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Family of products PDF Print E-mail
Written by DPR Biocides - Anses   

A product family is defined in Article 3.1.s) of Regulation ( EU) No 528/2012 as a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products.

 

Regulations

Chapter I, Article 3(1) point "s", and Article 19(6) of Regulation (EU) No 528/2012

Timeframe

Timelines similar to those defined for obtaining a national MA.

Fees payable to ANSES

  • Regardless of the application: 200% of the amount of the application
    • For example, for a first family MA: 2*40,000 = 80,000 euros
    • For example, for mutual recognition of a family: 2*15,000 = 30,000 euros
  • For an administrative change to the family: 800 euros
  • For notification of new product belonging to the family: 800 euros

Composition of the dossier

  • See the type of application concerned.
  • The addition of a new member to a family of products is done by notification (administrative change procedure).
Last Updated on Thursday, 07 July 2016 16:26