A veterinary medicinal product may only be placed on the market in the European Economic Area (EEA) when a marketing authorization has been issued by the competent authority of a Member State (or EEA country) for its own territory (national authorization) or when an authorization has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a Community authorization). The marketing authorization holder must be established within the EEA.

 

The Marketing Authorisation Application (MAA) must be prepared in a specified format. This is true for both the Centralised and the Mutual Recognition approach.

 

It is possible to use the so called "Drug Master File" (DMF) procedure and this is especially useful where one company manufactures an active ingredient which it may license to a third party for use as a veterinary medicine but may not be willing to pass over detailed manufacturing or other information.

 

Provides independent expert opinion and helps its customers to develop innovative regulatory strategies tailored to the specific situation. Develops a good label strategy, which finds a compromise between economics and registration requirements to allow fast registration and a smooth entrance into the market at an affordable cost.

 

Provides Registration Project Management. It brings economic and scientific advantages when the same team is in charge of all the registrations related to a same compound. This include for example the EU registration of the active ingredient, the national registrations of formulated products, label extensions, import tolerance settings, harmonization of labels of national distributors, etc.

 

Selects laboratories with experience and certified compliance with OECD, national Good Laboratory Practice and GMP regulations. LKC can provide expert statements to save expenses and reduce testing efforts.

 

Contracts and monitors toxicology studies carried out in contract facilities. LKC toxicologists have considerable experience especially in toxicology of veterinary medicines.

 

Has the necessary experience to select the best available laboratory, monitor studies, to do the model calculations and to compile risk assessments. For special environmental issues LKC offers expert monitoring and can provide the study monitors to maintain close observation on the study procedures.

 

Has the experience in conducting detailed risk assessments and summarizing the results in registration format. The evaluation of results for the environmental risk assessment is a challenging task for registration in Europe and LKC offers clients the benefit of experience to achieve success

 

Prepares registration dossiers, complete or in part, including all risk assessments for Veterinary medicines in print and in electronic format. Has proven experience with the successful submission of Marketing Authorization Applications (MAA), Drug Master Files (DMF) and other regulatory documents, as well as the preparation of expert reports and risk assessments, especially for the chemical/pharmaceutical and toxicological summaries.