Instruction for Submission

In this chart you will find the instrctions for submission, presented per application type. In the last column the estimated period of handling is given. Note: this is the common period for handling, not the maximum period.

Characteristics of application

Instructions for submission

Period of handling*

Changing of the production process of the product

This notification will be confirmed by e-mail. So you don’t receive  an official decision.

This notification is for free.

Form WI 4 weeks

Minor changes composition (product)

Examples of minor changes in the composition:

§  replacing a co-formulant or auxiliary formula with a chemically comparable one that does not have a more severe classification and/or labelling than the original co-formulant.

§  changing the percentage of co-formulant, auxiliary formula or active substance. This percentage must not change significantly. For an auxiliary formula, this change can be no more than 25% relative to the previous formula. The content of active substance can change by no more than 10%.

In general: for a minor change no studies have to be submitted and no risk assessments have to be prepared.

If you are not sure whether there is a minor change you can send the information to our Service desk. The Service desk can advise you on what type of application is applicable.

Form WI, choose WSBNW

Composition statement

Instruction composition statement

12 weeks

Change of labelling

The changes applied for have to be explained. When the CLH change is based on new studies with the formulation, these have to be submitted, together with a reference list. Evaluation costs for these studies will be calculated according the Tariff Decree.

NOTE: for studies to be conducted with animals,  a request for information has to be submitted to the Ctgb. Conducting animal studies is not allowed without this request and the approval of the Ctgb.

Form WI, choose on this form:

WYB (change of labelling)

4 weeks

Change of packaging

Information to be submitted: Form WI, choose on this form:

WYB (change of packaging)

Studies to be submitted: see chart below.

4 weeks

Change of shelf life

Data are required to demonstrate that the product is stable in storage under the conditions and for the shelf life claimed for the product.

Data must be generated in the worst case commercial packaging to support the ambient storage of the product for the claimed shelf life.

For all proposed packaging types, packaging suitability should be addressed. Technical characteristics applicable to the formulation type must be addressed. Where relevant these must be generated to cover the maximum and minimum in use concentrations specified for the product.

Information on the relevant physical, chemical and technical properties for different formulation types is outlined in the FAO manual (FAO, 2010).

Form WI, choose on this form:

change of labelling (WYB)

4 weeks

Administrative changes

The following applications concerning administrative changes:
§  WNT (name changes for products)

NOTE: Information about acceptable product names can be found in the Policy note about naming (Goverment Gazette, in Dutch).

Form WI, choose WNT 4 weeks
§  WNAW (name changes for companies) Form WI, choose WNAW 4 weeks
§  OT (transfers of authorisations to a different company) Form WI, choose OT 4 weeks
§  INTR (withdrawals of authorisations)

free application

Form WI , choose INTR 8 weeks
§  WWGGA(minor changes WGGA/WG: Amendment label instructions: Risk review is not necessary. Or restricted field of use. Form WI, choose WWGGA 4 weeks

*: No rights can be derived from these handling periods. Period starts when application and payment have been received.

Send the application on paper to: Ctgb, P.O. box 8030, NL 6710 AA Ede ánd by e-mail (or by DVD/CD-rom) on the same day. Make sure that the individual files have logical names. For example: “submission letter”, “application form”, “legal conditions for use/instructions for use (WGGA)”. If you send a DVD/CD-rom: Label the CD-ROM/DVD with the name of the product and application type and, if known, the application number (for example: ProductX, 20140122 AG).

Note: For this type of small applications, please don’t send a cover letter if not necessary.

Data to be submitted for a change in packaging:

Section No.

Information, test or study required for biocidal product

(for compulsory or conditional requirements, see TNsG on data requirements)

Information, test/study provided Y(n)/P/N/n.a.

Justification
provided Y/N

Confidential data Y/N Reliability indic. 0-4/n.a. Official use only Data Gap Y/N
3.7 Storage stability – stability and shelf-life
9 PACKAGING (type, materials, size, etc.)