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Following the serious incidents recorded recently, consecutive to the use of treatments with external antiparasitic veterinary medicinal products, the National Sanitary Veterinary and Food Safety Authority (ANSVSA) makes the following clarifications:
All veterinary medicinal products authorized by the Romanian veterinary authorities or by the European Medicines Agency (EMA) are intended exclusively for use in animals, and any decision regarding their use in humans belongs to the competent authorities for human medicinal products.
Veterinarians do not have the legal competence to recommend, prescribe, commercialize, or dispense veterinary medicinal products to be used in the treatment of humans.
Prescription-only veterinary medicinal products are prescribed exclusively by a licensed veterinarian who has examined the animal and established a diagnosis.
In the case of veterinary medicinal products administered to food-producing animals, the veterinarian is required to indicate in the medical prescription the withdrawal period that must be observed, in accordance with the product's leaflet.
Owners or holders of animals may possess and administer only those veterinary medicinal products that are legally acquired under the supervision of a veterinarian.
In the case of the use and administration of veterinary medicinal products to animals within veterinary medical assistance units, at the facility or in field conditions, the veterinarian records the activity in the consultation and treatment register, and in the case of food-producing animals, notifies the owner regarding the observance of the withdrawal period.
Retail sale of authorized veterinary medicinal products for food-producing animals is carried out only through veterinary pharmacies, according to the legal provisions in force.
ANSVSA is the competent authority for the supervision and control of veterinary medicinal products.
Through its subordinate structures, it authorizes and controls the quality and circulation of veterinary medicinal products, from manufacture to use.
Regarding the control activity, we mention that ANSVSA annually implements both the Official Control Plan regarding the circulation and use of veterinary medicinal products, and the Plan for Sampling and Testing of Veterinary Medicinal Products.