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In vitro diagnostic

The National Veterinary Research Institute (NVRI) issues certificates about in vitro diagnostic product used in veterinary medicine, product intended for tests performed for the needs of Veterinary Inspection on request of:

  • manufacturer
  • distributor

The types of applications:

  • issuing certificate about the product resulting in the entry of the product to the List of products for in vitro diagnostics used in veterinary medicine established by Chief Veterinary Officer (more information…)
  • issuing certificate about the extension of validity of the entry of the product on the List established by Chief Veterinary Officer (more information…)
  • issuing certificate on a change in opinion regarding the changes in the product parameters, which is placed on the List established by Chief Veterinary Officer for in vitro diagnostic products used in veterinary medicine  (more information…)

Deadlines:

The Application for issuing certificate about the product should be submitted no later than 60 days before:

  • the planned marketing authorisation;
  • the expiry of the entry of the product on the List of in vitro diagnostic products used in veterinary medicine established by Chief Veterinary Officer;
  • the planned change of the parameters of the product, which is placed on the List established by Chief Veterinary Officer for in vitrodiagnostic products used in veterinary medicine.

NVRI issues certificates within 60 days from the date of receipt of complete Application together with the sample for testing. In case of a need to complete the documentation or to send samples, the deadline is calculated from the date of completing the documentation or sending samples.

Fees:

Fees are in conformity with the price list of NVRI.



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