Applications
1. New application
Before starting a clinical trial, the sponsor is required to apply for an authorisation from the FAMHP.
A clinical trial should be conducted in accordance with the Guideline on Good Clinical Practices.
The new application contains the following elements.
- Administrative data
For a clinical trial involving food-producing animals, the applicant should provide 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 of the application, the applicant should transfer this data to the FAMHP before the start of the clinical trial. The FAMHP is responsible for submitting this data to the Belgian Federal Agency for the Safety of the Food Chain (FASFC).
You will find below the links to the application forms.
- Clinical data
For a clinical trial involving food-producing animals, the proposed withdrawal period must always be substantiated. If this is not possible, the applicant must ensure that the animals or their products (milk, eggs, honey) will not enter the food chain.
In the case of a clinical trial for which the veterinary medicinal product already has a marketing authorisation granted in Belgium or another EU member state, and the medicinal product 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 withdrawal period or the health safety arrangements for the target animal.
Link to the document on clinical requirements
- Quality file
A medicinal product used in animals for a clinical trial, must be produced according to good manufacturing practices (GMP).
When a clinical trial involves a medicinal product for veterinary use that already has a marketing authorisation in Belgium or in another European member state, submitting the section on quality is not mandatory.
Link to the document on quality requirements
2. Amending an application
A new application must be submitted when making (an) amendment(s) to the test protocol, administrative file, or quality file that has been submitted. They can only be implemented after receiving a favourable opinion by the FAMHP on such (an) 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.
3. 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 start of the clinical trial;
- proof of payment of the fee.