Veterinary Medicines

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.

Veterinary Medicines Products

Pan EU approval

New compounds for ectoparasitics

Latest News

Nov-2019

Chemicals and REACH > News

New Treatment for Healthy Dogs, Pigs and Horses

The CVMP (Committee for Medicinal Products for Veterinary Use) is the European Medicines Agency's (EMA) committee responsible for veterinary medicines. This summer the Committee adopted...

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Oct-2019

Crop Protection > News

The Effect of Pesticides on Bees

bees

The EFSA (European Food Safety Authority) has outlined how it plans to review its guidance on the risk assessment of plant protection – and pesticides...

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Contact

LKC Switzerland Ltd
Hauptstrasse 10
P.O. Box 167
4414 Füllinsdorf
Switzerland

Phone: +41 (0) 61 906 8500
Fax: +41 (0) 61 906 8509
LKC@lkc-ltd.com

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Registration Number: CHE-113.597.134

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