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

May-2019

Biocides > News

The IUCLID April 2019 Release is Available

This new version of IUCLID contains improvements to the web interface and the possibility to create EU Poison Centre Notifications. The April 2019 service features:...

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Mar-2019

Chemicals and REACH > News

ECHA: Data on Chemicals Needs to be Improved

The REACH compliance study by the German Federal Institute for Risk Assessment (BfR) and the German Environment Agency (UBA) comes to a similar conclusion as...

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Contact Us

LKC 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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