Procedure for authorizing veterinary pharmacies*
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The procedure consists of the sanitary veterinary authorization of veterinary pharmacies by the County Veterinary and Food Safety Directorates, in accordance with the provisions of the Sanitary Veterinary Rule regarding the conditions for the organization and operation of veterinary pharmaceutical units, as well as the procedure for the sanitary veterinary 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.
The county veterinary-sanitary and food safety directorate in the county where the unit's point of work operates registers the application of the legal entity, checks the file, evaluates the unit, and issues the sanitary veterinary authorization within a maximum of 30 calendar days from the date of submission of the complete documentation. The term may be extended, only once, by the county veterinary-sanitary and food safety directorate, for a period of up to 15 calendar days, if the completion of the submitted documentation is requested.
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 necessary to complete the file.
If the submitted documentation is complete, the unit is evaluated by specialized staff regarding the distinctly meeting of the sanitary veterinary operating conditions provided by the legislation in force for the units and activities for which authorization is requested, and the evaluation pipeline is drafted at the unit's headquarters.
For units that meet the sanitary veterinary operating conditions, based on the evaluation pipeline, the county veterinary-sanitary and food safety directorate issues the sanitary veterinary operating authorization, in accordance with the model provided in Annex no. 7, within 5 working days from the date of drafting the evaluation pipeline.
If, as a result of the evaluation by the specialized staff of the county veterinary-sanitary and food safety directorate, it is found that the sanitary veterinary conditions of operation provided by the legislation in force are not met, a period for remediation of deficiencies is granted, up to a maximum of 30 days from the date of drafting the evaluation pipeline.
If, after checking the unit upon expiry of the remediation period granted, it is found that the sanitary veterinary conditions of operation 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 pipeline; the applicant is communicated the decision regarding the rejection of the file within 5 working days from the pipeline of finding the non-compliance with the legal operating conditions.
The settlement time runs from the date of receipt of the complete documentation.
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If economic operators are dissatisfied with the outcome of the request, they may file an appeal within the deadlines and conditions provided by Law no. 554/2004 on administrative litigation, with subsequent amendments and additions.
*Competent entities
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