If you encounter problems authorising veterinary medicinal products in the EU, this site is available.
It provides a free link to the relevant legislation that is current in the EU.
If needed, assistance can be given to guide you through these EU rules, to interpret these rules to your advantage or to help you in conducting the actual authorisation procedures.
The expertise of eudravet concentrates on the authorisation of veterinary medicinal products in the European Union.
In this field, assistance with the central procedure, the mutual recognition procedure and the requirements for product-dossiers can be offered both for pharmaceutical products and immunobiological products.
Eudravet can provide:
· An overview of the relevant legal texts, which are applicable to a specific problem.
· An exegesis on how to interpret these texts
· Suggestions on how to deal with a specific problem
· Assistance in contact with the authorities
· Assistance in conducting authorisation procedures
· Expert reports and SPCs based on a product dossier
· Suggestions on the content and wording of a product dossier
Outside the field of product authorisation, eudravet might be helpful with suggestions on other topics in veterinary medicines legislation.
Eudravet regrets that it will not offer to write complete product dossiers. The extensive information necessary for such an undertaking should remain with the applicant only. To a lesser extent the same holds true for the quality and production of a veterinary specialty. Generally the information required for sensible advice on these topics is beyond the information that should leave a company.
Eudravet conducts its business in "Eurospeak" English, a language understood by the EU authorities.
The expertise within eudravet is at your disposal.
For the background of eudravet click here
For our free link to official publications click here
For our homepage click here
If you want the assistance of eudravet click here
For contact: email@example.com