REGULATORY SERVICES FOR VETERINARY MEDICINAL PRODUCTS

  • Preparation of Regulatory Dossiers for Veterinary Medicinal Products in e-Application Format
  • Update of the dossiers of currently authorized products in accordance with the new legislation
  • Preparation of Section 3 and Section 4 only (excl. Section 1 C2 and 1 C3 expert report)
  • Preparation of Veterinary Medicinal Product Variation Dossiers (Type I A)
  • Preparation of Veterinary Medicinal Product Variation Dossiers (Type I B)
  • Preparation of Veterinary Medicinal Product Variation Dossiers (Type II)
  • Correspondence with the Ministry
  • Preparation of Summary of Product Characteristics, Package Leaflets, Inner-Outer label information
  • Application for Marketing Authorization renewal
  • Application for Authorization of Sale