Procedure for authorizing the activity of distribution of veterinary medicinal products, reagents and veterinary diagnostic kits*
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The procedure consists in authorizing the activity of distribution of veterinary medicinal products, reagents, and veterinary diagnostic kits by the County Veterinary Sanitary and Food Safety Directorates, in accordance with the provisions of the Veterinary sanitary norm regarding the conditions for organizing and operating veterinary pharmaceutical units, as well as the procedure for veterinary sanitary registration/authorization of units and activities in the veterinary pharmaceutical field, approved by Order of the ANSVSA president no. 83/2014, with subsequent amendments and completions.
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, regarding the need to submit the documents necessary to complete the file.
The evaluation of the distribution units for veterinary medicinal products, reagents, and veterinary diagnostic kits is carried out for each work point.
The authorizations for the distribution of veterinary medicinal products, reagents, and veterinary diagnostic kits are issued for each work point.
In the event that, following the verification by the specialized personnel within the county veterinary sanitary and food safety directorate, the failure to meet the conditions stipulated by the legislation in force is found, a period of maximum 30 calendar days from the date of drawing up the evaluation report is granted to remedy the deficiencies.
If, after verifying the unit, following the expiration of the granted remediation period, the failure to meet 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 regarding the rejection of the file, within 5 working days from the date of finding the failure to meet the legal operating conditions.
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In the event that the economic operators are dissatisfied with the outcome of the request, they may file an appeal within the terms and conditions provided by Law no. 554/2004 on administrative litigation, as subsequently amended and supplemented.
*Competent entities
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