Instruction for Submission
Changes in the authorisation of a biocidal product are defined according to Change Regulation (EU) 354/2013. In this chart below you will find instructions how to submit changes 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 |
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This notification will be confirmed by e-mail. So you don’t receive an official decision.
This notification is for free. |
Form W | 4 weeks |
Minor changes composition (product) |
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Examples of minor changes in the composition:
In general: for a minor change no studies have to be submitted and no risk assessments have to be prepared. |
Form W , choose Part 2.0
Composition statement Instruction composition statement |
12 weeks |
Change of labelling |
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The changes applied for have to be explained. When the CLH change is based on new studies with the formulation, NOTE: for studies to be conducted with animals, a request for information has to be submitted to the Ctgb. |
Form W , choose on this form:
Part 1.5 (change of labelling) |
8 weeks |
Change of packaging |
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Information to be submitted: | Form W , choose on this form:
Part 2.1 (change of packaging) |
8 weeks |
Change of shelf life |
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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. Information on the relevant physical, chemical and technical properties for different formulation types is outlined in the FAO manual (FAO, 2010). |
Form W , choose on this form:
Part 2.2 (change of shelf life) |
8 weeks |
Administrative changes |
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The following applications concerning administrative changes: | ||
NOTE: Information about acceptable product names can be found in the Policy note about naming (Goverment Gazette, in Dutch). |
Form W , choose Part 1.0 | 4 weeks |
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Form W , choose Part1.1 | 4 weeks |
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Form W , choose Part 1.2 | 4 weeks |
free application |
Form W , choose Part 3.0 | 8 weeks |
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Form W , choose Part 1.3 | 4 weeks |
*: No rights can be derived from these handling periods. Period starts when application and payment have been received.
The application dossier can be submitted digitally by using an upload link (request through post@ctgb.nl) or by sending a CD or DVD to our postal address. Digital signatures on application forms and Letters of Access are accepted.
It is possible to submit part of the dossier on paper and part digitally. Signed documents such as application forms and Letters of Access can be submitted in original paper version bu sending to to Ctgb’s postal address. However we request you to send all other parts of the dossier digitally. When using CD-ROM/DVD: 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). For all digital information submitted: make sure that the individual files have logical names; f.e. “submission letter”, “application form”, “legal conditions for use (WG)”. We accept Open format file but prefer Word files.
Note: For this type of small applications, please do not include a cover letter if not necessary. Explanatory information can be submitted as an annex . Please refer to the annex in the application form.
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 |
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.) |