Do you have a substance in your possession (both on paper and physically) that contains an active substance with anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties that can be used as a veterinary medicinal product? Then you need a registration for this (see Article 68 of Directive 2001.82.EC and Art. 4.1 of the Veterinary Medicinal Products Decree).
Importance of registration
In the European Union, banned veterinary medicinal products can enter the legal circuit. They may be products that have been manufactured illegally, contain inferior substances, contain no substances at all or contain incorrect dosages of substances. This results in a possible threat to public and/or animal health. To combat these problems, European Directive 2001/82/EU stipulates that only registered manufacturers and distributors may possess certain active substances.
Obligation to register
When you are in possession of the aforementioned substance(s), you must register with Farmatec. Farmatec is part of CIBG, an executive organisation of the Ministry of Health, Welfare and Sport.
When registering, you must indicate the category of active substances with which actions or activities take place. When registering, you must also enclose a current extract from the Trade Register of the Chamber of Commerce.
The regulations also stipulate that detailed records are kept of all transactions involving these active substances. These records must remain available for inspection by competent authorities for at least three years.
Registration is possible via Farmatec. Your application will be processed further by Farmatec. If you have any further questions, please contact Farmatec.