Lately the business with veterinary products and accessories designated for animals has been on the rise. Such goods can be found in the big retailers, in pharmacies, veterinary clinics and supermarkets. A big portion of those products is harmless and does not impose a risk for either business-owners, nor buyers or animals. But is that really so?
A significant amount of those products can be classified as “veterinary medicinal products” (VMP). Due to their specifics, they are subject to control by the authorities and have to meet specific requirements for their manufacturing, use and sale. The products must correspond with legislative requirements and standards, indroduced for the protection and safety of animals.
The veterinary medicinal products Act provides a definition of the term VMP: a substance or combination of substances which can:
a) be used for disease prevention and treatment among animals;
b) used for the recovery, correction or amendment of the physiological functions of animals via pharmacological, immunological or metabolic interference or diagnosis of diseases.
The use of veterinary medicinal products in Bulgaria is possible only after the issue of a license by the Bulgarian food safety agency (BFSA).
Production, import and export of veterinary medicinal products
The VMP manufacturers can be either physical or legal entities, registered under the Trade act, which posses a license for manufacturing issued by BFSA.
The license for manufacturing of VMP is issued for one of the following activities: cutting, tableting, packaging, mixing or production of active substances. The Executive Director of BFSA sends a copy of the issued license to the European Medicine Agency, which enters it into the EU database.
In order to be granted a license for manufacturing of VMP, the producers ought to have qualified personnel, production facilities, control and safety procedures along with the necessary equipment.
For the issue of a license for production of VMP, an application must be filed with the BFSA Executive Director.
Wholesale trade of VMP
Only physical or legal entities registered under the Trade act which received the necessary license can carry out wholesale trade with VMP. Only a certified veterinarian can operate a wholesale VMP trade business.
Retail sale of VMP
Retail sale of VMP can be carried out only in veterinary pharmacies. Only physical or legal entities registered under the Trade act which received the necessary license can carry out retail sail of VMP. The requirements for veterinary pharmacies are provided in a special ordinance of the minister of agriculture and foods.
Who exercises control?
BFSA exercises the control over the compliance with legal requirements for manufacturing, wholesale trade, retail sale, import, advertising and use of VMP. The Agency can also carry out inspections pursuant to signals by the competent authority of any member state of the EU, the European commission, as well as the European Medicine Agency. Inspections can be carried out via:
• taking samples for analysis by the BFSA or in a accredited laboratory in the EU;
• check-ups of documentation and facilities.
If you want to turn your love for animals into a successful business – don’t hesitate to contact us – your online legal consultant! We will assist you in obtaining all necessary licenses and in the legal compliance of your business. You make the first step, and we will take you to the finish line!
Vassil Kostov
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