- New application
Before starting a clinical trial, the sponsor is required to apply for an authorisation from the FAMHP.
A clinical trial should be performed in accordance with the Guideline on Good Clinical Practices (VICH Topic GL9). If the clinical trial cannot be carried out in accordance with this guideline, the applicant must argue why this guideline cannot be applied for this clinical trial.
A new application consists of the following elements.
1. Administrative details
For a clinical trial involving the use of food-producing animals, the applicant must supplement his application with a list of the participating livestock farm(s) from the Sanitel administrative database and a list of the Sanitel identification numbers of the individual animals (where applicable) for each farm.
If this data is not available at the time when the application is made, the applicant must transfer this data to the FAMHP before the clinical trial begins. The FAMHP is responsible for communicating such information to the Belgian Federal Agency for the Safety of the Food Chain (FASFC).
2. Quality file
Under the Belgian Medicinal Products Act of 25 March 1964, a medicinal product used on animals in the context of a clinical trial must always be produced according to good manufacturing practices (GMP).
In the case of a clinical trial for whose veterinary medicinal product a marketing authorisation has already been granted by Belgium or another EU Member State, the quality file does not need to be submitted.
For a clinical trial involving the use of food-producing animals, you must always substantiate the waiting period proposed. If this is not possible, as an applicant, you must undertake to ensure that the animals or products thereof (milk, eggs, honey) will not enter the food chain.
In the case of a clinical trial for whose veterinary medicinal product a marketing authorisation has already been granted by Belgium or another EU Member State, and where the medicinal product being trialled will be used in accordance with the approved posology and route of administration for the target animal concerned, the applicant does not need to substantiate the waiting period or the health safety arrangements for the target animal.
You can find further information about the requirements for these three sections of the application in the application form.
- Amending an application
The applicant must also submit an application to the FAMHP to make any amendments to the test protocol, the administrative dossier, or the quality dossier he/she has submitted. Changes may only be implemented after the applicant has received a favourable opinion on the amendment(s).
The application for an amendment consists of:
- a detailed list of the amendments with respect to the existing file;
- a statement of the reasons for the amendments requested;
- proof of payment of the fee.
- Renewing an application
Authorisations are granted for a maximum period of one year. If the clinical trial lasts longer than a year, the applicant must apply for an extension.
The application for an extension consists of:
- a statement of the reasons for the application for an extension;
- a detailed list of all adverse reaction reports since the beginning of the clinical trial;
- proof of payment of the fee.