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FAQ Misc. questions
Is it possible to submit just one first authorisation application for a product with different trade names?
No, you must submit an application for every trade name.
Can authorisation for a product (with a single trade name) be obtained for different companies that wish to market it and that are listed in the mutual recognition application?
The letters of access (concerning the information on the active substances and/or biocidal products) must specify that they are valid for the purpose of authorising a "given" product for a "given" company. The authorities are not entitled to use data for third parties without the agreement of the holders during the data protection period. The option of having one product with the same name sold by different companies is under consideration.
My formulation is sold in 2 different packaging sizes. Do I need to submit one or two applications?
Only a single application is required when the formulations are identical. However, you must present the labels for each of the different packaging types.
I would like to submit an authorisation application for my product but it comes in different forms (granules and a liquid solution). Do I need to submit one or two applications?
Two applications are required: one for each form of the product.
What is the difference between an application and a registration?
Applications are for products that contain substances listed in Annex I of Directive 98/8/EC. Registrations apply to products comprising active substances listed in Annex IA of the aforementioned Directive.
Will the labels be requested in their actual format after approvals are granted?
Yes, ANSES will request the actual format of the labels.
Is it possible to submit several label proposals if they are covered by the risk assessment?
Yes, as long as the risk assessments are enclosed.