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 Registration
Pharmacovigilance
Translations
Clinical
Trials
Qualified
Person
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Veterinary medicinal products
and vaccines
The requirements on 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 and herbal
medicine, including mineral and vitamin products.
Billev Pharma Aps has many years of experience with applications
for the registration of veterinary medicinal products both
by the national registration
procedure and by the Mutual Recognition Procedure.
The CTD procedure is not applicable for veterinary products.
The Notice to Applicants procedure is still in use.
The electronic format VNeeS is under development and is already
in use in some countries.
Billev Pharma Aps can also assist with electronic
submissions as we have the necessary software in house. |
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