In Europe marketing authorisations for veterinary medicinal products are subject to increasingly stringent requirements. This applies to new as well as to existing marketing authorisations for pharmaceuticals and vaccines. What implications does this have for marketing authorisation holders? Firstly, the administrative effort for each individual product is significantly increased. Secondly, there is an automatic tendency to concentrate only on the most important products.

Consumer safety testing
European legislation prescribes consumer safety tests for veterinary medicinal products which are administered to food-producing animals. This includes the specification of, and compliance with, the Maximum Residue Limit (MRL).

Environmental impact of veterinary medicinal products
The environmental impact must be defined on the basis of an ecotoxicological investigation and then evaluated positively in a risk-benefit assessment.

Electronic submissions
As of 2011 Ireland and Belgium accept only electronic submissions for certain parts of the marketing authorisation dossier. Initially, this will lead to increased administrative effort, as certain data will have to be converted into an electronic format for the first time. All the other EU member states will follow suit in the near future. In the area of pharmacovigilance an electronic submission system for  adverse drug reactions (ADR) will be introduced in the near future. It is planned to create a common EU database for all veterinary medicinal products – similar to the EVVet database for centralised marketing authorisations.

What does this mean for your day-to-day activities?
To find out more go to Need for action

In your role as a marketing authorisation holder this means that you are compelled to take action more frequently and more quickly. This results in a higher workload. At the same time the introduction of the European marketing authorisation system (DCP, MRP, centralised) has simplified the marketing of veterinary medicinal products within Europe. HOWEVER, these procedures are very complex and presuppose extensive experience and knowledge of the relevant regulatory requirements.

If you want to develop new markets for your products, it is essential to:

• review your product portfolio and establish whether the basic dossiers conform to current requirements;
• focus on the marketing of core products;
• define at an early stage necessary investments in the updating of individual dossiers.

Our experts will support you and guide you through the "regulatory jungle". Your benefits in brief:

• We offer you expert and objective insights into the strengths and weaknesses of your documentations.
• We do not view regulatory affairs as an end in itself; we also take into account the commercial potential of your products.
• We deploy your resources with a view to maximising profitability.

You need to concentrate your regulatory resources on urgent priorities. Regular maintenance and lifecycle management assignments can be delegated to external experts – experts who continuously monitor your compliance with current regulatory requirements and hence prevent unpleasant surprises. You will benefit not only from our constantly updated know-how, but also from our experts' high level of acceptance with the regulatory authorities. Such acceptance plays a pivotal role in safeguarding your existing revenues.

How can you respond to these demands? To find out more go to Strategy

You would like to exploit market opportunities and profit from simplified marketing authorisation? If so, you can rely on the full support of our experts. The increasing demands of marketing authorisation and the growing scope of product maintenance requirements can pose significant problems – even for "old hands".

Not every product can be marketed with the same degree of success in all countries. This is why it is important to ascertain the market value of your products in various countries during the coordination phase. By gearing your product portfolio to national markets you will be able to streamline the marketing process. In this way you can capitalise on the opportunities offered by the introduction of the European marketing authorisation system.

We offer a complete range of services from a single source – from initial development through to post-authorisation support. You can deploy your in-house resources with maximum effectiveness and harness our expert know-how to enhancing the market success of your products.

Marketing authorisations for veterinary medicinal products – pharmaceuticals and vaccines – and their subsequent regulatory maintenance (lifecycle management) differ substantially from the regulatory activities for medicinal products for human use. The target group spectrum ranges from pets to minor use minor species (MUMS) to food-producing livestock. To maintain a correct sense of proportion it is essential to know the market players and their expectations with regard to veterinary medicinal products.

For this reason you require the support of a team which has acquired long years experience in the veterinary industry.

How can we help you? To find out more go to Services

During development and prior to submission

• Evaluation of your existing marketing authorisation documents (due diligence)
• Advice and support during the initial and further development of veterinary medicinal products
• Regulatory compliance in accordance with current requirements
• Coordination and implementation of discussions with the regulatory authorities (regulatory or scientific advice)
• Selection and recruitment of institutes and service providers to carry out  pharmacological, toxicological and clinical investigations, as well as chemical analysis laboratories with Good Laboratory Practice status (GLP)
• Coordination of clinical trials
• Evaluation of ecotoxicity and residues (MRL)
• Project coordination (also on site) and costing
• Conduct of literature searches
• Compilation of expert reports
• Coordination of submissions
• Compilation of electronic dossiers, for example in the VNeeS and VNtA formats

During the marketing authorisation process

• Strategy consulting
• Ongoing support during the marketing authorisation process
• Compliance with the deadlines laid down by the regulatory authorities
• Processing of the List of Questions in the areas of Quality, Preclinical and Clinical
• Preparation of answers in electronic form

After marketing authorisation has been granted
Consultancy and support services:

• in connection with lifecycle management
  - e.g. renewal of marketing authorisations
  - e.g. submission and implementation of variations
• in connection with the creation of information texts (labelling), also in digital preprint materials