Regulations on experiment on insecticidal and germicidal preparation in Vietnam

Regulations on experiment on insecticidal and germicidal preparation in Vietnam (Internet image)

Insecticidal and germicidal preparation in Vietnam

According to Clause 3, Article 2 of Decree 91/206/ND-CP on the management of insecticidal and germicidal chemicals and preparations for household and medical use, Iisecticidal 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).

Regulations on experiment on insecticidal and germicidal preparation in Vietnam

According to Section 2, Chapter III of Decree 91/206/ND-CP, regulations on experiment on insecticidal and germicidal preparation in Vietnam include:

- Pursuant to Article 13 of Decree 91/206/ND-CP, cases subject to the experiment include:

+ New preparations of which the application for sale registration is carried out.

+ Preparations of which the additional registration is carried out as referred to in Point c and Point dd Clause 2 Article 21 of this Decree.

- Pursuant to Article 14 of Decree 91/206/ND-CP and Article 8, Clause 7, Clause 8, Article 9 of Decree 155/2018/ND-CP, the requirements for experiment establishments include:

+ An establishment carrying out experiments on preparations must be a health facility.

+ Requirements on personnel:

The person in charge of managing the experiment division must have at least 03 years of experience in the experiment on preparations.

+ Requirements on facilities:

++ Have a laboratory which is managed and operated under ISO 17025:2005 or ISO 15189:2012 or their editions. If the testing is conducted, it must be registered in accordance with the law on requirements for provision of conformity assessment services.

++ Have species of insects, germs or viruses available and sufficient for experiment;

+ Perform the declaration of eligibility to conduct experiment activities as referred to in Article 16 of this Decree.

 - Pursuant to Article 15 of Decree 91/206/ND-CP and Clause 7, Article 8 of Decree 155/2018/ND-CP, application for declaration of eligibility to conduct experiment activities include

+ The written declaration of eligibility to conduct experiment activities, using the Form No. 03 in Annex I herein.

+ The list of names of experiments which the experiment establishment is capable to conduct with its certification.

+ The declaration on personnel, using the form stated in Annex II herein.

+ The valid copy of Certificate of conformity to ISO 17025:2005 or ISO 15189:2012 or their editions.

+ The list of facilities and equipment serving experiment activities with the experiment establishment’s certification.

- Pursuant to Clause 9, Article 9 of Decree 155/2018/ND-CP, the declaration of eligibility to conduct experiment activities is as follows:

+ Before conducting the first experiment, the experiment establishment shall send the documents specified in Article 15 of Decree 91/206/ND-CP to the Ministry of Health. If the Ministry of Health adopts the methods of online declaration, the aforesaid application shall be submitted online.

+ Within 03 working days from the date on which the application is received, the Ministry of Health shall post the name, address and phone number of the experiment establishment on its website, as well as a list of experiment procedures carried out by the eligible experiment establishment.

+ If the experiment establishment changes their experiment conditions compared to the information declared in the application sent to the Ministry of Health, within 15 working days from the date on which the changes are made, such establishment shall send a written notification enclosed with the documents mentioned in Article 15 of Decree 91/206/ND-CP to the Ministry of Health.

+ Within 03 working days from the date on which the application is received according to Clause 3 of Article 9 of Decree 155/2018/ND-CP, the Ministry of Health shall update the information on its website.

+ If the additional documents are not satisfactory and the experiment establishment cannot develop any remedies within the time limit required by the Ministry of Health, such Ministry shall stop posting information related to the aforesaid establishment and send it a written notification about the termination.

The testing establishment shall not conduct the experiment from the date on which the aforesaid notification is received, due to the establishment's inability to satisfy the experiment requirements.

Nguyen Pham Nhut Tan

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