Draft 2 Circular Promulgating the List of toxic drugs, toxic drug raw materials
Promulgating the List of toxic drugs, toxic drug raw materials
Pursuant to Pharmaceutical law no 105/2016/QH13 dated 06 April 2016;
Pursuant to Decree no. /NĐ-CP dated mm yy of the Government regulating the implementation of a number of Article of Pharmaceutical law;
Pursuant to Decree no. 63/2012/NĐ-CP dated 31 August 2012 of the Government regulating the functions, duties, powers and organizational structure of Ministry of Health;
At the request of the Director of Drug Administration,
The Minister of Health hereby promulgates “Circular promulgating the List of toxic drugs, toxic raw materials”.
Article 1. Scope of regulation
This Circular promulgates the “List of toxic drugs, toxic drug raw materials” covering:
1. List of toxic chemo pharmaceutical drugs, vaccines, biologicals and pharmaceutical substances.
2. List of toxic medicinal material drugs.
Article 2. Interpretation of terms
1. Toxic drugs means drugs that contain high toxicity, direct exposure with or usage of which, even at a very small dose can cause harm to the users’ health, life or when using at normal conditions can cause serious adverse reactions, and belong to the List enclosed with this Circular.
2. Toxic pharmaceutical substances means pharmaceutical substances that contain high toxicity and belong to the List enclosed with this Circular.
3. Toxic containing medicinal materials means medicinal materials that belong to the List of medicinal materials of toxicity used for drug manufacture in Vietnam issued by the Minister of Health.
4. Serious adverse reactions means harmful reactions resulting in one of the following consequences:
a) Causing death;
b) Life threatening;
c) Requiring inpatient hospitalization or prolongation of hospitalization;
d) Leaving serious or permanent sequelae;
đ) Causing fetal congenital anomalies and similar defects.
Article 3. Principles for the formulation of the List of toxic drugs, toxic drug raw materials
1. The list of toxic drugs, toxic drug raw materials shall be formulated based on the following basis:
a. Literature on the safety of drugs or pharmaceutical substances.
b. Appropriateness with actual drug usage and supply of Vietnam.
c. Consulting other countries’ methods of classifying toxic drugs, toxic drug raw materials.
2. The Circular shall be reviewed, supplemented every 02 (two) years.
Any recommendations by pharmaceutical establishments, medical service establishments or drug registrant establishments for the revision, removal or supplementation of drugs into the List of toxic drugs, toxic drug raw materials of this Circular to make it more relevant, to accommodate the therapeutic requirements of patients, shall be made using Form no. 1 enclosed to this Circular and sent to Ministry of Health (Drug Administration) or Health Department of provinces, centrally-affiliated city for the latter to synthetize, review and make classification proposals to Ministry of Health (Drug Administration).
Article 4. Criteria for inclusion to the List of toxic drugs, toxic drug raw materials Drugs and pharmaceutical substances shall be included to the List of toxic drugs, toxic drug raw materials if satisfying one of the following criteria:
1. Drugs or pharmaceutical substances of high toxicity, direct exposure with or accidental use of which even at a small dose can cause harm to the users’ health, life.
2. Drugs with a narrow therapeutic range, required to be administered under physician’s supervision.
3. Drugs having a known potential for serious adverse effects or warned by World Health Organization, Vietnam’s or a foreign country’s competent regulatory authority as having such potential.
Article 5. Implementation organization
1. For pharmaceutical business establishments
a) With regard to dossiers registering drugs in Vietnam and dossiers applying for import license for drugs not yet licensed for marketing in Vietnam that have been submitted to Drug Administration before the effective date of this Circular, such establishments shall undertake to classify, revise, supplement documents relevant to the drugs’ classification in accordance with this Circular before they can be issued a certificate of marketing registration or import license respectively.
b) With regard to the drugs that have been licensed for marketing in Vietnam or licensed for importation before the effective date of this Circular, within 12 months from the date this Circular takes effect, the registrant establishments of such drugs shall classify, update, supplement to the drug’s labels, package insert with information relevant to the drugs’ classification in accordance with the provisions of this Circular before they can place such drugs on the market.
2. Drug Administration, Ministry of Health’s affiliated units, Health Departments of provinces, centrally-affiliated cities shall be responsible for the implementation of this Circular.
Article 8. Implementation provisions
1. This Circular shall take effect from 01 January 2017.
2. Where the documents referred to in this Circular are replaced or amended, supplemented, such replacing, amended, supplemented version of the documents shall apply.
– Office of the Government (Official gazette, Webportal);
– Ministry of Justice (Legal document checking Department, KSTTHC Department);
– Sectoral Health Services (National Defence, Public Security, Post and telematics, Transport);
– Ministerial Inspectorates, Administrations, Departments, VN General Pharmaceutical Corporation;
– Health departments of provinces, central affiliated cities;
– VN Pharmaceutical business association;
– Ministry of Health’s web portal;
– File: VT, PC, QLD (02 copies).
Nguyễn Thị Kim Tiến
RECOMMENDING THE AMENDMENT, REMOVAL OR SUPPLEMENTATION OF THE LIST OF TOXIC CHEMO PHARMACEUTICAL DRUGS, TOXIC PHARMACEUTICAL SUBSTANCES, TOXIC MEDICINAL MATERIALS
To: Drug Administration (Ministry of Health)
Or Health Department, province/city ……..
1. Name of recommending unit:
3. Contact telephone no.:
4. Contents and reasons of recommendation:
Pursuant to the inclusion criteria for non-prescription drugs specified in Article 4 of Circular no …../2016/TT-BYT of the Minister of Health promulgating the List of toxic drugs, chemo pharmaceutical raw materials for the manufacture of toxic drugs, [Name of recommending unit] recommends to amend/remove/supplement drugs to the List of toxic drugs, chemo pharmaceutical raw materials for the manufacture of toxic drugs, specifically as follows: [Elaborate contents recommended].
Reasons of the recommendation: [Elaborate reasons].
5. Document enclosures: [Enumerate documents enclosed (if any)]
For the above reasons, Drug Administration is kindly requested to consider the recommendations made by [Name of recommending unit].
Thanks and regards,
Head of the Unit
( Signature , seal )
LIST OF TOXIC DRUGS, TOXIC DRUG RAW MATERIALS
(Promulgated in enclosure with Circular no.: /2016/TT-BYT dd mm 2016 of the Minister of Health)
I. LIST OF CHEMO PHARMACEUTICAL DRUGS, VACCINES, BIOLOGICALS AND TOXIC MEDICINAL MATERIALS
1. LOCAL ANESTHETICS, GENERAL ANESTHETICS
1 Atropin sulfat
3 Bupivacain (hydroclorid)
10 Procain hydroclorid
11 Proparacain (hydroclorid)
13 Ropivacaine hydrochloride monohydrate
15 Thiopental (muối natri)
2. CANCER TREATMENT DRUGS AND IMMUNE REGULATION DRUGS
2.1. Cancer treatment drugs
18 Anti-human thymocyte immunoglobulin
19 Arsenic trioxid
20 Azathioprin và muối
27 Calci folinat
30 Carmustin và muối
33 Clodronat disodium
44 Epirubicin hydroclorid
49 Fluorouracil (5-FU)
54 Goserelin acetat
64 Leuprorelin acetat
79 Procarbazin và muối
84 Tegafur-uracil (UFT hoặc UFUR)
87 Thymosin alpha I
90 Tretinoin (All-trans retinoic acid)
92 Vinblastin (sulfat)
93 Vincristin (sulfat)
2.2. Immune regulation drugs
100 Glycyl funtumin (hydroclorid)
3. COAGULATION MODIFYING DRUGS
105 Aminocaproic acid
109 Enoxaparin (natri)
111 Heparin (natri)
113 Nadroparin calci
114 Phytomenadion (vitamin K1)
115 Protamin sulfat
117 Tranexamic acid
120 Warfarin (muối natri)
4. ANTITHROMBOTIC DRUGS
122 Acetylsalicylic acid
125 Dipyridamol + acetylsalicylic acid
127 Fondaparinux sodium
129 Prostaglandin E1
5. MYORELAXANTS AND CHOLINESTERASE INHIBITORS
132 Atracurium besylat
134 Botulinum toxin
138 Neostigmin metylsulfat
139 Neostigmin bromide
140 Pancuronium bromid
141 Pipecuronium bromid
142 Pyridostigmin bromid
144 Rocuronium bromide
145 Suxamethonium clorid
146 Tizanidin hydroclorid
149 Vecuronium bromide
6. ANDROGEN, ESTROGEN AND PROGESTERON PREPARATIONS
152 Estradiol benzoate
154 Estrogen + norgestrel
156 Ethinyl estradiol
159 Medroxy progesterone acetat
160 Methyl testosterone
161 Nandrolon decanoat
162 Nomegestrol acetat
167 Testosteron (acetat, propionat, undecanoat)
168 Other sex hormones
7. VACCINES AND BIOLOGICALS
Huyết thanh (sera)
Biến độc tố (toxoids)
Kháng độc tố
Kháng nguyên (antigens)
Huyết thanh miễn dịch (immunoglobulins)
II. LIST OF TOXIC MEDICINAL MATERIAL DRUGS:
Toxic medicinal materials are classified as toxic drugs if containing in its composition medicinal material(s) that belong to the List of toxic containing medicinal materials and the strength, concentration or volume of such constituent medicinal material(s) in the drug preparation exceed the limits prescribed in the List of toxic containing medicinal materials.
List of toxic drugs, toxic drug raw materials