Chapter I
GENERAL REGULATIONS
Article 1. Scope and regulated entities
This Circular deals with activities pertaining to addictive drugs, psychotropic drugs, drug precursors, commercial combined drugs that contain addictive ingredients, commercial combined drugs that contain psychotropic ingredients, commercial combined drugs that contain drug precursors used for healthcare, analysis, testing, and scientific research by organizations and individuals (hereinafter referred to as entities) in Vietnam and overseas.
Article 2. Interpretation of terms
In this Circular, the terms below are construed as follows:
1. Addictive drugs include:
a) Raw materials that contain addictive ingredients listed in Appendix I enclosed herewith.
b) Semi-finished products that contain any of the addictive ingredients listed in Appendix I enclosed herewith.
c) Commercial drugs that contain any of the addictive ingredients listed in Appendix I enclosed herewith, regardless of concentration.
d) Commercial drugs that contain an addictive ingredient in combination with other active ingredients, the concentration of additive ingredients in which is higher than the level prescribed in Appendix II enclosed herewith.
dd) Commercial drugs that contain an addictive ingredient in combination with other addictive ingredients; commercial drugs that contain an addictive ingredient in combination with psychotropic ingredients; commercial drugs that contain an addictive ingredient in combination with a drug precursor; commercial drugs that contain an addictive ingredient in combination with psychotropic ingredients and drug precursors, regardless of concentration of addictive ingredients, psychotropic ingredients, and drug precursors.
2. Finished addictive drugs are drugs specified in Points c, d, and dd Clause 1 of this Article.
3. Commercial combined drugs that contain addictive ingredients are commercial drugs that satisfy all requirements below:
a) Contain active ingredients other than addictive ingredients, psychotropic ingredients, and drug precursors;
b) Contain addictive ingredients; or contain addictive ingredients in combination with psychotropic ingredients; or contain addictive ingredients in combination with drug precursors; or contain addictive ingredients in combination with psychotropic ingredients and drug precursor;
c) Concentration of addictive ingredients, psychotropic ingredients, and drug precursors does not exceed the levels prescribed in Appendices II, IV and VI enclosed herewith.
4. Psychotropic drugs include:
a) Raw materials that contain any of the psychotropic ingredients listed in Appendix III enclosed herewith.
b) Semi-finished products that contain any of the psychotropic ingredients listed in Appendix III enclosed herewith.
c) Commercial drugs that contain any of the psychotropic ingredients listed in Appendix III enclosed herewith, regardless of concentration.
d) Commercial drugs that contain a psychotropic ingredient in combination with other active ingredients, the concentration of psychotropic ingredients in which is higher than the level prescribed in Appendix IV enclosed herewith.
dd) Commercial drugs that contain a psychotropic ingredient in combination with other psychotropic ingredients; or commercial drugs that contain psychotropic ingredients in combination with drug precursors, regardless of concentration.
5. Finished psychotropic drugs are drugs specified in Points c, d, and dd Clause 4 of this Article.
6. Commercial combined drugs that contain psychotropic ingredients are commercial drugs that satisfy all requirements below:
a) Contain active ingredients other than addictive ingredients, psychotropic ingredients and drug precursors;
b) Contain psychotropic ingredients or psychotropic ingredients in combination with drug precursors;
c) Concentration of psychotropic ingredients and drug precursors does not exceed the levels prescribed in Appendices IV and VI enclosed herewith.
7. Drug precursors include:
a) Raw materials that contain any of the drug precursors listed in Appendix V enclosed herewith.
b) Semi-finished products that contain any of the drug precursors listed in Appendix V enclosed herewith.
c) Commercial drugs that contain any of the drug precursors listed in Appendix V enclosed herewith, regardless of concentration.
d) Commercial drugs that contain a drug precursor in combination with other active ingredients, the concentration of the drug precursor in which is higher than the level prescribed in Appendix VI enclosed herewith.
dd) Commercial drugs that contain a drug precursor in combination with other drug precursors, regardless of concentration.
8. Commercial precursor drugs are drugs specified in Points c, d, and dd Clause 7 of this Article.
9. Commercial combined drugs that contain drug precursors are are commercial drugs that satisfy all requirements below:
a) Contain active ingredients other than addictive ingredients, psychotropic ingredients and drug precursors;
b) Contain drug precursors the concentration of which does not exceed the levels prescribed in Appendix VI enclosed herewith.
APPENDIX I
ADDICTIVE INGREDIENTS
No. |
INTERNATIONAL NAME |
SCIENTIFIC NAME |
1. |
ACETYLDIHYDROCODEIN |
(5 a, 6 a)- 4,5- epoxy-3- methoxy-17 methyl- morphinan-6-yl-acetat |
2. |
ALFENTANIL |
N-[1-[2-(4-ethyl-4,5- dihydro-5-oxo-1 H-tetrazol-1-yl) ethyl]-4- (methoxymethyl)-4-piperidinyl]- N- Phenylpropanamide |
3. |
ALPHAPRODINE |
a- 1,3- dimethyl-4- phenyl-4- propionoxypiperidine |
4. |
ANILERIDINE |
1- para-aminophenethyl-4- phenylpiperidine-4- carboxylic acid ethyl ester) |
5. |
BEZITRAMIDE |
(1-(3- cyano- 3,3- diphenylpropyl)- 4 (2- oxo- 3- propionyl-1- benzimidazolinyl)- piperidine) |
6. |
BUTORPHANOL |
(-)- 17- (cyclobutylmethyl) morphinan- 3,14 diol |
7. |
CIRAMADOL |
(-)-2- (a- Dimethylamino-3- hydroxybenzyl) Cyclohexanol |
8. |
COCAINE |
Methyl ester of benzoylecgonine |
9. |
CODEINE |
(3- methylmorphine) |
10. |
DEXTROMORAMIDE |
((+)-4 [2- methyl-4- oxo-3,3- diphnyl-4 (1- pyrrolidinyl)- butyl]- morpholine) |
11. |
DEZOCIN |
(-)- 13 b- Amino- 5,6,7,8,9,10,11 a, 12 octahydro- 5a- methyl-5, 11- methanobenzo- cyclodecen-3- ol |
12. |
DIFENOXIN |
(1- (3 cyano- 3,3- Diphenylpropyl)- 4- Phenylisonipecotic acid |
13. |
DIHYDROCODEIN |
6- hydroxy- 3- methoxy-N- methyl-4,5- epoxy- morphinan |
14. |
DIPHENOXYLATE |
1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylic acid ethyl ester |
15. |
DIPIPANONE |
4,4- Diphenyl-6- Piperidino-3- heptanone. |
16. |
DROTEBANOL |
(3,4- Dimethoxy- 17- Methyl morphinan-6 b, 14 diol) |
17. |
ETHYL MORPHIN |
3- Ethylmorphine |
18. |
FENTANYL |
(1- Phenethyl-4-N- Propionylanilinopiperidine) |
19. |
HYDROMORPHONE |
(Dihydromorphinone) |
20. |
KETOBEMIDON |
(4- meta- hydroxyphenyl-1- methyl-4- propionylpiperidine) |
21. |
LEVOMETHADON |
(3- Heptanone, 6- (dimethylamino)-4,4- Diphenyl, (R) |
22. |
LEVORPHANOL |
((-)- 3- hydroxy- N- methylmorphinan) |
23. |
MEPTAZINOL |
(3(3- Ethyl-1- methylperhydroazepin-3- yl) phenol |
24. |
METHADONE |
(6- dimethylamino- 4,4- diphenyl-3- heptanone) |
25. |
MORPHINE |
Morphinan-3,6 diol, 7,8-didehydro- 4,5- epoxy-17 methyl - (5 a, 6 a) |
26. |
MYROPHINE |
MyristylBenzylmorphine |
27. |
NALBUPHIN |
17- Cyclobutylmethyl- 7,8- dihydro- 14- hydroxy- 17- normorphine |
28. |
NICOCODINE |
Morphinan- 6- ol, 7,8- Dihydrro- 4,5- epoxy- 3- methoxy- 17- methyl- 3- pyridin mecarboxxylate (ester), ( 5a, 6a) |
29. |
NICODICODINE |
6- Nicotinyldihydrocodeine |
30. |
NICOMORPHINE |
3,6- Dinicotinylmorphine) |
31. |
NORCODEINE |
N- Dimethylcodein |
32. |
OXYCODONE |
(14- hydroxydihydrocodeinone) |
33. |
OXYMORPHONE |
(14- hydroxydihydromorphinone) |
34. |
PETHIDINE |
(1- methyl-4- phenylpiperidine-4- carboxylic acid ethyl ester) |
35. |
PHENAZOCINE |
(2’- Hydroxy-5,9- Dimethyl-2- Phenethyl-6,7- Benzomorphan) |
36. |
PHOLCODIN |
(Morpholinylethylmorphine) |
37. |
PIRITRAMIDE |
(1-(3- cyano-3,3- diphenylpropyl-4-(1- piperidino)- piperidine- 4- carboxylic acid amide) |
38. |
PROPIRAM |
( N- ( 1- Methyl- 2 piperidinoethyl- N- 2- pyridyl Propionamide) |
39. |
REMIFENTANIL |
1-(2-methoxy carbonylethyl)-4-(phenylpropionylamino)piperidine-4-carboxylic acid methyl ester |
40. |
SUFENTANIL |
(N-[4- (methoxymethyl)-1- [2- (2- thienyl)- ethyl]-4- piperidyl]- propionanilide) |
41. |
THEBACON |
( Acetyldihydrocodeinone) |
42. |
TONAZOCIN MESYLAT |
(+)-1- [( 2R*,6S*,11S*)- 1,2,3,4,5,6- hexahydro- 8- hydroxy- 3,6,11- trimethyl- 2,6- methano-3- Benzazocin- 11- yl]-3-one-methanesulphonate |
43. |
TRAMADOL |
(+)- Trans- 2- Dimethylaminomethyl-1-(3- methoxy phenyl) cyclohexan-1-ol |
* This Table includes:
- Esters and ethers of substances in the Table if they are not enumerated in other Tables, provided such esters and ethers exist.
- Salts of substances in this Table, including salts of esters, ethers, and isomers thereof, provided such salts exist.
APPENDIX II
LIMITS ON ADDICTIVE INGREDIENTS IN COMMERCIAL COMBINED DRUGS
No. |
NAME OF ADDICTIVE INGREDIENT |
CONCENTRATION IN THE FORM OF ALKALI IN A DIVIDED DOSE (Expressed as mg) |
CONCENTRATION IN THE FORM OF ALKALI IN A SINGLE-DOSE PRODUCTS (Expressed as %) |
1. |
ACETYLDIHYDROCODEIN |
100 |
2.5 |
2. |
COCAINE |
|
0.1 |
3. |
CODEINE |
100 |
2.5 |
4. |
DIFENOXIN |
Not exceeding 0.5 mg of Difenoxin and with at least 0.025 mg of Atropin Sulfate in a divided dose |
|
5. |
DIPHENOXYLATE |
Not exceeding 2.5 mg of Difenoxylat and with at least 0.025 mg of Atropin Sulfate in a divided dose |
|
6. |
DIHYDROCODEIN |
100 |
2.5 |
7. |
ETHYL MORPHIN |
100 |
2.5 |
8. |
NICODICODIN |
100 |
2.5 |
9. |
NORCODEIN |
100 |
2.5 |
10. |
PHOLCODIN |
100 |
2.5 |
11. |
PROPIRAM |
100 |
2.5 |
12. |
MORPHINE |
|
0.2 morphine expressed as pure morphine base |
13. |
TRAMADOL |
37.5 |
|
APPENDIX III
PSYCHOTROPIC INGREDIENTS
No. |
INTERNATIONAL NAME |
OTHER COMMON NAME |
SCIENTIFIC NAME |
1. |
ALLOBARBITAL |
|
5,5-diallylbarbituric acid |
2. |
ALPRAZOLAM |
|
8- chloro -1- methy -6- phenyl – 4H -s- triazolo [4,3-a] [1,4] benzodiazepine |
3. |
AMFEPRAMONE |
Diethylpropion |
2-(diethylamino) propiophenone |
4. |
AMINOREX |
|
2- amino-5- phenyl- 2-oxazoline |
5. |
AMOBARBITAL |
|
5-ethyl-5-isopentylbarbituric acid |
6. |
BARBITAL |
|
5,5-diethylbarbituric acid |
7. |
BENZFETAMINE |
Benzphetamine |
N-benzyl-N, a-dimethylphenethylamine |
8. |
BROMAZEPAM |
|
7-bromo-1,3-dihydro-5-(2-pyridyl)-2H-1,4-benzodiazepin-2-one |
9. |
BROTIZOLAM |
|
2- bromo-4-(o-chlorophenyl)-9 methyl-6H-thieno(3,2-f)-s-triazolo( 4,3- a)(1,4) diazepine |
10. |
BUPRENORPHINE |
|
21-cyclopropyl-7-a[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydro oripavine |
11. |
BUTALBITAL |
|
5-allyl-5-isobutylbarbituric acid |
12. |
BUTOBARBITAL |
|
5-butyl-5- ethylbarbituric acid |
13. |
CAMAZEPAM |
|
7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one dimethylcarbamate (ester) |
14. |
CHLODIAZEPOXID |
|
7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide |
15. |
CATHINE |
(+)-norpseudo-ephedrine |
(+)-(R)-a-[(R)-1-aminoethyl]benzyl alcohol |
16. |
CLOBAZAM |
|
7-chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepin-2,4 (3H,5H) dione |
17. |
CLONAZEPAM |
|
5- (o-chlorophenyl)-1,3-dihydro-7- nitro- 2H -1,4 -benzodiazepine-2 –one |
18. |
CLORAZEPATE |
|
7- chloro - 2,3 - dihydro - 2 - oxo -5-phenyl-1H-1,4-benzodiazepine -3-carbocilic acid |
19. |
CLOTIAZEPAM |
|
5-(o-chlorophenyl)-7-ethyl-1,3 dihydro-1 methyl-2H-thieno[2,3e]-1,4 -diazepin -2- one |
20. |
CLOXAZOLAM |
|
10-chloro-11b-(o-chlorophenyl)2,3,7,11b-tetrahydrooxazolo-[3,2-d] [1,4]benzodiazepin-6(5H) –one |
21. |
DELORAZEPAM |
|
7-chloro-5- (o-chlorophenyl)-1,3 dihydro-2H-1,4 benzodiazepin-2 – one |
22. |
DIAZEPAM |
|
7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4 benzodiazepin-2 – one |
23. |
ESTAZOLAM |
|
8-chloro-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepin |
24. |
ETHCHLORVYNOL |
|
1 - chloro -3- ethyl -1- penten -4 - yn -3-ol |
25. |
ETHINAMATE |
|
1- ethynylcyclohexanol carbamate |
26. |
ETHYLLOFLAZEPATE |
|
ethyl -7- chloro -5- (0-fluorophenyl) -2,3 - dihydro -2 - oxo -1H-1,4 -benzodiazepine -3- carboxylate |
27. |
ETILAMFETAMINE |
N-ethylamphetamine |
N-ethyl-a-methylphenethylamine |
28. |
FENCAMFAMIN |
|
N- ethyl-3- phenyl-2- norbornanamine |
29. |
FENPROPOREX |
|
(+) –3- [ (a- methylphenethyl) amino] propionitrile |
30. |
FLUDIAZEPAM |
|
7-chloro -5- (o-fluorophenyl) -1,3-dihydro -1- methyl- 2H - 1,4- benzodiazepin -2- one |
31. |
FLUNITRAZEPAM |
|
5-(o-fluorophenyl) -1,3 -dihydro-1- methyl -7- nitro-2H-1,4 benzodiazepin -2- one |
32. |
FLURAZEPAM |
|
7-chloro-1-[2-(diethylamino)ethyl] -5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin -2 – one |
33. |
GLUTETHIMID |
|
2-ethyl-2-phenylglutarimide |
34. |
HALAZEPAM |
|
7-chloro-1,3- dihydro -5- phenyl-1-(2,2,2 -trifluoroethyl)-2H-1,4-benzodiazepin -2 – one |
35. |
HALOXAZOLAM |
|
10-bromo-11b -(o-fluorophenyl)- 2,3,7,11b tetrahydrooxazolo [3,2-d] [1,4] benzodiazepin -6 (5H) –one |
36. |
KETAZOLAM |
|
11-chloro -8,12b - (dihydro - 2,8 - dimethyl - 12b - phenyl - 4H -[1,3] oxazino[3,2-d][1,4] benzodiazepin-4,7 (6H)-dione |
37. |
KETAMIN |
|
(+) –2- (2-Clorophenyl)-2-methylaminocyclohexanone. |
38. |
LEFETAMIN |
SPA |
(-)-N,N-dimethyl-1,2-diphenylethylamine |
39. |
LOPRAZOLAM |
|
6-(o-chlorophenyl)-2,4-dihydro-2-[(4-methyl-1-piperazinyl) methylene] -8-nitro-1H-imidazol[1,2-a] [1,4] benzodiazepin -1 –one |
40. |
LORAZEPAM |
|
7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4 benzodiazepin -2 – one |
41. |
LORMETAZEPAM |
|
7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-1-methyl-2H-1,4 benzodiazepin -2 – one |
42. |
MAZINDOL |
|
5-(p-chlorophenyl)- 2,5-dihydro -3H-imidazo[2,1-a] isoindol-5-ol |
43. |
MEDAZEPAM |
|
7-chloro-2,3-dihydro-1-methyl-5-phenyl-1H-1,4 benzodiazepine |
44. |
MEFENOREX |
|
N-(3- chloropropyl)- a - methylphenethylamine |
45. |
MEPROBAMAT |
|
2-methyl-2-propyl - 1,3-propanediol, dicarbamate |
46. |
MESOCARB |
|
3- (a methylphenethyl)- N- (phenylcarbamoyl) sydnone imine |
47. |
METHYLPHENIDATE |
|
Methyl a -phenyl-2-piperidineacetate |
48. |
METHYLPHENO-BARBITAL |
|
5-ethyl-1-methyl -5- phenylbarbituric acid |
49. |
METHYPRYLON |
|
3,3 diethyl-5- methyl-2,4 piperydine- dione |
50. |
MIDAZOLAM |
|
8- chloro- -6- (o-fluorophenyl) -1-methyl-4H-imidazol[1,5-a][1,4] benzodiazepine |
51. |
NIMETAZEPAM |
|
1,3 dihydro -1- methyl-7-nitro-5-phenyl-2H-1,4 benzodiazepin-2-one |
52. |
NITRAZEPAM |
|
1,3 dihydro -7-nitro-5-phenyl-2H-1,4 benzodiazepin-2-one |
53. |
NORDAZEPAM |
|
7-chloro- 1,3 dihydro-5- phenyl-2H-1,4 benzodiazepin-2-one |
54. |
OXAZEPAM |
|
7-chloro- 1,3 dihydro- 3hydroxy-5- phenyl-2H-1,4 benzodiazepin-2-one |
55. |
OXAZOLAM |
|
10-chloro--2,3,7,11b- tetrahydro-2-methyl-11b-phenyloxazolo[3,2-d] [1,4] benzodiazepin-6(5H) –one |
56. |
PENTAZOCIN |
|
(2R*,6R*,11R*)-1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol |
57. |
PENTOBARBITAL |
|
5-ethyl-5-(1-methylbutyl) barbituric acid |
58. |
PHENDIMETRAZIN |
|
(+)-(2S,3S)-3,4-dimethyl-2-phenylmorpholine |
59. |
PHENOBARBITAL |
|
5-ethyl-5-phenylbarbituric acid |
60. |
PHENTERMIN |
|
a,a- dimethylphenethylamine |
61. |
PINAZEPAM |
|
7-chloro-1,3-dihydro-5-phenyl-1-(2-propynyl)-2H-1,4-benzodiazepin-2-one |
62. |
PRAZEPAM |
|
7-chloro -1- (cyclopylmethyl) - 1,3 - dihydro -5- phenyl -2H- 1,4-benzodiazepin-2-one |
63. |
PYROVALERONE |
|
4’-methyl-2-(1-pyrrolidinyl) valerophenone |
64. |
SECBUTABARBITAL |
|
5-sec-butyl-5-ethylbarbituric acid |
65. |
TEMAZEPAM |
|
7- chloro - 1,3 - dihydro -3-hydroxy-1 -methyl-5-phenyl -2H- 1,4-benzodiazepin -2- one |
66. |
TETRAZEPAM |
|
7-chloro-5-(1-cyclohexen-1-yl)-1,3dihydro-1-methyl-2H-1,4 benzodiazepin -2- one |
67. |
TRIAZOLAM |
|
8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo[4,3-a][1,4] benzodiazepin |
68. |
VINYLBITAL |
|
5-(1-methylbutyl)-5-vinylbarbituric acid |
69. |
ZOLPIDEM |
|
N,N,6- trimethyl-2-p- tolylimidazol [1,2-a] pyridine-3- acetamide |
* This Table includes salts of substances therein, provided such salts exist.
APPENDIX IV
LIMITS ON PSYCHOTROPIC INGREDIENTS IN COMMERCIAL COMBINED DRUGS
No. |
NAME OF PSYCHOTROPIC INGREDIENT AND PRECURSOR |
MAXIMUM CONCENTRATION IN A DIVIDED DOSE |
1. |
ALLOBARBITAL |
10mg |
2. |
ALPRAZOLAM |
0.25mg |
3. |
AMOBARBITAL |
10mg |
4. |
BARBITAL |
10mg |
5. |
BROMAZEPAM |
1mg |
6. |
BROTIZOLAM |
0.25mg |
7. |
BUTOBARBITAL |
10mg |
8. |
CAMAZEPAM |
5mg |
9. |
CHLODIAZEPOXID |
5mg |
10. |
CLOBAZAM |
5mg |
11. |
CLONAZEPAM |
0.5mg |
12. |
CLORAZEPAT |
10 mg |
13. |
CLOTIAZEPAM |
5mg |
14. |
DIAZEPAM |
5mg |
15. |
ESTAZOLAM |
0.5mg |
16. |
FLUDIAZEPAM |
0.5mg |
17. |
FLUNITRAZEPAM |
0.5mg |
18. |
FLURAZEPAM |
5mg |
19. |
HALAZEPAM |
5mg |
20. |
KETAZOLAM |
5mg |
21. |
LOPRAZOLAM |
0.25mg |
22. |
LORAZEPAM |
0.5mg |
23. |
LORMETAZEPAM |
0.25mg |
24. |
MEPROBAMAT |
100mg |
25. |
MEDAZEPAM |
5mg |
26. |
METHYLPHENOBARBITAL |
10mg |
27. |
MIDAZOLAM |
5mg |
28. |
NITRAZEPAM |
5mg |
29. |
NORDRAZEPAM |
0.25mg |
30. |
OXAZEPAM |
10mg |
31. |
PARAZEPAM |
5mg |
32. |
PENTOBARBITAL |
10mg |
33. |
PHENOBARBITAL |
25 mg |
34. |
SECBUTABARBITAL |
10mg |
35. |
TEMAZEPAM |
25mg |
36. |
TETRAZEPAM |
5mg |
37. |
VINYLBITAL |
10mg |
38. |
CLOXAZOLAM |
1mg |
39. |
DELORAZEPAM |
0.25mg |
40. |
ETHYLCLOFLAZEPAT |
0.25mg |
41. |
NIMETAZEPAM |
0.25mg |
42. |
OXAZOLAM |
5mg |
43. |
PINAZEPAM |
1mg |
APPENDIX V
DRUG PRECURSORS
No. |
INTERNATIONAL NAME |
SCIENTIFIC NAME |
1. |
EPHEDRINE |
([R-(R*, S*)]--[1-(methylamino)ethyl]-Benzenemethanol |
2. |
N-ETHYLEPHEDRIN |
1-Ethylephedrin |
3. |
N-METHYLEPHEDRIN/ METHYLEPHEDRIN/ DL-METHYLEPHEDRIN |
(1R, 2S)-2- (dimethylamino)-1- phenyl- propanol |
4. |
PSEUDOEPHEDRINE |
[S-(R*, R*)]--[1-(methylamino)ethyl]-Benzenemethanol |
5. |
ERGOMETRINE |
Ergoline-8-carboxamide,9,10-didehydro-N-(2-hydroxy-1-methylethyl)-6-methy- [8 b(s)]. |
6. |
ERGOTAMINE |
Ergotaman-3’,6’,18’-trione,12’-hydroxy-2’-methyl-5’-(phenylmethyl)-(5) |
7. |
N-ETHYLPSEUDOEPHEDRIN |
Ethyl methyl amino – phenyl – propane - 1 - ol |
8. |
N-METHYLPSEUDOEPHEDRIN |
Dimethylamino – phenyl – propane – 1 - ol |
* This Table includes salts of substances therein, provided such salts exist.
APPENDIX VI
LIMITS ON PRECURSORS IN COMMERCIAL COMBINED DRUGS
No. |
PRECURSOR NAME |
MAXIMUM CONCENTRATION IN A DIVIDED DOSE |
MAXIMUM CONCENTRATION IN A SINGLE DOSE |
1. |
EPHEDRINE |
50 mg |
1.5% |
2. |
ERGOMETRINE |
0.125 mg |
|
3. |
N- ETHYLEPHEDRIN |
12.5 mg |
|
4. |
N- METHYLEPHEDRIN |
31.1 mg |
|
5. |
ERGOTAMINE |
01 mg |
|
6. |
PSEUDOEPHEDRINE |
120 mg |
0.5% |
APPENDIX VII
LIST OF EXPORTERS, IMPORTERS, AND SUPPLIERS OF ADDICTIVE DRUGS, PSYCHOTROPIC DRUGS, AND DRUG PRECURSORS
No. |
COMPANY'S NAME |
1. |
Central Pharmaceutical Company No. 1 |
2. |
Central Pharmaceutical Company No. 2 |
3. |
Central Pharmaceutical Company No. 3 |
4. |
Sapharco |
5. |
YTECO |
Name | Description | Status | Measures/Standards | Measure Class |
---|---|---|---|---|
Importing finished addictive drugs, psychotropic substances, precursor substances bearing sale numbers | Activities related to addictive drugs used in medicine, analysis, testing, and scientific research enumerated in the List of Addictive drugs | Active | Measure | Goods |
Importing finished products containing addictive elements bearing sale registration numbers | Finished drugs containing various active elements and substances in which an addictive substance is combined with other substances (that are not addictive drugs, psychotropic substances, precursor substances ) | Active | Measure | Goods |
Importing addictive drugs without registration numbers | Activities relating to addictive drugs used in medicine, analysis, testing, and scientific research without registration numbers | Active | Measure | Goods |
Importing unregistered addictive drugs under the specific needs of the hospital | Activities relating to addictive drugs used in medicine, analysis, testing, and scientific research without registration numbers | Active | Measure | Goods |
Finished combined drugs containing addictive elements without registration numbers | Activities relating to addictive drugs used in medicine, analysis, testing, and scientific research without registered numbers | Active | Measure | Goods |
Exporting addictive raw materials, psychotropic substances, precursor substances | Exporting addictive raw materials, psychotropic substances, precursor substances | Active | Measure | Goods |
Exporting finished addictive drugs, psychotropic substances, precursor substances with registration numbers | Exporting finished addictive drugs, psychotropic substances, precursor substances with registration numbers | Active | Measure | Goods |
Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers | Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers | Active | Measure | Goods |
Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers in combination form | Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers in combination form | Active | Measure | Goods |
Exporting combined finished addictive drugs, psychotropic, substances used for drug production without registration numbers | Exporting combined finished addictive drugs, psychotropic, substances used for drug production without registration numbers | Active | Measure | Goods |
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