Application process flowchart

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

Dossier is submitted in support of Active substance
in applicable product types

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

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

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.)

Omissions are addressed. Thus the dossier is considered complete

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

Evaluation process starts after clearance of evaluation payment

Evaluation
This process can take up to 12 months

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

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)

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

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

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

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.)