A veterinary medicinal product requires a marketing authorisation in accordance with Regulation (EC) No. 726/2004 to be placed on the European market. The Marketing Authorisation Application (MAA) must be prepared in a specified format for National, Mutual Recognition and Centralised procedures.
The Drug Master File (DMF) application approach is essential for a company who manufactures an active ingredient and plans to license to third parties for sales as a veterinary medicine.
LKC provides you with…
- Labelling strategies allowing a cost-effective and smooth entrance to the market;
- Project management services for EU approval of active substances and national or union-wide authorisation of products, including label extensions, import tolerance settings and maximum residue limits, (MRLs) harmonisation of national distributors’ labels;
- Selection, contracting and monitoring of studies compliant with guidelines and national practices (GLP & GMP) to ensure a high quality of scientific report for submission;
- Comprehensive risk assessment reports in submission format;
- Regulatory toxicology experience and know-how
- Dossier preparation of Marketing Authorization Applications (MAA), Drug Master Files (DMF) and submission documents.
Contact LKC to discuss your requirements.
- Pan EU approval
- New compounds for ectoparasitics