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

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

Circulating insecticidal and germicidal preparations in Vietnam

According to Clause 3, Clause 5, Article 2 of Decree 91/2016/ND-CP stipulating that:

- 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).

- Registration number holder refers to an organization or individual that has a Sale Registration Certificate granted in the name of that organization or individual.

Thus, insecticidal and germicidal preparations before being circulated in the market, will have to be registered for circulation, be tested according to the provisions of Points b, c, Clause 2, Article 9 and Article 13 of Decree 91/2016/ND-CP and meet the conditions for circulation of insecticidal and germicidal preparations according to the provisions of Decree 91/2016/ND-CP.

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

* According to Article 17 of Decree 91/2016/ND-CP, requirements for sale of insecticidal and germicidal preparations in Vietnam include:

- A preparation is allowed to be freely sold if having a registration number. And

- It must have a label or supplementary label containing sufficient information as referred to in Decree 91/2016/ND-CP.

- If the duration of registration number issued to a type of preparations expires but the registration number holder fails to apply for extension of that registration number, the preparations which are produced before the expiration date of that registration number are still freely sold on the market until the expiry date stated in their label is over.

* Pursuant to Article 18 of Decree 91/2016/ND-CP, registration number for insecticidal and germicidal preparations in Vietnam is as follows:

- One type of preparations shall be issued with a registration number.

- Each registration number shall be valid within 05 years from its issued date. In case of extension of registration number of a type of preparations, the issued registration number shall be maintained.

- Registration number is issued under a Sale Registration Certificate. The form of Sale Registration Certificate shall comply with regulations in Annex IV in Decree 91/2016/ND-CP.

* According to Article 19 of Decree 91/2016/ND-CP,requirements for registered insecticidal and germicidal preparations in Vietnam include:

- The toxicity of preparations of which the registration is carried out is not classified in Class Ia or Ib according to WHO’s classification system for pesticides (or insecticidal preparations), or in Heading I or II according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

- Preparations must not contain any of active ingredients in the list of active ingredients banned from use in preparations.

- The registration of preparations which contain any of active ingredients in the list of active ingredients with restricted use in preparations shall be made within the regulated scope of use only.

- Registered preparations must be made by a manufacturer that has declared its eligibility to produce preparations as regulated (domestic preparations) or attached with Certificate of Free Sale (for imported preparations).

* According to Article 20 of Decree 91/2016/ND-CP, holders of sale registration certificates include:

- The following entities may be holders of sale registration certificates:

+ A domestic enterprise, or co-operative, or business household that is the owner of preparations of which the registration is made or a representative office in Vietnam of a foreign trader who is the owner of relevant preparations;

+ A domestic enterprise, or a co-operative, or a business household that applies for the registration of preparations under the authorization of the owner of such preparations;

+ A representative office of foreign trader in Vietnam that applies for the registration of preparations under the authorization of the owner of such preparations.

- In case of additional registration of preparations, or extension of registration number, or re-issuance of Sale Registration Certificate, the holder of sale registration certificate is also the registration number holder.

- If the owner of preparations gives permission to its authorized entity to re-authorize another entity to apply for the registration of preparations, the permitted reauthorization must be clarified in the Letter of Authorization.

- If there are two or several entities in Vietnam apply for the registration of the same type of preparations under the authorization of the owner of that type of preparations, Ministry of Health shall only receive and settle the application submitted by the entity that comes first with a valid letter of authorization.

Nguyen Pham Nhut Tan

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