Veterinary medicinal product designates any substance or compound presented as possessing curative or preventative properties with respect to animal diseases, or that can be, administered to animals for establishing a medical diagnosis or restoring, correcting or modifying the organic functions of animals.
Obligations and controls
A Marketing Authorization (MA) is necessary in order to guarantee that the medicinal products for animals meet the requirements for quality, safety and efficacy.
A veterinary medicinal product with a marketing authorization may circulate freely within the European Union (EU). The transport, storage, and handling of medicinal products is subject to strict rules that are called Good Distribution Practices (GDP). These activities must be carried out according to the appropriate conditions defined by the marketing authorizations or by other specification directly related to the products in question.
The only agencies that can carry out at the activities described above are the following:
- holders of manufacture and import authorizations (MIA)
- holders of wholesale trade authorizations
- holders of certificates of good distribution practice.
Note: a marketing authorization is granted at the national level or by the European Medicines Agency. In this last case, it is valid throughout the EU.
Provisions applicable to medicinal products for human use are also applicable to veterinary medicines, unless covered by other specific provisions.
Note: a marketing authorization is not required for veterinary medicinal products exclusively intended for aquarium fish, apartment birds, homing pigeons, terrarium animals and small rodents, as long as these medicines do not contain substances whose use requires veterinary control.
A company that imports a veterinary medicinal product from a third country must possess a manufacturing authorization.
A company that manufactures veterinary medicinal products must have a manufacturing authorization even if the medicine is manufactured for export.
To deliver a manufacture and import authorization, the Pharmacy and Medication Department carries out inspections in order to verify the compliance with Good Manufacturing Practices (GMP) and, in case of imports from third countries, the compliance of batch release according to the same principles.
A manufacture and import authorization may then be delivered by the Ministry of Health.
The company carrying out the transport, storage and handling of veterinary medicinal products must possess a manufacture and import authorization, a wholesale trade authorization or a certificate of good distribution practices delivered by the Luxembourg Ministry or a competent national authority in other countries.
In Luxembourg, the Pharmacy and Medication Department of the National Health Directorate has authority over questions relating to medicinal products and pharmaceutical products, including those intended for animals. It controls the manufacture, marketing, advertising, distribution, import and export of these medicinal products.
The Pharmacy and Medication Department carries out inspections to make sure that the distribution sites are compliant with the requirements of good practices. Certificates of good distribution practices and wholesale trade authorizations are delivered as appropriate by the Ministry of Health.