In order to market veterinary medicinal products they must be authorized by the Ministry of Health or the European Medicines Agency (EMA).
Our consultancy for veterinary medicines mainly covers:
- Advice on national and international legislation
- Preliminary examination of documents prepared by the commissioning company
- Advice and preparation of applications for marketing authorizations for national, mutual recognition and decentralized procedures
- Consultancy and preparation of variations, renewals and transfers of marketing authorizations
- Advice on applications for manufacturing authorizations of raw materials and finished products
- Advice, drafting and translation of SPCs, labels and leaflets in accordance with current guidelines
- Requests for certificates of free sale
- Relations with consulates for visa issuance
- Due diligence and gap analysis
- Veterinary Pharmacovigilance
- Assistance with meetings with the Ministry of Health, the ISS or other regulatory agencies
- Design and creation of mock-ups of the primary and secondary packaging, brochures, leaflets and, if required, the printing
- Refresher courses to be held at our headquarters in Rome or Milan, or at the commissioning company