Clinical trial exemption

The Dutch Veterinary Medicinal Products Unit (Bureau Diergeneesmiddelen) may grant an exemption from the requirement to obtain an authorisation for the use of a veterinary medicinal product when conducting clinical trials.

Types of clinical trials for which you must apply for an exemption

You must apply for an exemption 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 or a change thereof.

An application for a clinical trial exemption must be submitted for all trials conducted under field conditions. When a clinical trial exemption is granted, an exemption for the possession and use of the proposed veterinary medicinal products is also automatically granted.

Chapter II ‘Clinical requirements’ of Part IV of the Veterinary Medicinal Products Regulation provides more information on the performance of clinical trials.

If a veterinary medicinal product is intended for clinical trials and a clinical trial exemption 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 exemption

There are certain types of clinical trials for which you do not have to apply for a clinical trial exemption.

  • 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 exemption 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.

    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 exemption 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 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.

Application for clinical trial exemptions

You may submit an application to the Veterinary Medicinal Products Unit for a clinical trial exemption involving veterinary medicinal products. You can do this by completing the Clinical Trial Exemption Application Form.

Further explanation on how to apply for a clinical trial exemption and completing the application form can be found here.

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 exemption

A condition for the clinical trial for which you are applying for an exemption is that the trial must not be intended for commercial purposes. A clinical trial exemption 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 will be granted provided that any food-producing animals used in the trials: 

  1. are not placed on the market, or
  2. are slaughtered or placed on the market only after a specified waiting period.

Conditions may also be imposed on the period of the exemption.

Requirements related to clinical trials

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 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 exemption to us.

Legal basis for the clinical trial exemption

More information

If you have any questions about the clinical trial exemption, you may contact the Veterinary Medicinal Products Unit.