View Procedure
| Procedure Name | Insecticide and disinfectant official circulation registration for household and medical use |
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| Description |
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Category
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Registration
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Responsible agency
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Medical environmental management bureau – Ministry of Health
Address:
Phone:
Email:
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Base on legal documents
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- Law on Product and Goods Quality 05/2007/QH12 dated November 21, 2007.
- Commercial Law 36/2005/QH11
- Law on Chemicals 06/2007/QH12 dated November 21, 2007 of the National Assembly
- Decree 187/2013/ND-CP dated November 20, 2013 of the Government, detailing the Commercial Law regarding international goods purchase and sale and goods purchase and sale agency, processing and transit activities with foreign partners
- Decree 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and Goods Quality
- Decree 26/2011/ND-CP dated April 8, 2011 of the Government amending and supplementing a number of articles of Decree 108/2008/ND-CP dated October 7, 2008 of the Government detailing and guiding the implementation of a number of articles of the Law on Chemicals
- Decree 91/2016/ND-CP On management of insecticidal and germicidal chemicals and preparations for household and medical use
- Circular 278/2016/TT-BTC Providing for fees in medical sector, and the collection, transfer, management and the usage
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Processing time
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Fee
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Required documents
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Serial
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Title
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Comment
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1
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A written request for official circulation registration
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Form 4 Annex 1
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2
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The registrant's business registration certificate, investment certificate or establishment license, for registrants being representative offices
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3
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The paper of authorization to carrying out circulation registration if Vietnam-based organizations and individuals that produce or trade in chemicals or preparations or Vietnam-based permanent representative offices of foreign enterprises which are authorized by chemical or preparation owners to carry out the registration
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Original
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4
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Results of testing of the composition and contents of active ingredients of the chemical or preparation
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5
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The assay result slip
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6
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The producer's written environmental protection commitment or decision issued by a competent state agency approving the producer's environmental impact assessment report
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7
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Technical documents of the chemical or preparation requested for registration 9 (covering the details specified in Annex V Decree 91/2016/ND-CP)
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8
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The specimen label and its content registered for circulation in Vietnam
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9
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A valid certificate of free sale granted by a competent authority of a country permitting the circulation of the chemical or preparation requested for registration
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Process steps:
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Step 1
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The enterprise shall submit the dossier of application for import via postal service or directly to the Document Unit of the Health Environment Management Agency - Ministry of Health
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Step 2
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Within 01 month, MoH (HEMA) issues permit license for experimental/test or reject reason
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Step 3
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Within 12 months, enterprise submit test result for supplementing circulation registration dossier
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Step 4
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Within 20 days after receiving test result, MoH (HEMA) issues circulation number or reject reason
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Step 5
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Return circulation number to enterprise
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Process map:
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| Category | Procedure |
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The following form/s are used in this procedure
This procedure applies to the following measures
| Name | Measure Type | Agency | Description | Comments | Legal Document | Validity To | Measure Class |
| Circulation registration for chemicals and preparations | Technical Measures | Ministry of Health | Preparations which are permitted to use abroad but imported to use in Vietnam for the first time must register for circulation | Additional registration of preparations shall apply to preparations whose registration number has been issued in Vietnam and is still in effect but there is one of the following changes occurs:
a) Change of the ownership of the registration number;
b) Change of the trade name of relevant type of preparations;
c) Change of manufacturer’s location or change of manufacturer;
d) Change of name or contact address of the entity carrying out the registration, or change of name of manufacturer or production location;
dd) Change of effects, quality criteria or method of using preparations | Decree No. 103/2016/ND-CP dated July 01, 2016 of the Government on Biosafety in Laboratories | 01-07-2016 | Good |
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