Procedure for obtaining the Manufacturing Authorization for reagents/diagnostic kits for veterinary use*
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Indigenous manufacturers of reagents/diagnostic kits for veterinary use may produce these products only after obtaining the manufacturing authorization issued by the Institute for Control of Biological Products and Veterinary Medicines. The manufacturing authorization is issued for each reagent and diagnostic kit for veterinary use and is valid for 5 years from the date of issuance.
Any modification of the documentation on the basis of which the manufacturing authorization was issued must be notified within 30 calendar days to the Institute for Control of Biological Products and Veterinary Medicines for the purpose of updating the manufacturing authorization.
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In case of litigation, between the competent authorities and the beneficiary who considers themselves injured in a right of theirs or in a legitimate interest, by the ICBMV through an administrative act or by failure to resolve a request within the legal term, they may address the competent administrative litigation court under the conditions established by the Administrative Litigation Law no. 554/2004.
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