Departments

The Veterinary Medicinal Products Evaluation Service (SEPMV) has the following structure:

A. Veterinary Pharmaceutical Medicinal Products Evaluation Department
B. Veterinary Biological Medicinal Products Evaluation Department
C. Post-Authorization Surveillance Department

A. The Veterinary Pharmaceutical Medicinal Products Evaluation Department (veterinary medicinal products, except biological veterinary medicinal products) has the following specific duties and responsibilities:

(1) Evaluates technical documentation for pharmaceutical veterinary medicinal products in accordance with the legislation and regulations in force through national procedures (authorization, variations requiring evaluation, marketing authorization, registration certificate for homeopathic veterinary medicinal products) and community procedures (authorization, variations requiring evaluation)
(2) Checks technical documentation for pharmaceutical veterinary medicinal products through national and community procedures for variations not requiring evaluation
(3) Prepares notes of completion/conformity of technical documentation for products under evaluation
(4) Prepares notes of approval/rejection of technical documentation for variations not requiring evaluation
(5) Prepares risk attribution sheets for pharmaceutical veterinary medicinal products
(6) Prepares assessment reports for pharmaceutical veterinary medicinal products through the national procedure (authorization, variations requiring evaluation, marketing authorization, registration certificate for homeopathic veterinary medicinal products)
(7) Requests samples for laboratory testing, as appropriate, in order to verify the data presented by the applicant in the technical documentation of pharmaceutical veterinary medicinal products undergoing the national authorization and marketing authorization procedure
(8) Collects data on sales volume and consumption of antimicrobial veterinary medicinal products from marketing authorization holders, centralizes the information and transmits it to the European Medicines Agency
(9) Maintains permanent contact with the Reference Member State and other Interested Member States involved in community procedures
(10) Coordinates the linguistic review process and verifies the conformity of the translation into Romanian of the summary of product characteristics, label and package leaflet from English of the medicinal products veterinary medicinal products authorized through the centralized procedure transmitted by the EMA (pre-opinions, post-opinions, framework documents)
(11) Evaluates the technical documentation that underlies the authorization of pharmaceutical veterinary medicinal products through the centralized procedure, as appropriate (RMS/Peer Review)
(12) Ensures the rapid exchange of information between ICPBMUV and ANSVSA, EMA, other Competent Authorities, institutes or bodies in the field of pharmaceutical veterinary medicinal products
(13) Participates within the EMA in the meetings of working groups, in the field of competence

B. The Biological Veterinary Medicinal Products Evaluation Department has the following specific duties and responsibilities:

(1) Evaluates technical documentation for biological veterinary medicinal products, in accordance with the legislation and regulations in force through national procedures (authorization, variations requiring evaluation) and community procedures (authorization, variations requiring evaluation)
(2) Checks technical documentation for biological veterinary medicinal products through national and community procedures for variations that do not require evaluation
(3) Prepares notes of completion/conformity of technical documentation for products under evaluation
(4) Prepares notes of approval/rejection of technical documentation for variations that do not require evaluation
(5) Prepares risk attribution sheets for biological veterinary medicinal products;
(6) Prepares evaluation reports for biological veterinary medicinal products through the national procedure (authorization, variations requiring evaluation)
(7) Requests samples for laboratory testing, as appropriate, in order to verify the data presented by the applicant in the technical documentation of biological veterinary medicinal products under the national authorization procedure;
(8) Maintains permanent contact with the Reference Member State and the other Interested Member States, involved in the community procedures
(9) Coordinates the linguistic review process and verifies the conformity of the translation into Romanian of the summary of product characteristics, label and package leaflet from English of veterinary medicinal products authorised through the centralised procedure transmitted by the EMA (pre-opinions, post-opinions, framework documents)
(10) Evaluates the technical documentation underlying the authorisation of biological veterinary medicinal products through the centralised procedure, as appropriate (RMS/Peer Review)
(11) Ensures the rapid exchange of information between ICPBMUV and ANSVSA, EMA, other Competent Authorities, institutes or bodies in the field of biological veterinary medicinal products
(12) Participates within the EMA in the meetings of working groups, in the field of competence

C. Post-authorization surveillance department has the following specific duties and responsibilities:

(1) Records in the European pharmacovigilance database all suspected adverse events for veterinary medicinal products that have been reported to ICBMV, other than those registered by marketing authorization holders and that have occurred on the territory of Romania
(2) Requests the marketing authorization holder to collect specific pharmacovigilance data
(3) Participates in carrying out pharmacovigilance inspections, at the request of ANSVSA
(4) Evaluates technical documentation for veterinary medicinal products, according to the legislation and regulations in force through national procedures (authorization, transfer, parallel trade) and community procedures (authorization, transfer)
(5) Checks technical documentation for veterinary medicinal products through national and community procedures for variations that do not require evaluation
(6) Prepares notes of completion/compliance of technical documentation for products under evaluation
(7) Prepares notes of approval/rejection of technical documentation for variations that do not require evaluation
(8) Prepares evaluation reports for veterinary medicinal products through the national procedure (authorization, parallel trade)
(9) Records intra-community trade operations for veterinary medicinal products authorized through the centralized procedure
(10) Checks advertising materials for authorized veterinary medicinal products and prepares supplemental/conformity notes
(11) Analyzes documents in order to issue a denial regarding the classification of veterinary products in the category of veterinary medicinal products, in collaboration with SCPFB
(12) Maintains permanent contact with the Reference Member State and the other Interested Member States, involved in community procedures
(13) Ensures the rapid exchange of information between ICPBMUV and ANSVSA, EMA, other Competent Authorities, institutes or bodies in the field of veterinary medicinal products
(14) Participates within the EMA in working group meetings, in the field of competence