How we handle your application
Applicants are requested to notify Ctgb well in advance of their intentions to submit an application. Therefore, applicants can contact the account managers Mr Geert-Jan Molema (Plant protection products) or Mrs Cindy van der Meer (Biocides). Note that for several types of applications, a formal notification with set conditions on format and time frame is a requirement. Ctgb will confirm the notification by e-mail.
When preparing their application, future applicants can contact the Ctgb Servicedesk to clarify regulatory and procedural issues related to the authorisation process. The Servicedesk is also the intermediate to organize a pre-submission information session with Ctgb specialists to sort out questions that you may have with regard to specific items in the dossier preparation. With Pre-submission support to applicants, Ctgb aims to increase quality and completeness of dossiers and as a consequence be more predictable in processing of applications.
We assess each application on an equal basis
As a rule we process applications of the same type in the order in which we receive them. In certain cases, such as renewal applications, we may take account of how long a time the existing approval applies.
When we have received your application, the application is registered and it is assigned an application number. State this number in the correspondence and if you contact us with questions about your application. The application number is intended to facilitate the administrative process and must not be confused with the authorisation number.
Generally within a week after receipt of the application, Ctgb will send an invoice. Note that an application will not be taken into consideration until the application has been received ànd the application fee has been paid. More information on the tariff structure of the application costs is available in the Ctgb Tariffs Decree on our website.
The processing of an application consists of several steps. The actual process flow of your application depends on the type of application that have been submitted. For details see the type of application in registration manual; chapter Registration process.
We will keep in touch with you
The basic process flow after receipt of an application consists of 3 steps: a) intake, b) assessment and c) decision. The process flow can be more complex when e.g. also other stakeholders such as concerned Member States, have to be consulted. In general after every step we will contact you and provide you with an update.
The intake consists of a screening to ensure that all the required information has been included. If so the application dossier is considered assessable. The Ctgb uses a list with key points to check an application in the intake. Please consult this list and the evaluation manual before submitting the dossier. The intake also includes an estimation of the evaluation hours needed for the dossier.
The applicant will be informed about the outcome and the work on the assessment can be started. If there are items that need clarification or if information is missing, the applicant is given a term to supply the missing data. In general there are two legal terms (see also the national legislation on this Bestuursreglement toelatingsprocedure Gewasbeschermingsmiddelen en Biociden Ctgb 2018):
- For questions from Ctgb concerning the Legal Instructions for Use (in Dutch WG) or GAP: the term to supply additional data (e.g. amended WG) is one week.
- For questions from Ctgb after the intake of the dRR by all aspects the term to supply additional data is two weeks.
In case the application is still considered incomplete after evaluation of the additional data or the applicant needs more time than these official terms the application is refused by Ctgb and the application process will be determined. The applicant needs to resubmit the dossier.
Experience has taught us that applicants in some cases need more time for submitting additional data (e.g. renewal applications and low-risk applications). In view of the strict terms applicants are advised to use our pre-application instruments to solve open datapoints in the dossier before submitting. This also concerns questions related to the EU- and national GAP.
To support the decision on authorisation, a science based risk assessment and draft decision is prepared by the Ctgb secretariat. Before the assessment report with draft decision is forwarded to the Board, this document is provided to the applicant to take notice.
The Board reviews the risk assessment and the draft decision prepared by the secretariat and decides on authorisation of the product and the conditions for use. After the board meeting, you will receive a response from Ctgb by regular mail. This will be in the form of a decision. The authorisations (included the changes) will be published in ‘De Staatscourant’ (Governmental Gazette) and in our Pesticides database.
After finishing the application (decision)
Do you disagree with a decision we have made? See: Objection and Appeal.
Quality assurance management
Ctgb has achieved ISO 9001-2015 certification for it’s quality management system and underlying processes on the authorization of plant protection products and biocidal products and the approval of active substances.