What is the procedure to follow to submit an MA application for a product containing an active substance that has been approved? Print
Written by DPR Biocides - Anses   

When a biocidal active substance has been approved, a biocidal product containing this substance must be authorised according to Regulation ( EU) No 528/2012. An MA application for the product should be submitted via the European R4BP system, no later than the approval date contained in the approval regulation for the active substance. You can find a calendar of these dates in the Regulations section.

If the approval date entered in the approval regulation for the active substance has already passed, then the product must be withdrawn from the market in accordance with Article 89.3 of the BPR.

Last Updated on Monday, 04 July 2016 10:56