The document by which the manufacturer nominates the company responsible for the authorization and commercialization of reagents and diagnostic kits on the territory of Romania.*

The document by which the representative of the manufacturer in Romania nominates the person responsible in the relationship with the Institute for the Control of Biological Products and Veterinary Medicinal Products*

The document by which the representative of the manufacturer requests the Institute for the Control of Biological Products and Medicines for Veterinary Use to authorize the reagents and diagnostic kits in their portfolio.*

The technical documentation shall accompany the application and shall mandatorily contain the following: information about the manufacturer: the manufacturer's name, the manufacturer's address, the contact person, the person designated as responsible by the manufacturer, in case the product originates from a third country; information about the product: the trade name of the product, the intended use of the product, the method principle, the product composition, the form of presentation, materials provided in the kit, the instructions for use of the product, precautions, validation conditions, interpretation of test results, storage conditions, shelf life; information about the preparation of the veterinary diagnostic kit, respectively about the preparation of its components; information on quality control and the product validation report; information regarding product performance: comparative diagnosis with other tests, studies regarding the application of the test, articles, communications related to the product; other documents: the marketing authorization of the product in the country of origin, the product validation report by reference laboratories from the European Union and/or those of the World Organisation for Animal Health, if validation was also performed by them, analysis bulletins issued by the manufacturer's internal control, original instructions for use and labels and, as the case may be, in Romanian and English. The technical documentation may contain, as applicable, a copy of the analysis bulletin or an evaluation documentation ot evaluation report issued by a national reference laboratory from a Member State of the European Union, a community reference laboratory or an international reference laboratory. In the case of domestic products, a copy of the manufacturing authorization is required.*

The Payment Estimate will be transmitted by ICBMV after the completion of laboratory tests*

It will be carried out after the payment notification is sent by ICBMV.*