Application process flowchart

1. • 
     Preparation for dossier submission
     Initial meeting between Applicant and Competent Authority (CA)

2. • 
     Dossier is submitted in support of Active substance
     in applicable product types

3. • 
     Invoice for initial fee, clearance of fee. Initial fee £10,000 (this covers further meetings and completeness check)
     Fees overview and application process – invoices and charges

4. • Completeness Check
     (All necessary data requirements need to be addressed, see UK guidance tool and
     TNsG Data Requirements

5. • 
     

     Omissions are not addressed by the Applicant. The EU COM are notified and they publish notice that dossier has been rejected due to being incomplete. Then there is a three-month period for a new Applicant to support, they then have two years to submit. (They will be entitled to same waivers as previous Applicant, but will have to provide proof of having commissioned the testing their dossier will require.)

6. • 
     Omissions are addressed. Thus the dossier is considered complete

7. • 
     Dossier has been accepted as complete by Competent Authority. Copy of Dossier circulated to Other Member States (OMS) by Applicant

8. • 
     Evaluation process starts after clearance of evaluation payment

9. • 
     Evaluation
     This process can take up to 12 months

10. • 
      Competent Authority circulates evaluation report to other UK Government departments for scrutiny

11. • UK position agreed, UK CA evaluation report sent to Applicant and EU COM. Put onto CIRCA for OMS comments.
      (UK CA has 1 month to produce public domain version)

12. • 
      Comments received in 90-day period
      UK CA has 90 days to respond
      Outstanding issues discussed by Technical and CA meetings
      

13. • 
      Commission prepares draft decision regarding Annex I listing or non-inclusion

14. • 
      Draft decision presented to the Standing Committee on Biocidal Products (consists of representatives of all Member States).

15. • SCBP make final decision within one year of receipt of draft
      
      (The legal procedures now start. A flowchart and guidance outlining this process are available.)