Minor or administrative changes
The legal basis for this type of application for plant protection products is Regulation 1107/2009 Article 45. The chapter bellow refers to minor changes of the active substances, minor changes of the product and administrative changes of the product.
Characteristics of application |
Instructions for submission |
Period of handling* |
Minor changes active substance: |
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Ctgb draws up a equivalence report, based on the submitted data. The report will published by the Ctgb on CircaBC, member states have 4 weeks to give comments. Ctgb will process the comments received, and finalise the decision. |
Form WI, choose PWSG
Data to be submitted for Change in production process and/or the production location of the active substance; see: Summary document Note: Ctgb will assess equivalence of active substances for which The Netherlands is Rapporteur Member state. For equivalence checks of other active substances, please refer to the Rapporteur member state of that substance. |
12 weeks |
This notification will be confirmed by e-mail. So you don’t receive an official decision. |
Form WI, choose PWSG-C | 4 weeks |
Minor changes composition productChanging 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 WI | 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. 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 WSGNW
Composition statement Instruction composition statement |
12 weeks |
Minor change to legal instructions for use (WG/WGGA) |
Minor change to legal instructions for use (WG/WGGA) | |
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, 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:
WYG (change of labelling) |
12 weeks |
Change of packaging |
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Information to be submitted:
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Form WI, choose on this form:
WYG (change of packaging) |
12 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. 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 (WYG) |
12 weeks |
Administrative changes product |
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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 WI – choose WNT | 4 weeks |
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Form WI – choose WNAW | 4 weeks |
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Form WI – Choose OT | 4 weeks |
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Form WI – Choose INTR | 8 weeks |
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Form WI – Choose NLWATG | 4 weeks |
*: No rights can be derived from these handling periods. Period starts when application and payment have been received.
Characteristics
Legal basis
Article 45 of Regulation (EC) No. 1107/2009 describes the possibility of withdrawing or amending an authorization at the request of the authorisation holder.
For changes that do not require a substantive assessment, it is not necessary to follow the zonal procedure. In those cases, the assessment can be evaluated at national level, without an European commentary round. For this purpose the Ctgb has various national application types, each with their own specific requirements.