䠅䚸⏕⏘⪅䛛䜙䛾ጤ௵≧/௵࿨≧䚸GMP 䛻ᚑ䛳䛶〇㐀䛥䜜䛶䛔䜛䛣䛸䜢ㄝ᫂䛧䛯ド᫂᭩䠄GMP ド᫂᭩䠄Certificate of GMP䠅䠅䜢ᥦฟ䛩䜛ᚲせ䛜䛒䜛䚹ཎ⏘ᆅド᫂᭩䚸⮬⏤㈍኎ド᫂᭩䚸GMP ド᫂᭩䛿䚸ཎ⏘ᅜ䛾ᡤ㎄ᐁᗇ䛜Ⓨ⾜䛧䚸⌧ᆅᅜ䛾䜲䞁䝗䝛䝅䜰኱౑㤋ཪ䛿䜲䞁䝗䝛䝅䜰㈠᫆㡿஦㤋䛛䜙䛾ᢎㄆ䜢ᚓ䜛䜒䛾䛸䛩䜛䚹158

5.6 CPOHB 䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛㎰ᴗ኱⮧Ỵᐃ➨ 466KptsTN.260V99 ྕ
APPENDIX: DECREE OF THE MINISTER OF AGRICULTURE
Number: 466/Kpts/TN.260/V/99 Date: May 7, 99
Guidelines for Good Veterinary Medicine Manufacturing Practices
1. General Conditions
The Good Manufacturing Practice of Veterinary Medicine 䠄CPOHB䠅 involves all aspects ofproduction and quality control and aims to ensure that the veterinary medicinal products madealways meet the predetermined quality requirements in accordance with their intended use.
1.1.Common Foundation
1.1.1.
In the manufacture of veterinary medicines, thorough supervision is essential toensure that consumers only use high-quality veterinary medicines.
Indiscriminate manufacture cannot be justified for veterinary medicines used tosave or restore or maintain animal health.
1.1.2.
It is not enough for a veterinary drug to pass a series of tests, but it is very
important that the quality of the veterinary drug should be molded into the
product. The quality of veterinary medicines depends on the starting materials,
the manufacturing and quality control processes, the premises, the equipmentused and the personnel involved in the manufacture of veterinary medicines.
1.1.3.
To ensure the quality of a veterinary drug, it is not acceptable to rely on a single
test alone. All veterinary medicines made should be made under carefully
controlled and monitored conditions.
1.1.4.
This CPOHB is a guideline that aims to ensure that the nature and quality of theveterinary drugs produced are as desired, if necessary adjustments can bemade provided that the predetermined quality standards of veterinary drugs arestill achieved.
1.2. Definition
In these guidelines the following definitions are used:
1.2.1.
Starting Material
All raw materials and packaging materials used in veterinary drug production.
1.2.2.
Raw Materials
All ingredients, both efficacious and inefficacious, altered and unaltered, used in
the processing of veterinary medicines even if not all of these ingredients arestill present in the finished product.
1.2.3.
Packaging Materials
All materials used in the packaging process of the finished product.
1.2.4.
Batch
A number of veterinary drugs originating from a production process at the sametime.
1.2.5.
Brochure
A sheet made of paper or other material containing the complete marking of ananimal medicine that is included in the container or outer wrapper or circulated
separately.
1.2.6.
Representative Sample
A sample that describes exactly a lot or batch or a number of materials sampled.
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1.2.7.

Passed / Eligible
The status of materials or products authorized for use in processing, packaging
or distribution.
1.2.8.
Rejected/Ineligible
The status of materials or products that are not authorized for use in processing,packaging or distribution.
1.2.9.
Documentation
All written procedures, instructions and records relating to the manufacture ofveterinary medicines.
1.2.10. Etiquette
Writing directly on the container or package containing the veterinary drug
marking and affixed directly to the container or outer package of the veterinary
drug.
1.2.11. Real Production Outcomes
The amount actually produced at each stage of production of a particularveterinary medicinal product from a given amount of starting material used.
1.2.12. Standardized Production Yield
The amount standardized by the manufacturer that should be achieved at eachstage of production of a particular veterinary medicinal product.
1.2.13. Theoretical results of production
The quantity produced at each stage of manufacturing a particular product,
calculated based on the number of components used, if no losses or errors
occur during manufacturing.
1.2.14. Factory Quarantine
The status of materials or products that are separated physically or by a certain
system pending the decision of the inspection results whether a material or
product can or cannot be used for processing, packaging or distribution.
1.2.15. Lot
A specific part of a batch that has uniform properties and quality within specified
limits. When a veterinary medicinal product is produced by a continuous
process, lot means a certain part produced in a unit of time or unit of quantity insuch a way as to ensure that this part has uniform properties and quality within
specified limits.
1.2.16. Batch number
A marking consisting of numbers or letters or a combination of both, which
identifies a number of veterinary drugs originating from the same production at
the same time, enabling the complete history of the veterinary drug to be traced,
including the stages of production, control and distribution.
1.2.17. Lot Number
A marking consisting of specific letters or numbers or a combination of both that
identifies a lot, allowing tracing back the complete history of the lot's
manufacture including the stages of production, control and distribution.
1.2.18. Veterinary Medicine
Veterinary medicine that is specifically used for animals.
1.2.19. Finished Veterinary Medicine
A veterinary drug product that has gone through all stages of the veterinary drug
manufacturing process.
1.2.20. Creation
Processing, mixing and converting activities for veterinary medicine raw
materials.

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1.2.21. In-process SupervisionInspection and testing instituted and carried out during the veterinary drug
manufacturing process, including inspection and testing of the environment andequipment.
1.2.22. Quality Control
All monitoring efforts are conducted during manufacture and are designed toensure that veterinary medicinal products continue to meet specified
specifications, identity, purity, safety and potency and other characteristics.
1.2.23. Packaging}
The part of the production cycle that is performed on the finished product toproduce the finished veterinary medicine.
1.2.24. Processing
A section of the production cycle starting from the receipt of raw materials to the
production of finished products.
1.2.25. Production
All manufacturing activities from receiving initial materials, processing topackaging to produce finished veterinary drugs.
1.2.26. Intermediate Products
Any material or mixture of materials that still requires one or more stages offurther processing to become a finished product.
1.2.27. Bulk Products
Each ingredient has been processed and only requires packaging to becomefinished veterinary medicine.
1.2.28. Sterile Room or Sterile Room
A room or space that has certain environmental conditions, where dust andmicrobial pollution are controlled. The room or space is constructed, equipped
and used in such a way as to reduce the entry, growth or retention of microbial
contamination.
1.2.29. Sanitation
All efforts made to ensure the realization of conditions that meet healthrequirements.
1.2.30. Material Specifications
The provision of a starting material, intermediate product, finished product orveterinary drug regarding chemical, physical and biological properties. The
specification states standards and allowable tolerances which are usually
expressed descriptively and numerically.
1.2.31. Sterilization
Inactivation or reduction of live microorganisms to acceptable limits, carried out
in an appropriate manner.
1.2.32. Expiration Date
A date stating that prior to that date a particular batch or lot still met the required
quality standard specifications.
1.2.33. Date of Manufacture
The date that indicates the completion of the manufacturing process of aparticular batch.
1.2.34. Validation
An act of proving by appropriate means that any material, process, procedure,
activity, system, equipment or mechanism used in production and control will
always achieve the desired results.

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2. Starting Material
2.1. All incoming, outgoing and remaining materials should be recorded. The record should
include a description of the inventory, batch or lot number, date of receipt or release,date of inspection and expiry date.
2.2. Each starting material, before being qualified for use, shall meet the established starting
material specifications and be labeled with the name stated in the specifications.
Unauthorized abbreviations, codes or names should not be used.
2.3. For each consignment or batch of starting material, a reference number should be
assigned that will indicate the identity of the consignment or batch during storage orprocessing. This number shall be clearly indicated on the container etiquette to enable
immediate retrieval of records for inspection, including analytical reports. For sampling,
testing and declaration of eligibility purposes different batches originating from a single
consignment shall be considered as separate batches.
2.4. On receipt of each consignment, a visual inspection of the general condition, integrity of
packaging, leaks and damage shall be made, and samples for testing shall be taken by
personnel using methods approved by the quality control manager. Such samples shallbe tested against specifications that can be recognized by a certificate of analysis of thestarting material concerned, corroborated by self-assessment of identity.
2.5. Measures should be taken to ensure that all packages in a consignment contain thecorrect starting material, and safeguards against possible mislabeling of containers by
suppliers.
2.6. Shipments of starting materials should be held in plant quarantine, until approved andqualified for use by the quality control manager.
2.7. The etiquette indicating the status of the starting material should only be posted bypersonnel appointed by the person in charge of the quality control section to prevent
confusion, the etiquette should be different from the label used by the supplier, forexample by including the company name or logo. If the status of the material changes,
then the status indicating etiquette must also be changed.
2.8. Supplies of starting materials shall be inspected at regular intervals to ensure that thecontainers are tightly closed, properly marked and in good condition. The material
should be resampled and retested at regular intervals as specified in the starting
material specification. Re- sampling should be preceded by re-labeling and/or using
other equally effective systems.
2.9. Starting materials that can be damaged by temperature should be stored in a room
where the air temperature is regulated.
2.10.Starting materials that tend to deteriorate or decrease in potency or activity during acertain period of storage, especially antibiotics, anthelmintics, sulfa preparations, somevitamins, enzymes, hormones and biologic materials should have a shelf life stated.
2.11.The initial release of materials for use should be carried out by authorized personnel inaccordance with approved procedures. Inventory records should be maintained so thatinventory referrals can be made.
2.12.There should be a separate handing room that is well equipped to prevent crosscontamination. A specially equipped area may be required, for weighing sensitizing or
highly toxic materials or materials such as cytotoxin hormones and certain antibiotics.
2.13.Weighing and measuring instruments shall be regularly marked and checked to provethat their capacity, accuracy and precision meet the requirements in accordance withthe amount of substance to be weighed or measured.
2.14.All unqualified starting materials should be clearly marked and should not be used in
production.

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3. Location and Building
The location and building should be adequate, so that any risk of errors, cross-contaminationand other errors that could reduce the quality of veterinary medicines, can be avoided.
Buildings for the manufacture of veterinary medicines shall be of adequate size, design,
construction and location to facilitate proper working, cleaning and maintenance.
3.1.

The location of the building should be such as to prevent pollution from thesurrounding environment, such as pollution from air, soil and water as well as fromnearby activities. If the building is located in an unsuitable place, effective measures
should be taken to prevent pollution.
3.2. Buildings should be constructed and maintained so that they are protected from theeffects of weather, flooding, seepage through the ground and the entry and harboringof nuisance animals.
3.3. In determining the design and arrangement of the building, the following points should
be considered:(a) Compatibility with other activities, which may be conducted in the same facility
or in adjoining facilities;(b) The size of the workspace, which allows the placement of equipment andmaterials in an organized and logical manner and allows for the implementation ofactivities, smooth flow of work, effective communication and supervision as well as
to prevent crowding and disorganization;(c) Prevent the use of production areas as general traffic for employees or materials
or as storage areas except for materials in process.
3.4. The interior surfaces of the room (walls, floor and ceiling)should be smooth, free ofcracks and open joints and easy to clean, and if necessary easy to disinfect. Floors inprocessing rooms should be made of impermeable materials, have a flat surface andallow for quick and efficient cleaning. Walls should also be watertight and have easily
washable surfaces. Corners between walls, floors and ceilings in specialized rooms
should be curved.
3.5. Sewers should be large enough to have control basins and good ventilation. Opendrains should be avoided as much as possible but if necessary should be shallow
enough to facilitate cleaning and disinfection.
3.6. Air intake and exhaust ports, pipes and ducts should be installed in such a way as toprevent contamination of the product.
3.7. Buildings should be effectively lit and ventilated with air control facilities (including
temperature, humidity and filters) appropriate for the activities within the building andthe surrounding environment.
3.8. Pipes and other installations in the manufacturing room should be installed in such a
way as to avoid the formation of grooves that cannot be cleaned. Such installations
should be installed outside the processing room as much as possible.
3.9. Electrical power should be sufficient to ensure the smooth functioning of production
and laboratory equipment.
3.10. All buildings, including production rooms, laboratories, warehouse aisles andsurrounding areas, should be maintained in a clean and tidy condition at all times. The
condition of the building should be checked regularly and repairs made where
necessary. Special care should be taken to ensure that building repairs or
maintenance activities do not negatively affect the product.

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3.11. The material storage room should be spacious, well-lit and arranged and equipped insuch a way as to allow the storage of materials and products in a dry, clean andorganized state.
3.11.1. Storage rooms should be suitable for the effective segregation of quarantined
materials and products in the factory. Special and separate rooms should be
provided for the storage of flammable, explosive and highly toxic materials,
and other hazardous veterinary drugs as well as for rejected products andmaterials;
3.11.2. If necessary, storage facilities with special conditions, such as temperature,humidity and security, should be provided;
3.11.3. The storage room should be organized in such a way as to allow effective
and orderly segregation of the various groups of materials stored and to
facilitate inventory turnover;
3.11.4. Separate storage should be provided for rejected or recalled items;
3.11.5. Storage should be organized in such a way that individual labels, as well asother printed matter, are kept separate to prevent mixing.
4. Room Setup
4.1. The design and arrangement of the building should meet the requirements.
4.1.1.
Prevent the risk of mixing of different veterinary drugs or components, thepossibility of cross-contamination by veterinary drugs or other ingredients andthe risk ofMissing a step in the production process. Suitable room dividers, air curtains
and other means can be used to achieve this goal. Special attention should
be given to the processing of highly toxic or sensitizing materials such as
hormones, cytotoxic materials, certain antibiotics and germ and virus seeds.
The production of biologic animal drugs (vaccines, antigens or antisera)
should be separated from the production of other animal drugs. Thisrequirement can be met by providing a separate warehouse for activities
related to biologic products or by providing effective isolation of activities
involving bacteria or viruses in one building. For both alternatives a separate
air management system should be provided.
4.1.2.
Materials processing activities for non-animal medicine products are
separated from the animal medicine production room.
4.1.3.
There is a separate room for cleaning moveable equipment and a room forstoring cleaning materials.
4.1.4.
Changing rooms and clothing storage are directly related to the processing
room but are located separately.
4.1.5.
Toilets do not open directly to the production room and are well ventilated.
4.1.6.
Animals are housed in separate buildings, or at least in well-isolated rooms.
4.2. Certain rooms are required for the following activities.
4.2.1.
Receiving materials
4.2.2.
Quarantine of incoming goods
4.2.3.
Storage of starting materials
4.2.4.
Weighing and delivery
4.2.5.
Processing
4.2.6.
Storage of finished products
4.2.7.
Packaging1644.2.8.
4.2.9.
4.2.10.
4.2.11.
4.2.12.

Quarantine of finished veterinary drugs while awaiting final inspection results
Storage of finished veterinary drugs
Delivery of goods
Laboratory
Equipment washing

4.3. Sterile product processing rooms should be separated from other production rooms
and specially designed and constructed. Separate spaces are required for thefollowing activities:
4.3.1.
Component packaging opening
4.3.2.
Washing of equipment and containers
4.3.3.
Processing
4.3.4.
Direct container filling and closing
4.3.5.
Air buffer space connecting the changing room with the charging room
4.3.6.
Change into sterile clothing before entering the sterile room.
5. Equipment
Equipment used in the manufacture of veterinary drugs should be of proper design andconstruction, of adequate size and properly located, so that the quality designed for eachveterinary drug product is guaranteed uniformly from batch to batch, and to facilitate
cleaning and maintenance.
5.1. Design and construction
5.1.1.
Equipment surfaces that come into contact with materials, intermediates,
finished products or finished veterinary medicines must not react, adsorb or
absorb, which may alter their identity, quality or purity, beyond specified
limits.
5.1.2.
Equipment must not cause adverse effects on the product, for example due
to leaking valves, dripping lubricating substances and other similar causes, ordue to incorrect repair, maintenance modification or adaptation.
5.1.3.
materials required for a special purpose, such as lubricants or coolants, must
not come into direct contact with the material being treated as this maychange the identity, quality or purity of the raw material, intermediatematerial, finished product or veterinary drug.
5.1.4.
Equipment should be easy to clean, both inside and out.
5.1.5.
All equipment used in the processing of flammable chemicals, placed inrooms where flammable materials are used, should be equipped withelectrical equipment that is explosion-proof and completely destroyed.
5.1.6.
Equipment used for weighing, measuring, testing and recording shall be
regularly checked for accuracy and tested according to an appropriate
program and procedure. The results of inspection and testing shall berecorded and the records kept properly.
5.1.7.
Filters for liquids must not release fibers into the product. Asbestoscontaining filters should not be used even if special filters that do not releasefibers are used afterwards.
5.2. Installation and Placement
5.2.1
Equipment should be placed so as to minimize the possibility of crosscontamination between materials in the same room.

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5.2.2
5.2.3
5.2.4

5.2.5

5.2.6
5.2.7
5.2.8

Equipment should be placed at a sufficient distance from other equipment toprovide working freedom and ensure that there is no mix-up or confusion.
All open mechanical tires and hoists should be equipped with safety guards.
Water, steam, compressed air or vacuum lines should be installed in such a
way that they are easily accessible during the activity. These ducts should beclearly labeled or marked for easy identification.
Each major piece of equipment should be given a clearly identifiable number.
This identifying number will be used on all batch orders and records toindicate the specific unit or tool used in the specific manufacturing process forthe batch, unless the tool is only used for one type of product.
All pipes, tanks, steam pipe casings or cooling pipes should be well insulated
to prevent possible defects and minimize energy loss.
Pipelines to equipment using pressurized steam should be equipped with avapor trap and a functioning drain.
Support systems such as heating, ventilation, air conditioning, drinking water,water purification, water, steam, compressed air and gas distillation systems
should be validated to ensure that they continue to function as intended.

5.3. Maintenance
5.3.1
Equipment should be maintained according to an appropriate schedule tokeep it in good working order and prevent contamination that could alter theidentity, quality and purity of the product.
5.3.2
Written procedures for equipment maintenance should be developed andfollowed.
5.3.3
Records of the maintenance and use of major equipment should be included
in a logbook showing the date, time, product, strength and number of eachbatch or lot processed with the equipment concerned. Records for equipmentused specifically for one product only may be included in the production
record of the specific product batch.
6. Personnel
The number of Experts and Employees at all levels should be sufficient and have theknowledge, skills and abilities appropriate to their duties. They should also be of soundmental and physical health.
so that they are able to carry out their duties professionally and properly. They should have ahigh attitude and awareness to realize the goals of CPOHB.
6.1. Organization, Qualifications and Responsibilities
6.1.1.
The organizational structure of the company should be such that the
production and quality control departments are headed by different experts
who are not responsible for each other. Each should be given full authority
and the means necessary to carry out their duties effectively. Neither shouldhave any other interests outside the factory organization, which may hinder
or limit his/her responsibilities or which may lead to conflicts of personal or
financial interest.
6.1.2.
The production manager shall be a qualified Veterinarian or Pharmacist with
sufficient practical experience in the veterinary drug industry and leadershipskills to enable him/her to perform his/her duties in a professional manner.
The production manager shall have full authority and responsibility for
managing the production of veterinary medicines. The production manager

1666.1.3.

6.1.4.

6.1.5.

6.1.6.

6.1.7.
6.1.8.

should have joint responsibility for veterinary drug quality with both the quality
control manager and the engineering manager.
The quality control manager shall be a qualified Veterinarian or Pharmacist
with sufficient practical experience and training to enable him/her to perform
his/her duties professionally. The quality control manager shall have fullauthority and responsibility for all quality control tasks, namely thedevelopment, verification and implementation of all quality control
procedures. The quality control manager is the only one who has theauthority to decide to approve or reject starting materials, intermediate
products, finished products and finished veterinary medicines if they conformto the specifications, or if they are not made in accordance with approved
procedures and specified conditions.
The production manager and quality control manager are jointly responsible
or co-responsible for the development and approval of written procedures,monitoring and supervision of the veterinary drug manufacturing
environment, plant hygiene and validation of production processes;
calibration of measuring instruments, personnel training, approval of material
suppliers and contractors; safeguarding of products and materials against
damage and deterioration of quality in record keeping.
To support and assist the core personnel mentioned above, a suitable
number of skilled personnel may be appointed.
to exercise direct supervision in production and quality control. Eachsupervisor should be adequately trained and have sufficient technical skills
and practical experience in the field related to their duties. They report to the
production manager or quality control manager.
In addition to the above staff, a sufficient number of technically trained
personnel should be available to carry out production or quality control
activities in accordance with predetermined procedures and specifications.
They should be familiar with written work instructions. At the time of
appointment, they should be given adequate training.
The responsibilities assigned to each employee should not be so excessive
as to pose a risk to the quality of veterinary medicines.
Duties and responsibilities should be given clearly and be well understood byeach employee.

6.2. Exercise
6.2.1.
All employees who directly participate in veterinary drug manufacturing
activities and whose duties require them to enter the veterinary drug
manufacturing room should be trained on specific activities relevant to theirduties as well as on CPOHB principles.
6.2.2.
Training should be provided by a qualified person. Special attention should
be given to training for those who work in sterile and clean rooms or those
who work with high-risk, toxic or sensitizing materials.
6.2.3.
Training on the CPOHB should be conducted on an ongoing basis and with
sufficient frequency to ensure that employees are familiar with the CPOHB
requirements relevant to their duties.
6.2.4.
Training on CPOHB should be conducted according to a written programapproved by the production manager and quality control manager.
6.2.5.
Records of employee training on the CPOHB should be maintained and theeffectiveness of the training program should be assessed regularly.

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6.2.6.

After training, employees' performance should be assessed. To determine
whether they are adequately qualified to carry out the tasks they have been
assigned.

7. Sanitation and Hygiene
A high level of sanitation and hygiene should be established in every aspect of veterinary
drug manufacturing. The scope of sanitation and hygiene includes personnel, premises,
tools and equipment, production materials as well as
containers, and anything that may be a source of product contamination. Sources ofcontamination should be eliminated through a comprehensive and integrated sanitation andhygiene program.
7.1. Personnel
7.1.1.
All employees should undergo medical examinations, both prior toemployment and during employment. Employees who serve as visualinspectors should undergo regular eye examinations.
7.1.2.
All employees should practice good personal hygiene and should be trainedin personal hygiene. All employees in contact with the manufacturing process
should observe a high level of personal hygiene.
7.1.3.
Any employee who at any time contracts an illness or suffers from an open
wound, which could be detrimental to the quality of the product, shall be
prohibited from handling raw materials, packaging materials, in-processmaterials and finished veterinary drugs until he/she has recovered.
7.1.4.
All employees should be instructed and encouraged to report to their
immediate supervisor any situation (plant, equipment or personnel) that intheir judgment could be detrimental to the product.
7.1.5.
Direct contact between hands and raw materials, intermediates and finishedproducts should be avoided.
7.1.6.
For their own safety and to ensure the protection of products fromcontamination, employees should wear clean protective clothing including
clean hair coverings, soiled uniforms should be kept in a closed container
until washing. Soiled cleaning rags, which can be reused, should be kept in aclosed container until washing.
7.1.7.
Only authorized personnel are allowed to enter buildings and facilities
declared as confined spaces.
7.1.8.
Employees should be instructed to wash their hands before entering the
production room. Appropriate posters should be displayed for this purpose.
7.1.9.
Smoking, eating, drinking, chewing, placing plants or storing food, beverages,smoking materials and personal medication are only allowed in certain rooms
and are prohibited in production rooms, laboratories, storage rooms andother rooms that may be detrimental to quality.
7.1.10. Personal hygiene procedures, including the requirement to wear protective
clothing, should apply to all persons entering the production room, whether
they are permanent or temporary employees or non-employees who are oncompany premises, e.g.
contractor employees, visitors, company leadership staff and inspectors.
7.1.11. Specific requirements for the manufacture of sterile veterinary medicines arecovered in items 8.7.8 and 8.7.9.
7.2. Building1687.2.1.
7.2.2.
7.2.3.
7.2.4.

7.2.5.

7.2.6.

7.2.7.

7.2.8.

7.2.9.

Buildings used for veterinary drug manufacturing are appropriately designed
and constructed to facilitate the implementation of good sanitation.
There should be a sufficient number of well-ventilated toilets andhandwashing stations for employees within easy reach of the workspace.
Adequate facilities should be provided for the proper storage of work clothes
and personal clothing.
The sink should be located outside the sterile room. If installed in a sterileroom, it should be of proper quality and equipped with a system that prevents
overflow and the water supplied to the sink should at least meet drinking
water quality standards.
The preparation, storage and consumption of food and beverages should be
restricted to a dedicated room, such as a dining room. These facilities shouldmeet hygiene standards.
Waste should not be allowed to accumulate. Rubbish should be collected insuitable containers for transfer to a storage area outside the building anddisposed of frequently in a safe and sanitary manner.
Rodenticides, insecticides, fumigation agents and cleaning agents must notcontaminate equipment, raw materials, packaging materials, in-processmaterials or finished veterinary drugs.
There should be a written procedure that identifies the person in charge ofsanitation and outlines in detail the schedule, methods, equipment andcleaning materials to be used and the facilities to be cleaned. These written
procedures should be followed.
Specific requirements for the manufacture of sterile veterinary medicines arecovered in point 8.7.1.1.

7.3. Equipment
7.3.1.
After use, equipment should be cleaned both inside and out in accordancewith established procedures, and maintained and stored in a clean
condition. Before use its cleanliness is checked again to ensure that all
products or materials from the previous batch have been removed.
7.3.2.
Vacuum or wet cleaning is recommended. Compressed air and brushes
should be used with caution and avoided wherever possible as they
increase the risk of product contamination.
7.3.3.
Cleaning and storage of moveable equipment and storage of cleaningmaterials should be done in a room separate from the processing room.
7.3.4.
Sufficiently detailed written procedures for cleaning and sanitizing
equipment and containers used in veterinary drug manufacturing should be
developed and adhered to. These procedures should be designed
appropriately to prevent contamination of equipment by cleaning andsanitizing agents. The procedure should include at least the person
responsible for cleaning, the schedule, methods, equipment and materials
used in cleaning and methods of disassembling and reassembling
equipment as may be necessary to ensure thorough cleaning. If necessary
the procedure also includes sterilization of equipment, de-identification ofprevious batches and protection of clean equipment against contamination
before use.
7.3.5.
Records of cleaning, sanitizing, sterilizing and inspecting equipment before
use should be kept.

169

7.4. Validation and Reliability of Procedures
Sanitation and hygiene procedures should be validated and evaluated periodically toensure that they are effective and continue to meet requirements.
8. Production
Production should be carried out following established procedures that can ensure thecontinuous production of veterinary drugs that meet the specified specifications.
8.1. Process Validation
8.1.1.
All procedures should be validated appropriately. Validation should be carriedout according to a predetermined procedure and a record of the results
should be kept. The extent and level of validation undertaken depends on thenature and complexity of the products and processes concerned. The
validation program and documentation should attest to the suitability of thematerials used, the reliability of the equipment and systems and the capabilityof the personnel.
8.1.2.
Before a Master Processing Procedure is established, steps should be taken
to prove that the procedure is suitable for routine production, and that theestablished process using the specified materials and equipment will always
produce products that meet the specified specifications.
8.1.3.
Significant changes in processes, equipment or materials should beaccompanied by a revalidation action, in order toguarantee that the changes will still produce a product that meets thepredetermined specifications.
8.1.4.
Processes and Procedures should be regularly and critically re- evaluated toensure that they continue to deliver the desired results.
8.2. Pollution
Chemical or microbial contamination of a veterinary drug that is detrimental toanimal health or reduces the therapeutic power or affects the quality of a product is
not acceptable. Particular attention should be paid to the issue of crosscontamination, as even if its nature and extent does not directly affect animal
health, it is indicative of veterinary drug manufacturing practices that do not comply
with the CPOHB.
8.3. Batch and Lot Numbering System
8.3.1.
A system that details how batches and lots are numbered is required toensure that the intermediate product, finished product or finished veterinary
drug of a batch or lot can be identified by a specific batch or lot number.
8.3.2.
The batch and lot numbering systems used at the processing level and thesubsequent packaging level should be interrelated.
8.3.3.
The batch and lot numbering system should ensure that the same batch or lot
number is not used repeatedly.
8.3.4.
Allocated batch or lot numbers should be recorded immediately in a logbook.
The record should include the date of numbering, the identity of the productand the size of the batch or lot concerned.
8.4. Weighing and Delivery
8.4.1.
The weighing, or counting and delivery of raw materials, packaging materials,
intermediate products and finished products is considered a part of the170

production cycle and requires complete documentation and reconciliation.
Control of the release of the aforementioned materials and products into
production is critical.
8.4.2.
Methods for handling, weighing, counting and handing over raw materials,
packaging materials, intermediates and finished products shall be covered in
written procedures.
8.4.3.
All releases of raw materials, packaging materials, intermediate products andfinished products, including additional materials beyond those originallydelivered, should be documented.
8.4.4.
Only raw materials, packaging materials, intermediate products and finishedproducts that have been approved by the quality control department may besubmitted.
8.4.5.
After weighing, handing and marking, raw materials, finished products andintermediate products should be transported and stored appropriately so that
their integrity is maintained until the next processing.
8.4.6.
To avoid mixing, only one specific type of printed matter may be placed in themarking area at a time. Between the marking areas, there should be
adequate separation barriers.
8.4.7.
Prior to weighing, checks should be made on the correctness of the markingof raw materials including the graduation label from the quality control
section.
8.4.8.
The capacity, accuracy and precision of the weighing and measuring
instruments used should be in accordance with the amount of material being
weighed and measured.
8.4.9.
For each weighing or measurement, it is necessary to prove the correctness,accuracy of the identity and amount of the material weighed and measured
by two separate officers.
8.4.10. The success of weighing and handing places should be maintained. Sterile
raw materials should be weighed and delivered in a sterile room.
8.4.11. Weighing and handing should be done using suitable and clean equipment.
8.4.12. Raw materials, intermediate products and finished products that are delivered
should be double-checked for correctness and signed off by the production
supervisor before being handed over to the production department.
8.5. Returns
8.5.1. All raw materials, packaging materials, intermediates and finished products
returned to storage should be properly documented and referenced.
8.5.2 Raw materials, packaging materials, intermediate products and finished products
shall not be returned to the warehouse unless they meet the specifications.
8.6. Processing
8.6.1. All materials used in processing should be checked before use.
8.6.2. The condition of the processing room should be monitored and restored to
the level required for the activity to be performed. Before processing begins,measures should be taken to ensure that the processing room andequipment are free of materials, products or documents that are not required
for the processing in question.
8.6.3. All equipment used in processing shall be inspected before use. Equipment
should be declared clean in writing before use.

171

8.6.4. All processing activities should be carried out following the prescribed written
procedures. Any retention should be reported with reasons and explanations.
8.6.5. Containers and covers used for materials to be processed, for intermediates
and finished products, should be clean, of an appropriate nature and type toprotect products and materials against contamination or damage.
8.6.6. All containers and equipment containing intermediate products should beappropriately labeled stating the stage of processing. Before these labels areapplied, all previous inappropriate labels or markings should be removed orcompletely removed. Before these labels are applied, all previous
inappropriate labels or markings should be removed or completely removed.
8.6.7. All intermediates or finished products must be appropriately labeled andquarantined within the factory, until approved by the quality control
department.
8.6.8. All in-process controls, as required, must be carefully recorded at the time ofprocessing.
8.6.9. The actual and standard results of each batch made should be recorded andmatched against the theoretical results. If there is any significant deviation,action shall be taken to prevent the release or further processing of the batch
until a definite explanation is obtained, which will permit release for further
processing.
8.6.10.In all stages of processing, primary attention should be paid to the issue ofcross-contamination.
8.6.11.Dry materials and products.
8.6.11.1. The handling of dry materials and products poses problems of
dust control and cross-contamination, which require special
attention in the design, maintenance and use of facilities andequipment. To handle dusty materials wherever possible, aclosed manufacturing system that prevents the spread of dust orother suitable methods should be applied.
8.6.11.2. Effective air suction systems should be installed with properly
located exhaust openings to prevent contamination of otherproducts or processes. A filtration system or other suitablesystem should be installed to contain dust. The use of dust
removal devices on tablets and capsules is highly recommended.
8.6.11.3. Special care should be taken to protect the product against
contamination by metal, glass or wood fragments. The use ofglassware should be avoided wherever possible. Sieves, sieves,tablet pestles and tablet mortar should always be checked forwear or damage before and after use.
8.6.11.4. Care should be taken not to leave any tablets or capsules in theequipment, counting device or container of the finished product.
8.6.12 Powder and Granule Manufacturing.
8.6.12.1. Mixing, sieving and stirring machines should be equipped withdust control systems, except when working with closed systems.
8.6.12.2. Critical operational parameters (e.g. time, speed, temperature)for each mixing, agitating and drying process shall be listed in the
Master Production Document, and monitored throughout theprocess, and recorded in batch records.
8.6.12.3. The filter bags installed in the belly-belly dryer should not be
used for different products without prior washing. For some high-172risk or sensitizing products, special filter bags should be used foreach product. Air entering the dryer should be filtered. Safetymeasures are required to prevent cross contamination by dust
escaping from the dryer.
8.6.12.4. The preparation and use of solutions and suspensions should be
carried out in such a way that the risk of contamination or growthof microorganisms is prevented.
8.6.13. Tablet Printing.
8.6.13.1.
Tablet presses should be equipped with effective dust control
facilities and located so as to avoid mixing of products. Eachmachine should be located in a separate room, unless they aremaking the same product. Machines equipped with a closed aircontrol system may be placed in an unseparated room.
8.6.13.2.
To prevent mixing between granules and tablets, it is necessary
to control both physically, procedurally and marking.
8.6.13.3.
Care should be taken to keep a precise and calibrated weighing
instrument available for use in monitoring the weight of tablets
in process.
8.6.13.4.
Tablets taken from the tableting room for testing or otherpurposes must not be returned to the bacth.
8.6.13.5.
Rejected or discarded tablets should be placed in a container
clearly marked as to their status and the quantity recorded on
the Batch Processing Record.
8.6.13.6.
Each time before use, all such tablet pestles and tablet mortars
shall be inspected for wear and conformity to specifications. A
record of their use should be kept.
8.6.14. Shrouding.
8.6.14.1
The air delivered into the dressing container for drying should
be filtered and of the right quality.
8.6.14.2
Dressing solutions are prepared and used in a manner thatminimizes the risk of microorganism growth. Preparation anduse must be documented.
8.6.15. Hard Capsule Filling.
8.6.15.1
Empty capsules should be considered and treated as starting
material. Empty capsules should be stored in conditions thatprevent them from drying out, getting wet or being exposed tomoisture.
8.6.15.2
Requirements in points 8.6.13.1. to 8.6.13.6. also apply to thefilling of hard capsules.
8.6.16. Marking of Coated Tablets and Capsules.
8.6.16.1
Special measures should be taken to avoid product mix-up
during the marking process of coated tablets and capsules.
When marking different products at the same time, or indifferent batches, or in different batches, the work should be
separated.
8.6.16.2
If ink is used in marking, the coloring material should meet therequirements for feed auxiliaries.
8.6.16.3
Special care should be taken to avoid mix-ups during theinspection, sorting and polishing of capsules and coatedtablets.

173

8.6.17. Liquids, Cremes and Ointments.
8.6.17.1.
Liquid, cream and ointment products should be made in such a
way that they are protected from microorganism and othercontamination. Closed manufacturing and transfer systems arehighly recommended.
8.6.17.2.
The chemical and microbiological quality of the water usedshould always be monitored. The water used must meet
drinking water quality standards.
8.6.17.3.
Where pipelines are used to convey raw materials or finishedproducts, care should be taken to make the system easy toclean. Pipelines should be properly designed and installed sothat they can be easily dismantled and cleaned.
8.6.17.4.
The accuracy of a measuring system should be verified.
Measuring sticks shall only be used for specific containers andhave been marked for the container concerned. They should bemade of non-reacting and non-absorbent materials.
8.7. Sterile Products
8.7.1.
Sterile products should be made with special supervision and attention todetail in order to eliminate the contamination of microorganisms andforeign particles. Supervision in the manufacturing process of sterile
products is very important.
8.7.2.
According to the production method, sterile products can be classified into
two main categories: those that must be processed in an aseptic mannerat all stages, and those that are sterilized in the final container, also called
final sterilization.
8.7.3.
All sterile products should be made under controlled conditions andcarefully monitored.
8.7.4.
To gain confidence in the sterility of sterile products made asepticallywithout final sterilization, special measures are required, including sterility
testing.
8.7.5.
To manufacture sterile products, a separate, specially designed room isrequired. Entry to this room should be through an air buffer chamber orother suitable passageway. The room should always be dust-free andsupplied with air that passes through a bacteria filter. The air pressure in
the room should be higher than in the adjacent room. The filters usedshould be checked at the time of installation and periodically. All surfaces
in the processing room should be properly designed to facilitate cleaningand sanitizing. Routine counts of indoor microorganisms should be carriedout before and during processing. The results of the count should becompared with the standardized
Determined. Microbial count data should be documented.
8.7.6. Manufacturing sterile products requires three different room qualities:
8.7.6.1
The changing room is a room for taking off factory work clothes
and the next room is a room for putting on sterile protective
clothing.
8.7.6.2
The clean room for carrying out clean activities does not haveto be sterile, it is also used for component preparation andsolution preparation. Products to be final sterilized can beworked on in this room. The room must not contain more than174

3,500,000 particles of o.5 microns or larger and no more than
500 microorganisms per cubic meter of air.
8.7.6.3
Sterile rooms are used for sterile activities. Employees enter
this room through an air conditioning room or other suitablemeans. The sterile room must not contain more than 350,000
particles measuring o.5 microns or larger and not more than
100 microorganisms per cubic meter of air. The room under thelaminaer airflow in a sterile room must not contain more than
3,500 particles of 0.5 million or larger and not more than 5
microorganisms per cubic meter of air.
8.7.7. It is important that microbial contamination in clean rooms and sterile rooms
does not exceed the specified limit values. These rooms should bemonitored for microbial contamination.
8.7.8. Personnel.
8.7.8.1
Employees working exclusively in clean rooms and sterilerooms should be carefully selected to ensure that they can berelied upon to work with discipline and are not suffering from adisease or health condition that could cause microbiologicalcontamination of the product.
8.7.8.2
High standards of personal hygiene and cleanliness are
essential. Employees should be instructed to report any healthconditions (e.g. diarrhea, cough, influenza, skin or hairinfections, wounds, etc.) that may lead to contamination withabnormal numbers and types of microorganisms. In addition,
periodic health checks should be conducted.
8.7.8.3
Only a limited and necessary number of employees are allowed
in clean rooms and sterile rooms when there is activity.
Examination and supervision should be carried out from theoutside as much as possible.
8.7.8.4
All employees, including those from maintenance, who work inclean rooms or sterile rooms, should receive training in areas
related to the manufacture of sterile products, including hygieneand basic microbiology.
8.7.9. Clothing.
8.7.9.1
Employees entering a clean room or sterile room shouldchange into special clothing including headwear and footwear.
These garments should not shed fibers or particles and should
be comfortable to wear and loose enough to prevent friction.
These garments should only be worn in the clean room orsterile room for which they are intended.
8.7.9.2
In the sterile room, employees should wear sterile overalls or
pants that can be put together with the neck, tied at the wrists
and ankles. Head coverings should cover all hair and chin andbe tucked into the neck of the shirt. Foot coverings should
cover the entire foot. Sterile clothing should be worn every time
you enter a sterile room. Plastic or rubber gloves are to be wornwith the sterile garment, either overalls or trousers, which canbe attached to the neck and fastened at the wrists and ankles.
Head coverings should cover all hair and chin and be tucked
into the neck of the garment. Foot coverings should cover the175

8.7.9.3

8.7.9.4
8.7.9.5

8.7.10. Building.
8.7.10.1.

8.7.10.2.

8.7.10.3.

8.7.10.4.

8.7.10.5.

entire foot. Sterile clothing should be worn every time you entera sterile room. Plastic or rubber gloves should be shaped. The
ends of the sleeves are tucked into the gloves. The facecoverings used prevent contamination from the face and are
comfortable to wear. When leaving the sterile room, the facecover should be taken off.
Ordinary clothing from outside should not be brought into thechanging rooms associated with clean rooms or sterile rooms.
Employees entering the changing room should wear standard
work clothes. Dressing and laundering should follow written
procedures.
Watches, jewelry and cosmetics should not be worn in clean
rooms and sterile rooms.
Clothing for the sterile room and sterile room should be
washed, ironed, sterilized and handled appropriately to avoid
contamination, and washing facilities should be separate.
Sterile products are processed in specially designed andconstructed production rooms, separate from other production
rooms. Space for each different type of work such as
preparation of starting materials and other components,
solution preparation, solution filling and sterilization should be
separate.
Processing rooms should be effectively supplied with positive
pressure air through filters that have the desired efficiency. This
airflow should realize positive pressure differences relative tothe surroundings and also between different rooms or activity
spaces. The final air filter should be installed directly or as close
as possible to the air inlet to the room. A warning system isrequired for high-risk rooms where the air is in direct contact
with the product. Special care should be taken to ensure thatairflow does not spread particles from employees' bodies,machinery (ampoule cutters, vial closures, etc.)and activities
that could spread particles into a space with a high risk to the
product.
Non-sterile products should not be with sterile products in thesame space and at the same time. If a sterile room is used forthe processing of non- sterile products, it should beappropriately fumigated and air-filtered before being used forthe manufacture of sterile products and verified against sterileroom requirements.
Wall, floor and ceiling surfaces should be smooth, watertightand not cracked to reduce the spread or accumulation ofparticles and to allow repeated use of cleaning and pestrepellent agents. Uncoated wood should not be used.
To reduce dust fertilization and facilitate cleaning, there should
be no hidden and difficult-to-clean parts. Protruding corners,
shelves, cabinets, equipment, inventory items and electric light
fixtures should be as few as possible. Angles between walls,

176

8.7.10.6.
8.7.10.7.

8.7.10.8.

8.7.10.9.

8.7.10.10.

8.7.10.11.

8.7.10.12.
8.7.10.13.

8.7.10.14.

floors and ceilings in spaces
Sterile and clean rooms should be curved.
The ceiling should be properly sealed to prevent pollution fromthe room above.
Pipes and ducts should be properly installed so that there areno hidden parts that are difficult to clean. Pipes and ducts
should be embedded into the wall through which they pass.
Drains should be avoided in sterile rooms unless absolutely
necessary. If installed, they should be fitted with effective andeasily cleaned traps containing buffer air to prevent backflow.
All floor drains should be open, sufficiently shallow and easy toclean and connected to external drains appropriately to prevent
possible microbial contamination.
Sinks in the clean room should be eliminated as much as
possible. All sinks installed in the clean room should be
stainless steel, non-overflowing and meet drinking water quality
standards.
Room temperature and humidity should be kept at a level that
does not cause employees to sweat excessively and does not
wet their work clothes.
Entry for personnel to the sterile and clean rooms can only bethrough the changing rooms. Changing rooms should beequipped with an air buffer chamber, effectively supplied withfiltered air at a positive pressure lower than that in the clean
room and sterile room. Changing rooms should beappropriately designed and used to avoid microbial andparticulate contamination of protective clothing and allow
separation of the various stages of changing clothes andwashing limbs.
The changing room is for staff use only and should not be used
for traffic of materials, containers and equipment.
The intermediate space or air buffer space for the traffic ofmaterials, equipment and other items into the clean room andsterile room is properly arranged so that only one door on one
side can be opened at a time. Push doors are avoided because
push teeth are difficult to clean. If such a door opening
mechanism is not possible, there should be an appropriate
procedure or system in place that allows the door to be opened
at any one time.
can prevent the outer door and inner door from being opened
simultaneously. The conveyor belt must not penetrate thebarrier wall of the sterile room. The conveyor belt ends at thewall and further product transportation only passes through thestatic surface. Special care is needed to avoid contamination of
the sterile room when goods are passed through an air buffer
space or an intermediate space.
Mechanical or electrical systems for oral communication to andfrom the sterile room should be properly designed and installed
so that they can be easily cleaned and effectively disinfected.

1778.7.10.15.

Clean rooms and sterile rooms should not be used to carry out
sterility testing or other microbiological testing.
8.7.11. Cleanliness and hygiene.
8.7.11.1.
Clean rooms, sterile rooms and other related rooms should becleaned frequently and carefully according to a written program.
If cleaning is carried out using disinfectants, the type should beexchanged in rotation to prevent resistance of microorganisms.
8.7.11.2.
Disinfectants and detergents used should be monitored for
microbial contamination. Dilutions should be placed inthoroughly washed containers and should not be stored unlesssterilized. Partially empty containers should not be refilled.
8.7.11.3.
Clean rooms and sterile rooms should be frequently
microbiologically monitored by placing petri dishes, taking
surface samples, air samples or other appropriate means.
Records of monitoring results should be documented andcorrective actions taken as soon as deviations are observed.
8.7.12. Equipment.
8.7.12.1.
Equipment should be designed and installed appropriately sothat it is easy to clean, disinfect or sterilize.
8.7.12.2.
Electrical outlets and other equipment should be designed andplaced appropriately so that personnel performing maintenanceand repairs do not need to enter the clean room or sterile room
as far as possible.
8.7.12.3.
The recording device should be carefully measured at the timeof installation and possibly checked at regular intervals.
8.7.12.4.
Validation of the results of installation, periodic maintenanceand checks on the capability of critical equipment such as
sterilizers, air filter systems and distillers is essential. Validation
results should be documented.
8.7.13. Processing.
8.7.13.1.
Starting materials should not contain significant levels of
microorganisms or pyrogens. Particular attention should be
paid to starting materials used for large volumes of parenteralpreparations. Starting material specifications should include
requirements for monitoring the content of microorganisms, if
necessary with specific limits.
8.7.13.2.
Measures should be taken to prevent contamination of products
by microorganisms at all stages of processing both before andafter sterilization.
8.7.13.3.
To prevent the spread of particles and microorganisms,
activities in clean rooms and sterile rooms are limited as muchas possible, as is the movement of personnel.
8.7.13.4.
Containers and materials that may release particles or fibers
should not be brought into the clean room or sterile room.
8.7.13.5.
After final cleaning of containers and other components, theyshould be handled appropriately to prevent re-contamination.
Final rinsing should be done with distilled water or water ofsuitable quality.

1788.7.13.6.

The time between washing and sterilization of equipment,
containers and other components should be as short as
possible.
8.7.13.7.
The time between sterilization of equipment, containers andother components and their use in the aseptic process should
be as short as possible.
8.7.13.8.
The time between the start of solution preparation andsterilization should be as short as possible with a certain time
limit found The volume of the homemade solution should bemade no larger than the filling capacity of a day and should be
filled into the final container and sterilized on the same day.
Residual solution whose filling and sterilization cannot becompleted on the same day should be specially stored.
8.7.13.9.
Water sources, water treatment equipment and treatment water
should be monitored regularly.
for chemical and microbial contamination and if necessary for
pyrogens. Monitoring results and countermeasures taken
should be documented.
8.7.13.10. Water treatment plants should be properly designed,
constructed and maintained to ensure that the water produced
meets the specified drinking water quality requirements. Water
treatment, storage and distribution should be appropriate sothat the growth of microorganisms is prevented.
8.7.13.11. To prevent bacterial growth and the emergence of pyrogens,distilled water that will be used for processing or sterilization
should not be left for more than 24 hours except under special
conditions such as by storing at temperatures above 650 c.
8.7.13.12. Where water and solutions are stored in hermetically sealedcontainers, all safety valves should be protected withhydrophobic bacterial screens.
8.7.13.13. Items that are used in the sterile room and require sterilization
should be sterilized and put through a two-door sterilizer unit orother means that can provide the same results.
8.7.13.14. The effectiveness of aseptic procedures should be validated
when a new aseptic process is introduced and continued
periodically. Validation is also done when there are significant
changes in the process or equipment, or when personnel arebeing trained.
8.7.14. Sterilization.
8.7.14.1.
Sterilization can be carried out by heat sterilization (by wet
heating and dry heating), by ethylene oxide gas, by filtration
recommended by aseptic filling into sterile final containers, orby ionizing radiation. Each sterilization method has limitations
and is used for specific applications. Heat sterilization is the first
choice.
8.7.14.2.
When biological indicators are used, strict safeguards should
be taken to prevent microbial contamination of the indicator.
8.7.14.3.
A clear way to distinguish between products that have and havenot been sterilized is required. All containers for products orother components should be clearly labeled with the name,179batch number and an indication of whether they have beensterilized or not.
8.7.15. Heat Sterilization.
8.7.15.1.
All heat sterilization cycles shall be recorded on a timetemperature chart or by other suitable means. Timetemperature records should be part of the batch record.
Chemical and biological indicators may be used in addition to
but not in place of physical monitoring.
8.7.15.2.
In the cooling period after reaching the highest temperaturephase, the possibility of contamination by non-sterile air
entering the autoclave or sterilizer during cooling should be
prevented.
8.7.16. Wet Heat Sterilization.
8.7.16.1.
This method is suitable for aqueous solutions and wettablematerials. Other types of materials should be sterilized by othermethods.
8.7.16.2.
Wet heat sterilization is achieved by using pressurized
saturated water vapor in a suitable container. In this situation
there is a definite relationship between temperature and water
vapor pressure, but the pressure is used only to achieve thedesired temperature and does not play a role in sterilization,
time, temperature and pressure are used to supervise andmonitor the sterilization process.
8.7.16.3.
Sterilized items, other than aqueous products in hermeticallysealed containers, should be wrapped in a material that allows
the penetration of moisture, which under normal circumstances
will not cause back contamination by microorganisms aftersterilization.
8.7.16.4.
Care should be taken that the water vapor used in sterilization
is of the right quality and does not contain additives in levels
that could contaminate the product or equipment.
8.7.17. Dry Heat Sterilization.
8.7.17.1.
Dry heating is suitable for sterilization of equipment, nonaqueous solutions and other materials that are resistant to thedesired sterilization temperature.
8.7.17.2.
Heating should be carried out in a sterilization cabinet or otherequipment that can achieve sterilization conditions for the entire
load. The air delivery and air suction system of the sterilization
cabinet should be equipped with appropriate filters.
8.7.18. Filter Method Sterilization.
8.7.18.1.
Sterilization by filtration should not be used if heat sterilizationis still possible.
8.7.18.2.
Solutions or liquids can be sterilized by filtration with a nominal
pore size of 0.22 microns or the same ability to withstandmicroorganisms. The filter results are collected in a sterilized
container.
8.7.18.3.
The integrity of the filter device should be checked byappropriate methods such as the point-bubble pressure test or
the forward-flow pressure test carried out immediately before

180and after use of the filter. The inspection results are recorded in
the batch record.
8.7.18.4.
The filter must not have an adverse effect on the solution, suchas absorbing efficacious ingredients from the solution orreleasing substances into the solution.
8.7.18.5.
Because filter sterilization carries a greater risk than othersterilization methods, it is recommended to re- filter through asterile bacterial filter immediately before filling.
8.7.18.6.
The lifetime of the sterile filter should be limited to ensure that
there is no growth of microorganisms in the filter.
8.7.19. Sterilization with Ethylene Oxide Gas.
8.7.19.1
The effectiveness of ethylene oxide gas as a sterilizing agent
depends on the concentration, temperature, humidity, durationof contact with the material and the level of microbial
contamination. Where possible, other sterilization methods
should be used as an option to sterilization with ethylene oxide
gas.
8.7.19.2
The entire sterilization cycle should be monitored withappropriate biological indicators placed throughout the load.
Monitoring results are recorded in the batch record.
8.7.19.3
After sterilization is complete, the material should be placed in awell-ventilated room to remove residual ethylene oxide and its
reaction products. Steps should be taken to prevent backcontamination of the sterilized material. Records should be kept
to check that all biological indicators have been removed fromthe product.
8.7.19.4
During the sterilization cycle, records shall be kept of the lengthof time to complete one cycle, pressure, temperature, gasconcentration and humidity in the sterilization cavity. The
pressure, temperature and relative humidity during the cycle
should be monitored and recorded in a graph.
or by other appropriate means. This record forms part of thebatch record.
8.7.20. Sterilization by Radiation.
8.7.20.1. Radiation sterilization is used primarily to sterilize heat-sensitive
materials and products. This method is only used when it has
been proven that there is no detrimental effect on the product.
8.7.20.2. The radiation used can be either gamma rays from radio
isotopes (e.g. cobalt-60)or high-energy electrons from anelectron accelerator.
8.7.20.3. The usual minimum sterilization dose is 2.5 mega rad.
8.7.20.4. During sterilization the radiation dose should be monitored. For
this purpose there should be a dose measurement procedurethat determines the amount or size of the dose received by the
product Biological indicators should be used only as an adjunct.
Monitoring results are recorded in the batch record.
8.7.20.5. Clear markings should be provided to distinguish between
irradiated and non-irradiated materials. The design of radiation
facilities and the use of radiation- sensitive plates can help
provide this assurance.

1818.7.21. Water.
8.7.21.1.

The water used to make sterile products, including the storage
and distribution system, should be monitored according to thespecifications set for each activity.
8.7.21.2.
Water for injection is made by distillation or other suitablemeans.
8.7.21.3.
Water for injection is stored and circulated continuously at atemperature of at least 650 C. Water that is not stored andcirculated should only be used for no more than 24 hours.
8.7.21.4.
Water for injection used in the formulation is considered andapplied as starting material.
8.7.21.5.
A logging device should be used to monitor the storage
temperature.
8.7.21.6.
Water for injection is stored in clean, sterile, non-reactive, nonabsorptive, non-additive containers and protected fromcontamination.
8.7.22. Sterile Product Finishing.
8.7.22.1.1. When detergents or similar materials are used in the finalcontainer rinsing sequence, procedures should be in place toensure that no residue remains in the container. Final rinsing
distilled water or water that meets water quality standards
should be used.
8.7.22.1.2. Staff should not handle containers with bare hands. The finalwashed, dried and sterilized containers should be used within
the specified time limit.
8.7.22.1.3. The final container of sterile product must be sealed in an
appropriate manner. Closure ability is checked by appropriate
procedures.
8.7.22.1.4. Containers filled with injection solution should be checkedindividually for visible particles. If this is an eye examination, it
should be carried out with appropriate lighting and background.
Examiners should be given adequate rest periods during theexamination and receive regular eye examinations.
8.7.22.1.5. If the examination is performed electronically or photoelectrically, the effectiveness of the device should be validated
and its sensitivity monitored.
8.7.23. Biological and Chemical Indicators.
8.7.23.1.
Biological and chemical indicators cannot be used as evidence
that sterilization has been effective.
8.7.23.2.
Monitoring using biological indicators is less reliable thanphysical monitoring except for sterilization with ethylene oxide
gas.
8.7.23.3.
Strict safety measures should be taken in handling biologicalindicators, to prevent contamination of an otherwise
microbiologically clean room. Biological indicators should be
stored according to the manufacturer's specifications.
8.7.23.4.
Chemical indicators for heat sterilization, ethylene oxide gas
and radiation sterilization are usually available in the form oftapes, adhesive sheets, color dot cards, small tubes, smallbags or plastic dosimeters. These indicators will change color

182

as a result of the chemical reactions that occur due to thesterilization process. This color change may occur before thesterilization time is completed. Therefore such indicators are
not sufficient as evidence of sterilization, except for plastic
dosimeters used in the radiation sterilization process.
8.8. Packaging
8.8.1. The packaging activity functions to divide and package the processed products
into finished veterinary medicines. Packaging process should be carried out
under strict supervision to maintain the identity, integrity and quality of the
packaged goods.
8.8.2. For packaging activities, there should be a written procedure outlining thereceipt and identification of finished products and packaging materials, controls
to ensure that the correct finished products and packaging materials (printed or
unprinted)are used, in-process controls during packaging, reconciliation offinished products and printed packaging materials, and final inspection of
packaging results. All packaging activities shall be carried out in accordancewith the instructions given and using the packaging materials listed in the Master
Packaging Procedure. Details of packaging operations should be recorded in thebatch packaging record.
8.8.3. Before packaging activities begin, checks should be made to ensure that theequipment and workspace are clean and free of product and other productresidues or documents that are not required for the activities being carried out.
8.8.4. Every delivery of finished products and packaging materials shall be checked
and scrutinized for compliance with the Master Packaging Procedure or
packaging order.
8.8.5. Pre-marking on Packaging Materials.
8.8.5.1. Labels, cartons and other components that require pre-marking withbatch or lot numbers, expiry dates and information in accordance withthe packaging order shall be closely monitored at every step of theprocess, from receipt from the warehouse until they become part of thefinished or destroyed veterinary drug.
8.8.5.2. Packaging materials that have been determined to be pre-marked
should be stored in tightly closed containers and placed in a separate
room where safety is guaranteed.
8.8.5.3. Pre-marking of packaging materials should be carried out in a room
separate from other packaging activities.
8.8.5.4. All packaging materials that have been pre-marked should be checked
before being moved into the packaging room.
8.8.6. Packaging Line Readiness.
Immediately before placing the packing material on the packing line a readinesscheck of the packing line concerned shall be carried out by the designatedpersonnel, in accordance with the written procedure specified for:(a) Ensure that all materials and packaged products originating fromprevious packaging activities have been completely removed from thatpackaging line and the surrounding space.
(b) Examine the cleanliness of the path and surrounding space.
(c)Ensure the cleanliness of the equipment to be used.
8.8.7. In-Process Packaging.

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8.8.7.1. Written procedures for in-process control should be followed. This
procedure should describe the method of sampling, the frequency ofsampling, the number of samples taken for inspection, thespecifications to be inspected and the acceptable limits for eachspecification.
8.8.7.2. In-process supervision should also include the following generalprocedures:(a) Products to be packaged should be inspected at the time of
packaging;(b) Packaged products should be checked during the packaging
process at regular intervals to ensure compliance with thespecifications stated in the Master packaging Procedure.
8.8.7.3. The results of tests and inspections in the process should be recordedon the bacth packing record.
8.8.8. Packaging Implementation.
8.8.8.1 The occurrence of errors in packaging can be minimized in thefollowing ways:(a) label usage;(b) bacth coding directly on the label installation line;(c) use of electronic code readers and label counters;(d) labels and other printed matter are designed so that they havedistinctly different markings for different products;(e) In addition to visual inspection during packaging, a separate
inspection should be carried out by the quality control
department during and after completion of packaging.
8.8.8.2. Products that are the same or nearly the same in shape andappearance should not be packed on adjoining lines, unless there isa physical separation.
8.8.8.3. On each packaging line, the name and batch number of the productbeing packaged should be clearly visible.
8.8.8.4. Containers used to store freshly partially packaged or subbatches offinished products or veterinary medicines shall be labeled or marked
as to indicates the identity, quantity, batch number and status of the
product.
8.8.8.5. Containers to be filled should be delivered to the packaging
department in a clean state.
8.8.8.6. All packaging personnel should be trained to appreciate theimportance of monitoring the process and reporting any irregularities
that may be noticed as they perform their duties.
8.8.8.7. The packaging room should be cleaned at certain times during theworking day and at any time of soiling. Cleaners should be trained
to avoid actions that may cause mixing or cross-contamination.
8.8.8.8. Any printed packaging materials found during cleaning should begiven to the supervisor, who will place them in a designated area forreconciliation and destroy them at the end of the packaging process.
8.8.8.9. Finished and near-finished products found to be outside thepackaging line should be handed over to a supervisor and should
not be immediately returned to the packaging process. If the producthas been checked by a supervisor and found to have the same
identity as the batch being packaged and is in good condition, the184supervisor may return it to the packaging process in progress. If theidentity is different then the item should be destroyed and thequantity recorded.
8.8.8.10.Products that have been filled into the final container but have notbeen labeled should be separated and marked to avoid mixing withother products.
8.8.8.11. Packaging equipment whose parts are not in direct contact with thefinished product should be cleaned because it can be a place for
dust, debris of packaging materials or products to accumulate which
can then contaminate the product being packaged or become asource of pollution.
8.8.8.12.Care should be taken to avoid the spread of dust during the
packaging process of dry products. Separate packing rooms are
required for certain products. For example, low-dose veterinary
drugs that pose a high risk. Toxic products and sensitizing
materials. Compressed air is not used for Clean the equipment in
the packaging room because it may cause cross-contamination.
8.8.8.13.The use of brushes as cleaning tools should be limited as they cancause contamination from the bristles.
8.8.8.14.Personnel who need medicine for their illness that does notendanger the product or others around them should be allowed toleave the packing room to take their medicine. Under nocircumstances should medicine be brought into the packaging room.
8.8.8.15.Staff should be reminded not to put packaging materials or productsin their pockets. Such materials should be carried by hand or inclosed containers that are clearly marked.
8.8.8.16.Materials required for packaging such as lubricants, adhesives, inks,
cleaning fluids should be placed in a separate container within the
product container that is clearly marked with the contents.
8.8.9. Packaging Product Completion.
8.8.9.1. At the completion of packaging the packaged product should be
carefully checked to ensure that the veterinary medicine complies withthe requirements of the Master Packaging Process.
8.8.9.2. Only finished veterinary medicines from a single batch should beplaced on a pallet. If a carton is not full, the quantity inside should be
written on the carton.
8.8.9.3. After the adjustment process is completed. Excess packaging materials
and finished products to be disposed of should be properly monitored
so that only materials that are found to be qualified can be returned to
the warehouse for reuse. Such materials should be clearly marked.
8.8.9.4. Supervisors should oversee the counting and destruction of packaging
materials and finished products that cannot be returned to thewarehouse. All unused and marked packaging materials should bedestroyed. The amount destroyed is recorded on the batch packing
record.
8.8.9.5. Supervisors should calculate and record the net usage of all packaging
materials and finished products.
8.8.9.6. Any packaging deviations that cannot be explained or do not meet
specifications should be thoroughly investigated by consider otherbatches or products that may be affected.

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8.8.9.7. Once the reconciliation has been matched, the finished veterinary drug
should be kept in factory quarantine pending clearance by the quality
control department.
8.9. Selected products, leftover products and finished veterinary medicines returned fromthe factory warehouse
8.9.1. Intermediate products or ruined products can be reprocessed and recovered
provided that the materials are suitable for reprocessing under certain
authorized procedures, and the results still meet the specified specification
requirements.
8.9.2. Reprocessing procedures should be specifically authorized and documented,
after an assessment has concluded that the risk is negligible.
8.9.3. Leftover products and recovered products can only be added into the next batch
if they meet the specified specifications.
8.9.4. Procedures for handling leftover or recovered products and adding them to thenext batch should be specifically authorized and documented.
8.9.5. There should be a limit approved by part of quality control on the amount ofresidual recovered product that can be added to the next batch.
8.9.6. Batches containing residual or recovered product are only considered eligible
after all batches from which the residual or recovered product originated havebeen assessed and found to meet the prescribed specifications. Consideration
should also be given to the need for additional testing of all finished veterinary
medicines containing by-products.
8.9.7. Finished veterinary medicines that are returned from the factory warehouse, forexample because the label or outer packaging is soiled or damaged, can berelabeled provided there is no risk to the product and the work is specificallyauthorized and documented. When finished veterinary medicines are relabeled,care must be taken to avoid confusion with other products or mislabeling.
8.10. Quarantine of Finished Veterinary Medicine Factory and Delivery to Finished
Veterinary Medicine Warehouse
8.10.1. The finished animal plant quarantine is the final point of control before thefinished animal medicine is transferred to the warehouse and ready for
distribution. Before finished veterinary medicines are transferred to thewarehouse, strict controls should be in place to ensure that a comprehensive
record of the batch meets the requirements.
8.10.2. Written procedures should include how finished veterinary medicines aredelivered to the quarantine room, how they are stored while in quarantine.
waiting for graduation, the requirements fulfilled to obtain graduation and how tofurther transfer to the finished veterinary medicine warehouse.
8.10.3. While awaiting clearance by the quality control department, all packaged
batches or lots should be held in factory quarantine status.
8.10.4. No veterinary medicine may be taken from a batch, as long as the finishedveterinary medicine is still in the quarantine room, except for samples for thequality control section.
8.10.5. The factory quarantine room is a room restricted to personnel who are strictly
required or authorized.
8.10.6. Any veterinary drug that requires special storage requirements should be clearlylabeled stating the required storage requirements, and the veterinary drug

186should be stored in a suitable storage area within the quarantine room of theplant under specified conditions.
8.10.7. The approval of finished veterinary drugs by the quality control department must
be preceded by satisfactory completion of the following:a. The finished product meets the quality requirements in a processing andpackaging specification.
b. The quality control department sets aside and stores a sufficient amount of
the finished veterinary drug as a lagging sample.
c. The final packaging or marking meets the requirements, subject to theinspection results of the quality control section.
d. Reconcile suitable printed packaging materials.
e. Finished veterinary drugs received at the factory quarantine room are inaccordance with the quantity stated on the goods transfer document.
8.10.8. After the quality control department approves a batch or lot, the finishedveterinary medicine should be transferred from the factory quarantine room tothe finished veterinary medicine warehouse.
8.10.9. When receiving the finished veterinary drugs, the warehouse staff should record
the entry of the batch in the finished veterinary drug inventory card.
8.11. Supervision of Finished Animal Medicine Distribution.
8.11.1. The distribution system should be designed appropriately to ensure that finishedveterinary medicines that arrive early are distributed first.
8.11.2. The system also includes a way of recording so that the distribution of eachbatch can be known immediately to facilitate investigation and recall ifnecessary.
8.11.3. Written procedures for the distribution of finished veterinary medicines should be
developed and implemented.
8.11.4. Deviations from the first principle of exit are only permitted for a short period oftime with the approval of the responsible leader.
8.12. Storage of Starting Materials, Intermediate Products. Ruined Products and Finished
Veterinary Medicines.
8.12.1. All materials should be stored in a neat and organized manner to prevent therisk of mixing or contamination and to facilitate inspection and management.
8.12.1.1. All materials should be stored at a sufficient distance from othermaterials and walls and not on the floor.
8.12.1.2. Materials should be stored under appropriate environmental
conditions, any special storage conditions required should be
provided in factory quarantine rooms and warehouses.
8.12.1.3. Storage outside the building is allowed for materials packed inimpermeable containers (e.g. metal drums) whose quality is notaffected by temperature, humidity and other factors.
8.12.1.4. Storage activities should be clearly separated from other activities.
8.12.1.5. All deliveries to the storage area including returns should beproperly recorded.
8.12.1.6. Each starting material, intermediate product, finished product andveterinary drug stored should have an inventory card. The cardshould be reconciled at all times and any irregularities noted with an
explanation.
8.12.2. Storage of raw materials and packaging materials.

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8.12.2.1. All raw materials and packaging materials delivered to the storage
room should be checked for identity, container condition and a pass
mark from the quality control department.
8.12.2.2. If the identity or condition of the container of a raw material or
packaging material is in doubt or does not match the identity or
condition requirements, the container should be sent to the factory
quarantine room. For further inspection by the quality control
department.
8.12.2.3. Rejected raw materials and packaging materials should not be
stored together with approved materials but stored in a special roomdesignated for rejected materials.
8.12.2.4. Printing-packaging materials should be kept in a specific storage
room and removed under strict supervision.
8.12.2.5. Certain inventories and approaching expiry dates of approved raw
materials and packaging materials that have been utilized inadvance.
8.12.2.6. Raw materials and packaging materials should be retested as to theidentity of their quality strength and purity when necessary, forexample after long storage or after exposure to hot air or otherinfluences that reduce their quality.
8.12.3. Storage of intermediate products, processed products and finished veterinary
drugs.
8.12.3.1. Intermediate products, processed products and finished veterinary
medicines should be kept in the quarantine room of the factory
pending inspection and decision by the quality control department.
8.12.3.2. Each delivery should be checked to ensure that the materialdelivered complies with the delivery document.
8.12.3.3. Each container of intermediate products, finished products andveterinary drugs delivered to the storage room should be checked
for identity and the condition of the container.
8.12.3.4. If the identity or condition of the container of an intermediate
product, processed product and finished veterinary drug is in doubt
or does not meet the identity or condition requirements, thecontainer should be quarantined for further inspection by the quality
control department.
9. Quality Control
Quality control is an essential part of good veterinary medicine manufacturing so that every
veterinary medicine made meets the quality requirements for its intended use. A sense ofengagement and responsibility of all elements in all stages of manufacturing is essential toproduce quality veterinary medicines from the time they are made to the distribution offinished veterinary medicines. For this purpose, there should be a stand-alone quality control
department.
9.1. General Conditions
9.1.1. The quality control system should be designed appropriately to ensure thateach veterinary drug contains ingredients of the correct quality and in thespecified quantity and is made under the right conditions or following standard
procedures. So that the veterinary drug meets the established specifications
regarding physical identity, content, purity, potency and safety.

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9.1.2. Quality control covers all analytical functions performed in the laboratory
including sampling examination and testing of starting materials, intermediate
products, finished products and finished veterinary medicines. Quality control
also includes the stability test program of work environment monitoring,
validation, documentation of a batch, sample storage program and preparationand storage in accordance with the applicable specifications of each material
and product including the test method.
9.1.3. The documentation system and the quality control procedures and approvals
should ensure that the necessary checks and tests are carried out
appropriately and that starting materials, intermediates and finished products
are not used and finished veterinary medicines are not distributed or sold until
the results of the quality checks and tests are judged to meet the
specifications. The system should also ensure the implementation of any othermatters that require approval from the quality control department.
9.1.4. The quality control section carries out the following main tasks:a. Develop and refine supervision procedures.
b. Maintain detailed written instructions for each inspection and test.
c. Develop a written plan and procedure for sampling for examination.
d. Keeping the leftover samples for future reference.
e. Approve or reject each batch of starting materials, intermediate products,
processed products and finished veterinary drugs and other prescribedmatters.
f. Examine records relating to the processing, packaging and testing offinished veterinary drugs of the batch in question before approving for
distribution.
g. Evaluate the stability of all finished veterinary drugs on an ongoing basis,starting materials if necessary, and prepare instructions on how to store
starting materials and finished veterinary drugs in the factory based on theavailable stability data.
h. Establish expiration dates and time limits for the use of starting materials
and finished veterinary drugs based on their stability data and storage
conditions.
i.
Evaluate and approve product reprocessing procedures.
j.
Approve the supply of raw materials and packaging materials that are
known to be capable or reliable of supplying starting materials that meetthe established quality specification materials.
k. Take part or provide assistance in the implementation of the validation
program.
l.
Evaluate all complaints received or deficiencies found in a batch, and if
necessary cooperate with other departments to take necessary corrective
actions.
m. Provide secondary comparison books according to the specifications
contained in the test procedure.
n. Keep records of the examination and testing of all samples taken.
o. Evaluate returned veterinary drugs and determine whether they can beused directly or reprocessed or destroyed.
p. Participate in the Internal Inspection program with other parts of thecompany.
q. Provide recommendations for the manufacture of veterinary drugs byother parties on a contract basis after an evaluation of the contractor

189concerned is considered capable of making veterinary drugs that meet theestablished quality standards.
9.2. Testing laboratory
9.2.1. Building
9.2.1.1 Testing laboratories should be properly designed, constructed andequipped to accommodate and carry out the required activities.
9.2.1.2 Suitable and safe facilities should be provided for waste andresidual materials to be disposed of. Toxic and flammable materials
should be stored in a special and separate place.
9.2.1.3 The laboratory room should be separate from the production room.
9.2.1.4 Biology, microbiology and chemistry laboratories should be
separated from each other.
9.2.1.5 A separate room for the instrument may be required to protect
against electrical noise, vibration, excessive humidity and otheroutside disturbances or where the instrument needs to be isolated
from other equipment.
9.2.1.6 The design of the laboratory should take into account the suitabilityof the building materials used, outlets for harmful gases and fumes
and ventilation. Separate air control units should be installed foreach of the biology, microbiology and rodioisotope laboratories.
9.2.1.7 All pipes and equipment for the distribution of water, gas, air, steam
and so on should be clearly marked. In this regard, it is necessary to
pay attention to the availability of non-interchangeable pipe
connections or adapters for hazardous gases or liquids.
9.2.2. Personnel
9.2.2.1. Every employee who is given the task of supervising or directly
performing laboratory work should have the appropriate education,
training or experience to enable them to carry out their duties
properly. The duties and responsibilities of each employee should
be clear, either in writing in their job description or in otherappropriate forms.
9.2.2.2. Each employee should wear protective clothing and safety
equipment such as respirators or masks, goggles and gloves as
required to perform their duties.
9.2.3. Equipment
9.2.3.1. Testing laboratory equipment and instruments should be suitable forthe test procedure being performed.
9.2.3.2. Standard work procedures for all instruments and equipment should
be available and placed near the instrument or equipment
concerned.
9.2.3.3. Equipment and instruments should be serviced and tested at set
intervals and documented. Checks to ensure that instruments are ingood working order should be carried out daily or before each use.
9.2.3.4. The date on which the equipment has been tested and serviced andthe date of the next test and service shall be indicated on each
instrument or by other suitable means.
9.2.3.5. It should be clearly marked to indicate that the equipment is not
functioning properly or is being serviced so that it is not used.

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9.2.3.6. Safety showers and eye washes should be available near the
workplace.
9.2.4. Reagents and Breeding Media
9.2.4.1. Receipt and manufacture of reagents and culture media should berecorded.
9.2.4.2. Reagents made in the laboratory should follow written
manufacturing procedures and be labeled accordingly.
The label includes the concentration, standardization factor, time
limit for use, date of re-standardization, storage conditions, alongwith the date of manufacture and signature of the person who madethe reagent.
9.2.4.3. Both positive and negative controls should be used to ensure thesuitability of the culture medium used. The amount of inoculum inthe positive control should be adjusted to the desired growthsensitivity.
9.2.5. Standard Comparison
9.2.5.1. Benchmarks should be under the responsibility of a designatedperson.
9.2.5.2. Official benchmarks are only used for the purposes described in therelevant monograph.
9.2.5.3. Secondary standards of comparison or working standards ofcomparison can be made and used after appropriate testing andperiodic and regular checks to correct deviations that occur and toensure the accuracy of the results.
9.2.5.4. All comparator standards should be stored and used appropriately
so that their quality does not deteriorate.
9.2.5.5. The label of the comparator should include the concentration, dateof manufacture, expiration date, date the container lid was first
opened and if necessary the storage conditions.
9.2.6. Specifications and Test Procedures
9.2.6.1. Test procedures should be validated with respect to the facilities
and equipment available before they are used in routine testing.
9.2.6.2. Specifications and test procedures for each raw material,
intermediate product, processed product and finished veterinary
drug shall contain provisions and methods for examination andtesting regarding its identity, purity, content, potency and safety.
9.2.6.3. The test procedure shall contain:a) the number of samples required for testing and those that should
be stored for future reference.
b) The amount of each reagent, aqueous solution, etc. required forthe test.
c) Equipment and instruments required for testingd) Calculations and formulas used.
e) Target value and tolerance of each test.
9.2.6.4. The test procedure shall include the frequency of re-examination ofeach raw material determined by considering its stability.
9.2.6.5. All tests conducted should follow the instructions contained in thetest procedure for the respective material or product. Test results,
especially those concerning calculations, should be checked by asupervisor before the material or product is accepted or rejected.

1919.2.7. Testing Notes
Test records should include:(a) name and batch number of the sample.
(b) Name of the officer who took the sample.
(c) analysis method used.
(d) All analyzed data such as weight, burret reading, volume and dilution.
(e) calculations and formulas used.
(f) requirements regarding allowable tolerances.
(g) requirements whether it meets or does not meet the specification
requirements.
(h) date and signature of the officer conducting the test and the officer
checking the calculation.
(i) A statement on whether to pass or reject and advice on further action
signed and dated by the authorized officer.
(j) Name of supplier, quantity of initial material received.
(k) Total number and quantity of containers, intermediates, finished products
and finished veterinary drugs from the batch or lot of origin being
analyzed.
9.2.8. Leftover Sample
9.2.8.1. Residual samples with other identifiers representing each batch ofreceived efficacious starting materials shall be retained for a certain
period of time.
9.2.8.2. Clearly identified residual samples representing each batch offinished veterinary medicines in full package form should be kept fora certain period of time. These samples of finished veterinary
medicines should be stored under the same conditions as thoseindicated on the etiquette.
9.2.8.3. The number of leftover samples should be at least twice the numberof samples required for a complete test.
9.3. Validation
9.3.1 Quality control section validates
9.3.1.1. Level determination procedure
In the validation exercise, the level determination principle isconsidered suitable for the procedure. Validation is intended todetermine the accuracy and precision of the determination and not
to determine the cause of the observed deviations. If the accuracy
and precision of the determination is not satisfactory, the procedureneeds to be reviewed, redesigned, improved or replaced.
9.3.1.2. Equipment:
Testing of equipment used in testing shall be carried out periodicallyto ensure that that the equipment continues to provide precise
measurement and weighing results.
9.3.2 The quality control department shall provide necessary assistance or take part inperiodic validation by other departments, especially the production
department, to ensure that all veterinary medicinal products produced meetthe minimum requirements.
9.4. Supervision of Starting Materials, Intermediate Products, Ruined Products and Finished
Veterinary Medicines192

9.4.1. Specifications
Each specification should be approved in advance and kept by the quality
control department. Matters covered by the specifications for starting materials,
intermediates, finished products and finished veterinary medicines will be
described separately. Periodic amendments of each specification should bemade in accordance with the latest edition of the Indonesian Veterinary
Pharmacopoeia or other official regulations.
9.4.2. Sampling
9.4.2.1. Samples should be representative of the batch of material taken.
Sampling shall be conducted in accordance with approved written
methods.
9.4.2.2. Sampling should be done properly so that there is no contaminationof or by other product ingredients.
9.4.2.3. Equipment used to collect samples should be cleaned and if
necessary sterilized, before and after use and stored separately fromother laboratory equipment.
9.4.2.4. Containers and equipment used for sampling should not affect thequality of the veterinary drug substance or product from which thesample is taken.
9.4.2.5. Each sample container should be labeled to indicate:(a) the product name of the sample taken;(b) batch or lot number;(c) amount packaging products thatsamples were taken;(d) signature of the officer who took it;(e) sampling date.
9.4.2.6. Sampling should be carried out in accordance with establishedprocedures, the sampling procedures will be explained later.
9.4.3. Testing
9.4.3.1. Raw Materials
Each raw material should be tested for physical specifications,
identity, purity, quality, strength and other specified requirements.
9.4.3.2. Packaging Materials
Packaging materials should meet the specified specifications,especially in terms of the suitability of the type of material for the
product that is contained in the material. Critical physical defects andthe accuracy of material identity markings that may cast doubt on theveracity and quality of the product should be checked.
9.4.3.3. Intermediates, Ruined Products and Finished Veterinary Medicines.
(a) To ensure batch uniformity and integrity, in- process control
should be carried out by taking representative samples of eachbatch of intermediate products, finished products and finishedveterinary drugs for testing of identity, strength, purity andpotency. Approval from the quality control department isabsolutely necessary after the completion of critical production
steps or if the product has been stored for a long time before thenext production step is carried out.
(b) Rejected intermediate products, processed products and finishedveterinary medicines shall be marked and monitored with afactory quarantine system designed to prevent their use in further

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production processes or for distribution unless they are deemed
to be reprocessable.
(c) Sterility Test
Sterility tests performed on finished veterinary drugs should beconsidered as the last step in a series of control measures toensure sterility. Qualified test results do not guarantee thesterility of the entire batch as it is possible that unsterile
containers were not selected during sampling.
In addition, the breeding method used has limited sensitivity. So
it does not always allow the growth of all microorganisms. Evenso, with the right sampling method and the use of appropriate
media, the results of the sterility test can be used as a guideline
for passing or rejecting a batch in carrying out the sterility test,
the following should be considered:(1) Guidelines for the minimum number of sample packs to betested as well as the standard methods used for testing
different types of preparations for aerobic bacteria,
anaerobic bacteria and fungi, should be stated in the test
procedure.
(2) Samples of a batch should be taken at random, includingfrom the presumed coolest spot on the heat-sterilized load
and be from the initial and final fills of the batch aseptically.
(3) If the test results of a batch are found to be unqualified, thecause of this failure should be traced and appropriate
corrections made.
(4) All sterility testing results should be documented.
(d) Pyrogen Test
1) In the manufacture of sterile veterinary drugs, consideration
should be given to testing raw materials, intermediate
products, finished products and finished veterinary drugs for
pyrogens.
2) Water for injection is checked for pyrogenicity, if it is labeled"pyrogen-free" or if its volume is more than 10 ml in the final
package.
9.4.4. Environmental Monitoring
The work environment supervision carried out is as follows:a. Regular monitoring of the chemical and microbiological quality of waterused in veterinary medicine processing, especially that leaving thepremises where it will be directly used. Sample sizes and testing
methods should be capable of detecting small concentrations of indicatororganisms (e.g. Pseudomonas).
b. Periodic microbiological monitoring of the production environment.
c. Periodic testing of the environment around the production room to detect
the presence of other animal drugs that will contaminate the productbeing processed.
d. Monitoring of pollution in the surrounding air.
9.4.5. In-process Supervision
9.4.5.1. To ensure batch uniformity and integrity of finished veterinary
medicines, written procedures for the supervision and testing or
inspection of in-process products from each batch should be194established and followed. Such control procedures are established tomonitor production results and validate production processcapabilities that may be the cause of non-uniformity of in-process
product properties.
9.4.5.2. In-process specifications should be consistent with finished veterinary
drug specifications. These specifications should be derived frompreviously accepted process averages and where possible based on
estimates of process variability and where necessary establishedusing statistical methods.
9.4.5.3. In-process products shall be tested for identity, purity andgrade/potency at appropriate stages and declared qualified or
unqualified by the quality control department during the production
process.
9.4.6. Packaging Supervision
9.4.6.1. The packaging line should be inspected by the quality control
department prior to the packaging activity.
9.4.6.2. During packaging, samples should be taken at the beginning, middle
and end of packaging.
9.4.6.3. The final packaged product should be kept in factory quarantine until
a declaration of minimum qualified results is issued by the quality
control department.
9.4.7. Retesting of Approved Veterinary Materials or Drugs
9.4.7.1. Appropriate storage time limits should be set for each starting
material, intermediate product, processed product and finishedveterinary medicinal product. After this time, the material or productmust be retested by the quality control department for identity, purity
and potency. Based on the results of the retest, the material or
product is either approved for use or rejected.
9.4.7.2. If a material is stored under improper conditions, it should be retested
and approved by the quality control department before use.
9.5. Production procedures and changes
9.5.1.
The quality control department should participate in the development of the
Master Processing Procedure and Master Packaging Procedure for eachbatch size of a product to ensure uniformity from batch to batch produced.
Any changes and adjustments to the Master Packaging must be approved by
the quality control department before use.
9.5.2.
The quality control department should approve the procedures for cleaningand sanitizing production equipment.
9.6. Review of Production Batch Records
9.6.1.
All production and control records for each batch of finished veterinary
medicine should be scrutinized by the quality control department to determine
whether the batch meets all established procedures before being released for
distribution.
9.6.2.
Each batch that deviates or fails to meet specifications shall be thoroughly
investigated by the quality control department. Investigations should becontinued into other batches of the same product and other products that
may be associated with the particular deviation or failure. A written report ofthe investigation shall be made with conclusions and follow-up actions.

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9.7. Stability Check
9.7.1.
A stability testing program should be designed to determine the stability
properties of the finished product to determine suitable storage conditions
and expiry dates.
9.7.2.
The stability testing program shall be adhered to and include:a. The number of samples and testing schedule are based on statistical
criteria for each trait tested, to ensure correct stability estimates.
b. Storage conditions.
c. Specific and reliable test methods.
d. Testing in the same packaging as the marketed veterinary drug
packaging.
e. In finished veterinary drugs for reconstruction, stability testing is
performed both before and after reconstruction.
9.7.3.
Stability checks should be carried out in the following cases:
a. New products (generally done on trial batches).
b. New packaging that differs from the established standard.
c. Changes in formula, processing method or source of raw materials.
d. Batches that have qualified by exception or batches that are
reprocessed.
9.7.4.
Againstsample left
medicineanimal so please make follow-up
observations.
9.8. Outside Laboratory
9.8.1.
Some or all aspects of quality testing may be performed by a laboratory
outside the factory for comparison.
The manufacturer should assess that the laboratory is capable of performing
the tests specified by the manufacturer.
9.8.2.
Although quality analysis and testing can be done by outside laboratories, theresponsibility for quality control remains with the manufacturer.
9.8.3.
The nature and extent of the analysis performed should be agreed upon andclearly defined in a contract.
9.8.4.
Relevant detailed test methods should be provided to the outside laboratory.
9.8.5.
Arrangements should be made for the storage of leftover samples and the
keeping of records of test results.
9.8.6.
The external laboratory test report includes the name of the external
laboratory concerned, product name, date of analysis, batch number or lot
number, method of analysis, test results, signature of the officer responsible
for the analysis.
9.8.7.
Approval for graduation is at the discretion of the factory concerned.
9.9. Supplier Assessment
9.9.1.
The quality control department should be responsible for determining
suppliers who are capable and trustworthy in providing starting materials thatmeet predetermined specifications.
9.9.2.
All candidates should be evaluated before an order is placed. Supplierinspections should be conducted when the supplier's history, reputation or
assurances are deemed sufficient that inspection is not required.

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9.9.3.

9.9.4.

9.9.5.

Inspections should be conducted jointly by representatives from quality
control, production and purchasing to determine which suppliers can betrusted.
As prospective buyers, representatives of the quality control, production andpurchasing departments should assess the technical qualifications of the
supplier and try to determine its attitude toward quality.
All suppliers should be evaluated regularly.

10. Internal Inspection
The purpose of internal inspections is to assess whether all aspects of production andquality control comply with the CPOHB. The internal inspection program should bedesigned to look for weaknesses in the implementation of the CPOHB and to establish
corrective actions. Internal inspections should be conducted on a regular basis.
Suggested corrective actions should be implemented. An inspection team capable ofobjectively assessing the implementation of the CPOHB shall be appointed for internal
inspections. Procedures and records of internal inspections should be established.
10.1. Things to Inspect
In order to achieve a minimum and uniform standard of internal inspection, achecklist should be compiled that is as comprehensive as possible. The checklist
should include questions about the following, among others:
a. Employees
b. Building including facilities for employees
c. Storage of ingredients and finished veterinary drugs
d. Equipmente. Production
f. Quality control
g. Documentationh. Building and equipment maintenance10.2. Internal Inspection TeamThe internal inspection team is appointed by the company and consists of at least 3
experts in different fields who are familiar with CPOHB. Members may come fromwithin the company or from outside the company. Each member of the team shallbe free to provide an assessment of the inspection results.
10.3. Implementation and Interval of Internal Inspection
Internal inspections can be carried out section by section according to the needs ofthe plant concerned. Thorough internal inspections should be carried out at least
once a year.
10.4. Internal Inspection Report
Upon completion of the internal inspection, a report shall be prepared that includes:a. Inspection-internal Resultb. Assessment and conclusionc. Proposed corrective action
10.5. Internal inspection follow-up
Based on report internal inspection, leadership the company takes the necessary
corrective actions
11. Handling of Observations, Complaints and Recalls of Veterinary Drugs in circulation
11.1. Recall of Finished Veterinary Medicine
A finished animal medicine recall can be in the form of a recall of a certain batch or
all finished animal medicines from all distribution links. Recalls are conducted if197there are products that do not meet quality requirements or on the basis of
unaccounted for side effects that are detrimental to health. The recall of all finishedanimal drugs is a follow- up to the cessation of manufacture of a particular type offinished animal drug.
11.1.1. Finished Animal Medicine Recall Decision
11.1.1.1. Recalls may be made on the manufacturer's own initiative or the
instruction of the competent government.
11.1.1.2. The decision to recall a finished veterinary drug is the
responsibility of the person in charge of the factory and thecompany management.
11.1.1.3. The decision to recall a finished veterinary drug may be to recall
one or more batches or all of the finished veterinary drug inquestion.
11.1.1.4. The decision to recall a finished veterinary drug may also mean
the cessation of manufacture of the finished veterinary drug inquestion.
11.1.2. Recall Implementation
11.1.2.1. Recall actions should be taken as soon as it is known that afinished veterinary drug does not meet the requirements or has
unaccounted for side effects that endanger health, both animal
health and human health.
11.1.2.2. For finished veterinary medicines that pose a major risk to animaland human health, in addition to the recall action, special
measures should be taken so that the veterinary medicine
concerned is embargoed from use. In this case, the recall should
also be carried out up to the level of veterinary drug users.
11.1.3.
The factory documentation system should be able to support theimplementation of recalls and embargoes effectively, quickly andthoroughly.
11.1.4.
Appropriate finished veterinary drug recall guidelines andprocedures should be established so that recalls and embargoes
can be carried out quickly and effectively from all links of the
distribution chain.
11.1.5.
Records and reports should be kept on the implementation,
results of recalls and embargoes of finished veterinary
medicines.
11.2. Complaints and Reports
Complaints and reports may concern quality, residues, adverse side effects or otherveterinary medical issues. All complaints and reports shall be investigated andevaluated and appropriate follow-up action taken.
11.2.1. Types of complaints and reports can be:a. Quality complaints concern the physical, chemical and biological stateof the product or its packaging.
b. Complaints or reports of adverse side effects such as allergic reactions,
toxic reactions, fatal or near-fatal reactions and so on.
c. Other medical report complaints such as lack of efficacy or lack ofclinical response.
11.2.2. Complaints and Reports Handling.

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11.2.2.1. A written record should be made of all complaints and reports
received.
11.2.2.2. Complaints and reports should be handled by the relevant
department according to the type of complaint or report
received.
11.2.2.3. Each complaint should be thoroughly researched and evaluatedincluding:(a) Review all incoming information about the complaint orreport.
(b) Check or test the samples received and, if necessary, also
check the samples left over from the batch in question.
(c) re-examining all pertinent data and documentation,
including batch records, distribution records, test result
records and so on.
11.2.3. Follow-up
11.2.3.1. Based on the results of the evaluation and investigation, followup actions are carried out in the form of, among others:(a) corrective actions required(b) recall of batches of finished veterinary medicines or all
finished veterinary medicines concerned(c) other appropriate follow-up
11.2.3.2. The results of the handling of complaints and reports including
the results of research evaluation and follow-up actions taken
shall be recorded and reported to the relevant section
submitted to the Minister of Agriculture in this case to the
Director General of Livestock.
12. Documentation
Veterinary drug manufacturing documentation is part of a management information
system that includes specifications; procedures, methods and instructions; records andreports and other types of documentation required in the planning, implementation,
control and evaluation of all veterinary drug manufacturing activities.
Documentation is essential to ensure that each officer receives detailed and clear
instructions on the tasks to be performed, thereby minimizing the risk of misinterpretationand errors that usually arise from relying solely on oral communication.
The documentation system should describe the complete history of each batch or lot of a
product to enable investigation and traceability of the batch or lot.
Documentation systems are also used in monitoring and controlling, for example,
environmental conditions, equipment and personnel.
12.1. General Conditions
12.1.1. Documents should be carefully designed and created so that they can beused easily, correctly and effectively.
12.1.2. Documents should record activities in production, quality control,
equipment maintenance, warehousing, distribution and other specificmatters related to CPOHB.
12.1.3. Documents should include all important data, but not be excessive, and be
kept up to date. Any changes should be officially authorized. It should also
allow for periodic review and revision, if necessary.
12.1.4. A system should be in place to prevent the use of outdated documents.

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12.1.5. If an error occurs or is found on a document, it should be corrected in an
appropriate way so that the original writing or record is not completely lost
and the correction is written or included next to the original writing, theninitialed and signed.
12.1.6. If the document contains instructions, they should be written in a tone ofcommand organized in sequentially numbered steps. The instructions
should be clear, precise, without double meaning and in a language thatthe user can understand.
12.1.7. Each document should be signed and authorized by the production
manager and quality control manager. The department or person receiving
the derivative document should be listed at least on the original document.
12.1.8. Documents should be made available to all relevant parties.
12.1.9. Documents and records relating to a batch as well as reference samplesof finished veterinary drugs and their starting materials shall be retainedby the company for the period specified by the Ministry of Agriculture.
12.2. Specifications
Specifications include raw materials, packaging materials, intermediate products,
processed products and finished veterinary drugs.
12.2.1. Raw Material Specifications
12.2.1.1. Raw material specifications should contain:
a. Product names and codes defined and used by the company.
b. The name and code provided by the supplier.
c. Reference the monograph or test method used for examinationand testing of the specification or pharmacopoeia used.
d. Frequency of retesting of stored materials, if necessary.
e. Specific types of testing required for the reassessment of
expired materials to determine possibility extension its
expiration date.
f. Conditions storage and other necessary security measures.
g. Age limit if required.
h. Name of the approved supplier.
i.
Date the specification was put in order.
12.2.1.2. Speciation material raw materials can be separately or
included in the Master Production Document.
12.2.2. Packaging material specifications
12.2.2.1. Packaging material specifications shall include:a. Product names and codes defined and used by the company.
b. The name and code provided by the supplier.
c. Providing betweentype material, thickness, dimensions color
strength, text.
d. Technical drawings when necessary.
e. Reference the monograph or test method used for inspection andtesting of the specification and pharmacophore used.
f. Frequency of re-inspection of stored materials.
g. Storage conditions and necessary safety measures.
h. Required age limit.
i. Name of the approved supplier.
j. Date of issuance of the specification.

200

12.2.2.2. Packaging material specifications may be separate or includedin the master production document.
12.2.3. Specifications of intermediate products, processed products and finishedveterinary drugs
12.2.3.1. Specifications of intermediate products, processed products orfinished veterinary medicinal products, according to thedosage form and manufacturing stage, should contain:(a) name and the products that the company puts out.
(b) Dosage form and strength(c) Feeding, chemical characteristics as well as microbiologicalstandards, if any.
(d) Reference the monograph or test method used for inspection andtesting of the specification or pharmacopoeia used.
(e) Physical properties, such as standard weight or filling volume(including limit values), pH, viscosity, density, hardness,
firmness, disintegration time and in-vitro bioavailability, if
necessary.
(f) Specifications for finished veterinary medicines should also
include the type and specifications of packaging materials used.
(g) Age limit or expiration limit.
(h) Storage conditions and safety measures.
(i) Packaging and labeling specifications.
12.2.3.2. Intermediate product, finished product or finished veterinary
drug specifications may be separate or included in the Master
Production Document.
12.3. Documents In Production Documents in production consist of:a. Master Production Document which is the basic production guideline foreach type of finished veterinary drug with a certain dosage form andstrength regardless of batch size.
b. The Master Production Procedure consists of a Master Packaging
Procedure which is a more detailed processing and packaging guideline
for each finished veterinary drug by dosage form, strength and batch size.
The Master Production Procedures have basically been validated.
c. Batch Production Records consisting of batch processing records andbatch packaging records are basically a continuation of the Master
Production Procedure which already contains data and information on theimplementation of production, processing and packaging. Sometimes the
Batch Production Procedure is included again in detail.
12.3.1. Master Production Document
12.3.1.1. The Master Production Document should contain the productname, dosage form, strength, naming of constituents andparts, names of inspectors involved, table of contents anddistribution list.
12.3.1.2. The contents of the Master Production Document should
include:a. A general section containing the type of packaging oralternative packaging, a statement on product stability,
safety measures during storage and other safety201

measures that need to be implemented during processing
and packaging.
b. Composition/formula for each unit dose or sample for thesize of one batch used.
c. a complete list of raw materials, both those that are fixed,
those that will not change and those that will undergochanges in the process.
d. Raw material specifications.
e. complete list of packaging materials.
f. packaging material specifications.
g. outline processing and packaging procedures.
h. list of equipment that can be used for processing andpackaging.
i. in-process controls that must be implemented during
processing and packaging.
j. general product/expiration limits.
12.3.2. Parent Processing Procedure
12.3.2.1. This Master Processing Procedure should also include
procedures and instructions procedures and instructions
regarding processing, including in- process supervision to be
carried out by the production and processing departments.
Section supervision quality control, safety measures andmatters special matters that need to be considered during
processing and during storage of intermediate and finishedproducts. The Master Processing Procedure shall provide aroom for record data. Document This document should becreated, dated and signed by the production manager.
production manager and checked separately, dated andsigned by the quality control manager.
12.3.1.2. The Master Processing Procedure shall include the following:(a) name and strength of the product and description of thedosage form.
(b) A complete list of raw materials, with specific names
and codes to indicate specific quality characteristics
and/or reference monographs.
(c) A statement regarding the use of an excess amount of
raw materials that has been accounted for.
(d) The amount of leftover product that can be added in thenext batch, if needed.
(e) The number of batches of certain active and inactive
raw materials that may be used for each batch of
product.
(f) A statement of the theoretical weight or size obtained ata particular processing stage.
(g) A statement of the theoretical results obtained including
the maximum and minimum percentage of actual results
to the theoretical results allowed.
(h) Processing location and equipment to be used.
12.3.3. Product Packaging Procedure20212.3.3.1. Master Packaging Procedures shall contain complete anddetailed procedures and instructions on packaging including
supervision of the process.to be performed by the production
department and quality control department, safety measuresand special matters to be considered during packaging. The
master packaging procedure should provide space forrecording data. This document should be created, dated andsigned by the production manager and separately checked,
dated and signed by the quality control manager.
12.3.3.2. The Master Packaging Procedure shall include the following:(a) name, dosage form and strength and description of thefinished product.
(b) A complete list of containers, lids and other packing
materials including a sample of labels and other markings
signed and dated by an officer authorized to approve
such markings.
(c) A statement of the theoretical results obtained including
the maximum and minimum percentage of actual results
to the theoretical results allowed.
(d) Procedures for reconciliation between finished products
and packaging materials issued.
(e) Packaging location and equipment to be used.
12.3.4. Batch Processing Notes
12.3.4.1. A Batch Processing Record shall be maintained for eachbatch of veterinary drugs and shall include complete data on
the processing and supervision of the batch concerned. The
form for the Batch Processing Record is a reproduction of the
Parent Batch Processing Procedure which has been checked
for accuracy, dated and signed by the production manager.
12.3.4.2. Batch Processing Records shall show that each processing
step as listed in the Master Processing Procedure has been
completed and include:(a) batch number.
(b) Start date and end date of processing.
(c) The identity of each major piece of equipment as wellas the identity of the path or location used.
(d) The actual weight or volume and batch number of eachraw material used during processing as well as thesignature of the person who weighed or measured andinitials of the officer who conducted the countercheck.
(e) Batch number and/or reference approval number andquantity of recovered material used, if any.
(f) Records on the cleaning of equipment used.
(g) In-process monitoring results and laboratory testing
results.
(h) Real results as well as the percentage of theoreticalresults at a certain processing stage.
(i) Sampling carried out in various stages of processing,including the amount.

203

(j)

The initials of the personnel who performed and directlysupervised or checked each processing step.
(k) Details of the authorization of each deviation from the
Master Processing Procedure.
(l) A dated and signed approval by authorized personnel
stating that all processing activities have been carriedout according to the Master Processing Procedure andthat process variations and yield variations areadequately explained.
(m) Investigation of specific failures or deviations.
12.3.5.Batch Packaging Notes
12.3.5.1. A batch packing record shall be maintained for each batch ofveterinary drugs and shall include complete data on thepacking operations and supervision of the batch concerned.
The form for the Batch Packaging Record is a reproduction of
the Parent Packaging Procedure which has been checked for
accuracy and signed by the production manager.
12.3.5.2. On the Batch Processing record it should be addressed thateach packaging step as listed in the Master Packaging
Procedure has been provided and covered:(a) Batch number.
(b) Start date and end date of packaging.
(c) The identity of each major piece of equipment and thepath or location used.
(d) The actual quantity and batch number of eachpackaging material and finished product used and theinitials of the personnel who used them weighing or
counting and the signature of the officer conducting thecountercheck.
(e) In-process surveillance results.
(f) Records on the cleaning of equipment used.
(g) Pre-use packaging line readiness check by authorized
personnel.
(h) The real results as well as the percentage against thetheoretical results that the packaging turnaround time.
(i) Complete samples of printed-packaging materials andtheir inspection records including all printed-packaging
materials that have been assigned a marking code.
(j) Sampling conducted during and after packaging
includes the number of samples.
(k) The signature of the officer who implemented anddirectly supervised or checked each step.
(l) Results of reconciliation and implementation ofremaining unused packaging materials.
(m) Product inspection results and packaging residue.
(n) Investigation of specific failures or deviations.
12.4. Documents in quality control.
Documents in quality control consist of:204

(a) procedures in quality control and testing methods, in addition, the mostimportant procedure in control is the sampling procedure for testing.
(b) Records and reports of test results, records of stability test results are usually
kept separately. Test result reports can be in the form of analyzed results.
12.4.1. Sampling procedure for testing
The sampling procedure for testing consists of a sampling pattern and methodthat is authorized by affixing the signature of the compiler and the date andincludes the following:(a) Sampling methods for testing including formulas or standards used.
(b) Tools and containers used.
(c) Packaging measures during sampling, such as the use of special
clothing by the person taking the sample.
(d) The section authorized to take samples.
(e) Sampling location.
(f) Number of samples taken.
(g) Sample distribution pattern if necessary.
12.4.2. Test method.
Test methods are detailed procedures for the examination and testing ofspecifications of starting materials - intermediate products, finishedproducts and finished veterinary medicines. Test procedures should
include reagents required for analysis, identification and determination oflevels and calculation methods for obtaining analytical results.
12.4.3. Sampling notes.
Records should be kept of the sampling of samples to be used for testingin accordance with the prescribed sampling procedures.
12.4.4. Test result records and reports
12.4.4.1. Records shall be made of the results of inspection and testingof the specifications of starting materials, intermediates,intermediate products, finished products and veterinary drugs,in accordance with the test method, indicating the pass orrejection along with the test and supervisor.
12.4.4.2. The test result record shall contain:(a) the date of the test.
(b) material identification, including product code if
applicable.
(c)the name of the supplier for the starting material.
(d) date of receipt.
(e) batch number of the starting material.
(f)number batch which provided by quality control
department.
(g) the amount received.
(h) sampling date and quantity.
(i)reference to the test method performed with the dateand signature of the examiner and supervision.
(j)a record of the results of the tests carried out with thedate and signature of the examiner and supervision.
(k)a record of the results of the tests carried out with thedate and signature of the carrying out officer andsupervisor.

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(l)

Approval or rejection from the quality control
department with the date and signature of the person in
charge.
(m) The certificate number issued for the decision to pass orreject.
(n) Cross-reference or comparison with previous
certificates, if necessary.
12.4.4.3. An analysis certificate is a form of record and report of test
results and should contain the following:(a) name and address of the manufacturer or issuing
institution.
(b) Certificate number.
(c) Name of ingredients and name of dosage form andstrength of finished veterinary medicine.
(d) Batch number from the manufacturer.
(e) Test results and standard limit values.
(f) Decisionson graduation or rejection are accompanied bynecessary explanations.
(g) Date and signature of the person conducting the analysis
and the quality control manager.
12.4.4.4. Notes on stability tests in addition to containing the items
mentioned in item 1.2.4.4.2 shall also contain the following
items:(a) a complete description of the packaging materials used.
(b) The period of the stability test.
(c)Storage conditions during the stability test such astemperature and humidity of the finished veterinary drug.
(d) Test results after each specific storage period.
(e) Test results are compared with finished veterinary drug
specifications and preliminary test results.
12.5. Storage and Distribution Documentation.
Records should be kept of the distribution storage documents. The most important
distribution storage documents are inventory cards and distribution records.
12.5.1. Inventory card
An inventory card should be maintained that consists of a record of thequantities received, issued and available for each starting material,
intermediate material, finished product and finished veterinary medicine.
12.5.1.1.The inventory card should contain :(a) code number and the name of the material or product.
(b) date of receipt or delivery and inventory.
(c) amount supply ordeliveryand inventory.
(d) batch number.
(e) storage location.
(f) status of the material, whether quarantined or passed ornot.
12.5.1.2. For each product group, such as packaging materials, auxiliarymaterials, active ingredients; processed products or finishedveterinary drugs, an inventory card should be created using a
different color.

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12.5.1.3. Inventory cards should support the implementation of the firstin-first-out principle. Deviations from this principle are only
permitted for short periods of time with the approval of theauthorized manager.
12.5.2. Finished Veterinary Medicine Distribution Record.
12.5.2.1. Distribution records are records relating to the distribution offinished veterinary medicinal products from the factory.
Distribution records of finished veterinary medicines should beproperly established so that complete, actual and progressive
data on each batch of finished veterinary medicines can beobtained immediately and easily followed and traced andfacilitate the implementation of effective and prompt recall
actions.
12.5.2.2. Distribution notes should contain:(a) name and address of the recipient.
(b) number and date of the delivery order.
(c) date of submission.
(d) names of dosage forms and strengths of veterinary
drugs.
(e) batch number.
(f) expiration date, if any.
(g) terms storage special or
security measures may be required.
12.5.2.3. Inventories of finished veterinary drugs should be recorded ininventory as mentioned in the item.
12.6. Documents in the Maintenance, Cleaning and Control of Rooms and Equipment.
The maintenance, cleaning and control documents for rooms and equipment are
mainly maintenance and cleaning procedures and records for equipment, rooms
and pest extermination and monitoring of particles and microorganisms.
12.6.1. Equipment Cleaning Maintenance Procedures and Records.
12.6.1.1. A maintenance and cleaning procedure should be developedfor each piece of equipment that includes the type of work to
be performed and a maintenance schedule. Maintenance andcleaning operations should be recorded, including
replacement of parts or repairs.
12.6.1.2. A procedure should be developed for cleaning equipment usedin the production process that describes how to clean eachproduct change or batch change.The cleaning procedure
should include methods and equipment and cleaningmaterials used. Cleaning operations should be recorded andattached to the relevant batch records.
12.6.2. Procedures and Records for Room and Production Cleaning A cleaning
procedure should be developed for each production room that includes
the room to be cleaned, the method of cleaning the tools and materials
used, and the time and schedule for cleaning. Records should be kept ofcleaning operations.
12.6.3. Pest Extermination Procedures and Records
A pest extermination procedure should be established that includes theextent and schedule of the extermination, the rooms to be covered, the207

methods, tools and materials to be used, the safety measures, and thedepartments or persons involved in carrying out the pest extermination.
Pest extermination should be recorded.
12.6.4. Procedures and Records for Monitoring Particles and Microorganisms A
procedure for monitoring airborne particles and microorganisms inspecific rooms should be developed, covering the methods and rooms to
be monitored, specifications, including alert levels and action levels.
Monitoring results should be recorded.
12.7. Documents in handling complaints, reports and destruction of veterinary materials
and drugs.
12.7.1. Grievance procedures and records
12.7.1.1. A procedure for handling complaints and reports of adverse
reactions from finished veterinary medicines should beestablished, including definitions of complaints and adverse
reactions, types of complaints and reports, handling andevaluation.
12.7.1.2. A record should be made of each complaint and reportcontaining:(a) product name and batch number(b) types of complaints and reports(c) place of origin of the complaint or report(d) sample of the product in question(e) summary of the complaint or report(f) investigation result(g) evaluation(h) response and follow-up to complaints or reports
12.7.2. Procedures and handling of returned veterinary drugs Procedures forhandling returned veterinary medicines should be established, including
guidelines on finished veterinary medicines that can be salvaged,
reprocessed and destroyed. The handling of returned veterinary
medicines should be recorded.
12.7.3. Finished veterinary medicine return procedures and records
12.7.3.1. Procedures should be established to recall a batch or lot or all
finished veterinary medicines from circulation.
12.7.3.2. Records of recall actions should be made, including:(a) product name, batch number and batch size.
(b) Date started and completion recall(c) Reason for withdrawal.
(d) The remaining amount and the amount that has been
distributed from the batch or to the product in question
as of the initial date of the recall.
(e) Number of returned products.
(f) Place of origin of the returned product(g) Evaluation.
(h) Follow-up.
(i) Recall handling reports including reports to thegovernment, if required.
12.7.4. Procedures and Records for Destruction of Rejected Materials andProducts.

20812.7.4.1.

12.7.4.2.

Procedures should be established for the destruction of
rejected materials or products that include precautions,environmental pollution and the possibility of the productfalling into the hands of unauthorized persons.
A record should be made of the destruction of rejectedmaterials or products containing, among other things:(a) material name, batch number and quantity of thematerial or product.
(b) origin of the material or product.
(c) Destruction method(d) Name of the officer who carried out and who witnessed
the destruction(e) Date of destruction

12.8. Documents for Specialized Equipment
Important documents for special equipment are work procedures as well as lighting
procedures and records for special equipment.
12.8.1 Work procedures for specialized equipment
Work procedures should be established for each specific piece ofequipment to avoid errors that could affect the quality of a batch or that
could damage the equipment. Work procedures are generally based on
the equipment manual.
12.8.2. Specialized Equipment Lighting Procedures and Records.
A testing procedure should be developed for each specific piece ofequipment to ensure that it gives the correct weighing or measuring
results. The test procedure should include the schedule, reference
standards, reagents and equipment required, the test method used for
implementation and the test results should be recorded.
12.9. Procedures and Records on Internal Inspection
12.9.1. Procedures for internal inspections should be developed, including
checklists and internal inspection forms, team composition, and internal
inspection schedules.
12.9.2. A record should be made of the implementation and results of the selfinspection that includes evaluation, conclusions and necessary followup.
12.10. Guidelines and Notes on CPOHB Training for Employees
12.10.1. CPOHB training guidelines should be developed for employees inaccordance with their respective fields of work.
12.10.2. A record of the implementation and results of the CPOHB should be
kept which includes:(a) training date.
(b) Name of the employee who participated in the training.
(c) Name of the instructor, department or institution providing thetraining.
(d) Training materials and tools used.
(e) Demonstration performed, if any.
(f) Evaluation of trainees.

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