Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular provides for:
1. Lists of drugs and medicinal ingredients subject to special control, including:
a) The List of narcotic active ingredients in Appendix I hereof; maximum permissible concentrations of narcotic active ingredients in combined drugs in Appendix IV hereof;
b) The List of psychotropic active ingredients in Appendix II hereof; maximum permissible concentrations of psychotropic active ingredients in combined drugs in Appendix V hereof;
c) The List of drug precursors in Appendix III hereof; maximum permissible concentrations of drug precursors in combined drugs in Appendix VI hereof;
d) The List of drugs and active ingredients banned from certain fields in Appendix VII hereof.
2. Storage, production, concoction, dispensing, use, destruction, delivery, transport, reporting of drugs and medicinal ingredients subject to special control.
3. Supply of radiopharmaceuticals.
4. Documents about drugs and medicinal ingredients subject to special control, and retention thereof.
Article 2. Regulated entities
1. Regulations of this Circular on lists of controlled drugs and medicinal ingredients, documents about controlled drugs/medicinal ingredients apply to all pharmacy business establishments and the entities specified in Clause 2 of this Article.
2. Regulations of this Circular on storage, production, concoction, dispensing, use, destruction, delivery, transport, reporting of controlled drugs and medicinal ingredients only apply to the following entities:
a) Health facilities;
b) Rehabilitation centers;
c) Pharmacy research and training institutions;
d) Organizations having non-commercial pharmacy-related activities.
3. Regulations of this Circular on supply of radiopharmaceuticals only apply to health facilities that produce radiopharmaceuticals.
Article 3. Classification of controlled drugs
1. Narcotic drugs include:
a) Any drug that contains one or some narcotic active ingredients; any drug that contains both active ingredients and psychotropic active ingredients regardless of availability of drug precursors specified in Appendices I, II, III hereof.
b) Any drug that contains active ingredients (regardless of availability of psychotropic active ingredients or drug precursors) combined with active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors where the concentration of the narcotic active ingredient exceeds the limits specified in Appendix IV hereof.
2. Psychotropic drugs include:
a) Any drug that contains one or some psychotropic active ingredients; any drug that contains both psychotropic active ingredients and drug precursors specified in Appendices II and III hereof.
b) Any drug that contains psychotropic active ingredients (regardless of availability of narcotic active ingredients or drug precursors) combined with active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors where the concentration of the narcotic active ingredient (if any) does not exceed the limits specified in Appendix IV hereof.
3. Precursor drugs include:
a) Any drug that contains one or some drug precursors specified in Appendix III hereof;
b) Any drug that contains drug precursors (regardless of availability of narcotic active ingredients or psychotropic active ingredients) combined with active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors with where the concentration of the drug precursor exceeds the limits specified in Appendix VI hereof, the concentration of the narcotic active ingredient (if any) does not exceed the limits specified in Appendix IV hereof and the concentration of the psychotropic active ingredient (if any) does not exceed the limits specified in Appendix V hereof.
4. A combined drug that contains narcotic active ingredients is a drug that:
b) contains narcotic active ingredients or both narcotic active ingredients and psychotropic active ingredients, regardless of availability of drug precursors, where the concentrations of the narcotic active ingredients, psychotropic active ingredients and drug precursors do not exceed the limits specified in Appendix IV, V and VI hereof; and
b) contains active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors.
5. A combined drug that contains psychotropic active ingredients is a drug that:
a) contains psychotropic active ingredients or both psychotropic active ingredients and drug precursors where the concentrations of psychotropic active ingredients and drug precursors do not exceed the limits specified in Appendix V and VI hereof; and
b) contains active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors.
6. A combined drug that contains precursors is a drug that:
a) contains drug precursors where the concentrations of drug precursors do not exceed the limits specified in Appendix VI hereof; and
b) contains active ingredients other than narcotic active ingredients, psychotropic active ingredients and drug precursors.
7. Drugs and active ingredients banned from certain fields:
Drugs and active ingredients banned from certain fields are identified according to the criteria specified in Clause 2 Article 41 of Decree No. 54/2017/ND-CP.
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