Regulations on suspension of sale of insecticidal and germicidal preparations in Vietnam

Regulations on suspension of sale of insecticidal and germicidal preparations in Vietnam (Internet image) 

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

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Regulations on suspension of sale of insecticidal and germicidal preparations in Vietnam

According to the provisions of Section 4, Chapter IV of Decree 91/2016/ND-CP on suspension of sale of preparations in Vietnam:

* Pursuant to Article 36 of Decree 91/2016/ND-CP stipulating procedures for suspension of sale of preparations with warnings from the owner of preparations or registration number holder:

- If it is determined those preparations are defective or may cause adverse impacts on users’ health or the environment, the registration number holder shall:

+ Suspend the sale of preparations;

+ Send written notice to Ministry of Health and entities in charge of distributing such preparations; at the same time, publish on the mass media the suspension of sale and use of such preparations.

The written notice must include the number of lot of suspended preparations, defective elements or risks that cause adverse impacts on users’ health or the environment as well as the fact that such defective elements may or may not be remedied.

- If it is able to remedy defective elements or factors causing adverse impacts on users’ health or the environment:

+ Within 05 days from the receipt of the written notice sent by the owner of preparations or the registration number holder, Ministry of Health shall make a decision on the suspension of sale of preparations;

+ Within 90 days from the date on which a decision on the suspension of sale of preparations is made, the registration number holder shall be responsible for completing the remedy of defective elements or factors that cause adverse impacts on users’ health or the environment;

+ Upon the completion of the remedial measures, the registration number holder shall send a written report to Ministry of Health, enclosed with documents proving its completion of remedy of defective elements or risks.

+ Within 30 days from the receipt of the written report submitted by the registration number holder, Ministry of Health shall make a decision on the termination of suspension of sale of preparations. If Ministry of Health refuses to terminate the suspension of sale of preparations, it must specify reasons thereof in writing.

- If it is unable to remedy defective elements or factors causing adverse impacts on users’ health or the environment, or over the period for remedy which is stated in the decision on suspension of sale of preparations but the manufacturer fails to complete remedial measures, Ministry of Health shall make a decision on recalling of suspended preparations.

Decision on the recalling of suspended preparations must be published on the website of Ministry of Health.

- A decision on suspension of sale of preparations or a decision on the recalling of suspended preparations must include the following contents:

+ Name of type of preparations subject to the suspension or recalling;

+ The lot number of preparations subject to the suspension or recalling;

+ The registration number of preparations subject to the suspension or recalling;

+ Suspension period;

+ Requirements for settlement of recalled preparations.

* Pursuant to Article 37 of Decree 91/2016/ND-CP stipulating procedures for suspension of sale of preparations with warnings from preparations competent authorities:

- Within 05 working days from the receipt of the notice of active ingredients’ or preparations’ factors causing adverse impacts on users’ health or the environment from countries where such preparations are sold or from WHO, Ministry of Health shall make decision on suspension of sale of such preparations and send a written request to the registration number holder for explanation

- Within 05 working days from the receipt of the written request from Ministry of Health, the registration number holder shall send explanation report to Ministry of Health.

- Within 05 working days from the receipt of the report submitted by the registration number holder, Ministry of Health shall carry out the assessment of factors causing adverse impacts on human health and the environment contained in active ingredients or preparations.

- Within 05 working days from the date on which assessment results are given, if it was determined that active ingredients or preparations do not pose risks, Ministry of Health shall make decision on termination of suspension of sale of such preparations.

- If it was determined that active ingredients or preparations contain factors causing adverse impacts on human health or the environment and it is able to remedy such mistakes, Ministry of Health shall send a written notice to the registration number holder to carry out remedial measures as referred to in Clause 2 Article 36 of Decree 91/2016/ND-CP.

- If it was determined that active ingredients or preparations contain factors causing adverse impacts on human health or the environment but it is unable to remedy such mistakes, Ministry of Health shall, on the basis of features and level of such factors, make decision on recalling of lot(s) or entire preparations.

  Nguyen Pham Nhut Tan

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