Procedure for authorizing veterinary pharmacies*
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The procedure consists of the veterinary sanitary authorization of veterinary pharmacies by the County Veterinary Sanitary Directorates and for Food Safety, in accordance with the provisions of the Veterinary Sanitary Rule regarding the conditions for the organization and functioning of veterinary pharmaceutical units, as well as the procedure for the veterinary sanitary registration/authorization of units and activities in the veterinary pharmaceutical field, approved by the Order of the ANSVSA President no. 83/2014, with subsequent amendments and completions.
The county veterinary sanitary and food safety directorate in the area where the unit's working point operates registers the legal entity's application, verifies the file, evaluates the unit, and issues the veterinary sanitary authorization within a maximum of 30 calendar days from the date the complete documentation is submitted. 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, in case 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 necessity to submit the documents required to complete the file.
If the submitted documentation is complete, the unit is evaluated by specialized personnel, regarding the fulfillment of the veterinary sanitary operating conditions provided by the legislation in force for the units and activities for which authorization is requested, and an evaluation report is drawn up at the unit's headquarters.
For units that meet the veterinary sanitary conditions for operation, based on the evaluation report, the county veterinary sanitary and food safety directorate issues the veterinary sanitary operating authorization, according to the model provided in annex no. 7, within 5 working days from the date the evaluation report is drawn up.
If, following the evaluation by the specialized personnel within the county veterinary sanitary and food safety directorate, it is found that the veterinary sanitary operating conditions provided by the legislation in force are not met, a deadline of up to 30 days from the date the evaluation report is drawn up is granted to remedy the deficiencies.
If, following the verification of the unit after the expiry of the remediation term granted, it is found that the veterinary sanitary operating 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 the non-fulfillment of the legal operating conditions is ascertained.
The processing time commences from the date of receipt of the complete documentation.
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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 on administrative litigation, with subsequent amendments and completions.
*Competent entities
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