Directions for submission

Applicants

An applicant for the authorisation of a plant protection product is the manufacturer of the product, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his representative.

For some application types also third parties may apply for a product authorisation.

Third parties that may apply for an extension with minor uses (art 51.) or a parallel trade permit (art. 52.) are:

  1. official or scientific bodies involved in agricultural activities;
  2. professional agricultural organisations or
  3. professional users

Third parties that may apply for an authorisation through mutual recognition (art 40), where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, are

  1. official or scientific bodies involved in agricultural activities or
  2. professional agricultural organisations

Applications

Plant protection product applications consist of a cover letter, an application form and if relevant, enclosures. For the requirements for administrative and minor changes, see below.

  • All that needs to be submitted on paper is a signed application form and, if relevant, a signed Letter of Access.
  • Cover letter, application form and enclosures to the application are to be submitted on CD-ROM or DVD 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. For example: “submission letter”, “application form”, “legal conditions for use/instructions for use (WGGA)”.

Administrative applications and applications for minor changes:

For administrative applications and applications for minor changes, as mentioned below, please don’t submit a cover letter:  You will mention the changes on the application form clearly. If necessary, you can give an explanation in an appendix.

In the table below are the requirements presented for submission  of this kind of applications:

Application type

Form

How to submit

Derived authorisation

AG

The application must be submitted both on paper and on CD-ROM/DVD. We accept files in Open format and prefeably in Word, Excel forma or Acrobat reader PDF files. Caddy format is not necessary.

Label the CD-ROM/DVD with the name of the product and the application type (for example  AG).

Make sure that the individual files have logical names. For example: “ “application form”, “legal conditions for use (WG)”.

For this type of small applications, please don’t send a cover letter.

Prolongation derived authorisation AG (VAG)
Expanding field of use derived authorisation AG (UAG)
Restriction field of use derived authorisation WI (NLWATG)

Parallel trade permit

PAG
Prolongation parallel trade permit PAG (VPAG)
Expanding field of use parallel trade permit PAG(UPAG)
New batch parallel trade permit PAG(BPAG)
Restriction field of use parallel trade permit WI (N LWATG)

Minor change composition

WI(WSGNW)

Changing production process active substance

WI(PWSG)

Request for information animal testing

VIG

Export Certificate

EXP The request can be submitted on paper or electronically. Caddy format not necessary. For this type of  small applications, please don’t send a cover letter.

Trail permit

PG

The application must be submitted both on paper and on CD-ROM/DVD. Caddy format not necessaryLabel the CD-ROM/DVD with the name of the product and, if known, the application number and application type (for example 20140122 AG). Make sure that the individual files have logical names. For example: “submission letter”, “application form”, “legal conditions for use (WG)”. We accept Open format file but prefer Word files.

For this type of  small applications, please don’t send a cover letter.

Adjuvant

TT

Name changes for products

WI (WNT) The application must be submitted on paper. (We don’t  require a digital version).
For this type of small applications, please don’t send a cover letter.

Changes name company , address , city

WI (WNAW)

Transfers of authorisations to a different company

WI (OT)

Withdrawals of authorisations

WI (INTR)

Changing production process product

WI

Immediate notification by authorisation holder

The notification should preferably be send by e-mail. On the subject line enter “Immediate notification [company name]”.
Notification by regular mail is possible via the postal address below.

The application must be sent to the following address:

College voor de Toelating van gewasbeschermingsmiddelen en biociden (Ctgb)
PO Box 8030
6710 AA EDE
The Netherlands

Payment method

Once your application has been received by the Ctgb, you will receive a confirmation letter with an invoice. You do not pay the fee until after you have received the confirmation letter with invoice. As a rule we only start processing your application once we know that the fee has been paid. Please include “Application [application type] [name of the product]” with the payment. Make the payment to Bank Account Number 397076053 (Rabobank), at the name of Ctgb in Ede, the Netherlands. IBAN: NL27 RABO 0397076053; SWIFT-address: RABO NL2U. You can also choose to wait until you get an invoice.

Direct debit payment of invoices

The Ctgb encourages applicants to arrange direct debit payment of your Ctgb invoices. This payment uses the European successor to the national direct debit system: Euro direct debit (Euro-incasso). By arranging direct debit payment of your invoices, you no longer have to worry about timely payment, and we reduce your administrative burden. You still maintain control of your own bank account, and you can cancel direct debits beforehand or reverse the payment afterwards.

If you would like to pay your Ctgb invoices using European direct debit (Euro-incasso), please contact the Finance & Control department. We will then go through the procedural steps with you and prepare the necessary contracts.

Language

The language for communication or correspondence with Ctgb is English or Dutch. The decisions of the Ctgb however are written in Dutch. The working language for the preparation and assessment of registration reports is English. This to facilitate the exchange of evaluations between the EU Member States. Therefore the (d)RR must be drawn up in English.

The language in objection and appeal procedure however is Dutch.

Product names

The name of a plant protection protection or biocidal product must not be confusing for the consumer. A few criteria for this are:

  • the name of the product must not be confusing;
  • the pronounced name of the product must not be confusing;
  • the name must not cause confusion about the composition of the product;
  • the name of the product shall not be misleading with regard to the hazards/risks of the product;
  • there must be a clear distinction between the product name and the regular name of the active substances or how the actives substance works.

In case of doubt, the Board takes a decision.

This information can be found in the Goverment gazette: Staatscourant 2016, nr 54661

More names for one product

It is not possible to register more names for the same product – connected to one authorisation number for plant protection products. If you want to bring a same product under a different name on the market, you can do this by applying for a derived trade permit. In this case you become a new authorisation number for this product.  Please realize; also for a derived permit you have to pay also the annual fee.