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

Sep-2019

Biocides > News

ECHA: BPC Concludes on Union Authorisations

In late June 2019 the BP Committee (BPC) adopted four opinions, including one on the non-approval of the active substance (DBNPA – PT4) on ED...

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Aug-2019

Chemicals and REACH > News

ECHA: REACH 2018 registration data included in QSAR Toolbox

The update to the QSAR Toolbox integrates data from REACH registrations up to November 2018, including data from the last REACH registration deadline for low...

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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

Information

Registration Number: CHE-113.597.134

Upcoming Events

  • Date: December 03-04, 2019

    Location: Vienna Austria

    Biocides Europe 2019

  • Date: October 21-23, 2019

    Location: Basel Switzerland

    ABIM

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