The procedure for authorizing the distribution activity of veterinary medicinal products, reagents, and veterinary diagnostic kits*
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The procedure consists of authorizing the activity of distributing 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 Regulation concerning the conditions for organization and operation of 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 receipt of the application, regarding the need to submit the documents required to complete the file.
The evaluation of units distributing veterinary medicinal products, reagents, and veterinary diagnostic kits is done for each working point.
Distribution authorizations for veterinary medicinal products, reagents, and veterinary diagnostic kits are issued for each working point.
If, following verification by specialized personnel of the county veterinary sanitary and food safety directorate, it is found that the conditions provided by the legislation in force are not met, a deadline for remedying deficiencies of maximum 30 calendar days from the date of preparation of the evaluation report is granted.
If, after verification of the unit and after the expiration of the remediation deadline granted, it is found that the conditions provided by the legislation in force are still not met, the authorization file is rejected based on the findings made 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 ascertaining the non-fulfillment of the legal operating conditions.
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If the economic operators are dissatisfied with the result of the request, they may file an appeal within the deadlines and under the conditions provided by Law no. 554/2004 regarding administrative litigation, as subsequently amended and supplemented.
*Competent entities
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