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Dossiers and authorisation procedures for veterinary medicines

Directive 2001/82/EC, as amended, provides for that a veterinary medicinal products can be marketed in the European Union only following the release of a marketing authorisation (MA) by a EU Member State. To this end, it is required to prepare an appropriate authorisation dossier to be submitted to the Competent Authority, and apply for the MA via the authorisation procedure that is more suitable for the business strategies.

The main services offered in this field are:

  • due diligence, gap analysis
  • drafting of chemical, clinical and pharmaco-toxicological expertise
  • preparation of MA applications for national and European procedures
  • preparation of variations, extensions, renewals and transfers of marketing authorisations.

Foto di: joannafotograf da Pixabay