Marketing Authorization
During the marketing authorization procedure, the competent health authority evaluates the quality, relative safety, and efficacy of the new veterinary product. Authorizations are issued following national, decentralized, or mutual recognition registration procedures by the National Food Chain Safety Office (NÉBIH - Directorate of Veterinary Medicinal Products).
Applicants must submit pharmaceutical and immunological expert reports verifying the product's quality, safety, and efficacy, accompanied by referenced bibliographies. The manufacturing process and quality assurance systems must be fully documented. Dossiers must be submitted electronically in the required format to the competent national authorities.
Relevant Legislation
- Directive 2001/82/EC on the Community code relating to veterinary medicinal products
- EudraLex Volume 6A Chapter 1 on Marketing Authorisations
- EudraLex Volume 6B on the Presentation and Content of the Dossier
Adverse Event Reporting (Pharmacovigilance)
The marketing authorization holder (MAH) of a veterinary medicinal product is required to notify the Directorate electronically immediately, or within 15 calendar days at the latest, of any serious, unexpected adverse reactions, or adverse reactions observed in humans.
Email: E-Pharmacovigilance@nebih.gov.hu
Postal Address: Nébih ÁTI, H-1525 Budapest, P.O. Box 30, Hungary
Phone: +36-1-433-0330
The marketing authorization holder must also submit Periodic Safety Update Reports (PSURs) in accordance with Section 81 of Decree 128/2009 (X. 6.) FVM.
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