THE MINISTRY OF HEALTH _______ No. 11/2020/TT-BYT | THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness _______________________ Hanoi, June 19, 2020 |
CIRCULAR
On promulgating the List of prohibited and restricted active ingredients in insecticidal and germicidal preparations for household and medical use
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Pursuant to the Government
s Decree No. 75/2017/ND-CP dated June 20, 2017 on defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of insecticidal or germicidal chemicals and preparations for household and medical use;
At the proposal of the Director General of the Health Environment Management Agency,
The Minister of Health hereby promulgates the Circular on promulgating the List of prohibited and restricted active ingredients in insecticidal and germicidal preparations for household and medical use.
Article 1. Scope of regulation
This Circular promulgates the List of prohibited and restricted active ingredients in insecticidal and germicidal preparations for household and medical use (hereinafter collectively referred to as insecticidal and germicidal preparations for household and medical use).
Article 2. Subjects of application
This Circular applies to agencies, organizations and individuals involved in purchasing, manufacturing, and trading activities, and carrying out the registration procedures for circulation of insecticidal and germicidal preparations for household and medical use in Vietnam and relevant organizations and individuals.
Article 3. List of active ingredients
1. To promulgate the List of active ingredients prohibited from use in insecticidal and germicidal preparations for household and medical use as prescribed in Appendix No. 01 attached to this Circular.
2. To promulgate the List of active ingredients restricted from use in insecticidal and germicidal preparations for household and medical use as prescribed in Appendix No. 02 attached to this Circular.
Article 4. Effect
1. This Circular takes effect on August 20, 2020.
2. The Minister of Health’s Circular No. 47/2017/TT-BYT dated December 22, 2017 on promulgating the List of prohibited and restricted active ingredients in insecticidal and germicidal preparations for household and medical use in Vietnam shall cease to be effective from the effective date of this Circular.
Article 5. Transitional provisions
1. Insecticidal and germicidal preparations for household and medical use granted circulation registration numbers before the effective date of this Circular shall continue to be manufactured and imported for a maximum duration of 01 years, to be traded and used for a maximum duration of 02 years from the effective date of this Circular if:
a) Insecticidal and germicidal preparations for household and medical use contain one of the following active ingredients: Chlorpyrifos ethyl, Hexythiazox, Fipronil, Beta- cyfluthrin, Cyfluthrin, Trichlorfon, Diazinon, Acephate, Malathion and Methanol provided in Appendix No. 01 issued together with this Circular;
b) Insecticidal and germicidal preparations for household and medical use contain one of the following active ingredients: Emamectin benzoate and Spinosad whose use scope does not comply with the regulations on restriction of use provided in Appendix No. 02 issued together with this Circular.
2. From the effective date of this Circular, all dossiers of registering for insecticidal and germicidal preparations for household and medical use containing one of the following active ingredients: Chlorpyrifos ethyl, Hexythiazox, Fipronil, Beta-cyfluthrin, Cyfluthrin, Trichlorfon, Diazinon, Acephate, Malathion and Methanol, submitted before the effective date of this Circular but not been settled yet, shall not be accepted, handled and appraised.
3. For insecticidal and germicidal preparations for household and medical use that contain the active ingredients provided in Appendix No. 02 issued together with this Circular and have been granted with circulation registration numbers prior to the effective date of this Circular, their advertisements shall provide the exact descriptions of the effect written on the circulation registration certificate. In case wishing to advertise and expand the effect as prescribed in Appendix No. 02 issued together with this Circular, the establishment that has registered such preparations must register for additional circulation in accordance with the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of insecticidal or germicidal chemicals and preparations for household and medical use and the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amending and supplementing some regulations concerning business investment conditions under the state management of the Ministry of Health.
Article 6. Implementation responsibility
1. The Director General of the Health Environment Management Agency shall be responsible for organizing and implementing this Circular.
2. Chief of the Ministry Office, Chief of the Ministry Inspector, Directors and Director Generals of Departments, Agencies, Directorates, Ministry Office, Ministry Inspectorate, Directors of Health Departments of provinces and centrally run cities, heads of health units of regulatory bodies and relevant agencies, organizations and individuals shall be responsible for the implementation of this Circular.
Any difficulty and problem arising in the course of implementing should be promptly reported to the Ministry of Health for consideration and settlement./.
| FOR THE MINISTER THE DEPUTY MINISTER Do Xuan Tuyen |