EXPLANATION with the APPLICATION FOR A DERIVED AUTHORISATION OF A
BIOCIDE
Februari 2014
Statutory provisions
Biocides: Article 52 Wet gewasbeschermingsmiddelen en biociden [Plant protection products
and biocidal products Act]
Definition
Biocides:
Any substance or mixture, in the form in which it is supplied to
the user, consisting of, containing or generating one or more
active substances, with the intention of destroying, deterring,
rendering harmless, preventing the action of, or otherwise
exerting a controlling effect on, any harmful organism by any
means other than mere physical or mechanical action.
Any substance or mixture, generated from substances or
mixtures which do not themselves fall under the first indent, to
be used with the intention of destroying, deterring, rendering
harmless, preventing the action of, or otherwise exerting a
controlling effect on, any harmful organism by any means
other than mere physical or mechanical action.
A treated article that has a primary biocidal function shall be
considered a biocidal product.
General provisions
The derived authorisation simplifies the process of placing a fully evaluated and authorised
product on the market under another brand name without prejudice to the level of protection
for people, animals and the environment. The derived authorisation is based on a previous,
fully evaluated authorisation in the Netherlands. There is an original product, which is already
authorised and fully evaluated, and a derived product, which is completely identical to the
original product, but is being marketed under a different name.
Derived authorisations can only be requested for the Dutch market.
Conditions
The following conditions must be complied with:
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The derived product is identical in terms of formulation and packaging to the original
product.
The derived product originates directly or indirectly from the authorisation holder of the
original product (already authorised in the Netherlands). Indirect origination means that
the product has been obtained through the wholesale trade, but has indeed been
manufactured by, and originated from, the authorisation holder of the original product.
The holder of the original authorisation explicitly consents to the original authorisation
being used for the derived product.
The above condition must be satisfied by means of a declaration. This declaration is
necessary to enable a different authorisation holder to market the same product.
The applicant is required to use the declaration form that is included with the application
form. This declaration must be printed on the official stationary of the holder of the original
authorisation.
Explanation form AB – Februari 2014
page 1 of 2
The application must include a draft proposal for the legal conditions for use and the
directions for use (PGB). This must be the text as it will appear on the packaging. No uses
may be listed other than the uses for the original product. However, fewer uses can be listed.
The text must be the same as that on the packaging of the original product and can be
supplemented with technical instructions, if these are not prejudicial to the technical
instructions on the label of the original product.
Method of submission
The application must be submitted both on paper and on CD-ROM/DVD. We accept Word
files, Excel files and Acrobat reader PDF files. Label the CD-ROM/DVD with the name of the
product and, if known, the application number and application type (for example20130122
AB). Make sure that the individual files have logical names. For example: “submission letter”,
“application form”, “legal conditions for use/instructions for use (WGGA)”.
Application costs
The application fee must be paid simultaneously when the application is submitted. The
application costs are specified in the Ctgb Tariffs Decree on our website. The application will
not be taken into consideration until the application has been received and the application fee
has been paid. It is therefore important to make the payment immediately!
If the application is not accepted for consideration, if it is no longer being considered or if it is
rejected, the application fee will not be refunded.
Decision
You will receive a response from us by regular mail. This will be in the form of a decision.
Publication on the Internet and in De Staatscourant
The authorisation will be published in De Staatscourant (government gazette) and on our
website (www.ctgb.nl)
Annual fee
Besides the application fee, there is an annual fee. The fees can be found in the Tariff Decree
for the corresponding year. The annual fee is charged for all authorisations that are registered
on 1 February of the year to which the tariff decree applies.
Statutory time limits
Applications for a derived authorisation must be dealt with within 10 weeks.
Explanation form AB – Februari 2014
page 2 of 2