Clinical trial application

Application for approval of a clinical trial for veterinary medicinal products

In accordance with Regulation (EU) 2019/6, a 'clinical trial' is a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product. This study is conducted on livestock farms, or as part of normal veterinary practice, for the purpose of obtaining or modifying a marketing authorisation.

Clinical trials must comply with the international standards of good clinical practice, as defined by the Veterinary International Conference on Harmonisation (VICH), thereby guaranteeing rigorous and ethical conduct. The data collected during such trials is then included in the marketing authorisation application as part of the required information. Before granting their approval, the authorities also ensure that any food producing animals used in the trial will not enter the food chain, unless an appropriate withdrawal period has been established. For clinical trials conducted outside of the European Union, the results will only be taken into account if the trials adhere to the same international standards of good practice.

To facilitate the submission of applications, a European working group has put in place a number of tools, including a best practice guide, an application form and a question template, in order to ensure a harmonised approach to the assessment of multinational trials.

How to proceed

  • To conduct a clinical trial of a veterinary medicinal product, an application for approval must be submitted to the competent authority by email at luxvet@ms.etat.lu and clinicaltrials@ms.etat.lu, accompanied by the application file. Please refer to the List of documents to be included in the application file[SV1].
  • Applications to report a modification to a clinical trial must be sent to luxvet@ms.etat.lu and clinicaltrials@ms.etat.lu, accompanied by the protocol if required and the documents relating to the change(s). The email must refer to the trial in question, and explain the changes clearly.
  • Pursuant to the Grand-Ducal Regulation of 14 June 2013 setting the fees payable for the marketing of medicinal products, and the Law of 19 December 2014, which introduced a series of new fees in respect of human and veterinary medicinal products, applicable from 1 January 2015, applications for the authorisation referred to above, addressed to the Ministry of Health, are subject to the prior payment of a fee as follows:

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