Order No. 81 of the National Sanitary Veterinary and Food Safety Authority validating the Sanitary-Veterinary Regulation on the procedure for placing on the market and use of reagents and diagnostic kits for veterinary use.

This Sanitary Veterinary Regulation establishes the legal and technical framework regarding the procedure for placing on the market and use of reagents and diagnostic sets for veterinary use marketed on the territory of Romania, authorized by the National Sanitary Veterinary and Food Safety Authority, through the Directorate for Control and Coordination of Veterinary Pharmaceutical Activity. The competent authority for veterinary use of the aforesaid substances and kits is the Institute for the Control of Biological Products and Veterinary Medicines. National producers of veterinary reagents/diagnostic kits may manufacture these products only after obtaining the manufacturing authorization issued by the Directorate for Control and Coordination of Veterinary Pharmaceutical Activity within the National Sanitary Veterinary and Food Safety Authority. In order to obtain the manufacturing authorization, the legal representative of the legal person must submit to the Control and Coordination Directorate of Veterinary Pharmaceutical Activity within the National Sanitary Veterinary and Food Safety Authority a file containing the following documents: (a) the application from the part of the legal person, specifying the activities and the Classification of Activities in the National Economy (CANE) code; (b) copy of the registration certificate issued by the trade register office; (c) the ascertaining certificate issued by the trade register office, in original; (d) copy of the company deed, in legalized copy; (e) proof of ownership of the production space, deed of ownership or lease contract, in legalized copy; (f) technical design of the production unit; (g) technical substantiation; (h) list of specialized personnel; (i) list with diagnostic kits for veterinary use and reagents manufactured in the unit; (j) description of the manufacturing flow; and (k) statement on the manufacturer's own responsibility regarding the manufacture of reagents and diagnostic kits for veterinary use under conditions that ensure the quality of these products; The Directorate for Control and Coordination of Veterinary Pharmaceutical Activity within the National Sanitary Veterinary and Food Safety Authority registers the application of the legal person, verifies and evaluates the file within 30 working days from the date of registration of the application, in order to issue the manufacturing authorization.