VI What types of drugs are subject to special control? What are the business conditions for drugs that are subject to special control? How are the facilities of establishments that trading in drugs that are subject to special control regulated under Decree 163? Let’s find out more with Pham Consult!
What types of drugs are subject to special control?
Clause 26, Article 2 of the 2016 Law on Pharmacy stipulates as follows:
Explanation of terms
In this Law, the following terms are construed as follows:
- Drugs and pharmaceutical ingredients subject to special control (hereinafter referred to as drugs subject to special control) include:
- a) Drugs specified in Clauses 17, 18, 19, 20, 21, 22, 23 and 24 of this Article;
- b)Pharmaceutical ingredients that are psychotropic drugs, addictive substances, precursors used to make drugs or radioactive substances to produce drugs specified in Clauses 17, 18, 19, 20, 21, 22, 23 and 24 of this Article;
- c) Toxic drugs and toxic pharmaceutical ingredients on the list issued by the Minister of Health;
- d) Drugs and pharmaceutical ingredients on the list of substances banned from use ina number of specific sectors and fields according to Government regulations.
Thus, drugs subject to special control include:
– Drugs specified in Clauses 17, 18, 19, 20, 21, 22, 23 and 24, Article 2 of the 2016 Law on Pharmacy
– Pharmaceutical ingredients that are psychotropic drugs, addictive substances, precursors used to make drugs or radioactive substances to produce drugs specified in Clauses 17, 18, 19, 20, 21, 22, 23 and 24, Article 2 of the 2016 Law on Pharmacy
– Toxic drugs and toxic raw materials for making drugs on the list issued by the Minister of Health;
– Drugs and pharmaceutical ingredients on the list of substances banned from use in a number of specific sectors and fields according to Government regulations.
What are the business conditions for drugs subject to special control?
According to Clause 1, Article 34 of the 2016 Law on Pharmacy, establishments trading in drugs subject to special control must be approved in writing by the competent state management agency on pharmacy. The approval is based on the following conditions:
- Satisfy the conditions specified in Article 33 of the 2016 Law on Pharmacy in accordance with the conditions of each business establishment;
- Have security measures to ensure no loss of drugs and pharmaceutical ingredients subject to special control;
- In the case of trading in radioactive drugs, the conditions prescribed in the Law on Atomic Energy and other relevant legal documents must be met.
How are the physical facilities of drug trading establishments subject to special control regulated under Decree 163?
Pursuant to the provisions of Article 31 of Decree 163/2025/ND-CP, the physical facilities of drug trading establishments subject to special control are as follows:
(1) For establishments producing addictive drugs, psychotropic drugs, precursor drugs, drug ingredients that are addictive pharmaceutical substances, psychotropic pharmaceutical substances, and drug precursors:
- Have a separate warehouse or separate area that meets the principles and standards of Good Storage Practice for drugs and drug ingredients to preserve addictive drugs, psychotropic drugs, precursor drugs, drug ingredients that are addictive pharmaceutical substances, psychotropic pharmaceutical substances, and drug precursors. This warehouse or area must have a door and a secure lock;
- Have a camera system to monitor each stage in the process of producing and preserving drugs and drug ingredients;
- Have a management and monitoring system using records and books according to the regulations of the Minister of Health.
(2) For facilities producing combination drugs containing narcotic substances, combination drugs containing psychotropic substances, combination drugs containing precursors:
- Have a separate warehouse or separate area that meets the principles and standards of Good Storage Practice for drugs and pharmaceutical ingredients to preserve drug ingredients that are narcotic substances, psychotropic substances, and precursors used to make drugs. This warehouse or area must have a door and a secure lock;
- Have a separate warehouse or separate area that meets the principles and standards of Good Storage Practice for drugs and pharmaceutical ingredients to preserve combination drugs containing narcotic substances, combination drugs containing psychotropic substances, combination drugs containing precursors. The warehouse must have a door and a secure lock;
- Have a camera system to monitor each stage in the process of producing and preserving drugs and pharmaceutical ingredients
- Have a management and monitoring system using records and books according to the regulations of the Minister of Health.
(3) For radioactive drug manufacturing facilities:
- Have a separate warehouse or separate area that meets the principles and standards of Good Storage Practice for drugs and pharmaceutical ingredients to preserve radioactive drugs;
- Have a management and monitoring system using records and books according to the regulations of the Minister of Health;
- Have a camera system in the drug production and storage area.
(4) For export and import facilities, and business establishments providing services for preserving addictive drugs, psychotropic drugs, precursor drugs, pharmaceutical ingredients that are addictive pharmaceutical substances, psychotropic pharmaceutical substances, and precursors used to make drugs:
- Have a separate warehouse or separate area that meets the principles and standards of Good Storage Practice for drugs and pharmaceutical ingredients to preserve addictive drugs, psychotropic drugs, precursor drugs, pharmaceutical ingredients that are addictive pharmaceutical substances, psychotropic pharmaceutical substances, and precursors used to make drugs. This warehouse or area must have a door and a secure lock;
- There must be a camera system in the warehouse storing drugs and pharmaceutical ingredients;
- There must be a management and monitoring system using records and books according to the regulations of the Minister of Health.
(5) For export and import establishments, wholesale establishments, and establishments providing services for storing combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursors: There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practice for drugs and pharmaceutical ingredients to store combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursors. The warehouse must have a door and a secure lock; there must be a management and monitoring system using records and books according to the regulations of the Minister of Health.
(6) For establishments exporting, importing, wholesaling radioactive drugs and radioactive drug ingredients: There must be a management and monitoring system using records and books according to the regulations of the Minister of Health.
(7) For establishments wholesaling addictive drugs, psychotropic drugs, and precursor drugs:
- Have a separate warehouse or separate area that meets the principles and standards of Good Storage Practice for drugs and drug ingredients to store addictive drugs, psychotropic drugs, and precursor drugs. The separate warehouse or area must have a door and a secure lock;
- Have a camera system in the drug storage area;
- Have a management and monitoring system using records and books according to the regulations of the Minister of Health.
(8) For establishments retailing addictive drugs, psychotropic drugs, and precursor drugs:
- Addictive drugs, psychotropic drugs, and precursor drugs must be stored in a separate cabinet or separate compartment with a secure lock;
- Have a management and monitoring system using records and books according to the regulations of the Minister of Health.
(9) For retail establishments selling combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursors, monitoring must be carried out using a software system or records and books according to the regulations of the Minister of Health.
(10) For retail establishments selling radioactive drugs:
- Have a separate area to store radioactive drugs;
- Have a management and monitoring system using records and books according to the regulations of the Minister of Health.
(11) For establishments providing clinical drug trial services, providing drug bioequivalence testing services, providing testing services, and providing radioactive drug storage services:
- Have a separate warehouse or separate area that meets the principles and standards of Good Storage Practice for drugs and drug ingredients to store radioactive drugs; have a management and monitoring system using records and books according to the regulations of the Minister of Health; have a camera system for establishments providing radioactive drug storage services;
- Have a management and monitoring system using records and books according to the regulations of the Minister of Health;
- Have a camera system for establishments providing radioactive drug storage services.
(12) For establishments providing clinical drug trial services, drug bioequivalence testing services, drug testing services subject to special control, except for the cases specified in
(11), addictive drugs, psychotropic drugs, precursor drugs, drug ingredients that are addictive drugs, psychotropic drugs, precursors used to make drugs, combination drugs containing addictive drugs, combination drugs containing psychotropic drugs, combination drugs containing precursors must be stored in a separate area with a secure lock or in a separate cabinet or separate compartment with a secure lock.
(13) For establishments trading in toxic drugs, toxic pharmaceutical ingredients, drugs and pharmaceutical substances in the list of drugs and pharmaceutical substances in the list of substances banned from use in certain industries and fields, it is necessary to monitor by software system or records and books the entire process of export, import and inventory according to regulations of the Minister of Health.
