พรบ.ยา 2510

89
1 พพพพพพพพพพพพพ พพ พ.พ.2510 พพพ พพพพ พพพพพพพพพพพพพพ

description

dd

Transcript of พรบ.ยา 2510

  • ..2510

  • ... .. 2510

  • - - - -

  • - - -

  • - - -

  • ()- - -

  • - -

  • - - - - ,corticosteriod, clofibrate, dipyrone, ARVs ,cisapride, misoprostol ,neuromuscular blocking agents, ...

  • - - - , , ARVS , ABO, ..- : , Penicillin V potassium dry syrup 5 . . 2

  • 1.Dextromethorphan HBr 12 mg. 4 10 2.HCTZ 50 mg. 4 10 3.Ethinylestradiol 0.03-0.05 mg or Mestranol 0.03-0.05 mg. + Norgestrel 0.25-0.5 mg.or Levonorgestrel 0.125-0.25 mgor Norethisterone1.0-2.5 mgor Lynestrenol 1.0-2.5 mg

  • ()4. CPM 2 mg 4 20 5.Paracetamol 300 - 500 mg + CPM 1-2 mg 4 10 6. Aminophylline 100 mg 4 7. Theophylline anhydrous 60-150 mg+ Ephedrine HCL15-50 mg 4 8. Co-trimoxazole 400+80 mg 4 10 9. Phthalysulphathiazole 500 mg 4 20

  • 11. Mebendazole 100 mg or Mebendazole 500 mg per tablet 6 10 12.Dimenhydrinate 50 mg. 4 10 13. Sulphadoxine 500 mg + Pyrimethamine 25 mg 4 10 ()10. Penicillin V Potassium equivalent to Penicillin V 200,000 units 60 ml

  • -, , , , , , , , , , ,

  • 1. 2. 3. 4.

  • - - - - - -

  • - 30 - - ()

  • 4 1. 2. 3. 4.

  • (. 15) 6 (1) (2) (3) (4) (5) (6)

  • (1) (2) (3)

  • (1) (2) (3) (4)

  • (5) (6) () () () () (7)

  • (8) (9) ()

  • (.25) (1) (2) (3) (4) (5) (6) (7)

  • (. 26)(1) (2) (3) (4) (5) (6) (7) (8) -

  • 26 (4) 26

  • 26

  • ( 27) (1) (2) (3) (4) (5) (6)

  • (1) (2) (3) (4) (5) (6) (7)

  • (8) (9) (10) (11) 76 (7) (8) , (1) (4) (11)

  • ( 46) ( 47) (1.) (2.) 76 (1)

  • (2 ) (3.)(4.)

  • 4 1. 2. 3. 4.

  • 1) 2) 3)

  • 1. (. ..)2. (. .. )3. (. ..)

  • 48 () 68 69 70 (4) (5) (6)

  • ( 57)1) 2 2) 3) 4) 5)

  • 6) ( 54 ) [ 25 (.. 2537) ] ()

  • ( 58)1) 2 2) 3)

  • ( 59) (1) 2 (2)

  • (3) (4) (5) (56) ()

  • (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

  • .. 2510 ( 3) .. 2522 ( 5) .. 2530 4

  • ...( 79)

  • ( 79 )1) 2) 3)

  • 1) 2 ) ) 2) 3 ) ) )

  • ( 79) ) )

  • 2 1. 2.

  • 3 8.1.1 8.1.2 8.1.3

  • ( 83)(1) (2) (3) (4) (5)

  • (New Drugs) (1) (New chemical entities) (New derivatives) (2) (New Indication) (3) / (New Combination) (4) (New delivery) (Bioavailability)

  • 8.2.1 (Original products)8.2.2 (Generic products)

  • (Original products) 2 1. 2.

  • Original products (Original products) (Condition Approval)

  • Original products (1) (Protocol) 2 (2)

  • (3) (Unconditional Approval)

  • (Generic products) 3 1. (Bioequivalence)

  • 2. 8.1.1 3.

  • 1. 2.

  • 3. 4. 5. 6.

  • 3 1. 2. 3.

  • 1. 2. 3.

  • 3.1 3.2 3.3 3.4 3.5 3.6

  • 2 ) ) 83

  • 2 1. 2.

  • - - - - ()

  • 1. 2. 3. 4. (Disintegration time)5. (Dissolution time)6. 7.

  • 1. 2. 3. 2 1 1

  • - - Accreditation overseas suppliers FDA certificate of free sale-

  • - 1. 2. 3. 4.

  • 11.

    ( 72)

  • (1) (2) (3) (4) (5)

  • (1) (2) 86

  • (1) (2)

  • ( 85 )

  • 12. ( 88)(1) (2) (3)

  • (4) (5) (6) (7) (8) 77

  • (9) (.89)(10) (.90) ( 88 ) (1) (4) (5) (6) (7) (8)

  • 88 (1) ((2)

  • - - - - - - -

  • - - - - - ()

  • 1. - - - - - - - -

  • 2. - - - - 3. -