Details of the Registration Dossier for New Insecticidal Products Distribution

Decree 91/2016/ND-CP has been promulgated by the Government of Vietnam regarding the management of chemicals, insecticidal, and disinfecting preparations used in household and medical fields.

To be specific:, the dossier for new registration of insecticidal and disinfectant preparations used in the household and medical fields includes the following documents:

- Official letter requesting new registration for circulation.- Documentation on the legal status of the registering and manufacturing entities.- Authorization letter for the registration for circulation, except for the case specified in Point a, Clause 1, Article 20 of Decree 91/2016/ND-CP.- Technical documents of the preparation requesting registration, including the contents in Appendix V attached to Decree 91/2016/ND-CP.- Results of testing the components and active ingredient content in the preparation.- Experiment result response sheet.- Sample label of the preparation.- Certificate of free sale.- Documents, research results on safety and efficacy or recommendations from the World Health Organization or equivalent international organizations regarding the use of the preparation in household and medical fields.

More details can be found in Decree 91/2016/ND-CP effective from July 01, 2016.

- Thanh Lam -

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