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 relation to the Institute for the Control of Biological Products and Veterinary Medicines*

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

The technical documentation accompanies the application and will mandatorily contain the following: information about the manufacturer: manufacturer’s name, manufacturer’s address, contact person, responsible person designated by the manufacturer, in the case the product originates from a third country; information about the product: commercial name of the product, purpose of product use, method principle, product composition, presentation form, materials included in the kit, instructions for use, precautions, conditions for validation, interpretation of test results, storage conditions, expiry date; information about the preparation of the veterinary diagnostic kit, as well as about the preparation of its components; information regarding quality control and the product validation report; information about the product’s performance: comparative diagnosis with other tests, studies regarding the application of the test, articles, communications referring to the product; other documents: authorization for sale of the product in the country of origin, product validation report from reference laboratories of the European Union and/or 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 appropriate, in Romanian and English. The technical documentation may, as appropriate, contain a copy of the analysis bulletin or an evaluation report issued by a national reference laboratory in a European Union Member State, 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 sent by ICBMV after the completion of laboratory testing*

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