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: |
||
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 |
||
|
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:
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 |
||
|
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) |
4 weeks |
Change of packaging |
||
|
Information to be submitted:
|
Form WI, choose on this form:
WYG (change of packaging) |
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 (WYG) |
4 weeks |
Administrative changes product |
||
| 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 |
|
Form WI – choose WNAW | 4 weeks |
|
Form WI – Choose OT | 4 weeks |
|
Form WI – Choose INTR | 8 weeks |
|
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.
Application type criteria
The NLWG application procedure can be followed:
- for label changes that fall within the national specific aspects (National Addendum) of the authorization or
- for label changes that fall within the already assessed risk envelope.
An example is adding or removing a Dutch-specific restriction sentence, like the restriction for the use in groundwater protection areas.
The amendment should not affect the authorisation in other Member States, as the NLWG process does not have a commenting round.
This NLWG application procedure cannot be used for amendments in which the core part of the assessment must also be changed, like extensions with a new crop, addition of field cultivation to protected cultivation (and vice versa), major changes in the formulation, increased dose, or an extension with a completely different method of use. For such changes, a zonal application for amendment of the authorisation must be submitted with the corresponding request form.
Registration Process
The registration process of an national label amendment follows these steps:
Step 1. Intake
Validation
First Ctgb determines whether the application complies with the requirements for completeness.
The project manager performs an administrative check. In this check it will be determined if the submitted information is sufficient to undergo an evaluation.
A submission of a complete application will facilitate the Ctgb to handle the application within a limited time span and reduce the need for supplementary information later in the process. If the application is not complete and the need for supplementary information is extensive, the Ctgb may have to refuse the application. If supplementary information is requested, a period of maximum 2 weeks, is given to the applicant to complete the application.
Risk envelope
The Ctgb considers the risks in the requested amendment and compares them with the authorised uses to determine whether the risks of the amendment are less or equal compared to those of current authorisation.
If the amendment satisfies all conditions and falls entirely within the risk envelope, then the final decision (step 3) can be made. If not, a national assessment is required (step 2 and 3).
Step 2. Risk assessment
Ctgb assesses the risks for the national aspects that do not fall within the risk envelop. The risk assessment will be conducted in accordance with the framework at the time of the application.
During the assessment, it may be necessary to request more specific information from the applicant. The deadline for answering these supplementary questions is 4 weeks.
Step 3. Decision
Preparation of the draft decision and decision making by the Board.
The time needed for the Ctgb to make a decision on an application for a national amendment depends on the nature of the request and the completeness of the dossier.
Costs
The Ctgb requires an advance payment and charges the actual fees for processing (see: Ctgb Tariffs Decree).
Instructions for submission
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 Ctgb’s 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.
For submission on CD-ROM or DVD this has to be in the form of a CADDY dossier (one copy), preferably CADDY XML. Files that are not submitted in CADDY, should fulfil the following requirements: Files in Open format (ODT) but preferably as Microsoft Word, Microsoft Excel, PDF (Acrobat).
Label the CD-ROM/DVD with the name of the product, the application type and, if known, the application number (for example ProductX 20140122 AG). Make sure that the individual files have logical names; f.e. “submission letter”, “application form”, “legal conditions for use/ instructions for use (WGGA)”.
The Ctgb is legally obligated to comply with data protection regulations. In practical terms this means that if the application contains references to data owned by third parties, the applicant must demonstrate that they are entitled to access this data. This is arranged by means of a Letter of Access.
The following documents are requested and should be sent to Ctgb:
- Application Form NLWG
- Covering letter outlining the purpose of the application and brief details as to how you are supporting your application
- Wettelijk Gebruiksvoorschrift (WG: legal instructions for use)
- GAP Table NL
- Letter(s) of Access (LoA)
- Reference List
- Part A for the Netherlands (including a risk envelope analysis, if appropriate)
- dRR - National Addenda (only relevant national part B’s)
Exceptionally, in the event that all previous assessments of the product have not yet been done in RR format, a Part A in which the assessment of the proposed change has been incorporated will suffice.
These documents should be brought in line with the Registration Report (RR). Label changes that are requested in the Netherlands must always be covered in terms of risk by the RR.
Documentation
Guidances
- SANCO/13169/2010 Rev. 11 – Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009
- Guidance Document on the Preparation and Submission of Dossiers for Plant Protection Products according to the “Risk Envelope Approach” (SANCO/11244/2011 rev. 5 14 March 2011)