Regulations on registration for circulation of insecticidal and germicidal preparations in Vietnam

Regulations on registration for circulation of insecticidal and germicidal preparations in Vietnam (Internet image)

 Regulations on registration of circulation for insecticidal and germicidal preparations in Vietnam

According to Clause 3, Article 2 of Decree 91/2016/ND-CP, insecticidal and germicidal preparation is a product that contains insecticidal and germicidal active ingredients, has specific trade name and is directly used to sterilize and kill pests in the household and medical fields (hereinafter referred to as preparation).

Thus, when insecticidal and germicidal preparations before being circulated/widely used in the market, they will have to be registered for circulation in accordance with Decree 91/2016/ND-CP.

Pursuant to Article 21 of Decree 91/2016/ND-CP, forms of registration include:

- The registration of new preparations shall be carried out in the following cases:

+ New preparations which are produced domestically, except for those for export purpose;

+ Preparations which are permitted to use abroad but imported to use in Vietnam for the first time;

+ Preparations being issued with registration number but the extension of that registration number is not carried out within the period prescribed in Clause 2 Article 24 of Decree 91/2016/ND-CP.

- 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:

+ Change of the ownership of the registration number;

+ Change of the trade name of relevant type of preparations;

+ Change of manufacturer’s location or change of manufacturer;

+ Change of name or contact address of the entity carrying out the registration, or change of name of manufacturer or production location;

+ Change of effects, quality criteria or method of using preparations.

- The registration for extension of registration number shall apply to preparations which have been issued with the registration number but it reaches the period for carrying out the registration for extension as prescribed in Clause 2 Article 24 of Decree 91/2016/ND-CP.

- The registration for re-issuance of Sale Registration Certificate shall be carried out if the issued Sale Registration Certificate is lost or damaged.

Application for registration of new insecticidal and germicidal preparations in Vietnam

According to Article 22 of Decree 91/2016/ND-CP, application for registration of new insecticidal and germicidal preparations is as follows:

- The application form for registration of new preparations using the Form No. 04 stated in Annex I enclosed with Decree 91/2016/ND-CP.

- Documents proving legal status of the applicant or the manufacturer.

- Letter of authorization for registration of preparations, except for the cases stated in Point a Clause 1 Article 20 of Decree 91/2016/ND-CP.

- Technical documents of the type of preparations which applies for registration, including contents as prescribed in Annex V enclosed with Decree 91/2016/ND-CP.

- Testing results for ingredients and the content of active ingredients in preparations (the written notice of testing results must be supplemented).

- The written notice of experiment results (which is supplemented upon the written approval for experiment by Ministry of Health).

- Label sample of preparations.

- Certificate of Free Sale (for imported preparations).

- Documents and/or written results of the research on the safety and effects of preparations, or warnings by WHO or other international organizations about the use of relevant preparations in household and medical sectors (if the type of preparations that applies for registration contains active ingredients or this is the first application for registration of that type of preparations in Vietnam).

Requirements for application for registration of new insecticidal and germicidal preparations in Vietnam

Pursuant to Article 26 of Decree 91/2016/ND-CP and Clause 10, Article 9 of Decree 155/2018/ND-CP, requirements for application for registration of new insecticidal and germicidal preparations in Vietnam include:

- The application dossiers for registration of new preparations, or additional registration, or extension of registration number shall include 01 set in paper form, enclosed with PDF form files.

- Documents included in the application dossiers must be clearly printed and arranged in the order for each form of registration as prescribed in Articles 22, 23 and 24 of Decree 91/2016/ND-CP; it must have space between content parts in a document with cover page and list of documents.

- English documents must be translated into Vietnamese and enclosed with the originals thereof. Documents in a foreign language other than English must be translated into Vietnamese and notarized in accordance with the law.

- Requirements for documents in a set of application dossiers for registration:

+ The original letter of authorization for registration of preparations. The letter of authorization must meet requirements in Annex VII enclosed with this Decree;

+ The original or valid copy of Certificate of Free Sale (for imported preparations). Certificate of Free Sale must meet requirements in Annex VIII enclosed with this Decree;

+ The original or valid copy of the written notice of experiment results made by an entity that is independent (that is not the manufacturer or the applicant for registration of preparations) and qualified to conduct experiment activities as referred to in Article 14 of Decree 91/2016/ND-CP;

+ The original or valid copy of the written notice of testing results for ingredients and the content of active ingredients in preparations. Such written notice of testing results must be made by an entity that is qualified to conduct testing as referred to in Article 10 of Decree 91/2016/ND-CP.

If the testing establishments in Vietnam cannot conduct the testing, the applicant can use the testing results from the manufacturer or an independent laboratory which satisfies ISO 17025:2005 or ISO 15189:2012 or their editions. Also, such manufacturer or laboratory must take responsibility before the law for the legality of their testing results.

+ Label samples of all packaging specifications according to real package size with certification of the applicant. If several packaging specifications have the same label design, the applicant shall only submit the label sample of the packaging specification with the smallest package size.

If the label sample of imported preparations uses a foreign language, it must be attached with a secondary label with contents in Vietnamese. The sample and contents of the secondary label of preparations must meet requirements in Annex IX enclosed with this Decree.

+ Valid copies of documents proving the legal status of the applicant or the manufacturer;

+ The original or valid copy of the written notice of change of name, or address, or location, or change of manufacturer of a foreign manufacturer, which must be legalized by consular bodies in accordance with the law.

- Other documents in the application dossiers for registration must be fan-stamped or stamped on each page of a document by the applicant.

Nguyen Pham Nhut Tan

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