Request for information on animal testing
Products based on existing active substances for which the European assessment has not been completed will be assessed and authorised under the national legislation of Member States (transitional legislation in the Netherlands). Before an animal test can be commissioned, it must first be determined if such a test has previously been conducted.
The legal basis for application within the scope transitional law is the “Wet gewasbeschermingsmiddelen en biociden” (Wgb) like was into force before 6 November 2013, in which article 46 states the requirements for an applicant before animal studies are allowed to be conducted.
For applications within the scope of national legislation, a written request for information on animal testing can be sent directly to Ctgb by means of a VIB form. Form VIB has to be submitted to request for information on animal testing. It is important that the request is completely filled in. If the application is not complete, you risk not obtaining the information on time. If data are missing, you will only have one opportunity to correct this omission. If you do not use this opportunity, your application will not be taken into consideration. For the processing of your request, a fee will be charged.
On page 3 of the form VIB under 'Justification of the request' you have to fill in which tests / studies you want to conduct, together with a justification for each test or study you will mention.
The handling period is 8 week (but no rights can be derived from this handling period).
Consequences when the Ctgb is not been asked for information about animal testing
Unless the applicant can clearly demonstrate that animal testing will not be unnecessarily repeated, an application will not be taken into consideration if the dossier contains animal testing data and no information about previous testing has been acquired beforehand. Or: the Ctgb, after receiving a request to do so, has provided information about comparable animal testing data and the applicant cannot justify the need for new animal testing data. The form Request for information on animal (vertebrate) testing only concerning test on vertebrates. The applicant should have the intention to submit an application for authorisation, re-registration or change of authorisation.