The Dutch Veterinary Medicinal Products Unit (Bureau Diergeneesmiddelen) may grant an approval for conducting clinical trials with veterinary medicinal products.
|
Until 28 January 2022, the approval was referred to as a 'trial exemption'. Nothing has changed in terms of content: it remains a temporary possibility to collect data for a – not yet authorised – veterinary medicinal product or application by means of a clinical trial to build up a file. |
Types of clinical trials for which you must apply for an approval
You must apply for an approval in order to conduct certain clinical trials. This is based on Article 9 of the Veterinary Medicinal Products Regulation.
A clinical trial is a study that aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation of a veterinary medicinal product or a change thereof.
An application for a clinical trial approval must be submitted for all trials conducted under field conditions. The approval also automatically applies to the possession and use of the veterinary medicinal products.
If a veterinary medicinal product is intended for clinical trials and an approval for aclinical trial has been issued for this purpose, there is no need to apply for a manufacturing or distribution authorisation for the veterinary medicinal product in question. Furthermore, the GMP requirements are not applicable to the manufacturing process.
Types of clinical trials for which you do not have to apply for an approval
There are certain types of clinical trials for which you do not have to apply for a clinical trial approval.
- Pre-clinical studies
Pre-clinical studies do not fall under the category of clinical trials. Therefore, you do not need to apply for a clinical trial approval for this.
A pre-clinical study is a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof.
Appendix II, Chapter I ‘Pre-clinical requirements’ of Part IV of the Veterinary Medicinal Products Regulation provides more information on the performance of pre-clinical studies.
- Veterinary medicinal products intended for research and development purposes
You also do not need to apply for a clinical trial approval for veterinary medicinal products intended for use in research and development. Pursuant to Article 2(7), opening words and under (d) of the Veterinary Medicinal Products Regulation, such products fall outside the provisions of the Regulation.
However, these clinical trials if these are applied to an animal are subject to the Dutch Experiments on Animals Act (Wet op de dierproeven). You can find more information about this here.
If you wish to conduct experiments on animals, you must have an establishment permit from the Dutch Food and Consumer Product Safety Authority (NVWA). You must also have a project permit for each individual project involving experiments on animals. You may submit an application for the permit to the Dutch Central Committee on Experiments on Animals (Centrale Commissie Dierproeven, CCD). More information on how to apply for a permit can be found here in Dutch.
A list of holders of an institutional permit, as referred to in art. 2 of the Animal Experiments Act, is published by the NVWA in an edition of 'Zodoende' (Appendix 3) (only available in Dutch).
Application for clinical trial approval
You may submit an application to the Veterinary Medicinal Products Unit for a clinical trial approval involving veterinary medicinal products. You can do this by completing the Clinical Trial Approval Application Form.
Further explanation on how to apply for a clinical trial exemption and completing the application form can be found here.
Do you already have a clinical trial approval and would like to request a change to the terms and/or an extension of the clinical trial term? You can do this via the form change in the conditions and/or extension of the term of the clinical trial.
Assessment of the application
The application will be assessed by the Veterinary Medicinal Products Unit with the assistance of experts from scientific institutions, if necessary. A decision will be taken within 60 days of receipt of a complete application. The decision may set out additional conditions for conducting the clinical trials.
Conditions for the clinical trial approval
A condition for the clinical trial for which you are applying for an approval is that the trial must not be intended for commercial purposes. A clinical trial approval will be issued only if the clinical trial is being conducted for the purpose of collecting data for compiling a dossier. This means that the clinical trial is intended to serve as the basis for a veterinary medicinal product authorisation (modification or new application).
Approval for clinical trials is provided that food-producing animals used in the clinical trials:
- are not placed on the market for the production of foodstuffs from that animal;
- are only placed on the market for the production of foodstuffs from that animal after a specified withdrawal period. A withdrawal period is the minimum period that must elapse after the last application of a veterinary medicinal product before the production of foodstuffs from that animal can commence. This withdrawal period is carefully determined on the basis of the information provided about the veterinary medicinal product to be used. The established withdrawal period guarantees that no residues of the veterinary medicinal product end up in foodstuffs that are harmful to public health.
This is to ensure food safety and public health.
Conditions can be imposed on the period of this approval.
Requirements related to clinical trials
Annex II, chapter II ‘Clinical requirements’ of Part IV of the Veterinary Medicinal Products Regulation provides more information on the performance of clinical trials.
Clinical trials must be conducted in accordance with the international guidelines of the VICH on good clinical practices. These requirements also apply to clinical trials conducted outside the Union.
Studies involving GMOs
If you are conducting studies with existing or proposed veterinary medicinal products and if these studies involve a genetically modified organism (GMO), please note that the import or possession of a GMO and conducting studies involving a GMO always requires an authorisation from COGEM. The aforementioned activities may only take place after COGEM has granted an authorisation for this purpose. This applies to both laboratory tests as well as field trials.
If it involves a field trial, you must submit proof of this authorisation when you submit the application for the clinical trial approval to us.
Legal basis for the clinical trial approval
- Article 9 of the Veterinary Medicinal Products Regulation
More information
If you have any questions about the clinical trial approval, you may contact the Veterinary Medicinal Products Unit.