New application

Applications

  • New application

Before starting a clinical trial, the sponsor is required to apply for an authorisation from famhp.

Such an application consists of:

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 famhp before the clinical trial begins. famhp stands 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, the quality file does not need to be submitted.

3. Protocol

For a clinical trial involving the use of food-producing animals, you must always substantiate the waiting period proposed. If this is not possible, the applicant 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, 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, you do 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

You must submit a new application if you wish to make any amendments to the test protocol, the administrative dossier, or the quality dossier you have submitted and they may be implemented only after you have received a favourable opinion on the amendment(s).

The application for an amendment consists of:

1   a detailed list of the amendments with respect to the existing file;

2   a statement of reasons for the amendments requested;

3   proof of payment of the fee.

  • Renewing an application

Authorisations are granted for a maximum period of one year. If your clinical trial lasts longer than a year, you must apply for an extension.

The application for an extension consists of:

1   a statement of reasons for the application for an extension;

2   a detailed list of all adverse reaction reports since the beginning of the clinical trial;

3   proof of payment of the fee.

 

Last updated on 23/10/2017