Minor or administrative changes

Characteristics of application	Instructions for submission	Period of handling*
Minor changes active substance:
When equivalence is not reviewed in another member state: 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
When the equivalence is reviewed in another member state ánd published on CircaBC: 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 product 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 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: Shelf life following storage at ambient temperature (OECD Annex IIIA point 2.7.5) Description and specification of the packaging and materials used in packaging, size, capacity, size of openings, types of closure and seals (OECD Annex IIIA point 4.1.1)	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:
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
NLWATG (minor changes WGGA/WG: Amendment label instructions: GAP doesn’t change and risk review is not necessary. Or restricted field of use.) Note: For this type of changes the WG will change: a grace period  can be applied for. The new WG will have a new version number.	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 applicant should submit digital files (by email using a safe link or by CR-ROM) of the documents necessary for the evaluation. However the signed application form and, if applicable, a signed Letter of Access should be sent on paper. 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)