Veterinary Medicines

Achieving Veterinary Medicinal Products (VMP) EU Regulatory Approval

If you are a global pharmaceutical company looking to market your veterinary medicinal products (VMP) within Europe, we’re here to help. The regulatory process is stringent and can be lengthy, with EU regulations prone to changes. To make the process faster and more likely to succeed, it is recommended that you use a European based consultancy.

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February – March 2021

Read the highlights from the CVMP December 2020 meeting.

To find out more about the Animal Health Europe Information Day: March 25, 2021, click here.

LKC helps pharmaceutical companies achieve product approval for sales in Europe. Our service helps you in two ways:

  1. We provide a dossier preparation and risk assessment service for you to submit yourselves, or
  2. We act as your point of contact with the European and National Competent authorities, managing the regulatory procedure on your behalf

To market within Europe, your veterinary medicinal products must achieve both Regulation (EU) 2019/6 and Regulation (EC) No. 726/2004. Having worked with the EU regulatory authorities for many years, we understand the process, knowing which route to use for your application.

Maximum Residue Limits submissions (MRL dossiers)

A major part of the procedure is assessing how your active substance may transfer to humans when an animal product is eaten. Our team of experienced specialists calculate the toxicological values and MRL in products such as milk, eggs and meat for submission to the European Medicines Agency.

Assessment of risk to the environmental

Carrying out Environmental Risk Assessments (ERA) is another important part of the regulatory process and a legal requirement since 2015. LKC’s Ecotoxicology and environmental fate scientists are experienced in looking for any potential impacts of medicines, both human and veterinary (VMP), in the environment.

LKC’s specialist service includes:

  • Project management services for EU approval of active substances and national or union-wide authorisation of products
  • Writing high quality scientific reports for submission, including data gap analysis, summary and dossier writing
  • Compiling the Active Substance Master File (ASMF) and dossier sections for MAA or Marketing Authorisation Variation (MAV), including variations when needed
  • Human exposure assessment or User Safety Risk Assessment (USRA) of the veterinary medicine product, such as assessing the likely toxicology of compounds not yet tested; contracting and monitoring user safety studies, such as inhalation, dermal or eye irritation; reporting such studies in dossier
  • Labelling strategies allowing a cost-effective and smooth entrance to the market
  • Selection, contracting and monitoring of studies compliant with guidelines and national practices (GLP and GMP) to ensure a high quality of scientific reporting for submission
  • Comprehensive risk assessment reports in submission format
  • Assisting with your substance approvals for future renewals as regulations change

To ensure your veterinary medicines and active substances achieve regulation within the EU, Switzerland and the UK, talk to one of the LKC team today to discuss how we can help your transition into Europe. Email LKC@lkc-ltd.com or telephone +41 (0) 61 906 8500.

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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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