The procedure for authorizing the activity of distributing veterinary medicinal products, reagents, and diagnostic kits for veterinary use*
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The procedure consists of authorizing the activity of distribution of veterinary medicinal products, reagents, and diagnostic kits for veterinary use by the County Veterinary Sanitary and Food Safety Directorates, in accordance with the provisions of the Veterinary Health Standard regarding the conditions for organizing and operating veterinary pharmaceutical units, as well as the procedure for veterinary health registration/authorization of units and activities within the veterinary pharmaceutical field, approved by the ANSVSA President's Order no. 83/2014, with subsequent amendments and additions.
In the case of an incomplete application or documentation, the applicant is informed, within a maximum of 5 working days from the receipt of the application, about the need to submit the documents necessary to complete the file.
The evaluation of distribution units of veterinary medicinal products, reagents, and diagnostic kits for veterinary use is carried out for each working point.
Distribution authorizations for veterinary medicinal products, reagents, and diagnostic kits for veterinary use are issued for each working point.
If, after verification by specialized staff within the county veterinary sanitary and food safety directorate, non-compliance with the conditions provided by the legislation in force is found, a period for remedying the deficiencies of a maximum of 30 calendar days from the date the evaluation report is drawn up is granted.
If, after verification of the unit, upon expiry of the remediation period granted, non-compliance with the conditions provided by the legislation in force is found, the authorization file is rejected based on the findings carried out and recorded in the evaluation report; the applicant is informed of the decision to reject the file, within 5 working days from the date of finding the non-fulfillment of the legal operational conditions.
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If the economic operators are dissatisfied with the outcome of the request, they may lodge an appeal within the time limits and conditions stipulated by Law no. 554/2004 on administrative litigation, as subsequently amended and supplemented.
*Competent entities
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