Chapter IV
INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE
Article 8. Annulments of the following articles of the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of insecticidal and germicidal chemicals for household and medical use
1. Clause 1, Article 4.
2. Clause 1c and Clause 2, Article 5.
3. Clause 1c, 1e, 1g and Clause 2c, Article 7.
4. There must be documents proving that the technical standards for safety distance of the Ministry of Industry and Trade are satisfied according to Clause 1d, Article 7.
5. Clause 1, Article 10.
6. Clause 2b; Clause 3b, 3d, 3dd and 3e of Article 14.
7. Clause 5, Article 15.
8. Clause 1b, Article 40.
9. Clause 1 and Clause 3, Article 41.
10. Clause 3, Article 42.
Article 9. Amendments to some Articles of the government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of insecticidal and germicidal chemicals and preparations for household and medical use
1. Clause 1, Article 6 is amended as follows:
“Satisfy the requirements in Section 1, Chapter II, of the Government’s Decree No. 113/2017/ND-CP dated October 09, 2017 providing guidelines on some Articles of the Law on Chemical.”
2. Clause 2d, Article 7 is amended as follows:
“d. The documents specified in Clause 1d and 1dd must be confirmed by the manufacturer."
3. Clause 4, Article 8 is amended as follows:
"4. Within 03 working days from the date on which the application is received, the Ministry of Health shall publish the name, address and phone number of the manufacturer on its website."
4. Clause 5a, Article 8 is amended as follows:
“a. Changes of its personnel: The written request for change of information relating to the declaration of eligibility to produce preparations shall be submitted, enclosed with the documents mentioned in Clause 1b, Article 7 hereof.” <0}
5. Clause 2, Article 10 is amended as follows:
“2. Testing establishments must meet requirements defined in ISO 17025:2005 or its editions certified by the certification organization which has registered for the Certificate of Eligibility to Conduct Evaluation Business according to the law."
6. Article 12 is amended as follows:
“Article 12. Declaration of eligibility to conduct testing
1. Before conducting the first testing, the testing establishment shall send the application documents specified in Article 11 hereof to the Ministry of Health. If the Ministry of Health adopts the methods of online declaration, the aforesaid application shall be submitted online.
2. 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 testing establishment on its website, as well as a list of chemicals tested by the establishment.
3. If the testing establishment changes their testing conditions compared to the information declared in the application sent to the Ministry of Health, within 05 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 11 hereof to the Ministry of Health.
4. If the additional documents are not satisfactory and the testing 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 such termination. The testing establishment shall not conduct the testing from the date on which the aforesaid notification is received, due to the establishment's inability to satisfy the testing requirements.
7. Clause 2a, Article 14 is amended as follows:
“a. The person in charge of managing the experiment division must have at least 03 years of experience in the experiment on preparations.”
8. Clause 2a, Article 14 is amended as follows:
“a. 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.”
9. Article 16 is amended as follows:
“Article 16. Declaration of eligibility to conduct experiment activities
1. Before conducting the first experiment, the experiment establishment shall send the documents specified in Article 15 hereof to the Ministry of Health. If the Ministry of Health adopts the methods of online declaration, the aforesaid application shall be submitted online.
2. 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.
3. 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 hereof to the Ministry of Health.
4. Within 03 working days from the date on which the application is received according to Clause 3 of this Article, the Ministry of Health shall update the information on its website.
5. 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.
10. Clause 4d, Article 26 is amended as follows:
“d. 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 hereof. 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.”
11. Clause 3, Article 40 is amended as follows:
“3. Traders in common insecticidal and germicidal preparations, consisting of: mosquito coil; mosquito repellent tablets for household and medical use; insecticidal sprays; insect poisons; insect repelling cream, patch and band for human use; liquid mosquito repellents and killers; mosquito nets with mosquito repellents and killers; and germicidal preparations for household use are not required to satisfy the requirements in Clause 1 and Clause 2c of this Article."
12. Clause 2, Article 41 is amended as follows:
“2. The person directly performing insecticidal and germicidal works must have the following knowledge as confirmed by the provider:
a. Be able to read the information specified on the label of the preparation.
b. Be able to perform insecticidal and germicidal works with skills that are suitable to the provided service.
c. Can use and dispose insecticidal and germicidal preparations.”
13. Clause 2, Article 42 is amended as follows:
“2. A declaration of personnel which is confirmed by the provider."
14. Clause 1a is added to Clause 1, Article 63 as follows:
“1a. Provide trainings for the person directly performing insecticidal and germicidal works. If no training is provided, the provider must assign such person to receive trainings at the training units specified in Clause 2, Article 41 hereof."
15. Amend forms No. 01, 03, 04, 05, 06 and 08 in Appendix I; Appendix VI; Appendix VII and Appendix IX hereto.
Tìm kiếm
Nghị định 155/2018/NĐ-CP (Bản Pdf)
Nghị định 155/2018/NĐ-CP (Bản Word)