The applications shall comply with the requirements set in the National Legislation (http://www.dgv.min-agricultura.pt) and if applicable, with the Community requirementsnamely with “The Rules Governing Medicinal Products in the European Union” (Vols.4, 5, 6A e 6B, 7, 8 and 9).
Applicants are advised that the structure of dossiers for electronic submission should be in accordance with the TIGes vet e-submission guideline: http://esubmission.ema.europa.eu/tiges/vetesub.htm In order to avoid receiving great amounts of paper we would be pleased if you could send us the applications in electronic format.
