Certificate of registration of the veterinary medicinal product

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  Step 1. Submission of the application

  The applicant, by accessing the Request button, submits the application for obtaining the certificate of registration of the veterinary medicinal product, together with the technical normative file, through the automated information system for the management and issuance of permissive documents. The submitted registration file must be in one of the following languages: Romanian, English or Russian. In addition, the Summary of characteristics of the veterinary medicinal product, the Prospectus and information on labeling (in Romanian) are attached. As a result of submitting the application, the applicant will receive a "confirmative certificate" generated by the Automated Information System.

  

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  Step 2. Paying for the service

  Payment through the government electronic payment service Mpay. - for domestic veterinary medicines 2000 lei; - for imported veterinary medicinal product - 4500 lei;

  

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  Step 3. Processing and Review

  The National Agency for Food Safety carries out the preventive evaluation of the application and the submitted technical normative file and within 14 calendar days from the date of submission issues a preventive evaluation report. If the technical normative file does not meet the requirements, the term reserved for the preventive assessment is suspended and the Agency informs the applicant about. The term granted for the removal of non-conformities is 60 calendar days. If they are compliant, the application for registration and the technical normative file, together with the preventive evaluation report, are submitted for scientific evaluation to the Veterinary Medicines Commission. If at the stage of the scientific evaluation it is found that the documentation and materials presented are not compliant, the applicant is presented with the list of objections, the registration term being suspended until the applicant provides the additional information. The suspension period cannot exceed 90 calendar days. If the suspension periods (60 days, respectively 90 days) run out and the applicant does not present the requested materials, the application is rejected. The scientific evaluation procedure is completed with the issuance of a scientific evaluation report by which the registration of the veterinary medicinal product is decided. In case of deciding to reject the registration, the Veterinary Medicines Commission comes with a reasoned conclusion to the Agency, and it must inform the applicant within a maximum of 14 calendar days. Following the registration decision The Agency issues the registration order of the veterinary medicinal product, includes the veterinary medicinal product registered in the State Register of Veterinary Medicinal Products.

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  Step 4. Release/deferral/refusal of release

  The certificate of registration of the veterinary medicinal product is completed in SIA GEAP, assigned a QR code and signed electronically by the general director of ANSA. The signed certificate is available to the service requester in the section of SIA GEAP - "My office". Upon request, the certificate can also be issued in paper format (traditional) at the ANSA headquarters. The certificate contains three annexes: - Summary of the characteristics of the veterinary medicinal product; - Prospectus; - Labeling information.