The requirements to the documentation for the registration of veterinary medicinal products have been tightened over the years and are now as strict as for human medicinal products.
As each species must have its own clinical coverage and animals for human consumption must be covered for MRL (maximum residue level), the requirements are even stricter in some respects.
We have dealt with new products as well as with generics covering veterinary vaccines, veterinary pharmaceuticals, animal feed, food supplements and biocides.
The CTD format is not applicable for veterinary products and the Notice to Applicants format is still in use.
The electronic format VNeeS has been development and is already in use in many of the procedures and in most countries. We can also assist with electronic submissions as we have the necessary software in house.